🇺🇸 Amitryptiline in United States

59 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 27 March 2025 – 27 March 2026
• Total reports: 59

Most-reported reactions

1. Drug Ineffective — 8 reports (13.56%)
2. Drug Interaction — 7 reports (11.86%)
3. Headache — 7 reports (11.86%)
4. Malaise — 7 reports (11.86%)
5. Back Pain — 6 reports (10.17%)
6. Anxiety — 5 reports (8.47%)
7. Diarrhoea — 5 reports (8.47%)
8. Off Label Use — 5 reports (8.47%)
9. Somnolence — 5 reports (8.47%)
10. Arthralgia — 4 reports (6.78%)

Source database →

Frequently asked questions

Is Amitryptiline approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Amitryptiline in United States?

Mahatma Gandhi Institute of Medical Sciences is the originator. The local marketing authorisation holder may differ — check the official source linked above.