🇺🇸 prednisolon in United States

3,954 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: 3,954

Most-reported reactions

1. Dyspnoea — 564 reports (14.26%)
2. General Physical Health Deterioration — 536 reports (13.56%)
3. Pyrexia — 472 reports (11.94%)
4. Nausea — 439 reports (11.1%)
5. Fatigue — 367 reports (9.28%)
6. Pneumonia — 359 reports (9.08%)
7. Vomiting — 335 reports (8.47%)
8. Diarrhoea — 331 reports (8.37%)
9. Anaemia — 288 reports (7.28%)
10. Dizziness — 263 reports (6.65%)

Source database →

Frequently asked questions

Is prednisolon approved in United States?

Yes. FDA has authorised it.

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

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