What the label lists and what reports show

Trimipramine side effects

Trimipramine's FDA label lists its adverse reactions in its own words. FAERS holds 1,476 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is toxicity to various agents (125 reports).

Generic listed
Boxed warning

Check it at the source: the trimipramine FDA label on DailyMed (effective March 17, 2026, Breckenridge Pharmaceutical, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when trimipramine capsules are administered. Some of the adverse reactions included in this listing have not in fact been reported with trimipramine capsules. Cardiovascular Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric Confusional states (especially the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis. Neurological Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus; syndrome of inappropriate ADH (antidiuretic hormone) secretion. …

Source: FDA drug label, Breckenridge Pharmaceutical, Inc., effective March 17, 2026 (SPL set 4f31df66-7dc2-1f04-e054-00144ff88e88), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,476 reports list trimipramine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 244 are coded as a death and 776 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Drug Interaction (a use or a product term, not a reaction)129
Toxicity To Various Agents125
Nausea (named in the label)118
Dizziness (named in the label)111
Fatigue (named in the label)105
Vomiting (named in the label)100
Off Label Use (a use or a product term, not a reaction)99
Depression (a use or a product term, not a reaction)89
Coma85
Somnolence83
Headache (named in the label)79
Drug Ineffective (a use or a product term, not a reaction)75
Suicide Attempt75
Fall73
Diarrhoea (named in the label)65
Arthralgia64
Dyspnoea64
Abdominal Pain Upper60
Asthenia60
Condition Aggravated (a use or a product term, not a reaction)60
Abdominal Discomfort59
Drug Abuse55
Weight Increased53
Arthropathy52
General Physical Health Deterioration51

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Trimipramine: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions