Actos Side Effects

Generic name: pioglitazone

Note: This document contains side effect information about pioglitazone. Some of the dosage forms listed on this page may not apply to the brand name Actos.

Some side effects of Actos may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pioglitazone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking pioglitazone (the active ingredient contained in Actos) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pioglitazone and call your doctor at once if you have any of these serious side effects:

• stomach pain, blood in your urine;

• painful urination;

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

• chest pain, general ill feeling;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• blurred vision;

• increased thirst or hunger, urinating more than usual; or

• pale skin, easy bruising or bleeding, weakness.

Less serious side effects of pioglitazone may include:

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• headache;

• gradual weight gain;

• muscle pain;

• back pain; or

• tooth problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pioglitazone: oral tablet

General

The types of side effects reported when pioglitazone (the active ingredient contained in Actos) 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 (the active ingredient contained in Actos) 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 (the active ingredient contained in Actos) 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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