Glimepiride / pioglitazone Side Effects

Some side effects of glimepiride / pioglitazone 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 glimepiride / pioglitazone: oral tablet

Stop using glimepiride and pioglitazone and Get emergency medical help if you have any of these signs of an allergic reaction while taking glimepiride / pioglitazone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• stomach pain, blood in your urine, painful urination;

• swelling in your feet, rapid weight gain, feeling short of breath (even with mild exertion);

• pale skin, easy bruising or bleeding;

• pain or burning when you urinate; or

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• nausea, vomiting, weakness, loss of appetite, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure.

Less serious side effects of glimepiride / pioglitazone may include:

• sneezing, stuffy nose, cough, sore throat, or other cold symptoms;

• gradual weight gain;

• mild nausea, diarrhea;

• headache, dizziness, blurred vision; 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 glimepiride / pioglitazone: oral tablet

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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