Glimepiride / rosiglitazone Side Effects

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

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

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

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating, fever, confusion or weakness;

• changes in your vision;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

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

Less serious side effects of glimepiride / rosiglitazone may include:

• headache;

• gradual weight gain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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 / rosiglitazone: oral tablet

Endocrine

Endocrine side effects have included hypoglycemia.

Cardiovascular

Cardiovascular side effects have included edema and congestive heart failure.

Respiratory

Respiratory side effects have included upper respiratory tract infection, pulmonary edema and pleural effusions.

Nervous system

Nervous system side effects have included dizziness, asthenia, and headache.

General

General side effects have included injury.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, gastrointestinal pain, and diarrhea,

Hepatic

Hepatic side effects have included elevations of liver enzyme levels, cholestasis, jaundice, and hepatitis.

Hypersensitivity

Hypersensitivity side effects have included angioedema and urticaria.

Dermatologic

Dermatologic side effects have included pruritus, erythema, urticaria, porphyria cutanea tarda, photosensitivity reactions, allergic vasculitis, and morbilliform or maculopapular eruptions.

Hematologic

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

Metabolic

Metabolic side effects have included hepatic porphyria reactions, disulfiram-like reactions, and hyponatremia. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported.

Ocular

Ocular side effects have included changes in accommodation and blurred vision. New onset or worsening (diabetic) macular edema with decreased visual acuity has been reported very rarely in postmarketing experience with rosiglitazone. In some cases, symptoms improved following discontinuation of rosiglitazone. Physicians should consider the possibility of macular edema if a patient reports decreased visual acuity.

Musculoskeletal

Musculoskeletal side effects have included an increased incidence of bone fracture in female patients. The majority of the fractures in the women who received rosiglitazone occurred in the upper arm, hand, and foot. These sites of fracture are different from those usually associated with postmenopausal osteoporosis (e.g., hip or spine). No increase in fracture rates was observed in men treated with rosiglitazone.

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