🇺🇸 Augmentin (ES)-600 in United States

FDA authorised Augmentin (ES)-600 on 22 June 2001 · 120 US adverse-event reports

Marketing authorisation

FDA — authorised 22 June 2001

  • Application: NDA050755
  • Marketing authorisation holder: US ANTIBIOTICS
  • Local brand name: AUGMENTIN ES-600
  • Indication: FOR SUSPENSION — ORAL
  • Status: approved

Read official source →

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. Diarrhoea — 27 reports (22.5%)
  2. Vomiting — 22 reports (18.33%)
  3. Tooth Discolouration — 14 reports (11.67%)
  4. Drug Ineffective — 10 reports (8.33%)
  5. Pyrexia — 9 reports (7.5%)
  6. Urticaria — 9 reports (7.5%)
  7. Pruritus — 8 reports (6.67%)
  8. Rash — 8 reports (6.67%)
  9. Medication Error — 7 reports (5.83%)
  10. Pharmaceutical Product Complaint — 6 reports (5%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is Augmentin (ES)-600 approved in United States?

Yes. FDA authorised it on 22 June 2001.

Who is the marketing authorisation holder for Augmentin (ES)-600 in United States?

US ANTIBIOTICS holds the US marketing authorisation.