Avandia Side Effects
Generic Name: rosiglitazone
Note: This page contains information about the side effects of rosiglitazone. Some of the dosage forms included on this document may not apply to the brand name Avandia.
Not all side effects for Avandia may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to rosiglitazone: oral tablet
In addition to its needed effects, some unwanted effects may be caused by rosiglitazone (the active ingredient contained in Avandia). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking rosiglitazone:Less common
- Abdominal or stomach pain
- blurred vision
- chest pain or discomfort
- decrease in the amount of urine
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- irregular heartbeat
- noisy, rattling breathing
- pain in the shoulders, arms, jaw, or neck
- pale skin
- rapid or unusual weight gain
- swelling of the fingers, hands, feet, or lower legs
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- cold sweats
- dark urine
- fast heartbeat
- loss of appetite
- slurred speech
- Blue lips and fingernails
- changes in vision
- coughing that sometimes produces a pink frothy sputum
- hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- itching or skin rash
- light-colored stools
- redness of the skin
- yellow eyes or skin
Some of the side effects that can occur with rosiglitazone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Ear congestion
- general feeling of discomfort or illness
- hoarseness or other voice changes
- joint pain
- muscle aches and pains
- runny or stuffy nose
- sore throat
- trouble sleeping
- Back pain
- pain or tenderness around the eyes and cheekbones
For Healthcare Professionals
Applies to rosiglitazone: oral tablet
Rosiglitazone (the active ingredient contained in Avandia) 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.
Healthy volunteers receiving rosiglitazone (the active ingredient contained in Avandia) 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 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 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 (the active ingredient contained in Avandia) 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 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 (the active ingredient contained in Avandia) alone and in combination with other hypoglycemic agents.
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 side effects have included rare postmarketing reports of urticaria and angioedema. Postmarketing experience has included rare reports of anaphylactic reactions.
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 (the active ingredient contained in Avandia) 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 side effects have included angioedema and urticaria. Rash, pruritus, and Stevens-Johnson syndrome have been reported rarely postmarketing.
Respiratory side effects have included new or worsening dyspnea in patients with congestive heart failure.
Gastrointestinal side effects have included diarrhea.
Reductions in femoral neck, total hip, and lumbar spine bone mineral density and increased bone turnover markers were observed in a randomized, double-blind study of postmenopausal women with type 2 diabetes mellitus who were treated with rosiglitazone (the active ingredient contained in Avandia) for 52 weeks.
Musculoskeletal side effects have included arthralgia and fractures of the upper arm, hand and foot in women.
More about Avandia (rosiglitazone)
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