Pioglitazone

Pronunciation: pye-oh-GLI-ta-zone.

Generic name
pioglitazone
Drug class
Thiazolidinedione (TZD), oral antidiabetic agent
Form
Tablet, 15 mg, 30 mg, or 45 mg
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: ACTOS (and multiple current generics, e.g. Vexazone) (5) · Full directory

What pioglitazone is and how it works

Pioglitazone is a prescription oral medicine used, alongside diet and exercise, to help control blood sugar in adults with type 2 diabetes. It works by making the body's own tissues more responsive to insulin. (1)

Take pioglitazone exactly as your prescriber directs. It is not used for type 1 diabetes or diabetic ketoacidosis. Because it carries real risks around heart failure, bladder cancer, and bone fractures, your prescriber will weigh these against the benefits for your specific situation and monitor you accordingly.

Mechanism of action: how pioglitazone works

Pioglitazone is a thiazolidinedione that acts as a selective agonist at the peroxisome proliferator-activated receptor gamma (PPAR-gamma), improving insulin sensitivity in adipose tissue, skeletal muscle, and liver. (1) (2)

What pioglitazone is used for

Type 2 diabetes

Used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes, either alone or combined with other diabetes medicines such as metformin or a sulfonylurea when those alone are not enough. (1) (2) (4)

Before taking pioglitazone

Do not take / not appropriate for

  • Do not take pioglitazone if you have established heart failure -- in the US this applies specifically to NYHA Class III or IV (more severe) heart failure, while UK/EU labelling treats heart failure of any severity as a contraindication. Your prescriber will apply the guidance relevant to your country and situation. (market-specific -- see note) (1) (2)
  • Do not take pioglitazone if you have active bladder cancer, or (per UK/EU labelling) a prior history of bladder cancer. (market-specific -- see note) (1) (2)
  • Do not take pioglitazone if you have significant liver impairment, or blood in your urine that has not been medically investigated. (United Kingdom / European Union) (2)
  • Do not take pioglitazone if you have had a serious allergic reaction to it or any of its ingredients. (all countries) (1) (2)

Tell your clinician about

  • Any history of heart failure or heart problems.
  • Any current or past bladder cancer, unexplained blood in your urine, or bladder cancer risk factors such as smoking history.
  • Any liver problems -- liver function tests are needed before starting and periodically during treatment.
  • Any history of bone fractures or osteoporosis, especially if you are a woman.
  • Any vision changes, since new or worsening diabetic eye swelling (macular oedema) has been reported.
  • Whether you could become pregnant -- pioglitazone can restart ovulation in some women who were not previously ovulating, creating a possibility of unintended pregnancy.
  • All other medicines you take, especially insulin, sulfonylureas, or gemfibrozil.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2)

How to take pioglitazone

  • Take once daily, with or without food, exactly as your prescriber directs.
  • Do not change your dose on your own -- your prescriber will adjust it gradually based on your blood sugar response and monitoring results.
  • If you also take insulin or a sulfonylurea, your prescriber may need to adjust those doses to reduce the risk of low blood sugar.
  • Attend all scheduled monitoring appointments, including liver function tests and checks for swelling, weight gain, or breathlessness.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, contact your prescriber or pharmacist for guidance rather than doubling your next dose.

Overdose

Seek urgent medical attention if you think too much pioglitazone has been taken, or if you have symptoms of very low or very high blood sugar. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Upper respiratory tract infection, sinusitis, and pharyngitis (cold-like symptoms).

What to notice: Upper respiratory tract infection, sinusitis, and pharyngitis (cold-like symptoms).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache and muscle pain (myalgia).

What to notice: Headache and muscle pain (myalgia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Weight gain and fluid retention (oedema), which are dose-related and more common when combined with insulin.

What to notice: Weight gain and fluid retention (oedema), which are dose-related and more common when combined with insulin.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Anaemia and visual disturbances.

What to notice: Anaemia and visual disturbances.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of new or worsening heart failure — boxed_warning

Symptoms: Rapid or excessive weight gain, shortness of breath, or swelling in the legs, ankles, or abdomen.

Action: Contact your prescriber promptly, or seek emergency care if breathing difficulty is severe. Do not change your dose yourself -- your prescriber will decide on the appropriate management. (1) (2) (4)

Signs of possible bladder cancer — high caution

Symptoms: Blood or a red/pink colour in the urine, a new or worsening urgent need to urinate, or pain when urinating.

Action: Contact your prescriber promptly for evaluation. (1) (4)

Signs of liver problems — high caution

Symptoms: Yellowing of the skin or eyes, unusual tiredness, loss of appetite, dark urine, or abdominal pain.

Action: Contact your prescriber promptly -- liver function will be checked before and during treatment, and rare cases of serious, sometimes fatal, liver failure have been reported. (1) (2)

New or worsening vision changes — high caution

Symptoms: Blurred vision or other new visual disturbance.

Action: Tell your prescriber and arrange an eye examination -- new-onset or worsening diabetic macular oedema has been reported. (1) (2)

Bone fracture, particularly in women — high caution

Symptoms: New bone pain or a fall resulting in a suspected fracture.

