🇺🇸 FIX in United States
799 US adverse-event reports
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: 22 April 2025 – 22 April 2026
- Total reports: 799
Most-reported reactions
- Blood Pressure Increased — 149 reports (18.65%)
- Malaise — 101 reports (12.64%)
- Cerebrovascular Accident — 92 reports (11.51%)
- Hypertension — 90 reports (11.26%)
- Diabetes Mellitus — 88 reports (11.01%)
- Death — 66 reports (8.26%)
- Drug Ineffective — 61 reports (7.63%)
- Blood Pressure Decreased — 52 reports (6.51%)
- Fall — 50 reports (6.26%)
- Pain — 50 reports (6.26%)
Other Hematology approved in United States
Frequently asked questions
Is FIX approved in United States?
FIX does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for FIX in United States?
Bioverativ Therapeutics Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.