🇺🇸 Acthar in United States

FDA authorised Acthar on 29 April 1952 · 2,064 US adverse-event reports

Marketing authorisations

FDA — authorised 29 April 1952

  • Application: NDA008372
  • Marketing authorisation holder: MALLINCKRODT IRELAND
  • Local brand name: ACTHAR GEL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

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 — 276 reports (13.37%)
  2. Fatigue — 252 reports (12.21%)
  3. Death — 225 reports (10.9%)
  4. Multiple Sclerosis Relapse — 218 reports (10.56%)
  5. Weight Increased — 206 reports (9.98%)
  6. Headache — 188 reports (9.11%)
  7. Condition Aggravated — 179 reports (8.67%)
  8. Dyspnoea — 178 reports (8.62%)
  9. Insomnia — 175 reports (8.48%)
  10. Asthenia — 167 reports (8.09%)

Source database →

Acthar 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 Acthar approved in United States?

Yes. FDA authorised it on 29 April 1952; FDA has authorised it.

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

MALLINCKRODT IRELAND holds the US marketing authorisation.