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Molecule

Amoxapine

Tricyclic Antidepressant
Available on requestPsychiatry
Presentations
4
Brands
0
Manufacturers
0
Available from stock
0

Amoxapine is a tricyclic antidepressant indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is available as tablets for oral use. MedsAcross supplies Amoxapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Tricyclic Antidepressant
ATC classification
N06AA17 Amoxapine · Antidepressant, subgroup N06AA
US FDA first approval
22 September 1980
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII R63VQ857OTRxCUI 722CAS 14028-44-5DrugBank DB00543Q58356

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.

Source: US FDA prescribing information

Dosing overview

Effective dosage of amoxapine may vary from one patient to another. Usual effective dosage is 200 to 300 mg daily. Three weeks constitutes an adequate period of trial providing dosage has reached 300 mg daily (or lower level of tolerance) for at least two weeks. If no response is seen at 300 mg, dosage may be increased, depending upon tolerance, up to 400 mg daily. Hospitalized patients who have been refractory to antidepressant therapy and who have no history of convulsive seizures may have dosage raised cautiously up to 600 mg daily in divided doses. Amoxapine may be given in a single daily dose, not to exceed 300 mg, preferably at bedtime. If the total daily dosage exceeds 300 mg, it should be given in divided doses. Initial Dosage for Adults Usual starting dosage is 50 mg two or three times daily.

Source: US FDA prescribing information

Contraindications

Amoxapine is contraindicated in patients who have shown prior hypersensitivity to dibenzoxazepine compounds. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amoxapine, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amoxapine should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.

Source: US FDA prescribing information

Warnings and precautions

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amoxapine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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.

Source: US FDA prescribing information

Side effects

Adverse reactions reported in controlled studies in the United States are categorized with respect to incidence below. Following this is a listing of reactions known to occur with other antidepressant drugs of this class. Incidence Greater Than 1% The most frequent types of adverse reactions occurring with amoxapine in controlled clinical trials were sedative and anticholinergic: these included drowsiness (14%), dry mouth (14%), constipation (12%), and blurred vision (7%). Less frequently reported reactions are: CNS and Neuromuscular: anxiety, insomnia, restlessness, nervousness, palpitations, tremors, confusion, excitement, nightmares, ataxia, alterations in EEG patterns. Allergic: edema, skin rash. Endocrine: elevation of prolactin levels. Gastrointestinal: nausea. Other: dizziness, headache, fatigue, weakness, excessive appetite, increased perspiration.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Amoxapine, sorted by availability.

MedicineManufacturerRegisterAvailability
Amoxapine 100 mg tabletOralGeneric name—US FDAAvailable on request
Amoxapine 150 mg tabletOralGeneric name—US FDAAvailable on request
Amoxapine 25 mg tabletOralGeneric name—US FDAAvailable on request
Amoxapine 50 mg tabletOralGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 22 September 1980Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Amoxapine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Amoxapine available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Amoxapine and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Amoxapine approved by the US FDA?

Yes. The US FDA first approved Amoxapine on 22 September 1980, according to Drugs@FDA.

Does Amoxapine need cold chain shipping?

No listed presentation of Amoxapine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Amoxapine in?

Amoxapine is classified under ATC code N06AA17 (Amoxapine).

References

  1. Amoxapine prescribing information (Chartwell RX). U.S. National Library of Medicine, DailyMed. Retrieved 18 December 2024

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