🇺🇸 Roflumilast 500 in United States

291 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. Diarrhoea — 46 reports (15.81%)
  2. Nausea — 45 reports (15.46%)
  3. Insomnia — 40 reports (13.75%)
  4. Weight Decreased — 37 reports (12.71%)
  5. Decreased Appetite — 31 reports (10.65%)
  6. Headache — 28 reports (9.62%)
  7. Dizziness — 21 reports (7.22%)
  8. Back Pain — 15 reports (5.15%)
  9. Asthenia — 14 reports (4.81%)
  10. Myalgia — 14 reports (4.81%)

Source database →

Roflumilast 500 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 Roflumilast 500 approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Roflumilast 500 in United States?

Spanish Research Center for Respiratory Diseases is the originator. The local marketing authorisation holder may differ — check the official source linked above.