Trimipramine Maleate side effects: what 395 FDA adverse event reports show

Trimipramine Maleate · 10 reaction terms · 131 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

395 reports · 92% serious · 36 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Trimipramine capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients.

FDA label, Indications and Usage

What it is

DESCRIPTION Trimipramine maleate is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form). Molecular Formula: C 20 H 26 N 2 ∙ C 4 H 4 O 4 Molecul.

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 7 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 2Labeled (related wording) 1Reporting / coding artifact 1Not in label — unassessed 2

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.
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. 3 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
Suicide attempt	45	39.2 29.8–51.7ROR 44.1 · χ² 1,643 / p <1e-300	38.6 EB05 30.0 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 24.6	no trial data cached
Hypertensive crisis	8	38.0 19.1–75.4ROR 38.7 · χ² 252 / p 4e-57	35.0 EB05 18.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 23.8	no trial data cached
Drug toxicity	7	26.8 12.9–55.9ROR 27.3 · χ² 149 / p 1e-34	24.6 EB05 11.8 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.5	no trial data cached
Coma	23	25.6 17.2–38.0ROR 27.1 · χ² 519 / p 3e-115	25.1 EB05 17.6 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.0	no trial data cached
Sopor	6	23.8 10.7–52.6ROR 24.1 · χ² 109 / p 8e-26	20.8 EB05 8.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Serotonin syndrome	8	22.2 11.2–44.0ROR 22.6 · χ² 141 / p 7e-33	20.4 EB05 9.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.0	no trial data cached
Intentional overdose	23	19.1 12.9–28.4ROR 20.2 · χ² 378 / p 2e-84	18.8 EB05 13.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4 · ♀ 45% (drug 66%) · 95% clinician	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
Suicide attempt	45	39.2 29.8–51.7ROR 44.1 · χ² 1,643 / p <1e-300	38.6 EB05 30.0 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 24.6	no trial data cached
Intentional overdose	23	19.1 12.9–28.4ROR 20.2 · χ² 378 / p 2e-84	18.8 EB05 13.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4 · ♀ 45% (drug 66%) · 95% clinician	no trial data cached
Coma	23	25.6 17.2–38.0ROR 27.1 · χ² 519 / p 3e-115	25.1 EB05 17.6 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.0	no trial data cached
Serotonin syndrome	8	22.2 11.2–44.0ROR 22.6 · χ² 141 / p 7e-33	20.4 EB05 9.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.0	no trial data cached
Hypertensive crisis	8	38.0 19.1–75.4ROR 38.7 · χ² 252 / p 4e-57	35.0 EB05 18.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 23.8	no trial data cached
Drug toxicity	7	26.8 12.9–55.9ROR 27.3 · χ² 149 / p 1e-34	24.6 EB05 11.8 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.5	no trial data cached
Sopor	6	23.8 10.7–52.6ROR 24.1 · χ² 109 / p 8e-26	20.8 EB05 8.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Intentional self-injury	4	10.5 4.0–27.8ROR 10.6 · χ² 26 / p 2e-7	6.1 EB05 2.3 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	no trial data cached
Caesarean section	4	18.0 6.8–47.8ROR 18.2 · χ² 48 / p 2e-12	12.0 EB05 3.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Parkinsonism	3	16.3 5.3–50.3ROR 16.4 · χ² 29 / p 3e-8	8.7 EB05 2.3 · IC025 +0.3 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Trimipramine?

In FDA FAERS, the most frequently co-reported reaction terms for Trimipramine are suicide attempt, coma, serotonin syndrome, hypertensive crisis, drug toxicity, sopor. 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 Trimipramine 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 Trimipramine 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 4f31df66-7dc2-1f04-e054-00144ff88e88, effective 20260317; matched on openfda.generic_name.exact:"TRIMIPRAMINE")
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, 10 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.