Prescription medication · Thiazolidinedione
pioglitazone
Also sold as Actos. Pioglitazone is used to help manage blood sugar in adults who have type 2 diabetes.
Data updated 2026-05-15
- 42,504
- FDA reportsOften reported
- 10
- InteractionsSeveral interactions
- $0.07
- Generic price (NADAC)
What the data shows
pioglitazone (Actos) is a prescription Thiazolidinedione, reported at a middle-of-the-pack volume (42,504 FDA reports), with 10 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
pioglitazone (Actos) is a prescription Thiazolidinedione. Pioglitazone is used to help manage blood sugar in adults who have type 2 diabetes.
Pioglitazone (Actos) is a medicine that helps control blood sugar levels in adults with type 2 diabetes. It works along with diet and exercise.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.07/unit
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Pioglitazone is used to help manage blood sugar in adults who have type 2 diabetes.
Common side effects
Upper respiratory infection, Headache, Sinus infection
Key warnings
Pioglitazone can cause or worsen heart failure in some people.
The sections below are summarized in plain English from pioglitazone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Pioglitazone belongs to a class of drugs called thiazolidinediones. It makes your body more sensitive to insulin, which helps lower blood sugar. It works by activating a certain receptor in your body called PPAR gamma.
How to Take It
Take pioglitazone once a day. You can take it with or without food. The starting dose is usually 15 mg or 30 mg. Your doctor may increase the dose up to 45 mg per day if needed.
This is a plain-language summary of pioglitazone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if pioglitazone can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if pioglitazone passes into breast milk, so talk to your doctor about breastfeeding while taking this medicine.
This is a plain-language summary of pioglitazone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of pioglitazone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store pioglitazone at room temperature (68° to 77°F), away from light, moisture, and humidity, and keep the container tightly closed.
Side Effects (from patient reports)
Based on 42,504 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for pioglitazone, by number of reports
- Cancer of the bladder
Cancer of the bladder
8,736 reports
- Increased blood sugar 3,385
Increased blood sugar
3,385 reports
- Feeling sick to your stomach 2,917
Feeling sick to your stomach
2,917 reports
- Weight loss 2,084
Weight loss
2,084 reports
- Loose or watery stools 1,680
Loose or watery stools
1,680 reports
- Death 1,541
Death
1,541 reports
- Feeling tired 1,481
Feeling tired
1,481 reports
- Throwing up 1,433
Throwing up
1,433 reports
- Shortness of breath 1,407
Shortness of breath
1,407 reports
- Feeling lightheaded 1,405
Feeling lightheaded
1,405 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for pioglitazone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where pioglitazone sits
pioglitazone has more FDA adverse-event reports than 70% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pioglitazone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 42,504 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
42,504
Reports Mentioning Death
4,296
10.1% of reports — not proof of cause
Hospitalization Reports
11,530
Top Indication
Type 2 Diabetes Mellitus
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BLADDER CANCER | 8,736 |
| 2 | BLOOD GLUCOSE INCREASED | 3,385 |
| 3 | NAUSEA | 2,919 |
| 4 | WEIGHT DECREASED | 2,083 |
| 5 | DIARRHOEA | 1,679 |
| 6 | DEATH | 1,541 |
| 7 | FATIGUE | 1,480 |
| 9 | VOMITING | 1,432 |
| 10 | DYSPNOEA | 1,408 |
| 11 | DIZZINESS | 1,405 |
| 12 | DECREASED APPETITE | 1,391 |
| 13 | WEIGHT INCREASED | 1,294 |
| 14 | BLOOD GLUCOSE DECREASED | 1,201 |
| 15 | ASTHENIA | 1,154 |
| 16 | HEADACHE | 1,090 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Pioglitazone can cause or worsen heart failure in some people. Watch for signs like rapid weight gain, shortness of breath, and swelling. If you have heart failure, it should be managed, and stopping or lowering the dose of pioglitazone should be considered. If you have severe heart failure (NYHA Class III or IV), you should not start taking pioglitazone.
