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Pioglitazone and Glimepiride ›
Regulatory · United States
Marketing authorisation
FDA — authorised 28 July 2006
Application: NDA021925
Marketing authorisation holder: TAKEDA PHARMS USA
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 15
Most-reported reactions
Blood Glucose Increased — 3 reports (20%) Bronchitis — 2 reports (13.33%) Headache — 2 reports (13.33%) Product Dose Omission Issue — 2 reports (13.33%) Abnormal Dreams — 1 report (6.67%) Arthralgia — 1 report (6.67%) Completed Suicide — 1 report (6.67%) Condition Aggravated — 1 report (6.67%) Cough — 1 report (6.67%) Covid-19 Pneumonia — 1 report (6.67%)
Source database →
Pioglitazone and Glimepiride 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 Pioglitazone and Glimepiride approved in United States?
Yes. FDA authorised it on 28 July 2006.
Who is the marketing authorisation holder for Pioglitazone and Glimepiride in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.