🇺🇸 Metformin ER in United States

FDA authorised Metformin ER on 16 March 2018 · 885 US adverse-event reports

Marketing authorisation

FDA — authorised 16 March 2018

  • Application: ANDA209313
  • Marketing authorisation holder: GRANULES
  • Indication: Labeling
  • 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 — 122 reports (13.79%)
  2. Nausea — 117 reports (13.22%)
  3. Fatigue — 109 reports (12.32%)
  4. Blood Glucose Increased — 103 reports (11.64%)
  5. Headache — 94 reports (10.62%)
  6. Drug Ineffective — 84 reports (9.49%)
  7. Dizziness — 73 reports (8.25%)
  8. Pain — 66 reports (7.46%)
  9. Dyspnoea — 61 reports (6.89%)
  10. Vomiting — 56 reports (6.33%)

Source database →

Metformin ER 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 Metformin ER approved in United States?

Yes. FDA authorised it on 16 March 2018.

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

GRANULES holds the US marketing authorisation.