FDA — authorised 31 July 1944
- Application: NDA005545
- Marketing authorisation holder: ABBVIE
- Local brand name: DICUMAROL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DICUMAROL in United States
FDA authorised DICUMAROL on 31 July 1944 · 118 US adverse-event reports
Marketing authorisations
FDA — authorised 9 April 1976
- Application: NDA005509
- Marketing authorisation holder: LILLY
- Local brand name: DICUMAROL
- Indication: CAPSULE — ORAL
- 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: 20 April 2025 – 20 April 2026
- Total reports: 118
Most-reported reactions
- Chest Pain — 16 reports (13.56%)
- Osteoporosis — 16 reports (13.56%)
- Rib Fracture — 16 reports (13.56%)
- Upper Respiratory Tract Infection — 16 reports (13.56%)
- Cough — 15 reports (12.71%)
- Hyperparathyroidism Secondary — 15 reports (12.71%)
- Pleuritic Pain — 15 reports (12.71%)
- Overdose — 4 reports (3.39%)
- Drug Interaction — 3 reports (2.54%)
- Cardiac Arrest — 2 reports (1.69%)
DICUMAROL 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 DICUMAROL approved in United States?
Yes. FDA authorised it on 31 July 1944; FDA authorised it on 9 April 1976; FDA has authorised it.
Who is the marketing authorisation holder for DICUMAROL in United States?
ABBVIE holds the US marketing authorisation.