🇺🇸 Fluconazole 150 mg in United States

FDA authorised Fluconazole 150 mg on 23 December 1993 · 28 US adverse-event reports

Marketing authorisations

FDA — authorised 23 December 1993

  • Application: NDA020090
  • Marketing authorisation holder: PFIZER
  • Local brand name: DIFLUCAN
  • Indication: FOR SUSPENSION — 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. Blister — 5 reports (17.86%)
  2. Burning Sensation — 3 reports (10.71%)
  3. Drug Ineffective — 3 reports (10.71%)
  4. Dyspnoea — 3 reports (10.71%)
  5. Product Quality Issue — 3 reports (10.71%)
  6. Urticaria — 3 reports (10.71%)
  7. Adverse Drug Reaction — 2 reports (7.14%)
  8. Anxiety — 2 reports (7.14%)
  9. Asthenia — 2 reports (7.14%)
  10. Back Pain — 2 reports (7.14%)

Source database →

Fluconazole 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 Fluconazole 150 mg approved in United States?

Yes. FDA authorised it on 23 December 1993; FDA has authorised it.

Who is the marketing authorisation holder for Fluconazole 150 mg in United States?

PFIZER holds the US marketing authorisation.