Plain-language summary, compiled from the cited regulatory records
Oxazepam is a medication belonging to the benzodiazepine derivatives drug class [1]. It is approved for the management of anxiety disorders and for the short-term relief of anxiety symptoms [1]. Oxazepam may also be helpful for anxiety associated with depression [1]. This medication has been found particularly useful in managing anxiety, tension, agitation, and irritability in older patients [1]. It is also used for acute tremulousness in individuals with alcoholism [1].
Oxazepam is available under various brand names [1]. In the past 12 months, there have been 1,625 adverse event reports associated with oxazepam [2]. The most frequently reported adverse events include toxicity to various agents, coma, drug use disorder, drug abuse, and deliberate poisoning [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 22, 2026[1]
Oxazepam is recommended for short term use of approximately 2-4 weeks. As with all benzodiazepines, doctors should be aware that long term use may lead to dependence and withdrawal symptoms in certain patients. Oxazepam is indicated for the short-term treatment of anxiety that is disabling or subjecting the individual to unacceptable distress, occurring alone or in association with psychosomatic, organic or psychotic illness.
How to take
CACanada· Health Canada
9 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
4 Geriatrics 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................
USOfficial regulatory label· revised November 14, 2024[3]
INDICATIONS
Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Anxiety associated with depression is also responsive to oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy.
The effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Drug interactions
Known interactions involving Oxazepam. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 513. 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) · 00402680 · revised March 22, 2025
[3]FDA DailyMed · 03440821-831c-40… · revised November 14, 2024 [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 22, 2026[1]
4). Treatment should be given for the shortest possible duration. Dosage and duration of therapy should be individualised and all patients receiving oxazepam should be carefully monitored and re-evaluated before any extension of the treatment period.
Long-term chronic use is not recommended. 4). 4).
Adults:
Anxiety 15 -30mg three or four times daily.
Insomnia associated with anxiety:
Generally 15-25mg one hour before retiring. This may be increased to a maximum of 50mg when necessary. Elderly patients and those who are particularly sensitive to benzodiazepines: 10-20mg three or four times a day.
Paediatric population:
Not recommended for children. Method of administration For oral administration.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]
4, and also see below), mild drowsiness*, disorientation, dreams, †nightmares, lethargy, amnesia (see below), mild excitatory effects with stimulation of effect**, numbed emotions, reduced alertness, †restlessness, †agitation, †irritability, †delusions, †rages, †psychoses, †inappropriate behaviour, behavioural adverse effects including paradoxical †aggressive outbursts, excitement, †hallucinations, confusion, uncovering of depression with suicidal tendencies***.
†These are more likely to occur in children and the elderly. Nervous system disorders Dizziness, light-headedness*, ataxia, vertigo, headache, syncope, slurred speech, tremor, dysarthria. Eye disorders Blurred vision, double vision. Vascular disorders Hypotension.
Gastrointestinal disorders Nausea, salivation changes, gastro-intestinal disturbances. Hepatobiliary disorders Increased liver enzymes, jaundice. Skin and subcutaneous tissue disorders Minor diffuse skin rashes (morbilliform, urticarial and maculopapular).
Musculoskeletal and connective tissue disorders Muscle weakness. Renal and urinary disorders Incontinence, urinary retention. Reproductive system and breast disorders Altered libido. General disorders and administration site conditions Fever, oedema, fatigue.
4 Special warnings and precautions): Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Injury, poisoning and procedural complications Fall. * Commonly seen in the first few days of therapy.
If this becomes troublesome dosage should be reduced. ** Reported in psychiatric patients and usually occur within the first few weeks of therapy. *** Extreme caution should therefore be exercised in prescribing benzodiazepines to patients with personality disorders.
Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. 4). Dependence When used at the appropriate recommended dosage for short term treatment of anxiety the dependence potential of oxazepam is low.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]
Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence of oxazepam, these substances should either be avoided or taken in reduced dosage. Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with oxazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[1]
1. • For phobic or obsessional states. • For the treatment of chronic psychosis. • In acute pulmonary insufficiency. • Respiratory depression. • In patients with myasthenia gravis. • In patients with sleep apnoea syndrome. • In severe hepatic insufficiency.
