🇺🇸 Mycobutin in United States

239 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.

Most-reported reactions

  1. Nausea — 37 reports (15.48%)
  2. Pyrexia — 35 reports (14.64%)
  3. Vomiting — 27 reports (11.3%)
  4. Drug Interaction — 23 reports (9.62%)
  5. Mycobacterium Avium Complex Infection — 22 reports (9.21%)
  6. Renal Impairment — 20 reports (8.37%)
  7. White Blood Cell Count Decreased — 20 reports (8.37%)
  8. Pain — 19 reports (7.95%)
  9. Asthenia — 18 reports (7.53%)
  10. Headache — 18 reports (7.53%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is Mycobutin approved in United States?

Yes. FDA has authorised it.

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

Harriet Shezi Children's Clinic is the originator. The local marketing authorisation holder may differ — check the official source linked above.