🇺🇸 Rifabutin 150 MG in United States

FDA authorised Rifabutin 150 MG on 23 December 1992 · 4 US adverse-event reports

Marketing authorisations

FDA — authorised 23 December 1992

  • Application: NDA050689
  • Marketing authorisation holder: PFIZER
  • Local brand name: MYCOBUTIN
  • Indication: CAPSULE — ORAL
  • Status: approved

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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. Hospitalisation — 1 report (25%)
  2. Hyperkalaemia — 1 report (25%)
  3. Pneumonia — 1 report (25%)
  4. Tuberculosis — 1 report (25%)

Source database →

Rifabutin 150 MG in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Rifabutin 150 MG approved in United States?

Yes. FDA authorised it on 23 December 1992; FDA has authorised it.

Who is the marketing authorisation holder for Rifabutin 150 MG in United States?

PFIZER holds the US marketing authorisation.