Pioglitazone Side Effects

Brand Names: Actos

Please note - some side effects for Pioglitazone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pioglitazone - for the Consumer

Pioglitazone

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pioglitazone:

Headache; muscle aches; sore throat; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, or feet); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes; sweating); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.

Side Effects by Body System

General

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

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

Hematologic

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.

Cardiovascular

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

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

Ocular

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

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