🇺🇸 actoplus met in United States

FDA authorised actoplus met on 29 August 2005 · 897 US adverse-event reports

Marketing authorisation

FDA — authorised 29 August 2005

  • Application: NDA021842
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Local brand name: ACTOPLUS MET
  • Indication: TABLET — ORAL
  • Status: approved

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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. Bladder Cancer — 310 reports (34.56%)
  2. Blood Glucose Increased — 114 reports (12.71%)
  3. Nausea — 104 reports (11.59%)
  4. Weight Decreased — 82 reports (9.14%)
  5. Death — 59 reports (6.58%)
  6. Flushing — 52 reports (5.8%)
  7. Blood Glucose Decreased — 46 reports (5.13%)
  8. Dizziness — 46 reports (5.13%)
  9. Drug Ineffective — 42 reports (4.68%)
  10. Dyspnoea — 42 reports (4.68%)

Source database →

Other Diabetes approved in United States

Frequently asked questions

Is actoplus met approved in United States?

Yes. FDA authorised it on 29 August 2005.

Who is the marketing authorisation holder for actoplus met in United States?

TAKEDA PHARMS USA holds the US marketing authorisation.