Plain-language summary, compiled from the cited regulatory records
Fluoxetine is a medication classified as a Selective Serotonin Reuptake Inhibitor (SSRI) [1]. It is approved for the treatment of several conditions. These include the acute and maintenance treatment of Major Depressive Disorder, as well as the acute and maintenance treatment of obsessions and compulsions in patients diagnosed with Obsessive Compulsive Disorder (OCD) [1]. Additionally, fluoxetine is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in individuals with moderate to severe Bulimia Nervosa [1]. It is also approved for the acute treatment of Panic Disorder [1].
Fluoxetine is available in the market under various brand names [1]. In the past 12 months, there have been 5703 adverse event reports associated with fluoxetine [2]. The most frequently reported events include off-label use, reports of the drug being ineffective, nausea, headache, and fatigue [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
Adults:
Major depressive episodes. Obsessive-compulsive disorder.
Bulimia nervosa:
Fluoxetine capsules are indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Children and adolescents aged 8 years and above:
Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4–6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
How to take
CACanada· Health Canada
42 products
Uses
CAOfficial regulatory label· revised December 16, 2025[2]
PRO-FLUOXETINE & FLUOXETINE-20 (fluoxetine capsules) is indicated in adults for: • Depression: PRO-FLUOXETINE & FLUOXETINE-20 is indicated for the symptomatic relief of Major Depressive Disorder (MDD). • Bulimia Nervosa: PRO-FLUOXETINE & FLUOXETINE-20 has been shown to significantly decrease binge- eating and purging activity when compared with placebo treatment.
• Obsessive-Compulsive Disorder (OCD): PRO-FLUOXETINE & FLUOXETINE-20 is indicated for the symptomatic treatment of obsessive-compulsive disorder (OCD). The obsessions or compulsions must be experienced as intrusive, markedly distressing, time consuming, or interfering significantly with the person’s social or occupational functioning.
The efficacy of fluoxetine in hospitalized patients has not been adequately studied. e. e. for more than 13 weeks) has not been systematically evaluated in controlled trials. Therefore, the health professional who elects to use PRO-FLUOXETINE & FLUOXETINE- 20 in these indications for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
USUnited States· FDA
25 products
Uses
USOfficial regulatory label· revised May 1, 2026[3]
1 Major Depressive Disorder Fluoxetine Capsules USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [ see Clinical Studies ( ) ] . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [ see Dosage and Administration ( ) ] .
2 Obsessive Compulsive Disorder Fluoxetine Capsules USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies ( ) ] .
, for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [ see Dosage and Administration ( ) ] .
Drug interactions
Known interactions involving Fluoxetine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02314991 · revised December 16, 2025
[3]FDA DailyMed · 1a2a5194-b793-4c… · revised May 1, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
Posology Adults Major depressive episodes Adults and the elderly:
The recommended dose is 20 mg daily. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. 1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Obsessive-compulsive disorder Adults and the elderly:
The recommended dose is 20 mg daily. Although there may be an increased potential for undesirable effects at higher doses, in some patients, if after two weeks there is insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 mg.
If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.
Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD.
Bulimia nervosa Adults and the elderly:
A dose of 60 mg/day is recommended. Long-term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa. All indications The recommended dose may be increased or decreased. Doses above 80 mg/day have not been systematically evaluated.
Paediatric population - Children and adolescents aged 8 years and above (Moderate to severe major depressive episode) Treatment should be initiated and monitored under specialist supervision. 5 ml of Fluoxetine Capsules oral solution.
Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose. After one to two weeks, the dose may be increased to 20 mg/day. Clinical trial experience with daily doses greater than 20 mg is minimal.
There is only limited data on treatment beyond 9 weeks. 2). For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered.
Elderly patients Caution is recommended when increasing the dose and the daily dose should generally, not exceed 40 mg. Maximum recommended dose is 60 mg/day. g. 5).
Withdrawal symptoms seen on discontinuation of Fluoxetine Capsules:
Abrupt discontinuation should be avoided. 8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Method of administration For oral administration. Fluoxetine may be administered as a single or divided dose, during or between meals. The capsules should be swallowed whole with a glass of water. When dosing is stopped, active drug substances will persist in the body for weeks.
This should be borne in mind when starting or stopping treatment.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]
a. Summary of the safety profile The most commonly reported adverse reactions in patients treated with fluoxetine were headache, nausea, insomnia, fatigue and diarrhoea. Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
b. Tabulated list of adverse reactions The table below gives the adverse reactions observed with fluoxetine treatment in adult and paediatric populations. Some of these adverse reactions are in common with other SSRIs. The following frequencies have been calculated from clinical trials in adults (n = 9297) and from spontaneous reporting.
