Pioglitazone
Pioglitazone is a once-daily diabetes pill that helps the body respond better to its own insulin, used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 52 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Pioglitazone (Actos) treats type 2 diabetes by helping muscle, fat and liver respond better to your own insulin; it is usually an add-on after metformin, on the market since about 1999 and available generically. Most people tolerate it well, though weight gain and ankle swelling are common. That fluid buildup is behind its boxed warning for heart failure, so report swelling, quick weight gain or shortness of breath right away, especially after starting or raising the dose. Expect liver blood tests and keep up with eye exams, since swelling at the back of the eye (macular edema) has been reported.
Clinical pearls
- On its own it rarely causes low blood sugar, but with insulin or a sulfonylurea such as glyburide, lows become possible.
- Tell any prescriber adding gemfibrozil or rifampin, since both change pioglitazone levels and the dose may need adjusting.
- Premenopausal women who have not been ovulating may start again, so unplanned pregnancy becomes possible and birth control deserves a fresh look.
- Its full effect builds slowly over several weeks, so early blood sugar readings may not show how well it works.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Pioglitazone can cause or worsen congestive heart failure in some people. It makes the body hold extra fluid, which can strain the heart.
Watch for fast weight gain, shortness of breath and swelling. Call your doctor right away if these occur, especially after starting or increasing your dose. It is not recommended if you have symptoms of heart failure. It must not be started if you have NYHA Class III or IV heart failure.
Patient information guide A plain-language walkthrough of Pioglitazone, written from its FDA label.
What Pioglitazone is used for
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Pioglitazone is used to improve blood sugar control in adults with type 2 diabetes.
- Used with diet and exercise, alone or combined with other diabetes medicines
- Actos, pioglitazone hydrochloride and pioglitazone tablets are all oral tablets with this same use
- Not for type 1 diabetes or diabetic ketoacidosis
How Pioglitazone works
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Pioglitazone is a thiazolidinedione. It activates PPAR-gamma receptors in fat, muscle and liver. This lowers insulin resistance, so tissues take up more glucose and the liver releases less.
It needs insulin to work and does not make the pancreas release more insulin.
Pioglitazone dosage
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Pioglitazone tablets are taken by mouth once daily, with or without food. Your prescriber chooses the dose and adjusts it based on HbA1c and how you tolerate it.
- Liver tests are done before starting
- You are monitored for weight gain, swelling and heart failure signs after starting or increasing the dose
- If you also take insulin or a sulfonylurea and have low blood sugar, those doses may need lowering
Follow your prescriber's directions and the pharmacy label.
Dosing details from the FDA-approved label
From the Pioglitazone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommendations for all patients (without congestive heart failure)
- Initiate at 15 mg or 30 mg once daily
- The dose can be titrated in increments of 15 mg based on glycemic response as determined by HbA1c
- Maximum: 45 mg once daily
- Can be taken once daily without regard to meals
- Patients with congestive heart failure (NYHA Class I or II)
- Recommended starting dose is 15 mg once daily
- The dose can be titrated in increments of 15 mg based on glycemic response
- Maximum: 45 mg once daily
- Monitor carefully for fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure after initiation or dose increase
- Concomitant use with an insulin secretagogue (e.g., sulfonylurea) if hypoglycemia occurs
- The dose of the insulin secretagogue should be reduced
- Concomitant use with insulin if hypoglycemia occurs
- The dose of insulin should be decreased by 10% to 25%
- Further adjustments individualized based on glycemic response
- Concomitant use with gemfibrozil or other strong CYP2C8 inhibitors
- Maximum recommended dose is 15 mg daily when used in combination
- Maximum: 15 mg daily
- Gemfibrozil increases pioglitazone exposure approximately 3-fold
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION •Initiate pioglitazone tablets 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 pioglitazone tablets. If abnormal, use caution when treating with pioglitazone tablets, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on pioglitazone tablets is not recommended in patients without liver disease. ( 5.3 ) 2.1 Recommendations for All Patients Pioglitazone tablets 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 pioglitazone hydrochloride 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 obtained prior to initiating pioglitazone tablets. Routine periodic monitoring of liver tests during treatment with pioglitazone tablets is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of pioglitazone hydrochloride or who are found to have abnormal liver tests while taking pioglitazone tablets should be managed as described under Warnings and Precautions [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )]. 2.2 Concomitant Use with an Insulin Secretagogue or Insulin If hypoglycemia occurs in a patient co-administered pioglitazone hydrochloride and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Pioglitazone side effects
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The most common side effects seen in trials were:
Common side effects
- Upper respiratory tract infection (cold-like symptoms)
- Headache
- Sinusitis (sinus infection)
- Muscle aches (myalgia)
- Sore throat (pharyngitis)
- Swelling (edema)
- Weight gain
- Low blood sugar when combined with insulin or sulfonylureas
When to get medical help
- Call your doctor right away if you have rapid or excessive weight gain, shortness of breath, or swelling. These can be signs of heart failure.
