Amitriptyline hydrochloride: adverse event reports filed with FDA

4,504

reports as suspect product

0% of all reports · about 201 a year

341

reports, 12 months to June 2026

442 in the 12 months before

90%

marked serious by the reporter

88.7% across the class

15.8%

record death among outcomes, as reported

711 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Amitriptyline hydrochloride reports recording the termmedian drug in tricyclic antidepressant

1. Toxicity to various agentspoisoning or toxic effect of one or more substances14.4%649
2. Painpain, site not specified14%631
3. Falla fall14%630
4. Hypotensionlow blood pressure12.7%572
5. Cognitive disorderproblems with thinking or memory12.1%547
6. Constipationconstipation12%539
7. Balance disorderproblems with balance11.7%526
8. Sedationdrowsiness from a medicine11.2%506
9. Depressed level of consciousness11%494
10. Orthostatic hypotension10.7%481
11. Mobility decreasedreduced ability to move about9.8%441
12. Blood calcium decreased9.5%427
13. Creatinine renal clearance decreased9.5%427
14. Sedation complication9.5%427
15. Drug interactionan interaction between medicines8.6%389
16. Drug ineffectivethe medicine did not work as expected8.2%370
17. Off label useused for a purpose or in a way not on the label7.2%325
18. Completed suicidedeath by suicide6.1%274
19. Dyspnoeashortness of breath6.1%274
20. Fatiguetiredness5.1%229
21. Nauseafeeling sick5%227
22. Product use in unapproved indicationused for a purpose not on the label5%227
23. Dizzinesslight-headedness or unsteadiness4.7%211
24. Somnolencedrowsiness4.5%203
25. Drug abusemisuse of a medicine4.4%199
26. Malaisegeneral feeling of being unwell4.2%188
27. Confusional stateconfusion4.1%186
28. Coma4.1%184
29. Insomniadifficulty sleeping4%180
30. Headachehead pain3.7%166

Top 30 of 1,015 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 11 drugs in the tricyclic antidepressant class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 18,174 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 26.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,504 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amitriptyline hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the tricyclic antidepressant class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Amitriptyline hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (13,256) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.