Pioglitazone
Pioglitazone Hydrochloride · Say it: pye-oh-GLI-tuh-zone
A prescription tablet taken once a day, with diet and exercise, to help adults with type 2 diabetes improve blood sugar control. It carries a boxed warning about heart failure.
⬛ Boxed warning (the FDA's strongest warning)
The boxed warning says that thiazolidinediones, including pioglitazone, can cause or worsen congestive heart failure in some people. After starting pioglitazone and after any dose increase, your doctor should watch you closely for signs of heart failure, such as fast weight gain, shortness of breath, or swelling. If heart failure develops, it should be treated under current standards of care, and your doctor must consider stopping the medicine or lowering the dose. Pioglitazone is not recommended for people with symptomatic heart failure. Starting pioglitazone is contraindicated in people with established New York Heart Association (NYHA) Class III or IV heart failure.
Used for
The label says pioglitazone is used, along with diet and exercise, to improve blood sugar (glucose) control in adults with type 2 diabetes. It may be taken alone or with other diabetes medicines. The label says it should not be used to treat type 1 diabetes or diabetic ketoacidosis, because it would not be effective in those settings. The label says to use caution in people with liver disease.
Comes as
Tablets in 15 mg, 30 mg, and 45 mg strengths. The 15 mg tablets are white to off-white, round, and uncoated, marked with "31" on one side and "H" on the other.
Common side effects
Upper respiratory tract infection, Headache, Sinusitis
| Generic name | Pioglitazone Hydrochloride |
|---|---|
| Brand names | — |
| Type of medicine | a diabetes medicine of the thiazolidinedione type |
| How it is sold | Prescription oral tablet |
| Comes as | Tablets in 15 mg, 30 mg, and 45 mg strengths. The 15 mg tablets are white to off-white, round, and uncoated, marked with "31" on one side and "H" on the other. |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-08-17 |
💊 What is Pioglitazone used for?
- The label says pioglitazone is used, along with diet and exercise, to improve blood sugar (glucose) control in adults with type 2 diabetes. It may be taken alone or with other diabetes medicines. The label says it should not be used to treat type 1 diabetes or diabetic ketoacidosis, because it would not be effective in those settings. The label says to use caution in people with liver disease.
How it works
The label describes pioglitazone as a thiazolidinedione and an agonist for PPAR gamma, a type of receptor in the body. The label says it exerts its blood sugar-lowering effect only in the presence of the body's own insulin. The label does not give further details about how it works.
How it is usually taken
- The label says to take pioglitazone exactly as your doctor tells you. It is taken one time each day, with or without food. Keep following your diet and exercise plan and test your blood sugar regularly, as the label advises. Your doctor may change your dose, so do not change it unless your doctor tells you to. The label says your doctor should check blood tests and HbA1c levels, and should check your eyes regularly, while you take it.
Comes as
- Tablets in 15 mg, 30 mg, and 45 mg strengths. The 15 mg tablets are white to off-white, round, and uncoated, marked with "31" on one side and "H" on the other.
⚠️ Pioglitazone side effects
Common side effects
- Upper respiratory tract infection
- Headache
- Sinusitis
- Muscle pain (myalgia)
- Sore throat (pharyngitis)
- Swelling (edema), which the label says can be dose-related
Get medical help right away if
- Get medical help right away if you have swelling or fluid retention, especially in the ankles or legs.
- Get medical help right away if you have shortness of breath or trouble breathing, especially when you lie down.
- Get medical help right away if your weight increases unusually fast.
- Get medical help right away if you have unusual tiredness.
- Get medical help right away if you have symptoms of low blood sugar (hypoglycemia). The label says this can happen if you skip meals, if you also take another blood sugar-lowering medicine, or if you have certain medical problems.
- Get medical help right away if you have signs of liver injury, such as ongoing tiredness, loss of appetite, pain in the upper right belly, dark urine, or yellowing of the skin or eyes (jaundice). The label notes that liver failure, sometimes fatal, has been reported.
- Get medical help promptly if you have sudden changes in your vision. The label mentions macular edema and says eye exams should be done regularly.
🛑 Who should not take Pioglitazone, and who should be careful
The label says not to take it if
- You have severe heart failure. The label says not to take pioglitazone in this case.
- You are allergic to pioglitazone or any other ingredient in the tablets.
- You have active bladder cancer. The label says not to use pioglitazone in this case.
Tell your doctor before taking it if
- Tell your doctor if you have heart failure.
- Tell your doctor if you have type 1 diabetes or have had diabetic ketoacidosis.
- Tell your doctor if you have diabetic eye disease that causes swelling at the back of the eye (macular edema).
- Tell your doctor if you have liver problems. The label says to use caution in people with liver disease.
- Tell your doctor if you have had or now have bladder cancer. The label says it may increase the risk of bladder cancer and should be used with caution if you have a history of it.
- Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.
- If you are a premenopausal woman who does not have regular periods, tell your doctor. The label says pioglitazone may increase the chance of becoming pregnant, so talk about birth control.
- Tell your doctor about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- The label says that female patients have an increased rate of fractures, and that bone health should be assessed and maintained under current standards of care.
