Trimipramine side effects: what 1,081 FDA adverse event reports show

Trimipramine · 94 reaction terms · 1,712 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,081 reports · 96% serious · 208 with death outcome · 69% 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 40 strongest signals

Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 33

What the badges mean

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.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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. 54 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
Gastrointestinal pain	32	56.8 40.4–80.0ROR 58.5 · χ² 1,695 / p <1e-300	54.9 EB05 40.7 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 51.7 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Brain oedema	36	55.5 40.2–76.5ROR 57.3 · χ² 1,867 / p <1e-300	53.8 EB05 40.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 33.5 · ♀ 19% (drug 69%)	no trial data cached
Pharyngitis	33	51.5 36.8–72.1ROR 53.1 · χ² 1,581 / p <1e-300	50.0 EB05 37.2 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 39.9 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Musculoskeletal disorder	33	33.5 23.9–46.9ROR 34.5 · χ² 1,007 / p 2e-221	32.9 EB05 24.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.9 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Feeding disorder	34	33.1 23.8–46.1ROR 34.2 · χ² 1,027 / p 1e-225	32.5 EB05 24.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 27.9 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Pneumonia aspiration	41	32.0 23.7–43.2ROR 33.2 · χ² 1,198 / p 7e-263	31.5 EB05 24.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 93% clinician	no trial data cached
Helicobacter infection	16	30.5 18.7–49.6ROR 30.9 · χ² 427 / p 4e-95	29.5 EB05 19.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 19.3	no trial data cached
Eating disorder	33	30.0 21.4–42.0ROR 30.9 · χ² 896 / p 5e-197	29.5 EB05 22.0 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.1 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Apathy	21	28.1 18.4–42.9ROR 28.6 · χ² 521 / p 1e-115	27.4 EB05 18.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 24.3	no trial data cached
Hypophagia	34	26.0 18.7–36.2ROR 26.8 · χ² 793 / p 8e-175	25.7 EB05 19.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.9 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Vitamin d deficiency	13	25.9 15.1–44.5ROR 26.2 · χ² 287 / p 1e-64	25.0 EB05 15.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.7	no trial data cached
Ear infection	35	25.6 18.5–35.5ROR 26.4 · χ² 803 / p 5e-177	25.3 EB05 19.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 28.0 · ♀ 100% (drug 69%) · 94% clinician	no trial data cached
Coma	62	25.3 19.8–32.2ROR 26.7 · χ² 1,422 / p <1e-300	25.1 EB05 20.2 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.2 · 92% clinician	no trial data cached
Breast cancer metastatic	13	23.5 13.7–40.4ROR 23.8 · χ² 258 / p 2e-58	22.7 EB05 13.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Aspiration	13	23.3 13.6–40.0ROR 23.6 · χ² 255 / p 8e-58	22.5 EB05 13.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
Folliculitis	11	20.7 11.5–37.2ROR 20.9 · χ² 187 / p 9e-43	19.6 EB05 11.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Supraventricular tachycardia	10	20.3 11.0–37.6ROR 20.5 · χ² 165 / p 6e-38	19.1 EB05 10.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Obesity	16	19.5 12.0–31.7ROR 19.7 · χ² 262 / p 3e-59	18.9 EB05 12.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Hypertensive crisis	11	19.1 10.6–34.4ROR 19.3 · χ² 171 / p 2e-39	18.0 EB05 9.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Adverse reaction	13	19.0 11.1–32.7ROR 19.2 · χ² 204 / p 1e-46	18.2 EB05 10.8 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=13	no trial data cached
Arthropathy	48	16.7 12.7–22.0ROR 17.4 · χ² 694 / p 3e-153	16.6 EB05 12.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · ♀ 100% (drug 69%) · 94% clinician	no trial data cached
Hand deformity	11	16.3 9.1–29.4ROR 16.5 · χ² 143 / p 3e-33	15.0 EB05 7.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Electrocardiogram qt prolonged	30	16.2 11.4–23.0ROR 16.6 · χ² 413 / p 5e-92	15.9 EB05 11.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · ♀ 100% (drug 69%) · 93% clinician	no trial data cached
Bursitis	10	16.1 8.7–29.8ROR 16.2 · χ² 127 / p 1e-29	14.5 EB05 7.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Oral herpes	16	16.0 9.8–26.0ROR 16.2 · χ² 210 / p 7e-48	15.2 EB05 9.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.1	no trial data cached
Middle insomnia	15	15.7 9.5–25.9ROR 15.9 · χ² 191 / p 8e-44	14.8 EB05 8.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.1	no trial data cached
Pemphigus	10	15.6 8.4–28.9ROR 15.7 · χ² 123 / p 9e-29	14.0 EB05 7.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Poisoning	10	15.4 8.3–28.5ROR 15.5 · χ² 120 / p 3e-28	13.7 EB05 6.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Pulmonary oedema	34	14.7 10.6–20.5ROR 15.2 · χ² 422 / p 5e-94	14.4 EB05 10.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.9 · ♀ 3% (drug 69%)	no trial data cached
