Rosiglitazone Side Effects

Some side effects of 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 rosiglitazone: oral tablet

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

Stop using rosiglitazone and call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

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

• nausea, stomach pain, low fever, 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 rosiglitazone may include:

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

• headache; or

• back pain.

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 rosiglitazone: oral tablet

General

Rosiglitazone is generally well tolerated with the incidence of adverse effects similar to placebo. Upper respiratory tract infections, injury, headache, back pain and hypoglycemia were reported slightly more frequently than placebo in clinical trials.

Cardiovascular

Healthy volunteers receiving rosiglitazone 8 mg once daily for 8 weeks experienced a statistically significant increase in median plasma volume compared to placebo. Patients with ongoing edema are more likely to have adverse events associated with edema if started on combination therapy with insulin and rosiglitazone.

Dose-related weight gain was seen with rosiglitazone alone and in combination with other hypoglycemic agents. The mechanism is unclear but probably involves a combination of fluid retention and fat accumulation.

In a 26-week study, edema was reported with higher frequency in the rosiglitazone plus insulin combination trials (insulin, 5.4%; and rosiglitazone with insulin 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at a rate of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with rosiglitazone.

In postmarketing experience, there have been rare reports of usually rapid increases in weight. Patients should be assessed for fluid accumulation and volume-related events such as edema and congestive heart failure.

Cardiovascular side effects have included mild to moderate edema. Patients with congestive heart failure have experienced new or worsening edema. Hypertension has also been reported.

Hematologic

Hematologic side effects have included decreases in hemoglobin and hematocrit. White blood cell counts also decreased slightly.

These changes may be related to the increased plasma volume observed during treatment with rosiglitazone and have not been associated with any significant hematologic clinical effects.

Hepatic

Hepatic side effects have included postmarketing reports of hepatitis and of hepatic enzyme elevations to three or more time the upper limit of normal. Very rarely, reports have involved hepatic failure with and without fatal outcome. Rosiglitazone is structurally related to troglitazone, a thiazolidinedione no longer marketed in the United States, which was associated with idiosyncratic hepatotoxicity and rare cases of liver failure, liver transplants, and death during clinical use. It is recommended that liver enzymes be checked in all patients prior to the initiation of therapy and every two months for the first twelve months and periodically thereafter.

Metabolic

Metabolic side effects have included increases in total cholesterol, LDL, and HDL and decreases in free fatty acids. These changes were statistically significantly different from placebo or glyburide controls. Dose related weight gain has been reported in patients treated with rosiglitazone alone and in combination with other hypoglycemic agents.

Endocrine

Endocrine side effects have included the resumption of ovulation in premenopausal, anovulatory women with insulin resistance. These patients may be at risk for pregnancy if adequate contraception is not used.

Hypersensitivity

Hypersensitivity side effects have included rare postmarketing reports of urticaria and angioedema. Postmarketing experience has included rare reports of anaphylactic reactions.

Ocular

Ocular side effects have included rare postmarketing reports of new onset or worsening (diabetic) macular edema with decreased visual acuity. In some cases, symptoms improved following discontinuation of rosiglitazone. Physicians should consider the possibility of macular edema if a patient reports decreased visual acuity. There is a case report of rosiglitazone induced proptosis.

Dermatologic

Dermatologic side effects have included angioedema and urticaria. Rash, pruritus, and Stevens-Johnson syndrome have been reported rarely postmarketing.

Respiratory

Respiratory side effects have included new or worsening dyspnea in patients with congestive heart failure.

Gastrointestinal

Gastrointestinal side effects have included diarrhea.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and fractures of the upper arm, hand and foot in women.

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