🇺🇸 MIS in United States

194 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: 194

Most-reported reactions

1. Death — 43 reports (22.16%)
2. Fatigue — 21 reports (10.82%)
3. Drug Ineffective — 20 reports (10.31%)
4. Therapy Interrupted — 20 reports (10.31%)
5. Hallucination — 17 reports (8.76%)
6. Hospitalisation — 17 reports (8.76%)
7. Constipation — 15 reports (7.73%)
8. Infection — 14 reports (7.22%)
9. Nausea — 14 reports (7.22%)
10. Balance Disorder — 13 reports (6.7%)

Source database →

Frequently asked questions

Is MIS approved in United States?

MIS does not currently have US marketing authorisation in our dataset.

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

Blood Transfusion Centre of Slovenia is the originator. The local marketing authorisation holder may differ — check the official source linked above.