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Pioglitazone

Published: July 26, 2026Updated: July 26, 2026

Pioglitazone is an oral antidiabetic drug classified as a thiazolidinedione, primarily used to enhance glycemic control in adults with type 2 diabetes by improving insulin sensitivity.

Quick summary

Pioglitazone is a diabetes medication that improves insulin sensitivity to help control blood sugar levels in type 2 diabetes.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
A10BG03
RxNorm
33738
Generic
Pioglitazone
Class
atc-a10
Brands
Oseni, Actos, Actoplus Met, Duetact
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
15-45mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
0.5mg/kg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
15mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause serious toxicity
Chronic overdose: cumulative toxicity from prolonged use above recommended doses
Immediate actions
supportive care, monitoring of blood glucose, intravenous fluids
Antidote
no specific antidote available(treatment is supportive and symptomatic)
Poison Control: 1-800-222-1222

Special Populations

11 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

avoid

Key Recommendations

discontinue therapy and switch to insulin if needed

Monitor

fetal growth monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid

Key Recommendations

discontinue before delivery

Monitor

fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
contraindicated
FDA Category
N
Dose Adjustment

contraindicated

Key Recommendations

do not breastfeed while on pioglitazone

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pediatric_age

children under 18
contraindicated
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not approved for use in pediatric patients

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly 65 plus
caution
FDA Category
N
Dose Adjustment

start at lowest dose

Key Recommendations

use with caution due to increased risk of bladder cancer and fractures

Monitor

regular monitoring of renal function and bladder symptoms

Use with caution and monitor for adverse effects.

⚠

renal_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

monitor renal function periodically

Monitor

check serum creatinine and eGFR regularly

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

monitor closely for adverse effects

Monitor

frequent renal function monitoring

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

monitor liver function tests

Monitor

regular LFT monitoring

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe
unsafe
FDA Category
N
Dose Adjustment

avoid

Key Recommendations

do not use in patients with active liver disease or elevated ALT

Monitor

liver function tests required

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

alcohol_users

chronic heavy drinking
caution
FDA Category
N
Dose Adjustment

avoid excess alcohol

Key Recommendations

limit alcohol consumption, may increase risk of lactic acidosis

Monitor

monitor liver function

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:1999

Pioglitazone first approved by FDA for type 2 diabetes treatment

drug_classWHO
2023

Drug class

Value:Thiazolidinedione (TZD)

Pioglitazone belongs to the thiazolidinedione class of peroxisome proliferator-activated receptor gamma (PPARγ) agonists

usageMedical guidelines
2023

Common uses

Value:Type 2 diabetes management

Primary therapeutic use is improving insulin sensitivity in patients with type 2 diabetes mellitus

mechanismFDA
2023

Mechanism of action

Value:PPARγ agonist

Activates peroxisome proliferator-activated receptor gamma to improve insulin sensitivity

Treatment of type 2 diabetes mellitus in adults, typically as monotherapy or in combination with other antidiabetic agents (such as metformin, sulfonylureas, or insulin) when diet and exercise alone do not provide adequate glycemic control.

Pioglitazone is a thiazolidinedione that decreases insulin resistance in peripheral tissues and the liver. It increases insulin-dependent glucose disposal in muscle and adipose tissue while reducing hepatic glucose production, leading to improved blood glucose control.

Pioglitazone requires the presence of insulin to be effective and is not indicated for type 1 diabetes or diabetic ketoacidosis. Common side effects include weight gain, edema, and fluid retention; it may increase risk of heart failure, bone fractures, and liver abnormalities. Regular monitoring of liver function tests is recommended during treatment.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy