AMOXAPINE
Amoxapine is a tricyclic antidepressant indicated for the symptomatic relief of various forms of depression. It is utilized in the treatment of patients with neurotic or reactive depressive disorders, as well as those with endogenous and psychotic depressions. The medication is also specifically indicated for cases where depression is accompanied by symptoms of agitation or anxiety.
How AMOXAPINE Works
Amoxapine is a tricyclic antidepressant (TCA) of the dibenzoxazepine class. It primarily functions by inhibiting the neuronal reuptake of norepinephrine and, to a lesser extent, serotonin. Distinctively among TCAs, amoxapine and its active metabolite, 7-hydroxyamoxapine, exhibit significant dopamine receptor antagonism (specifically at D2 receptors). This dual action—combining antidepressant reuptake inhibition with neuroleptic-like dopamine blockade—contributes to its efficacy in treating psychotic depression and depression with agitation.
Details
- Status
- Discontinued
- First Approved
- 1989-05-11
- Routes
- ORAL
- Dosage Forms
- TABLET
AMOXAPINE Approval History
What AMOXAPINE Treats
2 indicationsAMOXAPINE is approved for 2 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
- Anxiety
AMOXAPINE Boxed Warning
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. Short-term studies did not show an increase in the risk of suicidality wi...
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. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amoxapine is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )
AMOXAPINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMOXAPINE
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMOXAPINE FDA Label Details
Indications & Usage
FDA Label (PDF)AMOXAPINE is indicated for the treatment of Depression; Anxiety.
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 ...
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ASENDIN
Full clinical data, patents, trials, and competitive landscape for amoxapine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.