This is not medical advice. Consult a qualified healthcare professional.
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ..............................................................................................
6 5 OVERDOSAGE ................................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 7 7 WARNINGS AND PRECAUTIONS ......................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women ...................................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL............................................................................. 15 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 15 PART II: SCIENTIFIC INFORMATION ........................................................................................
16 13 PHARMACEUTICAL INFORMATION ............................................................................... 16 14 CLINICAL TRIALS ...........................................................................................................
CAOfficial regulatory label· revised March 22, 2025[2]
4 Geriatrics 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
1 Adverse Reaction Overview As with other benzodiazepines, adverse reactions most observed include drowsiness, dizziness, fatigue and ataxia. Other adverse reactions reported are headache, vertigo, diplopia, blurred vision, weakness, hypotension, impairment of memory, slurred speech, sluggish response, hypoactivity, dysarthria, depression, euphoria, anorexia, nausea, constipation, incontinence or urinary retention, changes in libido, urticaria, skin rashes, generalized exfoliative dermatitis, tremors, edema and changes in the EEG pattern (increased fast activity).
Drug dependence after withdrawal, abstinence symptoms such as anxiety, muscle twitches, convulsions or delirium with psychotic manifestations may occur (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance). Release of hostility and other paradoxical reactions such as irritability, excitability, rage, hallucination, increased muscle spasticity and sleep disturbances may occur with oxazepam tablets.
Leukopenia, jaundice, hypersensitivity reactions and abnormal kidney and liver function tests have been reported with this class of drugs (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic; Renal). 5 Post-Market Adverse Reactions Injury, Poisoning and Procedural Complications There have been reports of falls and fractures in benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia.
The risk is increased in those taking concomitant sedatives (including alcoholic beverages), the elderly and debilitated patients (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures). Dependence/Withdrawal Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as oxazepam tablets.
Severe and life-threatening symptoms have been reported (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse and Misuse; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
4 Geriatrics 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................
6 5 OVERDOSAGE ................................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 7 7 WARNINGS AND PRECAUTIONS ......................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women ...................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
). No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experiences suggests that use in the geriatric population is associated with differences in safety or effectiveness.
Long-term use of APO-OXAZEPAM should be avoided in elderly patients. 1 Dosing considerations; 7 WARNING AND PRECAUTIONS, Falls and Fractures). 2 CONTRAINDICATIONS APO-OXAZEPAM is contraindicated in: • patients with previous history of hypersensitivity reactions to oxazepam tablets, to other benzodiazepines 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. • infants • patients with a history of glaucoma • patients with myasthenia gravis APO-OXAZEPAM (oxazepam tablets) Page 5 of 28
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised November 14, 2024[3]
DOSAGE AND ADMINISTRATION
Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects. Oxazepam Usual Dose Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease.
10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability and agitation. Initial dosage: 10 mg, 3 times daily.
If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily This product is not indicated in pediatric patients under 6 years of age.
Absolute dosage for pediatric patients 6 to 12 years of age is not established. Discontinuation or Dosage Reduction of Oxazepam To reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level.
Subsequently decrease the dosage more slowly [see WARNINGS :
Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE : Dependence ] .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,625 reports total. [4]
Toxicity To Various Agents 146
Coma 135
Drug Use Disorder 113
Drug Abuse 107
Poisoning Deliberate 105
Somnolence 100
Drug Interaction 85
Hypotension 84
Substance Use Disorder 79
Intentional Overdose 76
Fall 74
Death 71
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised November 14, 2024[3]
ADVERSE REACTIONS
The necessity for discontinuation of therapy due to undesirable effects has been rare. Transient mild drowsiness is commonly seen in the first few days of therapy. If it persists, the dosage should be reduced. In few instances, dizziness, vertigo, headache and rarely syncope have occurred either alone or together with drowsiness.
, excitement, stimulation of affect, have been reported in psychiatric patients; these reactions may be secondary to relief of anxiety and usually appear in the first two weeks of therapy. Other side effects occurring during oxazepam therapy include rare instances of minor diffuse skin rashes - morbilliform, urticarial, and maculopapular, nausea, lethargy, edema, slurred speech, tremor, and altered libido.
