FDA — authorised 15 December 1952
- Application: NDA008697
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CORTEF
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cortef in United States
FDA authorised Cortef on 15 December 1952 · 7,269 US adverse-event reports
Marketing authorisations
FDA — authorised 27 April 1955
- Application: NDA009866
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: supplemented
FDA — authorised 10 May 1955
- Application: NDA009900
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CORTEF
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA009864
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CORTEF
- Indication: INJECTABLE — INJECTION
- 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.
- Window: 27 March 2025 – 27 March 2026
- Total reports: 7,269
Most-reported reactions
- Off Label Use — 1,087 reports (14.95%)
- Fatigue — 839 reports (11.54%)
- Nausea — 813 reports (11.18%)
- Dyspnoea — 765 reports (10.52%)
- Headache — 681 reports (9.37%)
- Infusion Related Reaction — 666 reports (9.16%)
- Diarrhoea — 635 reports (8.74%)
- Pyrexia — 634 reports (8.72%)
- Arthralgia — 588 reports (8.09%)
- Pain — 561 reports (7.72%)
Other Other approved in United States
Frequently asked questions
Is Cortef approved in United States?
Yes. FDA authorised it on 15 December 1952; FDA authorised it on 27 April 1955; FDA authorised it on 10 May 1955.
Who is the marketing authorisation holder for Cortef in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.