🇺🇸 Liposomal irinotecan in United States

615 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: 615

Most-reported reactions

1. Off Label Use — 228 reports (37.07%)
2. Diarrhoea — 77 reports (12.52%)
3. Neutropenia — 72 reports (11.71%)
4. Decreased Appetite — 38 reports (6.18%)
5. Nausea — 37 reports (6.02%)
6. Fatigue — 34 reports (5.53%)
7. Overdose — 34 reports (5.53%)
8. Asthenia — 32 reports (5.2%)
9. Leukopenia — 32 reports (5.2%)
10. Vomiting — 31 reports (5.04%)

Source database →

Frequently asked questions

Is Liposomal irinotecan approved in United States?

Liposomal irinotecan does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Liposomal irinotecan in United States?

St. Jude Children's Research Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.