🇺🇸 Norditropin in United States

FDA authorised Norditropin on 20 June 2000 · 1,103 US adverse-event reports

Marketing authorisations

FDA — authorised 20 June 2000

  • Application: BLA021148
  • Marketing authorisation holder: NOVO NORDISK INC
  • Status: supplemented

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. Headache — 189 reports (17.14%)
  2. Off Label Use — 138 reports (12.51%)
  3. Hospitalisation — 126 reports (11.42%)
  4. Condition Aggravated — 102 reports (9.25%)
  5. Fatigue — 102 reports (9.25%)
  6. Death — 97 reports (8.79%)
  7. Vomiting — 93 reports (8.43%)
  8. Nausea — 90 reports (8.16%)
  9. Pyrexia — 85 reports (7.71%)
  10. Injection Site Pain — 81 reports (7.34%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Norditropin approved in United States?

Yes. FDA authorised it on 20 June 2000; FDA has authorised it.

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

NOVO NORDISK INC holds the US marketing authorisation.