Pioglitazone Side Effects

It is possible that some side effects of pioglitazone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to pioglitazone: oral tablet

As well as its needed effects, pioglitazone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pioglitazone, check with your doctor immediately:

More common
  • Chest pain
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • problems with teeth
  • shortness of breath
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • trouble with breathing
  • weight gain
  • wheezing
Less common
  • Pain or swelling in the arms or legs without an injury
  • pale skin
  • swelling
  • trouble with breathing when active
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Dark urine
  • loss of appetite
  • nausea or vomiting
  • stomach pain
  • unexplained, rapid weight gain
  • yellow eyes or skin

Some pioglitazone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Blurred vision or other changes in vision
  • cough
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • loss of consciousness
  • muscle pain or soreness
  • problems with your teeth
  • runny or stuffy nose
  • sore throat
  • stomachache
  • sweating
  • unexplained weight loss

For Healthcare Professionals

Applies to pioglitazone: oral tablet


The types of side effects reported when pioglitazone was used in combination with sulfonylurea, metformin or insulin were generally similar to those reported during pioglitazone monotherapy with the exception of an increase in the occurrence of edema in the insulin combination study.

Pioglitazone has been generally well tolerated with the incidence of adverse effects similar to placebo. Upper respiratory tract infections, headache, sinusitis, myalgia, tooth disorder and pharyngitis were reported slightly more frequently than placebo in clinical trials.


Endocrine side effects have included mild to moderate hypoglycemia which was reported during combination therapy with a sulfonylurea or insulin.


Hematologic side effects have included anemia which was reported in 1% of pioglitazone patients and none of the placebo patients. Pioglitazone may cause decreases in hemoglobin and hematocrit. Across all clinical studied, mean hemoglobin values declined by 2 to 4%. Anemia was reported more frequently when pioglitazone was combined with insulin, a sulfonylurea or metformin.


A case of angioneurotic edema, characterized as a sore throat followed by dyspnea and swelling of the lips and tongue, has been reported.

Cardiovascular side effects have included edema which was reported in 4.8% of pioglitazone patients versus 1.2% of placebo patients. In combination studies, edema was reported for 7.2% of patients treated with pioglitazone and sulfonylureas compared to 2.1% of patients on sulfonylureas alone. In combination therapy studies with metformin, edema was reported in 6.0% of patients on combination therapy compared to 2.5% of patients on metformin alone. In combination therapy studies with insulin, edema was reported in 15.3% of patients on combination therapy compared to 7.0% of patients on insulin alone.


Hepatic side effects have included reports of liver damage associated with pioglitazone therapy.


Ocular side effects have included postmarketing reports of new onset or worsening diabetic macular edema with decreased visual acuity.

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