Metastases to bone	12	14.2 8.1–25.0ROR 14.4 · χ² 135 / p 2e-31	12.9 EB05 6.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Toxicity to various agents	123	14.2 12.0–16.8ROR 15.9 · χ² 1,510 / p <1e-300	14.2 EB05 12.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.8 · 93% clinician	no trial data cached
Deafness	19	14.1 9.0–22.0ROR 14.3 · χ² 218 / p 1e-49	13.4 EB05 8.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Incorrect route of product administration	12	13.9 7.9–24.3ROR 14.0 · χ² 131 / p 1e-30	12.4 EB05 6.7 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 16.6	no trial data cached
Irritable bowel syndrome	15	13.6 8.2–22.5ROR 13.8 · χ² 163 / p 1e-37	12.6 EB05 7.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Haematoma	18	13.4 8.5–21.2ROR 13.6 · χ² 195 / p 1e-44	12.6 EB05 7.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Pericarditis	11	12.8 7.1–23.1ROR 12.9 · χ² 108 / p 1e-25	11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Depressed level of consciousness	26	12.8 8.7–18.7ROR 13.1 · χ² 271 / p 3e-61	12.2 EB05 8.4 · IC025 +2.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 7.9 · 96% clinician	no trial data cached
Wound	18	12.6 7.9–19.9ROR 12.8 · χ² 180 / p 2e-41	11.6 EB05 7.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Drug abuse	53	12.3 9.5–16.0ROR 12.9 · χ² 541 / p 7e-120	12.0 EB05 9.4 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5 · 92% clinician	no trial data cached
Restlessness	23	12.2 8.1–18.3ROR 12.4 · χ² 225 / p 3e-51	11.5 EB05 7.7 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.6 · ♀ 10% (drug 69%) · 96% 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
Toxicity to various agents	123	14.2 12.0–16.8ROR 15.9 · χ² 1,510 / p <1e-300	14.2 EB05 12.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.8 · 93% clinician	no trial data cached
Drug interaction	97	11.9 9.8–14.3ROR 12.9 · χ² 961 / p 3e-211	11.7 EB05 9.8 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.9 · ♀ 43% (drug 69%) · 94% clinician	no trial data cached
Coma	62	25.3 19.8–32.2ROR 26.7 · χ² 1,422 / p <1e-300	25.1 EB05 20.2 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.2 · 92% clinician	no trial data cached
Drug abuse	53	12.3 9.5–16.0ROR 12.9 · χ² 541 / p 7e-120	12.0 EB05 9.4 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5 · 92% clinician	no trial data cached
Arthropathy	48	16.7 12.7–22.0ROR 17.4 · χ² 694 / p 3e-153	16.6 EB05 12.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · ♀ 100% (drug 69%) · 94% clinician	no trial data cached
Completed suicide (death by suicide)	47	10.8 8.2–14.3ROR 11.3 · χ² 411 / p 9e-92	10.5 EB05 8.0 · IC025 +2.8 3/3 methods agree	Outcome field, not a reaction	serious PRR 6.5 · 98% clinician	no trial data cached
Gastrointestinal disorder	45	9.9 7.4–13.2ROR 10.3 · χ² 352 / p 9e-79	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.0 · ♀ 100% (drug 69%) · 91% clinician	no trial data cached
Pneumonia aspiration	41	32.0 23.7–43.2ROR 33.2 · χ² 1,198 / p 7e-263	31.5 EB05 24.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 93% clinician	no trial data cached
Brain oedema	36	55.5 40.2–76.5ROR 57.3 · χ² 1,867 / p <1e-300	53.8 EB05 40.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 33.5 · ♀ 19% (drug 69%)	no trial data cached
Ear infection	35	25.6 18.5–35.5ROR 26.4 · χ² 803 / p 5e-177	25.3 EB05 19.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 28.0 · ♀ 100% (drug 69%) · 94% clinician	no trial data cached
Adverse drug reaction	34	7.4 5.3–10.3ROR 7.6 · χ² 182 / p 1e-41	6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 12.8 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Pulmonary oedema	34	14.7 10.6–20.5ROR 15.2 · χ² 422 / p 5e-94	14.4 EB05 10.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.9 · ♀ 3% (drug 69%)	no trial data cached
Hypophagia	34	26.0 18.7–36.2ROR 26.8 · χ² 793 / p 8e-175	25.7 EB05 19.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.9 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Feeding disorder	34	33.1 23.8–46.1ROR 34.2 · χ² 1,027 / p 1e-225	32.5 EB05 24.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 27.9 · ♀ 100% (drug 69%) · 97% clinician	no trial data cached
Eating disorder	33	30.0 21.4–42.0ROR 30.9 · χ² 896 / p 5e-197	29.5 EB05 22.0 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.1 · ♀ 100% (drug 69%) · 97% clinician	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.

Gastrointestinal pain — n=32, PRR 56.8
Brain oedema — n=36, PRR 55.5
Pharyngitis — n=33, PRR 51.5
Musculoskeletal disorder — n=33, PRR 33.5
Feeding disorder — n=34, PRR 33.1
Pneumonia aspiration — n=41, PRR 32.0
Apathy — n=21, PRR 28.1
Hypophagia — n=34, PRR 26.0
Ear infection — n=35, PRR 25.6
Arthropathy — n=48, PRR 16.7

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 Trimipramine?

In FDA FAERS, the most frequently co-reported reaction terms for Trimipramine are toxicity to various agents, coma, arthropathy, gastrointestinal disorder, pneumonia aspiration, brain oedema. 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, 94 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.