Frequency estimate:
Very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Very Commo n Common Uncommon Rare Unknown Blood and lymphatic system disorders Thrombocytopenia Neutropenia Leucopenia Immune system disorders Anaphylactic reaction Serum sickness Endocrine disorders Inappropriate antidiuretic hormone secretion Metabolism and nutrition disorders Decreased appetite1 Hyponatraemia Psychiatric disorders Insomnia 2 Anxiety Nervousness Restlessness Tension Libido decreased3 Sleep disorder Abnormal dreams4 Depersonalisation Elevated mood Euphoric mood Thinking abnormal Orgasm abnormal5 Bruxism Suicidal thoughts and behaviour 6 Hypomania Mania Hallucinations Agitation Panic attacks Confusion Dysphemia Aggression Nervous system disorders Headache Disturbance in attention Dizziness Dysgeusia Lethargy Somnolence7 Tremor Psychomotor hyperactivity Dyskinesia Ataxia Balance disorder Myoclonus Memory impairment Convulsion Akathisia Buccoglossal syndrome Serotonin syndrome Eye disorders Vision blurred Mydriasis Ear and labyrinth disorders Tinnitus Cardiac disorders Palpitations Electrocardiogra m QT prolonged (QTcF ≥450 msec)8 Ventricular arrhythmia including torsades de pointes Vascular disorders Flushing9 Hypotension Vasculitis Vasodilatation Respiratory, thoracic and mediastinal disorders Yawning Dyspnoea Epistaxis Pharyngitis Pulmonary events (inflammatory processes of varying histopathology and/or fibrosis) 10 Gastrointestinal disorders Diarrhoea Nausea Vomiting Dyspepsia Dry mouth Dysphagia Gastrointestinal haemorrhage11 Oesophageal pain Hepato-biliary disorders Idiosyncratic hepatitis Skin and subcutaneous tissue disorders Rash12 Urticaria Pruritus Hyperhidrosis Alopecia Increased tendency to bruise Cold sweat Angioedema Ecchymosis Photosensitivit y reaction Purpura Erythema multiforme Stevens-Johnson syndrome Toxic Epidermal Necrolysis (Lyell Syndrome) Musculoskeletal and connective tissue disorders Arthralgia Muscle twitching Myalgia Renal and urinary disorders Frequent urination13 Dysuria Urinary retention Micturition disorder Reproductive system and breast disorders Gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15 Sexual dysfunction Galactorrhoea Hyperprolactinaem ia Priapism General disorders and administration site conditions Fatigue16 Feeling jittery Chills Malaise Feeling abnormal Feeling cold Feeling hot Mucosal haemorrhage Postpartum Haemorrhage17 Investigations Weight decreased Transaminases increased Gamma- glutamyltransfera se increased 1 Includes anorexia 2 Includes early morning awakening, initial insomnia, middle insomnia 3 Includes loss of libido 4 Includes nightmares 5 Includesanorgasmia 6 Includes completed suicide, depression suicidal, intentional self-injury, self- injuriousideation, suicidal behaviour, suicidal ideation, suicide attempt, morbid thoughts, self- injurious behaviour.
6) c. 4).
Bone fractures:
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to the risk is unknown.
Withdrawal symptoms seen on discontinuation of fluoxetine treatments:
Discontinuation of fluoxetine commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions.
4). 4). d. 1) Adverse […]
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]
Paediatric population - Children and adolescents under 18 years of age Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (Predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Fluoxetine Capsules should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes and it should not be used in other indications. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
3). 1). It has not been established whether there is an effect on achieving normal adult height. 8). Growth and pubertal development (height, weight and TANNER staging) should therefore be monitored during and after treatment with fluoxetine.
If either is slowed, referral to a paediatrician should be considered. 8). Therefore, regular monitoring for the occurrence of mania/hypomania is recommended. Fluoxetine should be discontinued in any patient entering a manic phase. It is important that the prescriber discusses carefully the risks and benefits of treatment with the child/young person and/or their parents.
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self- harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which Fluoxetine Capsules is prescribed can also be associated with an increased risk of suicide-related events.
In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[1]
1. g. 5). 5).
This is not medical advice. Consult a qualified healthcare professional.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1. Clinical Trial Adverse Reactions – Pediatrics. 2. 4 Geriatrics). PRO-FLUOXETINE& FLUOXETINE-20 (Fluoxetine Capsules) Page 5 of 55
How to take
CAOfficial regulatory label· revised December 16, 2025[2]
1 Dosing Considerations General: During maintenance therapy, the dosage should be kept at the lowest effective level. 4 Drug-Drug Interactions, Tricyclic Antidepressants section).
Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI):
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with PRO-FLUOXETINE & FLUOXETINE-20 . In addition, at least 5 weeks, perhaps longer, should be allowed after stopping PRO-FLUOXETINE & FLUOXETINE-20 before starting MAOI (see 2 CONTRAINDICATIONS section).
Discontinuation of Treatment:
When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment. Dosage tapering is unnecessary in most patients. Despite its long-half life, symptoms associated with the discontinuation of fluoxetine have been reported in clinical trials and post-marketing.
Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which PRO-FLUOXETINE & FLUOXETINE-20 is being prescribed. Fluoxetine has been only rarely associated with such symptoms.
1 Adverse Reaction Overview). 2 Recommended Dose and Dosage Adjustment Depression: Initial Adult Dosage: The usual initial dosage is 20 mg administered once daily in the morning. A gradual dose increase should be considered only after a trial period of several weeks if the expected clinical improvement does not occur.
Dosage should not exceed a maximum of 60 mg per day.
Long Term:
The efficacy of fluoxetine in maintaining an antidepressant response for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. 1 Clinical Trial by Indication section).
PRO-FLUOXETINE& FLUOXETINE-20 (Fluoxetine Capsules) Page 7 of 55 Bulimia Nervosa:
Adult Dosage: The recommended dosage is 60 mg per day, although studies show that lower doses may also be efficacious. Electrolyte levels should be assessed prior to initiation of treatment.
Obsessive-Compulsive Disorder:
A dose range of 20 mg/day to 60 mg/day is recommended for the treatment of obsessive - compulsive disorder.
Dose Adjustment:
Since it may take up to four or five weeks to reach steady-state plasma levels of PRO- FLUOXETINE & FLUOXETINE-20 , sufficient time should be allowed to elapse before dosage is gradually increased. Higher dosages are usually associated with an increased incidence of adverse reactions.
