FDA — authorised 7 April 1961
- Application: NDA012703
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ELAVIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 amitryptaline in United States
FDA authorised amitryptaline on 7 April 1961 · 29 US adverse-event reports
Marketing authorisations
FDA — authorised 11 April 1961
- Application: NDA012704
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ELAVIL
- Indication: INJECTABLE — INJECTION
- Status: approved
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: 29
Most-reported reactions
- Pain — 4 reports (13.79%)
- Arthralgia — 3 reports (10.34%)
- Burning Sensation — 3 reports (10.34%)
- Dizziness — 3 reports (10.34%)
- Gait Disturbance — 3 reports (10.34%)
- Malaise — 3 reports (10.34%)
- Product Substitution Issue — 3 reports (10.34%)
- Weight Increased — 3 reports (10.34%)
- Condition Aggravated — 2 reports (6.9%)
- Drug Ineffective — 2 reports (6.9%)
Other Other approved in United States
Frequently asked questions
Is amitryptaline approved in United States?
Yes. FDA authorised it on 7 April 1961; FDA authorised it on 11 April 1961; FDA has authorised it.
Who is the marketing authorisation holder for amitryptaline in United States?
ASTRAZENECA holds the US marketing authorisation.