🇺🇸 Bretaris in United States

210 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. Dyspnoea — 56 reports (26.67%)
  2. Chronic Obstructive Pulmonary Disease — 25 reports (11.9%)
  3. Pneumonia — 19 reports (9.05%)
  4. Nausea — 18 reports (8.57%)
  5. Dizziness — 17 reports (8.1%)
  6. Drug Ineffective — 17 reports (8.1%)
  7. Anaemia — 16 reports (7.62%)
  8. Asthenia — 15 reports (7.14%)
  9. General Physical Health Deterioration — 14 reports (6.67%)
  10. Headache — 13 reports (6.19%)

Source database →

Bretaris 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 Bretaris approved in United States?

Yes. FDA has authorised it.

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

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