🇺🇸 Benepali in United States

873 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. Drug Ineffective — 159 reports (18.21%)
  2. Rheumatoid Arthritis — 145 reports (16.61%)
  3. Product Substitution Issue — 80 reports (9.16%)
  4. Product Use In Unapproved Indication — 76 reports (8.71%)
  5. Immunosuppression — 72 reports (8.25%)
  6. Lower Respiratory Tract Infection — 69 reports (7.9%)
  7. Malaise — 69 reports (7.9%)
  8. Product Use Issue — 69 reports (7.9%)
  9. Pain — 68 reports (7.79%)
  10. Fatigue — 66 reports (7.56%)

Source database →

Benepali in other countries

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

Other Other approved in United States

Frequently asked questions

Is Benepali approved in United States?

Yes. FDA has authorised it.

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

University of Leeds is the originator. The local marketing authorisation holder may differ — check the official source linked above.