🇺🇸 Zolgensma in United States

2,672 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. Pyrexia — 523 reports (19.57%)
  2. Vomiting — 489 reports (18.3%)
  3. Aspartate Aminotransferase Increased — 340 reports (12.72%)
  4. Alanine Aminotransferase Increased — 306 reports (11.45%)
  5. Hepatic Enzyme Increased — 260 reports (9.73%)
  6. Thrombocytopenia — 188 reports (7.04%)
  7. Platelet Count Decreased — 164 reports (6.14%)
  8. Liver Function Test Increased — 142 reports (5.31%)
  9. Pneumonia — 132 reports (4.94%)
  10. Troponin I Increased — 128 reports (4.79%)

Source database →

Zolgensma 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 Zolgensma approved in United States?

Yes. FDA has authorised it.

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

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