🇺🇸 PREDNISOLONE ACETATE in United States

FDA authorised PREDNISOLONE ACETATE on 30 May 1973 · 4,508 US adverse-event reports

Marketing authorisations

FDA — authorised 30 May 1973

  • Application: NDA017011
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

FDA — authorised 10 July 1973

  • Application: NDA017469
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 2 August 2024

  • Application: ANDA216935
  • Marketing authorisation holder: LUPIN LTD
  • Status: approved

FDA — authorised 11 June 2025

  • Application: ANDA218256
  • Marketing authorisation holder: AMNEAL
  • 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.

Most-reported reactions

  1. Treatment Failure — 1,281 reports (28.42%)
  2. Drug Ineffective — 776 reports (17.21%)
  3. Off Label Use — 496 reports (11%)
  4. Eye Pain — 441 reports (9.78%)
  5. Eye Irritation — 273 reports (6.06%)
  6. Vision Blurred — 266 reports (5.9%)
  7. Fatigue — 264 reports (5.86%)
  8. Headache — 255 reports (5.66%)
  9. Diarrhoea — 239 reports (5.3%)
  10. Condition Aggravated — 217 reports (4.81%)

Source database →

PREDNISOLONE ACETATE 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 ACETATE approved in United States?

Yes. FDA authorised it on 30 May 1973; FDA authorised it on 10 July 1973; FDA authorised it on 2 August 2024.

Who is the marketing authorisation holder for PREDNISOLONE ACETATE in United States?

ABBVIE holds the US marketing authorisation.