, ventricular and septal defects) associated with use of fluoxetine. The mechanism is unknown. The use of PRO- FLUOXETINE & FLUOXETINE-20 during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus taking into account the risks associated with untreated depression.
1 Pregnant Women, Complications following late third trimester exposure to SSRIs). When treating pregnant women with PRO-FLUOXETINE & FLUOXETINE-20 during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment.
The health professional may consider tapering PRO- FLUOXETINE & FLUOXETINE-20 in the third trimester. • Geriatrics (≥ 60 years of age): Fluoxetine was evaluated in depressed elderly patients only at a dosage of 20 mg/day. A lower or less frequent dosage may be effective and should be considered in elderly patients with concurrent disease or on multiple medications.
• Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, including Self-Harm). PRO-FLUOXETINE& FLUOXETINE-20 (Fluoxetine Capsules) Page 8 of 55 • Renal/Hepatic Impairment or Otherwise Debilitated Patients: A lower or less frequent dosage should be used in patients with renal and/or hepatic impairment and in those on multiple medications.
4 Administration PRO-FLUOXETINE & FLUOXETINE-20 may be taken with or without food. The capsules should not be opened or chewed, and they must be swallowed whole. 5 Missed Dose In the event that a patient misses a dose, they should be instructed to take their dose as soon as they can.
The next dose should be taken at the next scheduled time.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised December 16, 2025[2]
1 Adverse Reaction Overview Commonly Observed Adverse Events In clinical trials, the most commonly observed adverse events associated with the use of fluoxetine and not seen at an equivalent incidence among placebo treated patients were: central nervous system complaints, including headache, nervousness, insomnia, drowsiness, fatigue or asthenia, anxiety, tremor, and dizziness or lightheadedness; gastrointestinal complaints, including nausea, diarrhea, dry mouth and anorexia; and excessive sweating.
Adverse Events Leading to Discontinuation of Treatment Fifteen percent of approximately 4,000 patients who received fluoxetine in North American clinical trials discontinued treatment due to an adverse event. The more common events causing discontinuation from depression trials in adults and elderly, included: psychiatric, primarily nervousness, anxiety, and insomnia; digestive, primarily nausea; nervous system, primarily dizziness, asthenia, and headaches; skin, primarily rash and pruritus.
1% of fluoxetine treated patients discontinued treatment early because of adverse events. Anxiety and rash, at incidences of less than 2%, were the most frequently reported events. 2% of fluoxetine treated patients discontinued treatment early because of adverse events.
Insomnia, anxiety and rash, at incidences of less than 2%, were the most frequently reported events. , headache, insomnia, paresthesias, nervousness, anxiety, nausea, sweating, numbness, dizziness, jitteriness, asthenia, or other symptoms which may be of clinical significance).
The majority of these are mild and self–limiting. Fluoxetine has been only rarely associated with such symptoms. Plasma fluoxetine and norfluoxetine concentrations decrease gradually at the conclusion of therapy, which makes dose tapering unnecessary in most patients.
1 Dosing Considerations, Discontinuation of Treatment; and 7 WARNINGS AND PRECAUTIONS, General. PRO-FLUOXETINE& FLUOXETINE-20 (Fluoxetine Capsules) Page 22 of 55 Serious Adverse Reactions Suicidal thoughts and acts are far more common among depressed patients than in the general population.
It is estimated that suicide is 22 to 36 times more prevalent in depressed persons than in the general population. A comprehensive meta-analysis of pooled data from 17 double blind clinical trials in patients with major depressive disorder compared fluoxetine (n = 1765) with a tricyclic antidepressant (n = 731) or placebo (n = 569), or both.
6% for tricyclic antidepressants. In countries where the drug has already been marketed, the following potentially serious adverse reactions have been reported; interactions with MAO inhibitors and possibly other drugs, allergic reactions, cardiovascular reactions, syndrome of inappropriate ADH secretion, and grand mal seizure.
Death and life-threatening events have been associated with some of these reactions, although causal relationship to fluoxetine has not necessarily been established. Post-marketing experience also confirms the profile of adverse reactions commonly reported during clinical trials with fluoxetine including allergic skin reactions.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse drug reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Multiple doses of fluoxetine had been administered to 10,782 patients with various diagnoses in US clinical trials as of May 8, 1995.
Adverse events were recorded by clinical investigators using descriptive terminology of their own choosing. , reduced) number of standardized event categories.
Adults:
In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse events. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.
An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, PRO-FLUOXETINE& FLUOXETINE-20 (Fluoxetine Capsules) Page 23 of 55 however, do provide the prescribing health professional with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
Table 2:
Treatment-Emergent Adverse Events Incidence in Fluoxetine versus Placebo Trials Listed by Indication Percentage of Patients Reporting Event Body System/ Adverse Event DEPRESSION* (Adults) Fluoxetine Placebo (N=1728) (N=975) DEPRESSION (Elderly) Fluoxetine Placebo (N=335) (N=336) OCD* Fluoxetine Placebo […]
CAOfficial regulatory label· Warnings and precautions· revised December 16, 2025[2]
1. Clinical Trial Adverse Reactions – Pediatrics. 2. 4 Geriatrics). PRO-FLUOXETINE& FLUOXETINE-20 (Fluoxetine Capsules) Page 5 of 55 2 CONTRAINDICATIONS • Hypersensitivity - PRO-FLUOXETINE & FLUOXETINE-20 is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • Monoamine Oxidase Inhibitors – In patients receiving serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma).
