🇺🇸 Braltus in United States

209 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. Confusional State — 27 reports (12.92%)
  2. Acute Kidney Injury — 26 reports (12.44%)
  3. Dyspnoea — 26 reports (12.44%)
  4. Abdominal Pain — 24 reports (11.48%)
  5. Malaise — 24 reports (11.48%)
  6. Diarrhoea — 19 reports (9.09%)
  7. Dizziness — 19 reports (9.09%)
  8. Hallucination — 15 reports (7.18%)
  9. Palpitations — 15 reports (7.18%)
  10. Fall — 14 reports (6.7%)

Source database →

Braltus 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 Braltus approved in United States?

Yes. FDA has authorised it.

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

Fundacio Privada Mon Clinic Barcelona is the originator. The local marketing authorisation holder may differ — check the official source linked above.