What the label lists and what reports show
Amitriptyline side effects
Amitriptyline's FDA label lists its adverse reactions in its own words. FAERS holds 17,441 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 pain (1,650 reports).
- Generic listed
- Boxed warning
Check it at the source: the amitriptyline FDA label on DailyMed (effective September 8, 2026, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsWithin each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. CNS and Neuromuscular: Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling, and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; …
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective September 8, 2026 (SPL set 4e520c63-1cf6-40f6-a51c-3f9b0e181342), via openFDA; the full label on DailyMed
What do FAERS reports show?
17,441 reports list amitriptyline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,314 are coded as a death and 5,755 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 23 reactions below, 10 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amitriptyline: 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