Pioglitazone: uses, dosing, side effects & brands
Pioglitazone is a peroxisome proliferator receptor alpha agonist sold in the U.S. under 3 brand and generic names, for type 2 diabetes mellitus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Peroxisome Proliferator Receptor Alpha Agonist
- Treats
- Type 2 Diabetes Mellitus
- Available as
- Tablet
- Sold as
- 3 products — Actos, Pioglitazone and Pioglitazone Hydrochloride
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 3 to 7 hours (parent drug)
- What the pharmacy pays
- about $3 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
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How pioglitazone is dosed
From the FDA label for Actos (application NDA021073). Other pioglitazone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Initiate ACTOS at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure. ( 2.1 ) • If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. ( 2.1 ) • Obtain liver tests before starting ACTOS. If abnormal, use caution when treating with ACTOS, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on ACTOS is not recommended in patients without liver disease. ( 5.3 ) 2.1 Recommendations for All Patients ACTOS should be taken once daily and can be taken without regard to meals. The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily. The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily. The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c. After initiation of ACTOS or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure [see Boxed Warning and Warnings and Precautions (5.5) ] . Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be…
Pioglitazone side effects
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 Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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. Over 8500 patients with type 2 diabetes have been treated with ACTOS in randomized, double-blind, controlled clinical trials, including 2605 patients with type 2 diabetes and macrovascular disease treated with ACTOS in the PROactive clinical trial. In these trials, over 6000 patients have been treated with ACTOS for six months or longer, over 4500 patients have been treated with ACTOS for one year or longer, and over 3000 patients have been treated with ACTOS for at least two years. In six pooled 16- to 26-week placebo-controlled…
Who shouldn’t take pioglitazone
Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning ] . • Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOS. • 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 ACTOS. ( 4 )
Pioglitazone drug interactions
Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit ACTOS 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 (t 1/2 ) of pioglitazone. Therefore, the maximum recommended dose of ACTOS 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. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with ACTOS, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for ACTOS [see Clinical Pharmacology (12.3) ] . 7.3 Topiramate A decrease in the exposure of pioglitazone and its active metabolites were noted with concomitant administration of pioglitazone and topiramate [see Clinical Pharmacology (12.3) ] . The clinical relevance of this decrease is unknown; however, when ACTOS and topiramate are used concomitantly, monitor patients for adequate glycemic control.
Every pioglitazone product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $3 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $3 | View → | |
| 3 | Not yet rated | Prescription | Tablet | Generic | $3 | View → |
What pioglitazone pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing pioglitazone
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
How long pioglitazone keeps
No pioglitazone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does pioglitazone expire? The in-use limits and storage rules from its labelsPioglitazone and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for pioglitazone: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of pioglitazone during breastfeeding. Pioglitazone is over 99% protein bound in plasma, so it is unlikely to pass into breastmilk in clinically important amounts. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised May 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about pioglitazone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,979 reports naming pioglitazone, and the FDA flagged 68% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- blood glucose increased474 reports
- nausea323 reports
- bladder cancer273 reports
- weight decreased219 reports
- blood glucose decreased170 reports
- decreased appetite162 reports
- dyspnoea129 reports
- vomiting120 reports
Read these as a signal, not a rate. A report does not mean pioglitazone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 27, 2026.
How long pioglitazone stays in your system
The elimination half-life of pioglitazone is about 3 to 7 hours (parent drug). The 3-7 hour figure is for parent pioglitazone only. Pioglitazone has two major ACTIVE metabolites, M-III (keto derivative) and M-IV (hydroxyl derivative), whose half-life is 16 to 24 hours — far longer than the parent. At steady state M-III and M-IV reach serum concentrations equal to or greater than pioglitazone itself, so the drug's overall effective persistence is governed by the metabolites, not the 3-7h parent number. Older adults: the label reports the mean parent half-life is prolonged to about 10 hours in the elderly vs about 7 hours in younger subjects (deemed not clinically relevant). Kidney impairment: the serum elimination half-life of pioglitazone, M-III and M-IV is unchanged in moderate (CLcr 30-50) and severe (CLcr <30) renal impairment; no dose adjustment. Liver impairment: hepatic impairment (Child-Pugh B/C) gives ~45% lower Cmax but no change in mean AUC and the label states no half-life change / no dose adjustment, though caution is advised due to postmarketing liver-failure reports.
Pioglitazone hydrochloride tablet — DailyMed label, §12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is pioglitazone?
ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo . No differences were found in the pharmacologic activity between the two enantiomers.
What kind of drug is pioglitazone?
The FDA classifies pioglitazone as a peroxisome proliferator receptor alpha agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does pioglitazone stay in your system?
The elimination half-life of pioglitazone is about 3 to 7 hours (parent drug) — that is how long the body takes to clear half of a dose. The 3-7 hour figure is for parent pioglitazone only. Pioglitazone has two major ACTIVE metabolites, M-III (keto derivative) and M-IV (hydroxyl derivative), whose half-life is 16 to 24 hours — far longer than the parent. At steady state M-III and M-IV reach serum concentrations equal to or greater than pioglitazone itself, so the drug's overall effective persistence is governed by the metabolites, not the 3-7h parent number. Older adults: the label reports the mean parent half-life is prolonged to about 10 hours in the elderly vs about 7 hours in younger subjects (deemed not clinically relevant). Kidney impairment: the serum elimination half-life of pioglitazone, M-III and M-IV is unchanged in moderate (CLcr 30-50) and severe (CLcr <30) renal impairment; no dose adjustment. Liver impairment: hepatic impairment (Child-Pugh B/C) gives ~45% lower Cmax but no change in mean AUC and the label states no half-life change / no dose adjustment, though caution is advised due to postmarketing liver-failure reports. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take pioglitazone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pioglitazone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is pioglitazone sold under?
We track 3 pioglitazone-containing products in the U.S.: Actos, Pioglitazone and Pioglitazone Hydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does pioglitazone come in?
Across the brands we track, pioglitazone is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pioglitazone?
Yes. Our catalog lists 2 generic pioglitazone products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pioglitazone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pioglitazone
- MLA
- “Pioglitazone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pioglitazone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pioglitazone on DailyMed (NIH) ↗ — including its boxed warning in full.