Amoxapine side effects: what 475 FDA adverse event reports show

Amoxapine · 25 reaction terms · 270 drug–reaction co-reports · data 2026-09-14

Drug class

Tricyclic Antidepressant

FDA label (Established Pharmacologic Class)

Who reports

475 reports · 84% serious · 115 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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.

FDA label, Indications and Usage

What it is

DESCRIPTION Amoxapine is an antidepressant of the dibenzoxazepine class, chemically distinct from the dibenzazepines, dibenzocycloheptenes, and dibenzoxepines. It is designated chemically as 2-Chloro-11-(1-piperazinyl)dibenz[b,f][1,4]oxazepine.

FDA label, Description section

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 19 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 3Labeled (related wording) 1Reporting / coding artifact 3Outcome field, not a reaction 1Not in label — unassessed 10

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 6 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Poisoning	40	140.7 104.5–189.3ROR 153.5 · χ² 5,394 / p <1e-300	131.5 EB05 100.8 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 97.5 · 98% clinician	no trial data cached
Poisoning deliberate	9	42.8 22.4–81.8ROR 43.6 · χ² 327 / p 2e-73	39.5 EB05 22.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.1	no trial data cached
Tachypnoea	12	39.2 22.4–68.6ROR 40.2 · χ² 409 / p 2e-91	37.1 EB05 22.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.5	no trial data cached
Neuroleptic malignant syndrome	9	33.5 17.5–64.0ROR 34.1 · χ² 252 / p 4e-57	31.4 EB05 17.5 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.9	no trial data cached
Parkinsonism	7	31.8 15.2–66.3ROR 32.2 · χ² 179 / p 4e-41	29.1 EB05 14.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Serotonin syndrome	13	30.1 17.6–51.4ROR 30.9 · χ² 337 / p 1e-75	28.9 EB05 17.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Hepatic cytolysis	7	25.4 12.2–52.9ROR 25.7 · χ² 140 / p 1e-32	23.1 EB05 10.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	no trial data cached
Altered state of consciousness	12	24.6 14.1–43.1ROR 25.3 · χ² 249 / p 2e-56	23.7 EB05 14.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Anorexia	6	20.3 9.2–45.0ROR 20.6 · χ² 92 / p 5e-22	17.2 EB05 6.3 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.2	no trial data cached
Drug abuse	37	19.6 14.4–26.7ROR 21.1 · χ² 636 / p 1e-140	19.4 EB05 14.6 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 95% clinician	no trial data cached
Status epilepticus	5	19.6 8.2–46.8ROR 19.8 · χ² 70 / p 2e-17	15.2 EB05 4.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Drug toxicity	6	19.2 8.7–42.6ROR 19.5 · χ² 86 / p 8e-21	16.0 EB05 5.9 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.6	no trial data cached
Muscle rigidity	5	18.5 7.7–44.3ROR 18.7 · χ² 66 / p 2e-16	14.1 EB05 4.6 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.2	no trial data cached
Cyanosis (blue skin from low oxygen)	6	16.8 7.6–37.3ROR 17.0 · χ² 74 / p 3e-18	13.4 EB05 5.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached
Hepatic function abnormal	14	16.7 10.0–28.0ROR 17.2 · χ² 192 / p 7e-44	15.9 EB05 9.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Drug level increased	6	16.0 7.2–35.5ROR 16.2 · χ² 70 / p 3e-17	12.5 EB05 4.7 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.1	no trial data cached
Completed suicide (death by suicide)	27	14.2 9.8–20.5ROR 15.0 · χ² 319 / p 1e-71	13.8 EB05 9.7 · IC025 +2.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 9.7 · 96% clinician	no trial data cached
Suicide attempt	17	12.4 7.8–19.7ROR 12.8 · χ² 167 / p 2e-38	11.4 EB05 7.0 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 8.5	no trial data cached
Intentional overdose	13	9.0 5.3–15.4ROR 9.2 · χ² 85 / p 1e-20	7.5 EB05 4.4 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Poisoning	40	140.7 104.5–189.3ROR 153.5 · χ² 5,394 / p <1e-300	131.5 EB05 100.8 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 97.5 · 98% clinician	no trial data cached
Drug abuse	37	19.6 14.4–26.7ROR 21.1 · χ² 636 / p 1e-140	19.4 EB05 14.6 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 95% clinician	no trial data cached
Completed suicide (death by suicide)	27	14.2 9.8–20.5ROR 15.0 · χ² 319 / p 1e-71	13.8 EB05 9.7 · IC025 +2.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 9.7 · 96% clinician	no trial data cached
Suicide attempt	17	12.4 7.8–19.7ROR 12.8 · χ² 167 / p 2e-38	11.4 EB05 7.0 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 8.5	no trial data cached
Hepatic function abnormal	14	16.7 10.0–28.0ROR 17.2 · χ² 192 / p 7e-44	15.9 EB05 9.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Intentional overdose	13	9.0 5.3–15.4ROR 9.2 · χ² 85 / p 1e-20	7.5 EB05 4.4 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached
Serotonin syndrome	13	30.1 17.6–51.4ROR 30.9 · χ² 337 / p 1e-75	28.9 EB05 17.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Altered state of consciousness	12	24.6 14.1–43.1ROR 25.3 · χ² 249 / p 2e-56	23.7 EB05 14.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Tachypnoea	12	39.2 22.4–68.6ROR 40.2 · χ² 409 / p 2e-91	37.1 EB05 22.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.5	no trial data cached
Neuroleptic malignant syndrome	9	33.5 17.5–64.0ROR 34.1 · χ² 252 / p 4e-57	31.4 EB05 17.5 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.9	no trial data cached
Poisoning deliberate	9	42.8 22.4–81.8ROR 43.6 · χ² 327 / p 2e-73	39.5 EB05 22.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.1	no trial data cached
Hepatic cytolysis	7	25.4 12.2–52.9ROR 25.7 · χ² 140 / p 1e-32	23.1 EB05 10.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	no trial data cached
Parkinsonism	7	31.8 15.2–66.3ROR 32.2 · χ² 179 / p 4e-41	29.1 EB05 14.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 25.1	no trial data cached
Drug level increased	6	16.0 7.2–35.5ROR 16.2 · χ² 70 / p 3e-17	12.5 EB05 4.7 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.1	no trial data cached
Cyanosis (blue skin from low oxygen)	6	16.8 7.6–37.3ROR 17.0 · χ² 74 / p 3e-18	13.4 EB05 5.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Poisoning — n=40, PRR 140.7

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Amoxapine?

In FDA FAERS, the most frequently co-reported reaction terms for Amoxapine are poisoning, suicide attempt, hepatic function abnormal, serotonin syndrome, altered state of consciousness, tachypnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Amoxapine have an FDA boxed warning?

Yes. The current FDA label carries a 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.

Do FAERS signals prove that Amoxapine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID eed5e856-dd7b-4eaa-9dad-508f2bef9328, effective 20241218; matched on openfda.generic_name.exact:"AMOXAPINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 25 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.