🇺🇸 Ursolvan in United States
154 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: 28 March 2025 – 28 March 2026
- Total reports: 154
Most-reported reactions
- Tremor — 19 reports (12.34%)
- Pyrexia — 18 reports (11.69%)
- Pancytopenia — 17 reports (11.04%)
- Cholestasis — 16 reports (10.39%)
- Weight Decreased — 16 reports (10.39%)
- Thrombotic Microangiopathy — 15 reports (9.74%)
- Off Label Use — 14 reports (9.09%)
- Neutropenia — 13 reports (8.44%)
- Overdose — 13 reports (8.44%)
- Pancreatitis Acute — 13 reports (8.44%)
Other Other approved in United States
Frequently asked questions
Is Ursolvan approved in United States?
Ursolvan does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Ursolvan in United States?
Hopital Foch is the originator. The local marketing authorisation holder may differ — check the official source linked above.