Action: Seek medical assessment -- pioglitazone is associated with a higher fracture rate in women, particularly in the arm, hand, or foot. (2)

Interactions

  • Gemfibrozil (a cholesterol medicine) increases pioglitazone levels by about 3-fold -- your prescriber may limit your dose to 15 mg daily if you take it together. (1) (2)
  • Rifampicin (an antibiotic) can reduce pioglitazone levels by around half; topiramate can also reduce pioglitazone concentrations. (1) (2)
  • Insulin and sulfonylurea diabetes medicines combined with pioglitazone can increase the risk of low blood sugar and fluid retention -- dose adjustment may be needed. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Not recommended in pregnancy. UK/EU labelling states pioglitazone is contraindicated in pregnancy due to a risk of fetal growth restriction; US labelling notes limited human data. Discuss alternative diabetes management in pregnancy with your prescriber. (1) (2) (3) (4) (5) (6)

Breastfeeding

Not recommended while breastfeeding under UK/EU labelling; US labelling notes it is not known whether pioglitazone passes into human breast milk. Discuss with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Not established as safe and effective in children in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6)

Elderly

Start at the lowest dose with gradual titration and closer monitoring, given age-related risks including heart failure and fracture. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Liver function should be checked before starting and periodically thereafter; avoid starting if liver enzymes are already significantly elevated, and UK/EU labelling contraindicates use in hepatic impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically restricted in the sources reviewed, though general monitoring principles for diabetes medicines apply -- discuss with your prescriber if you have kidney problems. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Liver function tests
  • Assessment of heart failure history/risk
  • Bladder cancer risk factor assessment (age, smoking history, family history, relevant occupational/chemical or prior treatment exposures)
  • Baseline weight

During treatment

  • Regular checks for signs of heart failure (weight gain, swelling, breathlessness), especially after starting or increasing the dose.
  • Periodic liver function tests.
  • Blood sugar control (HbA1c) monitoring.
  • Routine eye examinations per usual diabetes care.
  • Awareness of bone health, particularly in women.
(1) (2)

Storage

Store at room temperature, away from moisture and out of reach of children, per the product's packaging instructions.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States

Indication: Type 2 diabetes

Dose summary: Initial 15 mg or 30 mg once daily (15 mg starting dose if NYHA Class I-II heart failure); titrate in 15 mg increments to a maximum of 45 mg once daily. Limit to 15 mg/day with strong CYP2C8 inhibitors. Contraindicated in established NYHA Class III/IV heart failure.

Renal context: Not specifically restricted in the source reviewed. (1)

United Kingdom / European Union

Indication: Type 2 diabetes

Dose summary: Initial 15 mg or 30 mg once daily; may increase in increments up to 45 mg once daily. Contraindicated in heart failure of any NYHA stage (stricter than the US label), hepatic impairment, current/prior bladder cancer, and uninvestigated macroscopic haematuria.

Renal context: Not specifically detailed in the source reviewed. (2)

Mechanism of action

Hepatic guidance

Baseline and periodic liver function testing recommended; discontinue if ALT exceeds 3x the upper limit of normal (UK/EU) and do not restart without an alternate explanation for prior liver injury (US label).

Overdose note

Limited overdose data; manage supportively with monitoring of blood glucose and cardiac/fluid status, guided by a poison-information service or emergency clinician. (1) (2)

Frequently asked questions

Is pioglitazone available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, it is approved and available in all of these regions, both as the original brand (Actos) and as generic pioglitazone. (1) (2) (3) (4) (5) (6)

Does pioglitazone really increase the risk of bladder cancer?

Regulators in multiple countries have identified a real, if modest, increased bladder cancer risk signal, particularly with longer treatment duration and higher cumulative doses. Your prescriber will assess your individual risk factors (such as smoking history) before starting and will advise you to report any blood in your urine or new urinary symptoms promptly. (1) (2) (4)

Can I stop taking pioglitazone if I notice swelling or weight gain?

Contact your prescriber promptly if you notice swelling, rapid weight gain, or breathlessness -- these can be early signs of heart failure. Your prescriber will decide whether to adjust your dose or stop the medicine; this is a clinical decision that should not be made on your own. (1) (2)

What is the mechanism of action of pioglitazone?

Pioglitazone is a thiazolidinedione that acts as a selective agonist at the peroxisome proliferator-activated receptor gamma (PPAR-gamma), improving insulin sensitivity in adipose tissue, skeletal muscle, and liver. (1) (2)

What is the generic name of Pioglitazone?

The generic name is pioglitazone. (1) (4)

What class of drug is pioglitazone?

Pioglitazone is classed as: Thiazolidinedione (TZD), oral antidiabetic agent. (1) (4)

References

  1. PIOGLITAZONE tablets -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-30 · source 1
  2. Pioglitazone 30 mg Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Sandoz Limited · United Kingdom · accessed 2026-07-30 · source 2
  3. Actos European Public Assessment Report (EPAR)European Medicines Agency (EMA) · European Union · dated 2000-10-13 · accessed 2026-07-30 · source 3
  4. ACTOS (pioglitazone hydrochloride) -- Product MonographHealth Canada product monograph, Takeda Canada Inc. · Canada · dated 2018-01-18 · accessed 2026-07-30 · source 4
  5. ACTOS Pioglitazone tablet -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · dated 2001-02-06 · accessed 2026-07-30 · source 5
  6. VEXAZONE (pioglitazone) -- New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient pioglitazone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Actos45 mg, 30 mg, 15 mg · takeda pharmaceuticals america, inc.

United Kingdom

  • Pioglitazone (generic; Sandoz, Mylan, Brown and Burk and others) (2)MHRA licensed emc smpc confirmed · 15 mg, 30 mg, 45 mg · Sandoz Limited (and other licence holders)

Canada

  • ACTOS
  • ACH-PIOGLITAZONE

Australia

  • ACTOS (and multiple current generics, e.g. Vexazone) (5)TGA ARTG registered 2001-02-06 confirmed · 15 mg, 30 mg, 45 mg · Generic Health Pty Ltd (Actos); various generic sponsors

New Zealand

  • Vexazone (6)Medsafe approved confirmed · 15 mg, 30 mg, 45 mg · not specified in fetched source
View brands in additional countries.

European Union

Actos (3)

This page provides general reference information about pioglitazone and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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