🇺🇸 Medrol in United States

FDA authorised Medrol on 24 October 1957 · 35,619 US adverse-event reports

Marketing authorisations

FDA — authorised 24 October 1957

  • Application: NDA011153
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA — authorised 18 May 1959

  • Application: NDA011856
  • Marketing authorisation holder: PHARMACIA AND UPJOHN
  • Status: supplemented

FDA — authorised 27 May 1959

  • Application: NDA011757
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

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. Off Label Use — 4,662 reports (13.09%)
  2. Fatigue — 3,894 reports (10.93%)
  3. Pain — 3,795 reports (10.65%)
  4. Drug Ineffective — 3,773 reports (10.59%)
  5. Dyspnoea — 3,630 reports (10.19%)
  6. Nausea — 3,561 reports (10%)
  7. Headache — 3,268 reports (9.17%)
  8. Pyrexia — 3,191 reports (8.96%)
  9. Arthralgia — 3,013 reports (8.46%)
  10. Diarrhoea — 2,832 reports (7.95%)

Source database →

Medrol in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Medrol approved in United States?

Yes. FDA authorised it on 24 October 1957; FDA authorised it on 18 May 1959; FDA authorised it on 27 May 1959.

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

PFIZER holds the US marketing authorisation.