Moclobemide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 24, 2026🚩 Report this page

Moclobemide

Monoamine Oxidase A Inhibitors

Sold as MANERIX

GB MHRACA Health Canada

Drug class: Monoamine Oxidase A Inhibitors
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 16

Overview

Moclobemide is an active pharmaceutical ingredient in the Monoamine Oxidase A Inhibitors group (N06AG). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	11	April 24, 2026
CA Canada	Health Canada	5	January 6, 2026

GBUnited Kingdom· MHRA

11 products

Uses

GBOfficial regulatory label· revised September 1, 2025[1]

Moclobemide is indicated for the treatment of major depressive episodes.

How to take

GBOfficial regulatory label

CACanada· Health Canada

5 products

Uses

CAOfficial regulatory label· revised January 6, 2026[2]

MANERIX (moclobemide) is indicated for the treatment of major depressive disorder (MDD) in adults. 1 Pediatrics  The safety and efficacy of MANERIX has not been studied in pediatric population (<18 years of age). Therefore, its use is not indicated in this population.
2 Geriatrics  No dosage adjustments are necessary in elderly patients (see 10 CLINICAL PHARMACOLOGY, Special Populations, Single and Multiple Dose).

How to take

Sources & citations

[1]MHRA (UK) · PL044161418 · revised September 1, 2025
[2]Health Canada (DPD) · 00899356 · revised January 6, 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.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised September 1, 2025[1]

The undesirable effects observed during treatment with moclobemide are observed mainly during the first few weeks of treatment and regress subsequently, concomitantly with improvement of the depressive episode. This is particularly so for some of the undesirable effects that are related to the very nature of the depressive illness such as feelings of anxiety, agitation or irritability, mood switch with mania or delirium.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000), not known (cannot be estimated from the available data).
Metabolism and nutrition disorders Rare: decreased appetite*, hyponatraemia* Psychiatric disorders Very common: sleep disorders Common: agitation, anxiety, restlessness Uncommon: suicidal ideation, confusional state (these have resolved quickly on discontinuation of therapy) Rare: suicidal behaviors, delusion* Nervous system disorders Very common: dizziness, headache Common: paraesthesia Uncommon: dysgeusia Eye disorders Uncommon: visual impairment Cardiac disorders Moclobemide can cause QT interval prolongation.
QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia.
Vascular disorders:
Common: hypotension Uncommon: flushing Gastrointestinal disorders Very common: nausea, dry mouth Common: diarrhoea, constipation, vomiting Skin and subcutaneous tissue disorders Common: Rash Uncommon: oedema, pruritus, urticaria Reproductive system and breast disorders Very rare: galactorrhea General disorders and administration site conditions: Common: irritability Uncommon: asthenia Investigations: Rare: Serotonin syndrome* (co-administered with drugs that enhance serotonin, such as serotonin re-uptake inhibitors and many other antidepressants), Increased hepatic enzymes (without associated clinical sequelae).
*: Adverse reactions that were not reported in clinical studies but were only reported post-marketing are indicated by an asterix (*) 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 September 1, 2025[1]

Warnings As with other antidepressants, treatment may exacerbate the schizophrenic symptoms of depressive patients with schizophrenic or schizoaffective psychoses. If possible, therapy with long-acting neuroleptics should be continued in such patients.
Generally during therapy with moclobemide, special dietary restrictions are not necessary. Since hypersensitivity to tyramine may exist in some patients, all patients should be advised to avoid the consumption of large amounts of tyramine-rich food.
Hypersensitivity may occur in susceptible individuals. Symptoms may include rash and edema. Theoretical pharmacological considerations indicate that MAO inhibitors may precipitate a hypertensive reaction in patients with thyrotoxicosis or pheochromocytoma.
As experience with moclobemide in this population group is lacking, caution should be exercised with regard to prescribing moclobemide. In patients receiving moclobemide, additional drugs that enhance serotonin such as many other antidepressants, particularly in multiple-drug combinations, should be given with caution.
g. 5). 5). 5). St. John’s wort (Hypericum)-containing phytotherapeutic products should be used with care in combination with moclobemide as this may increase the serotonin concentration. Moclobemide contains lactose and sodium Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains less than 1 mmol (23 mg) sodium per film- coated tablet, that is to say essentially ‘sodium-free’. Precautions 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 Moclobemide 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.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised January 6, 2026[2]

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse 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 reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following table lists the adverse events reported during clinical trials in which 1,922 patients were treated with 50 to 600 mg/day MANERIX (moclobemide) for depressive illness.
Limited experience in 60 patients treated with 601 to 750 mg/day of MANERIX suggests that the incidence of adverse events may increase at higher doses. 3 Less Common Clinical Trial Adverse Reactions Other clinical adverse events with an incidence of < 1% in clinical studies, or reported in post - marketing surveillance, are as follows: PrMANERIX® Product Monograph Page 11 of 35  Psychiatric: Difficulty falling asleep, nightmares/dreams, hallucinations, memory disturbances, confusion, disorientation, delusions, increased depression, excitation/irritability, hypomanic symptoms, aggressive behaviour, apathy, tension.
Cases of suicidal ideation and suicidal behaviour have been reported during antidepressant therapy or early after treatment discontinuation (see 7 WARNINGS AND PRECAUTIONS).  Cardiovascular: Hypertension, bradycardia, extrasystoles, angina/chest pain, phlebitic symptoms, flushing.
 Central and Peripheral Nervous System: Migraine, extrapyramidal effects, tinnitus, paresthesia, dysarthria.  Dermatological/Mucocutaneous: Exanthema/rash, allergic skin reaction, itching, gingivitis, stomatitis, dry skin, conjunctivitis, pruritus, urticaria.
 Gastrointestinal: Heartburn, gastritis, meteorism, indigestion.  Genito-Urinary: Disturbances of micturition (dysuria, polyuria, tenesmus) metrorrhagia, prolonged menstruation.  Miscellaneous: General malaise, skeletal/muscular pain, altered taste sensations, hot flushes/cold sensation, photopsia, dyspnea, visual disturbances.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory examinations were performed in a total of 1,401 patients during clinical trials with MANERIX. Reductions were observed in leucocyte, SGOT and SGPT values, however, these reductions were attributed to raised baseline values returning to normal and were not considered clinically relevant.
No other laboratory abnormalities were noted during clinical trials. 5 Post-Market Findings In post-market surveillance, there appeared to be a low incidence of raised liver enzymes, without associated clinical sequelae PrMANERIX® Product Monograph Page 12 of 35

CAOfficial regulatory label· Warnings and precautions· revised January 6, 2026[2]

1 Drug-Drug Interactions).  Concomitantly with dextromethorphan (contained in many proprietary cough medicines).  In combination with trimipramine/maprotiline.  In combination with bupropion.  In combination with triptans.  In combination with tramadol.
1 Drug-Drug Interactions).  Patients with hepatic disease. 1 Drug-Drug Interactions). In patients receiving MANERIX concomitantly with cimetidine, a 50% reduction in the dosage of MANERIX may be necessary. 2 Recommended Dose and Dosage Adjustment Usual Adult Dosage The administration of MANERIX should be initiated at 300 mg daily dose (in two divided doses) and increased gradually to a maximum of 600 mg/day if needed, noting carefully the clinical response and any evidence of intolerance.
Individual patient response may allow for a reduction of the daily dose. As with other antidepressants, it should be kept in mind that there may be a lag time in therapeutic response. There is no evidence that increasing the dosage rapidly shortens this latent period and may, in fact, increase the incidence of side -effects.
3 Pharmacokinetics), the initial daily dose of 300 mg should not be increased until after this first week of therapy. g. cimetidine), the daily dose of MANERIX should be reduced to one third or one half of the standard dose. Renal Impairment Single dose pharmacokinetic data suggest that no dosage adjustment may be required in patients with impaired renal function.
However, multiple dose studies with MANERIX have not been performed in patients with renal dysfunction, therefore, MANERIX should be used with caution in this patient population. In normal volunteers, the absolute bioavailability almost doubles following multiple dosing as compared to a single dose.
Geriatrics No dosage adjustments are necessary in elderly patients. PrMANERIX® Product Monograph Page 6 of 35 5 OVERDOSAGE Symptoms Signs and symptoms of overdosage with MANERIX (moclobemide) include nausea, vomiting drowsiness, disorientation, slurred speech, amnesia, reduced reflexes, agitation, hypertension and convulsions.
One patient remained stuporous for 36 hours following an ov erdose with 1,550 mg MANERIX. All abnormal laboratory values and vital signs returned to within normal range one to five days after overdosage. No organ toxicity was reported.

This is not medical advice. Consult a qualified healthcare professional.