These reactions have also been reported in patients who have recently discontinued SSRI treatment and then started treatment on an MAOI. , serotonin syndrome). PRO-FLUOXETINE & FLUOXETINE-20 should not be used in combination with an MAOI (including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue) which are less well-known examples of MAOIs) or within 14 days of discontinuing therapy with an MAOI.
Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should elapse after discontinuing treatment with PRO-FLUOXETINE & FLUOXETINE-20 before starting an MAOI. Limited reports suggest that intravenously administered dantrolene or orally administered cyproheptadine may benefit patients experiencing such reactions.
4 Drug-Drug Interactions, Monoamine-Oxidase Inhibitors section. • Thioridazine - Thioridazine should not be administered concomitantly with PRO- FLUOXETINE & FLUOXETINE-20 or within a minimum of 5 weeks after PRO-FLUOXETINE & FLUOXETINE-20 has been discontinued, nor should PRO-FLUOXETINE & FLUOXETINE-20 be administered within 2 weeks after thioridazine has been discontinued.
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised December 16, 2025[2]
• Hypersensitivity - PRO-FLUOXETINE & FLUOXETINE-20 is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
• Monoamine Oxidase Inhibitors – In patients receiving serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma).
These reactions have also been reported in patients who have recently discontinued SSRI treatment and then started treatment on an MAOI. , serotonin syndrome). PRO-FLUOXETINE & FLUOXETINE-20 should not be used in combination with an MAOI (including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue) which are less well-known examples of MAOIs) or within 14 days of discontinuing therapy with an MAOI.
Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should elapse after discontinuing treatment with PRO-FLUOXETINE & FLUOXETINE-20 before starting an MAOI. Limited reports suggest that intravenously administered dantrolene or orally administered cyproheptadine may benefit patients experiencing such reactions.
4 Drug-Drug Interactions, Monoamine-Oxidase Inhibitors section. • Thioridazine - Thioridazine should not be administered concomitantly with PRO- FLUOXETINE & FLUOXETINE-20 or within a minimum of 5 weeks after PRO-FLUOXETINE & FLUOXETINE-20 has been discontinued, nor should PRO-FLUOXETINE & FLUOXETINE-20 be administered within 2 weeks after thioridazine has been discontinued.
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
An in vivo study suggests that drugs which inhibit P4502D6, including certain SSRI’s such as paroxetine, fluoxetine and fluvoxamine, will elevate plasma levels of thioridazine. Therefore, PRO-FLUOXETINE & FLUOXETINE-20 should not be used in combination with thioridazine.
4 Drug-Drug Interactions, Thioridazine section.
This is not medical advice. Consult a qualified healthcare professional.
3 Bulimia Nervosa Fluoxetine Capsules USP are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [ see Clinical Studies ( ) ] . The physician who elects to use fluoxetine capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [ see Dosage and Administration ( ) ] .
4 Panic Disorder Fluoxetine Capsules USP are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [ see Clinical Studies ( ) ] . , for more than 12 weeks, has not been established in placebo-controlled trials.
Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [ see Dosage and Administration ( ) ]. 5 Fluoxetine Capsules USP and Olanzapine in Combination: Depressive Episodes Associated With Bipolar I Disorder When using fluoxetine capsules USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® .
Fluoxetine Capsules USP and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine Capsules USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
How to take
USOfficial regulatory label· revised May 1, 2026[3]
1 Major Depressive Disorder Initial Treatment Adult — In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases.
Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose. A dose increase may be considered after several weeks if insufficient clinical improvement is observed. , morning and noon) and should not exceed a maximum dose of 80 mg/day.
Pediatric (children and adolescents) — In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [ see Clinical Studies ( ) ] .
Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day.
A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed. All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.
Maintenance/Continuation/Extended Treatment — It is generally agreed that acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Daily Dosing — Systematic evaluation of fluoxetine in adult patients has shown that its efficacy in Major Depressive Disorder is maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) at a dose of 20 mg/day [ see Clinical Studies ( ) ] .
Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [ see Warnings and Precautions ( ) and Drug Interactions ()].
2 Obsessive Compulsive Disorder Initial Treatment Adult — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo [ see Clinical Studies ( ) ] .
In one of these studies, no dose-response relationship for effectiveness was demonstrated. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose. Since there was a suggestion of a possible dose-response relationship for effectiveness in the second study, a dose increase may be considered after several weeks if insufficient clinical improvement is observed.
The full therapeutic effect may be delayed until 5 weeks of treatment or longer. , morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.
Pediatric (children and adolescents) — In the controlled clinical trial of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [ see Clinical Studies ( ) ] .
In adolescents and higher weight children, treatment should be initiated with a dose of 10 mg/day. After 2 weeks, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed.
A dose range of 20 to 60 mg/day is recommended. In lower weight children, treatment should be initiated with a dose of 10 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed.
A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg. Maintenance/Continuation Treatment — While there are no systematic studies that answer the question of how long to continue fluoxetine, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient.
Although the efficacy of fluoxetine after 13 weeks has not been documented in controlled trials, adult patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment.
3 Bulimia Nervosa Initial Treatment — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo [ see Clinical Studies ( ) ] .
Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting. Consequently, the recommended dose is 60 mg/day, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days.
Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. Maintenance/Continuation Treatment — Systematic evaluation of continuing fluoxetine 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking fluoxetine 60 mg/day during an 8 week acute treatment phase has demonstrated a benefit of such maintenance treatment [ see Clinical Studies ( ) ] .
Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment. 4 Panic Disorder Initial Treatment — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Panic Disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [ see Clinical Studies ( ) ] .
