🇺🇸 Pimecrolimus cream in United States

35 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. Product Use In Unapproved Indication — 7 reports (20%)
  2. Application Site Erythema — 4 reports (11.43%)
  3. Application Site Pain — 4 reports (11.43%)
  4. Condition Aggravated — 4 reports (11.43%)
  5. Drug Ineffective — 4 reports (11.43%)
  6. Eye Irritation — 3 reports (8.57%)
  7. Product Prescribing Error — 3 reports (8.57%)
  8. Application Site Rash — 2 reports (5.71%)
  9. Diarrhoea — 2 reports (5.71%)
  10. Drug Ineffective For Unapproved Indication — 2 reports (5.71%)

Source database →

Pimecrolimus cream 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 Pimecrolimus cream approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Pimecrolimus cream in United States?

LEO Pharma is the originator. The local marketing authorisation holder may differ — check the official source linked above.