75/100 · Elevated
Manufactured by Takeda Pharmaceuticals America, Inc.
High Serious Adverse Events Associated with Pioglitazone Use
74,368 FDA adverse event reports analyzed
Last updated: 2026-05-12
PIOGLITAZONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 74,368 FDA adverse event reports, PIOGLITAZONE has a safety score of 75 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for PIOGLITAZONE include BLADDER CANCER, BLOOD GLUCOSE INCREASED, NAUSEA, WEIGHT DECREASED, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PIOGLITAZONE.
Pioglitazone has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 74,368 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Bladder Cancer, Blood Glucose Increased, Nausea. Of classified reports, 71.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A significant proportion of adverse events are serious, with 71.5% of reports being serious.
Bladder cancer and renal failure are among the most frequently reported serious adverse events. Weight changes, including both increases and decreases, are commonly reported.
Patients taking Pioglitazone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pioglitazone is associated with serious adverse events such as bladder cancer and renal failure, and caution is advised when co-administered with other drugs that may affect kidney function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pioglitazone received a safety concern score of 75/100 (elevated concern). This is based on a 71.5% serious event ratio across 42,485 classified reports. The score accounts for 74,368 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 18,329, Female: 15,866, Unknown: 246. The most frequently reported age groups are age 65 (833 reports), age 68 (806 reports), age 66 (762 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 42,485 classified reports for PIOGLITAZONE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Pioglitazone is associated with serious adverse events such as bladder cancer and renal failure, and caution is advised when co-administered with other drugs that may affect kidney function.
If you are taking Pioglitazone, here are important things to know. The most commonly reported side effects include bladder cancer, blood glucose increased, nausea, weight decreased, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of bladder cancer and renal failure, especially in elderly patients. Regularly assess kidney function and adjust dosing as necessary. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of pioglitazone and has not issued a recall or ban. However, healthcare providers should be vigilant about monitoring patients for signs of serious adverse events.
The FDA has received approximately 74,368 adverse event reports associated with Pioglitazone. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Pioglitazone include Bladder Cancer, Blood Glucose Increased, Nausea, Weight Decreased, Diarrhoea. By volume, the top reported reactions are: Bladder Cancer (8,735 reports), Blood Glucose Increased (3,385 reports), Nausea (2,920 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pioglitazone.
Out of 42,485 classified reports, 30,398 (71.5%) were classified as serious and 12,087 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Pioglitazone break down by patient sex as follows: Male: 18,329, Female: 15,866, Unknown: 246. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Pioglitazone adverse events are: age 65: 833 reports, age 68: 806 reports, age 66: 762 reports, age 60: 731 reports, age 64: 730 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Pioglitazone adverse event reports is Takeda Pharmaceuticals America, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Pioglitazone include: Death, Fatigue, Drug Ineffective, Vomiting, Dyspnoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Pioglitazone to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Pioglitazone has a safety concern score of 75 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. A significant proportion of adverse events are serious, with 71.5% of reports being serious.
Key safety signals identified in Pioglitazone's adverse event data include: Bladder cancer and transitional cell carcinoma are key safety signals.. Renal failure and acute kidney injury are also significant safety signals.. Cardiac failure and myocardial infarction are important cardiovascular safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pioglitazone is associated with serious adverse events such as bladder cancer and renal failure, and caution is advised when co-administered with other drugs that may affect kidney function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pioglitazone.
Monitor patients for signs of bladder cancer and renal failure, especially in elderly patients. Regularly assess kidney function and adjust dosing as necessary.
Pioglitazone has 74,368 adverse event reports on file with the FDA. Bladder cancer and renal failure are among the most frequently reported serious adverse events. The volume of reports for Pioglitazone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of pioglitazone and has not issued a recall or ban. However, healthcare providers should be vigilant about monitoring patients for signs of serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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