Treatment should be initiated with a dose of 10 mg/day. After one week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day. A dose increase may be considered after several weeks if no clinical improvement is observed.
Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder. Maintenance/Continuation Treatment — While there are no systematic studies that answer the question of how long to continue fluoxetine, panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient.
Nevertheless, patients should be periodically reassessed to determine the need for continued treatment. 5 Fluoxetine and Olanzapine in Combination: Depressive Episodes Associated With Bipolar I Disorder When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adult — Fluoxetine should be administered in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. 5 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg.
Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies. Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules.
However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Safety and efficacy of fluoxetine in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and fluoxetine).
Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of fluoxetine and olanzapine versus Symbyax.
Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Table 1:
Approximate Dose Correspondence Between Symbyax Symbyax (olanzapine/fluoxetine HCL) is a fixed-dose combination of fluoxetine and olanzapine. 5 40 + 10 While there is no body of evidence to answer the question of how long a patient treated with fluoxetine and olanzapine in combination should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment.
The physician should periodically re-examine the need for continued pharmacotherapy. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. 7 Dosing in Specific Populations Treatment of Pregnant Women — When treating pregnant women with fluoxetine, the physician should carefully consider the potential risks and potential benefits of treatment.
Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [ see Use in Specific Populations ( ) ] . Geriatric — A lower or less frequent dosage should be considered for the elderly [ see Use in Specific Populations ( ) ].
Hepatic Impairment — As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment [ see Clinical Pharmacology ( ) and Use in Specific Populations ( ) ] . Concomitant Illness — Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [ see Clinical Pharmacology ( ) and Warnings and Precautions ( ) ] .
5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine.
Dosing modifications may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Fluoxetine and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age [ see Warnings and Precautions ( ) and Drug Interactions ( ) ].
8 Discontinuation of Treatment Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [ see Warnings and Precautions ( ) ] . 9 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine.
Conversely, at least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI intended to treat psychiatric disorders [see Contraindications ( )]. 10 Use of Fluoxetine With Other MAOIs Such as Linezolid or Methylene Blue Do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome.
In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications ( )]. In some cases, a patient already receiving fluoxetine therapy may require urgent treatment with linezolid or intravenous methylene blue.
If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluoxetine should be stopped promptly, and linezolid or intravenous methylene blue can be administered.
The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluoxetine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions ( )].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluoxetine is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions ( )] .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 5,703 reports total. [4]
Off Label Use 373
Drug Ineffective 355
Nausea 304
Headache 277
Fatigue 264
Intentional Overdose 263
Drug Interaction 262
Toxicity To Various Agents 261
Vomiting 248
Diarrhoea 228
Anxiety 190
Dizziness 189
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 1, 2026[3]
6 ADVERSE REACTIONS When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.
S. clinical trials. In addition, there have been 425 patients administered fluoxetine in panic clinical trials. Adverse reactions were recorded by clinical investigators using descriptive terminology of their own choosing. , reduced) number of standardized reaction categories.
In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse reactions. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed.
A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that reactions reported during therapy were not necessarily caused by it.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
S. S. S. controlled trials. S. S. S. Panic Disorder controlled clinical trials. Table 4 provides combined data for the pool of studies that are provided separately by indication in Table 3 .
Table 3:
Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials Incidence less than 1%. Percentage of Patients Reporting Event Major Depressive Disorder OCD Bulimia Panic Disorde r Body System/ Adverse Reaction Fluoxetine (N = 1728) Placebo (N = 975) Fluoxetine (N = 266) Placebo (N = 89) Fluoxetine (N = 450) Placebo (N = 267) Fluoxetine (N = 425) Placebo (N = 342) Body as a Whole Asthenia 9 5 15 11 21 9 7 7 Flu syndrome 3 4 10 7 8 3 5 5 Cardiovascular System Vasodilatation 3 2 5 -- 2 1 1 -- Digestive System Nausea 21 9 26 13 29 11 12 7 Diarrhea 12 8 18 13 8 6 9 4 Anorexia 11 2 17 10 8 4 4 1 Dry mouth 10 7 12 3 9 6 4 4 Dyspepsia 7 5 10 4 10 6 6 2 Nervous System Insomnia 16 9 28 22 33 13 10 7 Anxiety 12 7 14 7 15 9 6 2 Nervousness 14 9 14 15 11 5 8 6 Somnolence 13 6 17 7 13 5 5 2 Tremor 10 3 9 1 13 1 3 1 Libido decreased 3 -- 11 2 5 1 1 2 Abnormal dreams 1 1 5 2 5 3 1 1 Respiratory System Pharyngitis 3 3 11 9 10 5 3 3 Sinusitis 1 4 5 2 6 4 2 3 Yawn -- -- 7 -- 11 -- 1 -- Skin and Appendages Sweating 8 3 7 -- 8 3 2 2 Rash 4 3 6 3 4 4 2 2 Urogenital System Impotence Denominator used was for males only (N = 690 fluoxetine Major Depressive Disorder; N = 410 placebo Major Depressive Disorder; N = 116 fluoxetine OCD; N = 43 placebo OCD; N = 14 fluoxetine bulimia; N = 1 placebo bulimia; N = 162 fluoxetine panic; N = 121 placebo panic).
S. Panic Disorder clinical trials. S. S. Panic Disorder clinical trials. Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined (N = 1533) Major Depressive Disorder (N = 392) OCD (N = 266) Bulimia (N = 450) Panic Disorder (N = 425) Anxiety (1%) -- Anxiety (2%) -- Anxiety (2%) -- -- -- Insomnia (2%) -- -- Nervousness (1%) -- -- Nervousness (1%) -- -- Rash (1%) -- -- Other adverse reactions in pediatric patients (children and adolescents) — Treatment-emergent adverse reactions were collected in 322 pediatric patients (180 fluoxetine-treated, 142 placebo-treated).
The overall profile of adverse reactions was generally similar to that seen in adult studies, as shown in Tables 4 and 5 . However, the following adverse reactions (excluding those which appear in the body or footnotes of Tables 4 and 5 and those for which the COSTART terms were uninformative or misleading) were reported at an incidence of at least 2% for fluoxetine and greater than placebo: thirst, hyperkinesia, agitation, personality disorder, epistaxis, urinary frequency, and menorrhagia.
8% for fluoxetine-treated, 0% for placebo-treated). In these clinical trials, only a primary reaction associated with discontinuation was collected. Male and female sexual dysfunction with SSRIs — Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment.
In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them.
Accordingly, estimates of the incidence of untoward sexual experience and performance, cited in product labeling, are likely to underestimate their actual incidence. S. Major Depressive Disorder, OCD, and bulimia placebo-controlled clinical trials, decreased libido was the only sexual side effect reported by at least 2% of patients taking fluoxetine (4% fluoxetine, < 1% placebo).
There have been spontaneous reports in women taking fluoxetine of orgasmic dysfunction, including anorgasmia. There are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment. Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.
Priapism has been reported with all SSRIs. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects. 2 Other Reactions Following is a list of treatment-emergent adverse reactions reported by patients treated with fluoxetine in clinical trials.
This listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo.
Reactions are classified by body system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients.
Respiratory System — Rare: larynx edema. Skin and Appendages — Infrequent: alopecia; Rare : purpuric rash. Special Senses — Frequent: taste perversion; Infrequent: mydriasis. Urogenital System — Frequent: micturition disorder; Infrequent: dysuria, gynecological bleeding 2 .
1 MedDRA dictionary term from integrated database of placebo controlled trials of 15,870 patients, of which 9,673 patients received fluoxetine. 2 Group term that includes individual MedDRA terms: cervix hemorrhage uterine, dysfunctional uterine bleeding, genital hemorrhage, menometrorrhagia, menorrhagia, metrorrhagia, polymenorrhea, postmenopausal hemorrhage, uterine hemorrhage, vaginal hemorrhage.
Adjusted for gender. 3 Postmarketing Experience The following adverse reactions have been identified during post approval use of fluoxetine. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.
Voluntary reports of adverse reactions temporally associated with fluoxetine that have been received since market introduction and that may have no causal relationship with the drug include the following: aplastic anemia, atrial fibrillation 1 , cataract, cerebrovascular accident 1 , cholestatic jaundice, dyskinesia (including, for example, a case of buccal-lingual-masticatory syndrome with involuntary tongue protrusion reported to develop in a 77-year-old female after 5 weeks of fluoxetine therapy and which completely resolved over the next few months following drug discontinuation), eosinophilic pneumonia 1 , epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, galactorrhea, gynecomastia, heart arrest 1 , hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, kidney failure, memory impairment, movement disorders developing in patients with risk factors including drugs associated with such reactions and worsening of preexisting movement disorders, optic neuritis, pancreatitis 1 , pancytopenia, pulmonary embolism, pulmonary hypertension, QT prolongation, Stevens-Johnson syndrome, thrombocytopenia 1 , thrombocytopenic purpura, ventricular tachycardia (including torsade de pointes-type arrhythmias), vaginal bleeding, and violent behaviors 1 .
1 These terms represent serious adverse events, but do not meet the definition for adverse drug reactions. They are included here because of their seriousness.
USOfficial regulatory label· Warnings and precautions· revised May 1, 2026[3]
5 WARNINGS AND PRECAUTIONS When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. • Clinical Worsening and Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior () • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluoxetine, both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St.
John’s Wort). If such symptoms occur, discontinue fluoxetine and initiate supportive treatment. If concomitant use of fluoxetine with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
() • Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena () • Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania () • Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold () • Altered Appetite and Weight: Significant weight loss has occurred () • Abnormal Bleeding: May increase the risk of bleeding.
Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding () • Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants () • Hyponatremia: Has been reported with fluoxetine in association with syndrome of inappropriate antidiuretic hormone (SIADH).
Consider discontinuing if symptomatic hyponatremia occurs () • Anxiety and Insomnia: May occur () • QT Prolongation: QT prolongation and ventricular arrhythmia including torsade de pointes have been reported with fluoxetine use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure.
2 , , , , ) • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. 1 Clinical Worsening and Suicide Risk Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 1, 2026[3]
4 CONTRAINDICATIONS When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine.
Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue () • Pimozide: Do not use.
2 , , , ) • Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. 1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome.
The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration () and Warnings and Precautions ()]. Starting fluoxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [ see Dosage and Administration () and Warnings and Precautions ()].
2 Other Contraindications The use of fluoxetine is contraindicated with the following: • Pimozide [ see Warnings and Precautions ( ) and Drug Interactions (,)] • Thioridazine [ see Warnings and Precautions ( ) and Drug Interactions (, ) ] Pimozide and thioridazine prolong the QT interval.
Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval.
This is not medical advice. Consult a qualified healthcare professional.
A meta-analysis of placebo-controlled clinical trials of antidepressants drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
9). 5). If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started. If signs of cardiac arrhythmia occur during treatment with fluoxetine, the treatment should be withdrawn, and an ECG should be performed.
g. iproniazid) Some cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with an irreversible, non-selective monoamine oxidase inhibitor (MAOI). These cases presented with features resembling serotonin syndrome (which may resemble and be or diagnosed as neuroleptic malignant syndrome).