- Call your doctor if you have unusual tiredness, loss of appetite, pain in the upper right belly, dark urine or yellowing of the skin or eyes. These can be signs of liver problems.
- Tell your doctor about any blurry vision or vision changes. Macular edema (swelling in the back of the eye) has been reported.
- Tell your doctor if you notice signs of low blood sugar, especially if you also take insulin or a sulfonylurea.
- Report any bone fracture concerns, since fractures were more common in women taking pioglitazone.
Pioglitazone warnings and precautions
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- Heart failure (boxed warning): fluid retention can cause or worsen it.
- Liver: reports of liver failure, sometimes fatal. Stop and call your doctor if liver injury is suspected.
- Bladder cancer: a possible increased risk. Studies disagree. Avoid with active bladder cancer.
- Fractures: more common in women.
- Macular edema: swelling in the eye. Keep up with eye exams.
- Low blood sugar: risk rises with insulin or sulfonylureas.
Pioglitazone interactions
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These can change how pioglitazone works or raise its risks:
- Gemfibrozil and other strong CYP2C8 inhibitors raise pioglitazone levels, so the dose is limited
- Rifampin and other CYP2C8 inducers may lower levels
- Topiramate may lower levels, so blood sugar should be monitored
- Insulin and sulfonylureas raise the risk of low blood sugar. Insulin also raises the risk of fluid retention
Interactions listed in the FDA-approved label
From the Pioglitazone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP2C8 inhibitors (e.g., gemfibrozil): Significantly increases the exposure (AUC) and half-life of pioglitazone. Limit the dose to a maximum of 15 mg daily when used in combination.
- CYP2C8 inducers (e.g., rifampin): May significantly decrease the exposure (AUC) of pioglitazone. If an inducer is started or stopped during treatment, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg.
- Topiramate: A decrease in the exposure of pioglitazone and its active metabolites was noted with concomitant administration; the clinical relevance is unknown. Monitor patients for adequate glycemic control when used concomitantly.
Read the label’s full interactions text
7 DRUG INTERACTIONS • 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. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with pioglitazone hydrochloride, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for pioglitazone hydrochloride [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 pioglitazone hydrochloride and topiramate are used concomitantly, monitor patients for adequate glycemic control.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Pioglitazone
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- Do not start with established NYHA Class III or IV heart failure
- Do not use if allergic to pioglitazone or its ingredients
- Tell your doctor about heart failure, swelling, liver disease or bladder cancer history
- Pregnancy: limited data. Poorly controlled diabetes also carries risks in pregnancy
- Breastfeeding: no human data. Discuss benefits and risks
- Premenopausal women: ovulation may resume, so unintended pregnancy is possible
- Not recommended for children
- Older adults: no differences in safety or effectiveness were found, though data in those 75 and over are limited
- No dose change is required for kidney problems
Pioglitazone overdose
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In one clinical trial, a patient took much more than the recommended dose for 11 days and reported no symptoms. If an overdose happens, supportive treatment is given based on symptoms. Call poison control or seek medical help.
What Pioglitazone does in the body
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Pioglitazone improves insulin sensitivity. In type 2 diabetes it lowers blood glucose, insulin levels and HbA1c. It adds to the effect of sulfonylureas, metformin or insulin. On average, triglycerides fall and HDL (good) cholesterol rises, with no consistent change in LDL or total cholesterol. There is no conclusive evidence it reduces major heart and blood vessel events.
How your body processes Pioglitazone
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Pioglitazone peaks within about two hours. Food delays this to three to four hours but does not change how much is absorbed. It is heavily broken down in the liver, mainly by CYP2C8, into active metabolites. Steady levels are reached within seven days of daily use. The half-life is about three to seven hours for pioglitazone and 16 to 24 hours for its active metabolites. Most is eliminated through bile and feces.
How to store Pioglitazone
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Store at 20-25 o C (68-77 o F); excursions permitted to 15-30°C (59-86°F) . protect from light, moisture and humidity.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Pioglitazone
356 supplements and herbal products have documented interactions with Pioglitazone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 309
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Pioglitazone has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Pioglitazone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Pioglitazone — the kind of thing our pharmacy team would talk through with you at the counter.
