🇺🇸 Protaphane in United States

604 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. Foetal Exposure During Pregnancy — 128 reports (21.19%)
  2. Exposure During Pregnancy — 81 reports (13.41%)
  3. Gestational Diabetes — 70 reports (11.59%)
  4. Hypoglycaemia — 61 reports (10.1%)
  5. Premature Baby — 50 reports (8.28%)
  6. Dyspnoea — 49 reports (8.11%)
  7. Nausea — 43 reports (7.12%)
  8. Maternal Exposure During Pregnancy — 42 reports (6.95%)
  9. Blood Glucose Increased — 41 reports (6.79%)
  10. Caesarean Section — 39 reports (6.46%)

Source database →

Protaphane 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 Protaphane approved in United States?

Yes. FDA has authorised it.

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

Novartis Pharmaceuticals is the originator. The local marketing authorisation holder may differ — check the official source linked above.