Cyproheptadine or dantrolene may benefit patients experiencing such reactions. Symptoms of a drug interaction with a MAOI include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
3). Because of the two weeks-lasting effect of the latter, treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible, non-selective MAOI. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting an irreversible, non-selective MAOI.
Serotonin syndrome or neuroleptic malignant syndrome-like events On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with treatment of […]
An in vivo study suggests that drugs which inhibit P4502D6, including certain SSRI’s such as paroxetine, fluoxetine and fluvoxamine, will elevate plasma levels of thioridazine. Therefore, PRO-FLUOXETINE & FLUOXETINE-20 should not be used in combination with thioridazine.
4 Drug-Drug Interactions, Thioridazine section. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased risk of self-harm, harm to others, suicidal thinking and behaviour with antidepressant use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviours (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, including Self-Harm).
1 Dosing Considerations General: During maintenance therapy, the dosage should be kept at the lowest effective level. 4 Drug-Drug Interactions, Tricyclic Antidepressants section).
Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI):
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with PRO-FLUOXETINE & FLUOXETINE-20 . In addition, at least 5 weeks, perhaps longer, should be allowed after stopping PRO-FLUOXETINE & FLUOXETINE-20 before starting MAOI (see 2 CONTRAINDICATIONS section).
Discontinuation of Treatment:
When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment. Dosage tapering is unnecessary in most patients. Despite its long-half life, symptoms associated with the discontinuation of fluoxetine have been reported in clinical trials and post-marketing.
Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which PRO-FLUOXETINE & FLUOXETINE-20 is being prescribed. Fluoxetine has been only rarely associated with such symptoms.
1 Adverse Reaction Overview). 2 Recommended Dose and Dosage Adjustment Depression: Initial Adult Dosage: The usual initial dosage is 20 mg administered once daily in the morning. A gradual dose increase should be considered only after a trial period of several weeks if the expected clinical improvement does not occur.
Dosage should not exceed a maximum of 60 mg per day.
Long Term:
The efficacy of fluoxetine in maintaining an antidepressant response for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving PRO-FLUOXETINE & […]
Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with Major Depressive Disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients.
The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.
There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications.
These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 2 .
Table 2:
Suicidality per 1000 Patients Treated Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated Increases Compared to Placebo < 18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥ 65 6 fewer cases No suicides occurred in any of the pediatric trials.
There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. , beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for Major Depressive Disorder as well as for other indications, both psychiatric and nonpsychiatric.
Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms [ see Warnings and Precautions ( ) ] .
Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.
Such monitoring should include daily observation by families and caregivers. Prescriptions for fluoxetine capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
It should be noted that fluoxetine is approved in the pediatric population for Major Depressive Disorder and Obsessive Compulsive Disorder. Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules.
However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2 Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including fluoxetine, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St.
John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). , nausea, vomiting, diarrhea).
Patients should be monitored for the emergence of serotonin syndrome. The concomitant use of fluoxetine with MAOIs intended to treat psychiatric disorders is contraindicated. Fluoxetine should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue.
All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses.
There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking fluoxetine. Fluoxetine should be discontinued before initiating treatment with the MAOI [see Contraindications ( ) and Dosage and Administration (, )].
, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with fluoxetine and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. S. fluoxetine clinical trials, 7% of 10,782 patients developed various types of rashes and/or urticaria.
Among the cases of rash and/or urticaria reported in premarketing clinical trials, almost a third were withdrawn from treatment because of the rash and/or systemic signs or symptoms associated with the rash. Clinical findings reported in association with rash include fever, leukocytosis, arthralgias, edema, carpal tunnel syndrome, respiratory distress, lymphadenopathy, proteinuria, and mild transaminase elevation.
Most patients improved promptly with discontinuation of fluoxetine and/or adjunctive treatment with antihistamines or steroids, and all patients experiencing these reactions were reported to recover completely. In premarketing clinical trials, 2 patients are known to have developed a serious cutaneous systemic illness.
In neither patient was there an unequivocal diagnosis, but one was considered to have a leukocytoclastic vasculitis, and the other, a severe desquamating syndrome that was considered variously to be a vasculitis or erythema multiforme.
Other patients have had systemic syndromes suggestive of serum sickness. Since the introduction of fluoxetine, systemic reactions, possibly related to vasculitis and including lupus-like syndrome, have developed in patients with rash.
Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions. Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported.
Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom. Whether these systemic reactions and rash have a common underlying cause or are due to different etiologies or pathogenic processes is not known.
Furthermore, a specific underlying immunologic basis for these reactions has not been identified. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, fluoxetine should be discontinued.
4 Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania A major depressive episode may be the initial presentation of Bipolar Disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for Bipolar Disorder.
Whether any of the symptoms described for clinical worsening and suicide risk represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder; such screening should include a detailed psychiatric history, including a family history of suicide, Bipolar Disorder, and depression.
It should be noted that fluoxetine and olanzapine in combination is approved for the acute treatment of depressive episodes associated with Bipolar I Disorder [ see Warnings and Precautions section of the package insert for Symbyax ].
Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. S. 1% of patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with Major Affective Disorder treated with other marketed drugs effective in the treatment of Major Depressive Disorder [ see Use in Specific Populations ( ) ] .
S. 8% of patients treated with fluoxetine and no patients treated with placebo. S. placebo-controlled clinical trials for bulimia. S. 7% of 10,782 patients reported mania/hypomania [ see Use in Specific Populations ( ) ] . S. 2% of patients treated with placebo.
