Public record
Pioglitazone: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for pioglitazone
The FDA label read for pioglitazone (Actos, application NDA021073) was last revised on 2025-03-28. It carries a boxed warning headed "WARNING: CONGESTIVE HEART FAILURE". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2025-03-28 | |
| Label read | Actos | NDA021073, brand-name application |
| Boxed warning | Yes | heading as printed: "WARNING: CONGESTIVE HEART FAILURE" |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient pioglitazone from an original manufacturer
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Adverse event reports
Most reported events in FDA adverse event reports for pioglitazone
Through 2026-10-28, FDA had received 25,292 adverse event reports for pioglitazone, 19,539 of them marked serious by the reporter. The symptom terms named most often were bladder cancer (7,304), nausea (1,087) and diarrhoea (992).
| Measure | Value | Note |
|---|---|---|
| All reports received | 25,292 | |
| Reports the reporter marked serious | 19,539 | death, hospitalisation, disability or similar outcome |
| Bladder cancer | 7,304 reports | |
| Nausea | 1,087 reports | |
| Diarrhoea | 992 reports | |
| Blood glucose increased | 931 reports | |
| Fatigue | 859 reports |
How this was calculated
Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example death) were left out of the list.
Reports where FDA recorded pioglitazone as a single-ingredient active substance (any brand), all years to 2026-10-28
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Articles on Pioglitazone
- Actos (Pioglitazone) Rebound Effects When Stopping: What Clinicians and Patients Need to Know
- Actos (Pioglitazone) Renal Protection or Renal Risk: A Clinical Update
- Actos (Pioglitazone) Pre-Surgery Hold Window: Clinical Guide
- Actos (Pioglitazone) Label Updates 2020 to 2026: FDA Safety Changes, Warnings, and Clinical Context