Duetact Side Effects

Please note - some side effects for Duetact may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Duetact - for the Consumer

Duetact

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 Duetact:

Cold-like symptoms; diarrhea; headache; leg or arm pain; nausea; 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; chest pain; confusion; fever, chills, or persistent sore throat; irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain); symptoms of liver problems (eg, dark urine, severe or persistent nausea, stomach pain, unexplained vomiting or loss of appetite, yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety, chills, dizziness or drowsiness, headache, increased hunger, increased sweating, tremors); unusual bone pain; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Duetact Side Effects - for the Professional

Duetact

The adverse events reported in at least 5% of patients in the controlled 16-week clinical studies between placebo plus a sulfonylurea and pioglitazone (15 mg and 30 mg combined) plus sulfonylurea-treatment arms were upper respiratory tract infection (15.5% and 16.6%), accidental injury (8.6% and 3.5%) and combined edema/peripheral edema (2.1% and 7.2%), respectively.

The incidence and type of adverse events reported in at least 5% of patients in any combined treatment group from the 24-week study comparing pioglitazone 30 mg plus a sulfonylurea and pioglitazone 45 mg plus a sulfonylurea are shown in Table 4; the rate of adverse events resulting in study discontinuation between the two treatment groups was 6.0% and 9.7%, respectively.

In U.S. double-blind studies, anemia was reported in ≤ 2% of patients treated with pioglitazone plus a sulfonylurea.

Pioglitazone hydrochloride

Over 8500 patients with type 2 diabetes have been treated with pioglitazone in randomized, double-blind, controlled clinical trials. This includes 2605 high-risk patients with type 2 diabetes treated with pioglitazone from the PROactive clinical trial. Over 6000 patients have been treated for 6 months or longer, and over 4500 patients for one year or longer. Over 3000 patients have received pioglitazone for at least 2 years.

Most clinical adverse events were similar between groups treated with pioglitazone in combination with a sulfonylurea and those treated with pioglitazone monotherapy. Other adverse events reported in at least 5% of patients in controlled clinical studies between placebo and pioglitazone monotherapy included myalgia (2.7% and 5.4%), tooth disorder (2.3% and 5.3%), diabetes mellitus aggravated (8.1% and 5.1%) and pharyngitis (0.8% and 5.1%), respectively.

In monotherapy studies, edema was reported for 4.8% (with doses from 7.5 mg to 45 mg) of patients treated with pioglitazone versus 1.2% of placebo-treated patients. Most of these events were considered mild or moderate in intensity.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included edema, lower limb edema, and peripheral edema.

Hepatic

Hepatic side effects have included cholestasis, jaundice, and hepatitis which has lead to liver failure.

Endocrine

Endocrine side effects have included hypoglycemia and aggravation of diabetes mellitus.

Metabolic

Metabolic side effects have included hepatic porphyria reactions and disulfiram-like reactions. Hyponatremia, increased release of antidiuretic hormone, and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported.

Respiratory

Respiratory side effects have included upper respiratory tract infection and pharyngitis.

Hematologic

Hematologic side effects have included leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.

Gastrointestinal

Gastrointestinal side effecys have included vomiting, gastrointestional pain, diarrhea, and nausea.

Nervous system

Nervous system side effects have included headache, dizziness, and limb pain.

Musculoskeletal

Musculoskeletal side effects have included myalgia and asthenia.

Dermatologic

Dermatologic side effects have included allergic skin reactions, pruritus, erythema, urticaria, morbilliform and maculopapular eruptions. Porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported.

Genitourinary

Genitourinary side effects have included urinary tract infection.

General

General side effects have included weight gain, tooth disorder, and accidental injury.

Ocular

Ocular side effects have included changes in accommodation and blurred vision.

Macular edema has been reported in postmarketing experience in diabetic patients who were taking pioglitazone or another thiazolidinedione. Some patients presented with blurred vision or decreased visual acuity, but some patients appear to have been diagnosed on routine ophthalmologic examination. Some patients had peripheral edema at the time macular edema was diagnosed. Some patients had improvement in their macular edema after discontinuation of their thiazolidinedione. It is unknown whether or not there is a causal relationship between pioglitazone and macular edema. Patients with diabetes should have regular eye exams by an ophthalmologist, per the Standards of Care of the American Diabetes Association. Additionally, any diabetic who reports any kind of visual symptom should be promptly referred to an ophthalmologist, regardless of the patient's underlying medications or other physical findings.

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