🇺🇸 Amiodarone Hydrochloride Tablets in United States

160 US adverse-event reports

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: 28 March 2025 – 28 March 2026
• Total reports: 160

Most-reported reactions

1. Off Label Use — 25 reports (15.62%)
2. Fatigue — 23 reports (14.38%)
3. Dyspnoea — 20 reports (12.5%)
4. Asthenia — 17 reports (10.62%)
5. Cough — 17 reports (10.62%)
6. Wheezing — 14 reports (8.75%)
7. Blindness — 13 reports (8.12%)
8. Chest Pain — 12 reports (7.5%)
9. Dizziness — 10 reports (6.25%)
10. Pulmonary Fibrosis — 9 reports (5.62%)

Source database →

Frequently asked questions

Is Amiodarone Hydrochloride Tablets approved in United States?

Amiodarone Hydrochloride Tablets does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Amiodarone Hydrochloride Tablets in United States?

Jemincare is the originator. The local marketing authorisation holder may differ — check the official source linked above.