Known Drug Interactions
Gastroprokinetic Agents: Cisapride Contraindicated Cisapride: [See Contraindications ( 4.2 )] Lipid-lowering agents: Lomitapide Lovastatin Simvastatin Contraindicated Lomitapide, Lovastatin, Simvastatin: Clarithromycin may increase the exposure of these drugs by inhibition of CYP3A metabolism, thereby increasing the risk of toxicities from these drugs [see Contraindications ( 4.5 ) and Warnings and Precautions ( 5.4 )] Atorvastatin, Pravastatin, Fluvastatin: [See Warnings and Precautions ( 5.4 )] Atorvastatin Pravastatin Use With Caution Fluvastatin No Dose Adjustment Hypoglycemic Agents:...
Mechanism: Clarithromycin can interfere with how your body handles certain diabetes drugs, which may increase the risk of your blood sugar falling too low.
What to do: Watch your blood sugar levels carefully and consult your doctor for any needed dose adjustments.
(2.3 , 7.1) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. 7.2 CYP2C8 Inducers An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone.
Mechanism: Rifampin makes your body get rid of pioglitazone much faster than usual. This lowers the amount of medicine in your body and makes it less effective at controlling blood sugar.
What to do: Your doctor may need to adjust your dose of pioglitazone. Monitor your blood sugar levels closely while taking both medications.
7 DRUG INTERACTIONS Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase 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 pioglitazone 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) ].
Mechanism: Gemfibrozil blocks the liver enzyme that breaks down pioglitazone, which causes the drug to stay in your body longer and reach higher levels.
What to do: Your doctor should limit your pioglitazone dose to no more than 15 mg per day while you are taking gemfibrozil.
In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate.
Mechanism: Abiraterone blocks a protein in the liver that normally breaks down pioglitazone. This causes pioglitazone to stay in your body longer and reach higher levels.
What to do: Your doctor may need to monitor you more closely for side effects or adjust your dose of pioglitazone.
No dosing adjustments required for the following: Oral Antidiabetic Agents Metformin (1000 mg) 20 mg ↔ ↔ Pioglitazone (45 mg) 50 mg ↔ ↔ Sitagliptin (100 mg) 20 mg ↔ ↔ Glimepiride (4 mg) 20 mg ↔ ↔ Voglibose (0.2 mg three times daily) 10 mg ↔ ↔ Other Medications Hydrochlorothiazide (25 mg) 50 mg ↔ ↔ Bumetanide (1 mg) 10 mg once daily for 7 days ↔ ↔ Valsartan (320 mg) 20 mg ↓12% [↓3%, ↓20%] ↔ Simvastatin (40 mg) 20 mg ↔ ↔ Anti-infective Agent Rifampin (600 mg once daily for 6 days) 10 mg ↓7% [↓22%, ↑11%] ↓22% [↓27%, ↓17%] Nonsteroidal Anti-inflammatory Agent Mefenamic Acid (loading dose of...
Mechanism: These drugs do not significantly affect each other's levels in the body.
What to do: No dose changes are needed when taking these two medications together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take pioglitazone if I have heart problems?
Will pioglitazone cause low blood sugar?
Can pioglitazone affect my liver?
Does pioglitazone cause weight gain?
Can pioglitazone increase my risk of fractures?
Can pioglitazone affect my vision?
What should I do if I experience swelling while taking pioglitazone?
Can I drink alcohol while taking pioglitazone?
What if I am taking other medications?
How often should I check my blood sugar?
What are the common side effects of pioglitazone?
Does pioglitazone interact with other medications?
What drug class is pioglitazone?
Is pioglitazone safe during pregnancy?
Related Medications in Thiazolidinedione
Other drugs grouped near pioglitazone - same-class peers and common alternatives.
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bromocriptine
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canagliflozin
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for pioglitazone
The FDA label for pioglitazone (sold under brand names such as Actos) classifies it as a prescription-only medication in the Thiazolidinedione class. Pioglitazone is used to help manage blood sugar in adults who have type 2 diabetes. Official labeling lists 5 commonly reported side effects, including Upper respiratory infection, Headache, Sinus infection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 42,504 voluntary reports. The database also lists 10 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.07.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 17, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages