🇺🇸 amoxicillin plus clavulanic acid in United States

21 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. Pruritus — 4 reports (19.05%)
  2. Alanine Aminotransferase Increased — 2 reports (9.52%)
  3. Angioneurotic Oedema — 2 reports (9.52%)
  4. Aspartate Aminotransferase Increased — 2 reports (9.52%)
  5. Blood Bilirubin Increased — 2 reports (9.52%)
  6. Dyspnoea — 2 reports (9.52%)
  7. Gamma-Glutamyltransferase Increased — 2 reports (9.52%)
  8. Pancreatitis — 2 reports (9.52%)
  9. Rash Maculo-Papular — 2 reports (9.52%)
  10. Acute Kidney Injury — 1 report (4.76%)

Source database →

amoxicillin plus clavulanic acid in other countries

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

Frequently asked questions

Is amoxicillin plus clavulanic acid approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for amoxicillin plus clavulanic acid in United States?

Consorci Sanitari de Terrassa is the originator. The local marketing authorisation holder may differ — check the official source linked above.