What is pioglitazone for?
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How do I take it?
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What side effects are normal, and what should I call about?
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Why is there a heart failure warning?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Pioglitazone available over the counter?
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When was Pioglitazone first available?
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Who makes Pioglitazone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Pioglitazone on HelloPharmacist
Pioglitazone forms and strengths (how it comes)
Pioglitazone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Actos tablets improve blood sugar control in adults with type 2 diabetes, with diet and exercise.
- Pioglitazone hydrochloride tablets are used for the same purpose in adults with type 2 diabetes.
- Pioglitazone tablets are not for type 1 diabetes or diabetic ketoacidosis.
- Actos is taken by mouth once daily, with or without meals.
- Pioglitazone hydrochloride tablets are taken by mouth once daily, with or without meals.
- Pioglitazone tablets: liver tests are obtained before starting, and you are monitored for fluid retention after starting or increasing the dose.
Pioglitazone on the U.S. market: products, makers and brands
How Pioglitazone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
22 companies list 68 Pioglitazone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1999. Brand names on the directory include Actos; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Pioglitazone is used (Medicaid data)
A general measure of how commonly Pioglitazone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pioglitazone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pioglitazone prescribed? Of the 1,601 medications we measure, Pioglitazone ranks #259 by Medicaid prescriptions — more than 84% of them.
Utilization by Pioglitazone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
pioglitazone 30 MG Oral Tablet Most dispensed
Summed across the 15 of 149 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312440
pioglitazone 15 MG Oral Tablet
Summed across the 17 of 144 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 317573
pioglitazone 45 MG Oral Tablet
Summed across the 14 of 117 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312441
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pioglitazone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 46 of 410 listed Pioglitazone NDCs with Medicaid activity.
Compare Pioglitazone products
A representative set of FDA-listed product records for Pioglitazone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 15 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 45 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 15 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 30 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 15 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 15 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 30 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 45 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 15 mg | Oral | AvKARE | ANDA | View NDC → |
| 30 mg | Oral | AvKARE | ANDA | View NDC → |
| 45 mg | Oral | AvKARE | ANDA | View NDC → |
| 15 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 30 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 45 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 15 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 30 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 45 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 30 mg | Oral | Direct Rx | ANDA | View NDC → |
| 15 mg | Oral | GSMS, Incorporated | ANDA | View NDC → |
| 30 mg | Oral | GSMS, Incorporated | ANDA | View NDC → |
| 45 mg | Oral | GSMS, Incorporated | ANDA | View NDC → |
| 15 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 30 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 45 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 15 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 30 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 15 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 30 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 45 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 15 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | NuCare Pharmaceuticals,Inc. × 4 listings | ANDA | View NDC → |
| 15 mg | Oral | Preferred Pharmaceuticals, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Preferred Pharmaceuticals, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 30 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 15 mg | Oral | Quallent Pharmaceuticals Health Llc | ANDA | View NDC → |
| 30 mg | Oral | Quallent Pharmaceuticals Health Llc | ANDA | View NDC → |
| 45 mg | Oral | Quallent Pharmaceuticals Health Llc | ANDA | View NDC → |
| 15 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 30 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 45 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 15 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 45 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Solco Healthcare LLC | ANDA | View NDC → |
| 30 mg | Oral | Solco Healthcare LLC | ANDA | View NDC → |
| 45 mg | Oral | Solco Healthcare LLC | ANDA | View NDC → |
| 15 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 30 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 45 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 15 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 45 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 30 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 45 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
Showing 68 of 68 products — FDA National Drug Code Directory. See every product, package size and price: browse all 68 Pioglitazone NDCs →
Pioglitazone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pioglitazone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pioglitazone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Pioglitazone FDA approval history
How Pioglitazone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Pioglitazone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Pioglitazone recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05 Lots: Batch # PF4520028B & PF4520028A, Exp. Date 11/2022 FDA record D-0450-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 33738 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 374606In current FDA listings
Look up RxCUI 33738 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Pioglitazone supply and shortage status
Whether Pioglitazone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Pioglitazone brand names
Pioglitazone is sold under one brand name in the FDA directory — Actos. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Pioglitazone: manufacturers and labelers
22 companies list Pioglitazone products with the FDA. By number of product records, the largest are A-S Medication Solutions, NuCare Pharmaceuticals,Inc., Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Pioglitazone drug class (RxNorm)
Pioglitazone belongs to the Peroxisome Proliferator-activated Receptor alpha Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Pioglitazone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →