🇺🇸 Darzalex Faspro(Daratumumab) in United States

47 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: 47

Most-reported reactions

1. Off Label Use — 8 reports (17.02%)
2. Rash — 8 reports (17.02%)
3. Diarrhoea — 6 reports (12.77%)
4. Fatigue — 5 reports (10.64%)
5. Neutropenia — 4 reports (8.51%)
6. Platelet Count Decreased — 4 reports (8.51%)
7. Abdominal Pain Upper — 3 reports (6.38%)
8. Asthenia — 3 reports (6.38%)
9. Dizziness — 3 reports (6.38%)
10. Fall — 3 reports (6.38%)

Source database →

Frequently asked questions

Is Darzalex Faspro(Daratumumab) approved in United States?

Darzalex Faspro(Daratumumab) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Darzalex Faspro(Daratumumab) in United States?

Celltrion is the originator. The local marketing authorisation holder may differ — check the official source linked above.