🇺🇸 Lispro in United States

FDA authorised Lispro on 14 June 1996 · 9,060 US adverse-event reports

Marketing authorisations

FDA — authorised 14 June 1996

  • Application: BLA020563
  • Marketing authorisation holder: LILLY
  • Status: supplemented

FDA — authorised 22 December 1999

  • Application: BLA021017
  • Marketing authorisation holder: LILLY
  • Status: approved

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. Blood Glucose Increased — 2,910 reports (32.12%)
  2. Hypoglycaemia — 879 reports (9.7%)
  3. Incorrect Dose Administered — 854 reports (9.43%)
  4. Drug Ineffective — 807 reports (8.91%)
  5. Blood Glucose Decreased — 678 reports (7.48%)
  6. Dyspnoea — 653 reports (7.21%)
  7. Nausea — 652 reports (7.2%)
  8. Visual Impairment — 637 reports (7.03%)
  9. Vomiting — 513 reports (5.66%)
  10. Fall — 477 reports (5.26%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Lispro approved in United States?

Yes. FDA authorised it on 14 June 1996; FDA authorised it on 22 December 1999; FDA has authorised it.

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

LILLY holds the US marketing authorisation.