🇺🇸 Sativex in United States

227 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. Multiple Sclerosis Relapse — 48 reports (21.15%)
  2. Pyrexia — 29 reports (12.78%)
  3. Fatigue — 26 reports (11.45%)
  4. Urinary Tract Infection — 20 reports (8.81%)
  5. Gait Disturbance — 19 reports (8.37%)
  6. Headache — 18 reports (7.93%)
  7. Muscle Spasticity — 18 reports (7.93%)
  8. Dizziness — 17 reports (7.49%)
  9. Asthenia — 16 reports (7.05%)
  10. Constipation — 16 reports (7.05%)

Source database →

Sativex in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in United States

Frequently asked questions

Is Sativex approved in United States?

Yes. FDA has authorised it.

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

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