Actospioglitazone
According to the FDA label: Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin.
42,707 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Actos in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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- Bladder Cancer 8,738 reports
Blood Glucose Increased 3,391 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Nausea 2,945 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 2,087 reports
Diarrhoea 1,715 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Death 1,546 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Fatigue 1,494 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,479 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Vomiting 1,452 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 1,411 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,409 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Decreased Appetite 1,404 reports
Weight Increased 1,296 reports
Blood Glucose Decreased 1,204 reports
A blood test result showing a lower than normal blood sugar level. The opposite of blood glucose increased.
Full definition in the glossary →Asthenia 1,163 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 18,423 |
| Female | 15,955 |
| Unknown | 246 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 278 |
| 18-34 | 388 |
| 35-49 | 2,389 |
| 50-64 | 8,642 |
| 65-74 | 7,192 |
| 75+ | 4,782 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Actos. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 21,159 |
| Non-Serious | 12,154 |
| Hospitalization | 11,603 |
| Death | 4,306 |
| Life-Threatening | 1,673 |
| Disability | 1,148 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Actos. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 870 |
| 2005 | 1,325 |
| 2006 | 2,360 |
| 2007 | 2,677 |
| 2008 | 1,644 |
| 2009 | 1,881 |
| 2010 | 2,186 |
| 2011 | 3,106 |
| 2012 | 2,040 |
| 2013 | 1,282 |
| 2014 | 1,127 |
| 2015 | 6,601 |
| 2016 | 3,836 |
| 2017 | 1,859 |
| 2018 | 1,860 |
| 2019 | 1,684 |
| 2020 | 1,374 |
| 2021 | 1,090 |
| 2022 | 984 |
| 2023 | 905 |
| 2024 | 953 |
| 2025 | 896 |
| 2026 (partial) | 167 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Actos
In FDA adverse event reports that mention Actos, these medications appeared most often in the same report.
- Metformin (10,307 reports)
- Aspirin (5,586 reports)
- Glipizide (4,590 reports)
- Exenatide (4,516 reports)
- Insulin Glargine (4,423 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026