🇺🇸 Penlac in United States

FDA authorised Penlac on 17 December 1999 · 224 US adverse-event reports

Marketing authorisation

FDA — authorised 17 December 1999

  • Application: NDA021022
  • Marketing authorisation holder: VALEANT BERMUDA
  • Local brand name: PENLAC
  • Indication: SOLUTION — TOPICAL
  • Status: approved

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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. Fatigue — 27 reports (12.05%)
  2. Pain — 27 reports (12.05%)
  3. Drug Ineffective — 25 reports (11.16%)
  4. Dyspnoea — 22 reports (9.82%)
  5. Asthenia — 21 reports (9.38%)
  6. Depression — 21 reports (9.38%)
  7. Nausea — 21 reports (9.38%)
  8. Arthralgia — 20 reports (8.93%)
  9. Fall — 20 reports (8.93%)
  10. Pneumonia — 20 reports (8.93%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is Penlac approved in United States?

Yes. FDA authorised it on 17 December 1999.

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

VALEANT BERMUDA holds the US marketing authorisation.