🇺🇸 NovoRapid in United States

FDA authorised NovoRapid on 14 June 1996 · 10,067 US adverse-event reports

Marketing authorisations

FDA — authorised 14 June 1996

  • Application: BLA020563
  • Marketing authorisation holder: LILLY
  • Local brand name: HUMALOG
  • 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. Hypoglycaemia — 1,855 reports (18.43%)
  2. Diabetic Ketoacidosis — 1,217 reports (12.09%)
  3. Blood Glucose Increased — 1,120 reports (11.13%)
  4. Dyspnoea — 972 reports (9.66%)
  5. Hyperglycaemia — 938 reports (9.32%)
  6. Vomiting — 860 reports (8.54%)
  7. Diarrhoea — 823 reports (8.18%)
  8. Nausea — 787 reports (7.82%)
  9. Acute Kidney Injury — 758 reports (7.53%)
  10. Off Label Use — 737 reports (7.32%)

Source database →

NovoRapid 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 NovoRapid approved in United States?

Yes. FDA authorised it on 14 June 1996; FDA has authorised it.

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

LILLY holds the US marketing authorisation.