Such side effects have been infrequent and are generally controlled with reduction of dosage. A case of an extensive fixed drug eruption also has been reported. Although rare, leukopenia and hepatic dysfunction including jaundice have been reported during therapy.
Periodic blood counts and liver-function tests are advisable. Ataxia with oxazepam has been reported in rare instances and does not appear to be specifically related to dose or age. Although the following side reactions have not as yet been reported with oxazepam, they have occurred with related compounds (chlordiazepoxide and diazepam): paradoxical excitation with severe rage reactions, hallucinations, menstrual irregularities, change in EEG pattern, blood dyscrasias including agranulocytosis, blurred vision, diplopia, incontinence, stupor, disorientation, fever and euphoria.
Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. gov/medwatch for voluntary reporting of adverse reactions.
USOfficial regulatory label· Warnings and precautions· revised November 14, 2024[3]
WARNINGS
Risks from Concomitant Use with Opioids:
Concomitant use of benzodiazepines, including oxazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe oxazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
In patients already receiving an opioid analgesic, prescribe a lower initial dose of oxazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking oxazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when oxazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see PRECAUTIONS : Drug Interactions ].
Abuse, Misuse, and Addiction:
The use of benzodiazepines, including oxazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see DRUG ABUSE AND DEPENDENCE : Abuse ] .
, using a standardized screening tool). Use of oxazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of oxazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised November 14, 2024[3]
CONTRAINDICATIONS
History of previous hypersensitivity reaction to oxazepam. Oxazepam is not indicated in psychoses.
This is not medical advice. Consult a qualified healthcare professional.
8), Benzodiazepines may be associated with an increased risk of falling especially in elderly patients. As a result, caution should be exercised particularly when getting up at night. 2). 2) depending on the indication, but should not exceed 4 weeks, including tapering off process.
Extension beyond these periods should not take place without reevaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.
Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. Drug withdrawal syndrome Prior to starting treatment with oxazepam, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome.
A withdrawal strategy for ending treatment with oxazepam should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. When benzodiazepines with a long duration are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop.
Risk from concomitant use of opioids Concomitant use of oxazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as oxazepam with opioids should be reserved for patients for whom alternative treatment options are not possible.
2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of […]
15 11 STORAGE, STABILITY AND DISPOSAL............................................................................. 15 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 15 PART II: SCIENTIFIC INFORMATION ........................................................................................
16 13 PHARMACEUTICAL INFORMATION ............................................................................... 16 14 CLINICAL TRIALS ...........................................................................................................
16 17 SUPPORTING PRODUCT MONOGRAPHS ....................................................................... 17 PATIENT MEDICATION INFORMATION ................................................................................... 18 APO-OXAZEPAM (oxazepam tablets) Page 4 of 28 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-OXAZEPAM (oxazepam tablets) is indicated for the short-term symptomatic relief of excessive anxiety and tension in patients with anxiety neurosis.
Anxiety or tension […]
, opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
Dependence and Withdrawal Reactions:
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) [see DOSAGE AND ADMINISTRATION : Discontinuation or Dosage Reduction of Oxazepam ] .
Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including oxazepam, may lead to clinically significant physical dependence.
, seizures) [see DRUG ABUSE AND DEPENDENCE : Dependence ]. Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see DRUG ABUSE AND DEPENDENCE : Dependence ] .
As with other CNS-acting drugs, patients should be cautioned against driving automobiles or operating dangerous machinery until it is known that they do not become drowsy or dizzy on oxazepam therapy. Patients should be warned that the effects of alcohol or other CNS-depressant drugs may be additive to those of Oxazepam, possibly requiring adjustment of dosage or elimination of such agents.
Neonatal Sedation and Withdrawal Syndrome Use of oxazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate [see PRECAUTIONS , Pregnancy ].
Monitor neonates exposed to oxazepam during pregnancy or labor for signs of sedation and monitor neonates exposed to oxazepam during pregnancy for signs of withdrawal; manage these neonates accordingly.