🔀 Pioglitazone with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Gemfibrozil and other strong CYP2C8 inhibitors can significantly increase pioglitazone levels. The label says the maximum recommended dose is lower when used with gemfibrozil or similar medicines.
- Rifampin and other CYP2C8 inducers may decrease pioglitazone levels. If one is started or stopped, your diabetes treatment may need to change.
- Topiramate may decrease pioglitazone levels. The label says your blood sugar control should be monitored when they are used together.
- When used with insulin or sulfonylureas (insulin secretagogues), the risk of low blood sugar is higher. The label says the dose of these other medicines may need to be reduced by your prescriber.
Alcohol and food
The label says pioglitazone can be taken with or without food. The label does not discuss alcohol.
🤰 Pioglitazone in pregnancy and breastfeeding
Pregnancy
The label says it is not known if pioglitazone can harm an unborn baby. It also says there are risks to the mother and baby when diabetes is poorly controlled during pregnancy. If you are pregnant or planning a pregnancy, the label advises talking with your doctor about the best way to manage your blood sugar.
Breastfeeding
The label says it is not known if pioglitazone passes into breast milk or whether it could harm a baby. If you are breastfeeding or plan to, talk with your doctor about the best way to manage your blood sugar.
🗓️ Storage, missed doses and taking too much
Storage
Store at 20 to 25 degrees C (68 to 77 degrees F). Keep the container tightly closed and protect it from light, moisture, and humidity.
If a dose is missed
The label says that if you miss a dose, take your next dose as prescribed unless your doctor tells you otherwise. Do not take two doses at one time the next day.
If too much is taken
The label says that if you take too much pioglitazone, call your doctor or go to the nearest hospital emergency room right away. In clinical trials, one overdose case was reported, and the patient had no symptoms. Treatment is supportive and based on the person's signs and symptoms.
🗒️ Questions to ask about Pioglitazone
🎯 Check what you understood
1. What is the most important warning on the label for this medicine?
2. How does the label say pioglitazone is usually taken?
3. Is pioglitazone intended for people with type 1 diabetes?
❓ Pioglitazone: frequently asked questions
What is pioglitazone used for?
The label says it is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes. It may be taken alone or with other diabetes medicines.
Can pioglitazone be taken with or without food?
Yes. The label says it is taken once daily and can be taken with or without food.
What should I do if I miss a dose?
The label says to take your next dose as prescribed unless your doctor tells you otherwise. Do not take two doses at one time the next day.
Why does the label warn about swelling and weight gain?
The label says pioglitazone can cause fluid retention, which can lead to swelling and weight gain. Extra fluid can make heart problems worse or lead to heart failure, so you should call your doctor right away if these occur.
How should pioglitazone be stored?
The label says to store it at 20 to 25 degrees C (68 to 77 degrees F), keep the container tightly closed, and protect it from light, moisture, and humidity.
🧪 Tests and reports linked to Pioglitazone
The label text mentions these. If you have one of these reports, get every line of it explained.
- HbA1c and glucose
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- Culture and sensitivity
a test or report linked to this medicine
- Urinalysis
a test or report linked to this medicine
- Liver function tests
a test or report linked to this medicine
- ECG (EKG) reports
a test or report linked to this medicine
📖 Medical words used on this page
- Bilateral and unilateral
Bilateral means on both sides of the body and unilateral means on one side only, and reports usually also name the side.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Contraception
Contraception means methods used to prevent pregnancy, such as pills, implants, injections, coils (IUDs) and condoms.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Diabetic ketoacidosis
Diabetic ketoacidosis (DKA) is a serious complication of diabetes where ketone acids build up in the blood. It is a medical emergency.
- Edema
Edema is swelling caused by extra fluid trapped in the body's tissues, often in the feet, ankles and legs.
- HbA1c
HbA1c shows your average blood sugar over roughly the past two to three months by measuring how much sugar is attached to red blood cells.
- Heart failure
Heart failure means the heart is not pumping or filling as well as it should, so it struggles to meet the body's needs. It does not mean the heart has stopped.
- Hypoglycemia
Hypoglycemia means blood sugar (glucose) has dropped too low. It can cause shakiness, sweating and confusion, and severe cases need urgent help.
- Jaundice
Jaundice is yellowing of the skin or whites of the eyes, caused by a build-up of bilirubin in the blood.
- Ketoacidosis
Ketoacidosis is a dangerous build-up of acids called ketones in the blood. It is a medical emergency, most often linked to diabetes.
- Ketones
Ketones are substances the body makes when it burns fat for energy instead of sugar; they can be measured in urine or blood.
- Liver damage
Liver damage means injury to liver cells. On medicine labels it is a warning that taking too much, or mixing with alcohol, can harm the liver.
- Over-the-counter
Over-the-counter (OTC) means a medicine you can buy without a prescription, from a pharmacy, shop or supermarket.
📖 Medical words on this page
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Have the leaflet or prescription in front of you?
Explain my leafletDecode my prescription🔗 Trusted sources about Pioglitazone
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Pioglitazone on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Pioglitazone on the NHS website ↗
UK National Health Service medicine guide
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
Explain your own documents
Source: official FDA drug label (label updated 2026-08-17). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.