Pioglitazone — $0 on Listed Strengths

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• Glimepiride
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• Repaglinide
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• Tolvaptan
• Acarbose

What Pioglitazone is approved for (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, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

Source: Read the full FDA label on DailyMed. Label effective date: August 27, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Pioglitazone (FDA label)

WARNING: CONGESTIVE HEART FAILURE · Thiazolidinediones, including pioglitazone hydrochloride tablets, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions ( 5.1 )] . · After initiation of pioglitazone hydrochloride tablets , and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone tablets must be considered. · Pioglitazone hydrochloride is not recommended in patients with symptomatic heart failure. ( 5.1 ) · Initiation of pioglitazone tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning. • Thiazolidinediones, including pioglitazone hydrochloride, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) • After initiation of pioglitazone tablets, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema).

Source: FDA prescribing information (DailyMed). Set ID: c748f901-8321-4dc2-8848-b7ed27f11f97. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Pioglitazone (FDA label)

Round tablet contains pioglitazone as follows: • 15 mg: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 86" on one side and plain on the other side • 30 mg: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 87" on one side and plain on the other side • 45 mg: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 91" on one side and plain on the other side Tablets: 15 mg, 30 mg, and 45 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: c748f901-8321-4dc2-8848-b7ed27f11f97. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Pioglitazone (FDA label)

The following serious adverse reactions are discussed elsewhere in the labeling: Congestive heart failure [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Edema [see Warnings and Precautions ( 5.5 )] Fractures [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥ 5% )are upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: c748f901-8321-4dc2-8848-b7ed27f11f97. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Pioglitazone (FDA label)

• Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning]. ( 4 ) • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone hydrochloride.( 4 ) • Do not initiate pioglitazone tablets in patients with established NYHA Class III or IV heart failure [see Boxed Warning ] . ( 4 ) • Do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or its ingredients. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: c748f901-8321-4dc2-8848-b7ed27f11f97. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Pioglitazone (FDA label)

•Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. ( 5.1 ) • Hypoglycemia: When used with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. ( 5.2 ) • Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt pioglitazone hydrochloride and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart pioglitazone tablets if liver injury is confirmed and no alternate etiology can be found.( 5.3 ) • Bladder cancer: May increase the risk of bladder cancer. Do not use in patients with active bladder cancer.

Source: FDA prescribing information (DailyMed). Set ID: c748f901-8321-4dc2-8848-b7ed27f11f97. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Pioglitazone (FDA label)

• Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone tablets dose to 15 mg daily. ( 2.3 , 7.1 ) • CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.2 ) • Topiramate may decrease pioglitazone concentrations. (7.3) 7.1 Strong CYP2C8 Inhibitors An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life (t1/2) of pioglitazone. Therefore, the maximum recommended dose of pioglitazone hydrochloride is 15 mg daily if used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )]. 7.2 CYP2C8 Inducers An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone.

Source: FDA prescribing information (DailyMed). Set ID: c748f901-8321-4dc2-8848-b7ed27f11f97. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.