🇺🇸 Pioglitazone and Metformin in United States

FDA authorised Pioglitazone and Metformin on 5 November 2015 · 47 US adverse-event reports

Marketing authorisation

FDA — authorised 5 November 2015

  • Application: ANDA204802
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • Status: supplemented

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. Drug Ineffective — 6 reports (12.77%)
  2. Blood Glucose Increased — 5 reports (10.64%)
  3. Dizziness — 5 reports (10.64%)
  4. Fall — 5 reports (10.64%)
  5. Fatigue — 5 reports (10.64%)
  6. Headache — 5 reports (10.64%)
  7. Hypoglycaemia — 4 reports (8.51%)
  8. Nausea — 4 reports (8.51%)
  9. Pain — 4 reports (8.51%)
  10. Pneumonia — 4 reports (8.51%)

Source database →

Other Diabetes approved in United States

Frequently asked questions

Is Pioglitazone and Metformin approved in United States?

Yes. FDA authorised it on 5 November 2015.

Who is the marketing authorisation holder for Pioglitazone and Metformin in United States?

MACLEODS PHARMS LTD holds the US marketing authorisation.