FDA — authorised 30 May 1973
- Application: NDA017011
- Marketing authorisation holder: ABBVIE
- Status: supplemented
🇺🇸 PREDNISOLONE in United States
FDA authorised PREDNISOLONE on 30 May 1973 · 81,933 US adverse-event reports
Marketing authorisations
FDA — authorised 29 December 1995
- Application: ANDA074449
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: approved
FDA — authorised 25 April 2005
- Application: ANDA076913
- Marketing authorisation holder: PHARM ASSOC
- Status: approved
FDA — authorised 9 June 2005
- Application: ANDA075988
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 9 June 2008
- Application: ANDA078988
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- Status: approved
FDA — authorised 25 October 2022
- Application: ANDA216715
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 2 May 2024
- Application: ANDA218083
- Marketing authorisation holder: ZHEJIANG XIANJU
- Status: approved
FDA — authorised 5 June 2024
- Application: ANDA040775
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- 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: 20 April 2025 – 20 April 2026
- Total reports: 81,933
Most-reported reactions
- Off Label Use — 15,291 reports (18.66%)
- Drug Ineffective — 13,391 reports (16.34%)
- Pyrexia — 8,822 reports (10.77%)
- Dyspnoea — 7,284 reports (8.89%)
- Pneumonia — 7,220 reports (8.81%)
- Diarrhoea — 7,063 reports (8.62%)
- Condition Aggravated — 6,187 reports (7.55%)
- Nausea — 5,856 reports (7.15%)
- Fatigue — 5,427 reports (6.62%)
- Vomiting — 5,392 reports (6.58%)
PREDNISOLONE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is PREDNISOLONE approved in United States?
Yes. FDA authorised it on 30 May 1973; FDA authorised it on 29 December 1995; FDA authorised it on 25 April 2005.
Who is the marketing authorisation holder for PREDNISOLONE in United States?
ABBVIE holds the US marketing authorisation.