🇺🇸 Monotherapy in United States

15 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

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: 27 March 2025 – 27 March 2026
• Total reports: 15

Most-reported reactions

1. Malignant Neoplasm Progression — 3 reports (20%)
2. Alopecia — 2 reports (13.33%)
3. Fatigue — 2 reports (13.33%)
4. Polyneuropathy — 2 reports (13.33%)
5. Acute Promyelocytic Leukaemia — 1 report (6.67%)
6. Anticoagulant-Related Nephropathy — 1 report (6.67%)
7. Bronchitis — 1 report (6.67%)
8. Cholecystectomy — 1 report (6.67%)
9. Drug Exposure During Pregnancy — 1 report (6.67%)
10. Drug Ineffective — 1 report (6.67%)

Source database →

Frequently asked questions

Is Monotherapy approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Monotherapy in United States?

Gachon University Gil Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.