S. placebo-controlled clinical trials for either OCD or bulimia. S. 2% of 10,782 patients reported convulsions. The percentage appears to be similar to that associated with other marketed drugs effective in the treatment of Major Depressive Disorder.
Fluoxetine should be introduced with care in patients with a history of seizures. 6 Altered Appetite and Weight Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine.
S. placebo-controlled clinical trials for Major Depressive Disorder, 11% of patients treated with fluoxetine and 2% of patients treated with placebo reported anorexia (decreased appetite). 5% of patients treated with placebo. However, only rarely have patients discontinued treatment with fluoxetine because of anorexia or weight loss [ see Use in Specific Populations ( ) ] .
S. placebo-controlled clinical trials for OCD, 17% of patients treated with fluoxetine and 10% of patients treated with placebo reported anorexia (decreased appetite). One patient discontinued treatment with fluoxetine because of anorexia [ see Use in Specific Populations ( ) ] .
S. placebo-controlled clinical trials for Bulimia Nervosa, 8% of patients treated with fluoxetine 60 mg and 4% of patients treated with placebo reported anorexia (decreased appetite). 16 kg by patients treated with placebo in the 16 week double-blind trial.
Weight change should be monitored during therapy. 7 Abnormal Bleeding SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, non-steroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk.
Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding reactions related to SNRIs and SSRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation [ see Drug Interactions ( ) ] . 8 Angle-Closure Glaucoma Angle-Closure Glaucoma — The pupillary dilation that occurs following use of many antidepressant drugs including fluoxetine may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
9 Hyponatremia Hyponatremia has been reported during treatment with SNRIs and SSRIs, including fluoxetine. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Cases with serum sodium lower than 110 mmol/L have been reported and appeared to be reversible when fluoxetine was discontinued. Elderly patients may be at greater risk of developing hyponatremia with SNRIs and SSRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk [ see Use in Specific Populations ( ) ] .
Discontinuation of fluoxetine should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls.
More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death. S. placebo-controlled clinical trials for Major Depressive Disorder, 12% to 16% of patients treated with fluoxetine and 7% to 9% of patients treated with placebo reported anxiety, nervousness, or insomnia.
S. placebo-controlled clinical trials for OCD, insomnia was reported in 28% of patients treated with fluoxetine and in 22% of patients treated with placebo. Anxiety was reported in 14% of patients treated with fluoxetine and in 7% of patients treated with placebo.
S. placebo-controlled clinical trials for Bulimia Nervosa, insomnia was reported in 33% of patients treated with fluoxetine 60 mg, and 13% of patients treated with placebo. Anxiety and nervousness were reported, respectively, in 15% and 11% of patients treated with fluoxetine 60 mg and in 9% and 5% of patients treated with placebo.
S. placebo-controlled fluoxetine clinical trials were anxiety (2% in OCD), insomnia (1% in combined indications and 2% in bulimia), and nervousness (1% in Major Depressive Disorder) [see Table 5 ]. 11 QT Prolongation Postmarketing cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported in patients treated with fluoxetine.
Fluoxetine should be used with caution in patients with congenital long QT syndrome; a previous history of QT prolongation; a family history of long QT syndrome or sudden cardiac death; and other conditions that predispose to QT prolongation and ventricular arrhythmia.
Such conditions include concomitant use of drugs that prolong the QT interval; hypokalemia or hypomagnesemia; recent myocardial infarction, uncompensated heart failure, bradyarrhythmias, and other significant arrhythmias; and conditions that predispose to increased fluoxetine exposure (overdose, hepatic impairment, use of CYP2D6 inhibitors, CYP2D6 poor metabolizer status, or use of other highly protein-bound drugs).
2 ), Drug Interactions ( , ), Overdose (), and Clinical Pharmacology ( )] . Pimozide and thioridazine are contraindicated for use with fluoxetine. Avoid the concomitant use of drugs known to prolong the QT interval. , pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus) [see Drug Interactions ( , ) and Clinical Pharmacology ( )].
Consider ECG assessment and periodic ECG monitoring if initiating treatment with fluoxetine in patients with risk factors for QT prolongation and ventricular arrhythmia. Consider discontinuing fluoxetine and obtaining a cardiac evaluation if patients develop signs or symptoms consistent with ventricular arrhythmia.
12 Use in Patients With Concomitant Illness Clinical experience with fluoxetine in patients with concomitant systemic illness is limited. Caution is advisable in using fluoxetine in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
Cardiovascular — Fluoxetine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were systematically excluded from clinical studies during the product’s premarket testing.
However, the electrocardiograms of 312 patients who received fluoxetine in double-blind trials were retrospectively evaluated; no conduction abnormalities that resulted in heart block were observed. The mean heart rate was reduced by approximately 3 beats/min.
Glycemic Control — In patients with diabetes, fluoxetine may alter glycemic control. Hypoglycemia has occurred during therapy with fluoxetine, and hyperglycemia has developed following discontinuation of the drug. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic, dosage may need to be adjusted when therapy with fluoxetine is instituted or discontinued.
13 Potential for Cognitive and Motor Impairment As with any CNS-active drug, fluoxetine has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
14 Long Elimination Half-Life Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment.
This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with fluoxetine and norfluoxetine following the discontinuation of fluoxetine [ see Clinical Pharmacology ( ) ] .
, paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these reactions are generally self-limiting, there have been reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing treatment with fluoxetine. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.
16 Fluoxetine and Olanzapine in Combination When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.