FDA label
What is pioglitazone used for?
The FDA-approved uses of pioglitazone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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. Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabete...”
Run it in Rivvi
Which 2027 plans near you dropped or restricted pioglitazone?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Pioglitazone, tablet
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA200268). Cross-references to other label sections are left out.
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. Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease.
Source: DailyMed label, set id 4483b1c6-7095-4a63-8128-ac2d91e11040, version 11, effective May 17, 2025. NDC 57237-219, one of 62 listings for this product.
Pioglitazone, tablet
Indications and Usage, quoted from the label by Solco Healthcare LLC (ANDA207806). Cross-references to other label sections are left out.
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
Important Limitations of Use
Pioglitazone tablets exert their antihyperglycemic effects only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease.
Source: DailyMed label, set id 1b77dbeb-61d1-4df3-872b-2f4f75a110db, version 3, effective January 1, 2020. NDC 43547-426, one of 3 listings for this product.
Questions
What is pioglitazone used for?
The FDA label says: “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. Important Limitations of Use Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabete...”
What drug class is pioglitazone?
FDA lists pioglitazone in the Peroxisome Proliferator Receptor alpha Agonist and Peroxisome Proliferator Receptor gamma Agonist and Thiazolidinedione established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Pioglitazone
- Is Pioglitazone a controlled substance?Federal schedule
- Generic for ActosFDA Orange Book
- Peroxisome Proliferator Receptor alpha Agonists listFDA drug class
- Peroxisome Proliferator Receptor gamma Agonists listFDA drug class
- Thiazolidinediones listFDA drug class
- NDC 64764-151Pioglitazone NDC record
- NDC 64764-301Pioglitazone NDC record
- NDC 64764-451Pioglitazone NDC record