🇺🇸 ONO-4538 in United States
5 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: 23 April 2025 – 23 April 2026
- Total reports: 5
Most-reported reactions
- Decreased Appetite — 1 report (20%)
- Diarrhoea — 1 report (20%)
- Gastrointestinal Inflammation — 1 report (20%)
- Malaise — 1 report (20%)
- Malnutrition — 1 report (20%)
Other Oncology approved in United States
Frequently asked questions
Is ONO-4538 approved in United States?
ONO-4538 does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for ONO-4538 in United States?
Ono Pharmaceutical Co. Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.