🇺🇸 Cubicin in United States

3,402 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: 28 March 2025 – 28 March 2026
• Total reports: 3,402

Most-reported reactions

1. Blood Creatine Phosphokinase Increased — 515 reports (15.14%)
2. Product Use In Unapproved Indication — 485 reports (14.26%)
3. Off Label Use — 434 reports (12.76%)
4. Eosinophilic Pneumonia — 416 reports (12.23%)
5. Death — 376 reports (11.05%)
6. Pyrexia — 272 reports (8%)
7. Rhabdomyolysis — 266 reports (7.82%)
8. Drug Ineffective — 226 reports (6.64%)
9. Sepsis — 209 reports (6.14%)
10. Eosinophilia — 203 reports (5.97%)

Source database →

Frequently asked questions

Is Cubicin approved in United States?

Yes. FDA has authorised it.

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

Clinical Alliance for Research & Education - Infectious Diseases, LLC. is the originator. The local marketing authorisation holder may differ — check the official source linked above.