Nortriptyline hydrochloride: adverse event reports filed with FDA

1,702

reports as suspect product

0% of all reports · about 78 a year

225

reports, 12 months to June 2026

258 in the 12 months before

84.4%

marked serious by the reporter

88.7% across the class

18%

record death among outcomes, as reported

306 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 Nortriptyline hydrochloride reports recording the termmedian drug in tricyclic antidepressant

1. Off label useused for a purpose or in a way not on the label32.7%557
2. Hyperhidrosisexcessive sweating28.1%479
3. Drug ineffectivethe medicine did not work as expected27.1%462
4. Headachehead pain22%374
5. Painpain, site not specified21.3%363
6. Hypersensitivityan allergic-type reaction21.2%361
7. Exposure during pregnancythe medicine was taken during pregnancy19.8%337
8. Hepatic enzyme increasedraised liver enzymes19.8%337
9. Immunodeficiency19.6%334
10. Food allergy19.5%332
11. Overdosea dose above the recommended amount19%323
12. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease18.4%313
13. Product use issuea problem in how the product was used18.1%308
14. Prescribed overdose17.7%301
15. Upper respiratory tract infectiona cold or similar infection17.5%297
16. Joint swellinga swollen joint17.4%296
17. Rash erythematousa red rash17%290
18. Asthmaasthma16.9%288
19. Hypertensionhigh blood pressure16.8%286
20. Fatiguetiredness16.6%282
21. Intentional product misusedeliberate use not as intended16.3%277
22. Constipationconstipation16.2%276
23. Drug intolerancethe medicine was not tolerated16.2%275
24. Infusion related reactiona reaction during or soon after an infusion16.1%274
25. Drug hypersensitivityan allergic-type reaction to a medicine15.3%260
26. Contraindicated product administered15%256
27. Fluid retentionthe body holding extra fluid15%256
28. Pyrexiafever15%255
29. Temperature regulation disorder14.9%253
30. Rashskin rash14.7%250

Top 30 of 343 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. 27.4% 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 1,702 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nortriptyline 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 Nortriptyline hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,732) 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.