🇺🇸 Adriamycin in United States

14,349 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: 28 March 2025 – 28 March 2026
• Total reports: 14,349

Most-reported reactions

1. Alopecia — 3,930 reports (27.39%)
2. Psychological Trauma — 1,711 reports (11.92%)
3. Hair Texture Abnormal — 1,260 reports (8.78%)
4. Hair Colour Changes — 1,258 reports (8.77%)
5. Hair Disorder — 1,213 reports (8.45%)
6. Madarosis — 1,080 reports (7.53%)
7. Pain — 1,049 reports (7.31%)
8. Anxiety — 1,017 reports (7.09%)
9. Emotional Distress — 916 reports (6.38%)
10. Febrile Neutropenia — 915 reports (6.38%)

Source database →

Frequently asked questions

Is Adriamycin approved in United States?

Yes. FDA has authorised it.

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

Johann Wolfgang Goethe University Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.