FDA — authorised 5 December 2020
- Application: NDA020287
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
🇺🇸 Fragmin in United States
FDA authorised Fragmin on 5 December 2020 · 4,140 US adverse-event reports
Marketing authorisation
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: 4,140
Most-reported reactions
- Off Label Use — 508 reports (12.27%)
- Nausea — 496 reports (11.98%)
- Pulmonary Embolism — 495 reports (11.96%)
- Dyspnoea — 456 reports (11.01%)
- Vomiting — 392 reports (9.47%)
- Fatigue — 376 reports (9.08%)
- Diarrhoea — 372 reports (8.99%)
- Pyrexia — 360 reports (8.7%)
- Abdominal Pain — 352 reports (8.5%)
- Death — 333 reports (8.04%)
Fragmin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Fragmin approved in United States?
Yes. FDA authorised it on 5 December 2020.
Who is the marketing authorisation holder for Fragmin in United States?
PFIZER holds the US marketing authorisation.