Rosiglitazone Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 2, 2024.

Applies to rosiglitazone: oral tablet.

Important warnings This medicine can cause some serious health issues

Rosiglitazone can cause or worsen congestive heart failure. You should not use this medicine if you have severe or uncontrolled heart failure.

Stop using this medicine and call your doctor at once if you have shortness of breath (especially when lying down), unusual tiredness, swelling, or rapid weight gain.

Get emergency medical help if you have signs of an allergic reaction (hives, itching, dizziness, rapid heartbeats, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using rosiglitazone and call your doctor at once if you have symptoms of liver damage: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have:

• shortness of breath (especially when lying down), unusual tiredness, swelling, rapid weight gain;

• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• pale skin, feeling light-headed or short of breath, cold hands and feet;

• changes in your vision; or

• sudden unusual pain in your hand, arm, or foot.

Common side effects may include:

• headache; or

• cold symptoms such as stuffy nose, sinus pain, 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 rosiglitazone: oral tablet.

General adverse events

The most commonly reported adverse reports included upper respiratory tract infections, injury, and headache.^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, hypertension,
• Frequency not reported: Cardiovascular deaths, congestive heart failure (CHF), myocardial infarction, angina, angina pectoris, angina dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, coronary artery disorder^[Ref]

Major Adverse Cardiovascular Events:

Overall data from long-term rosiglitazone trials including the RECORD, ADOPT, and DREAM trials (rosiglitazone n=6311; control n=7756) showed no difference in overall mortality or major adverse cardiovascular events; however, a meta-analysis of shorter-term trials suggests and increased risk for myocardial infarction with rosiglitazone compared with placebo.

The RECORD trial (Rosiglitazone evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) revealed no significant difference in cardiovascular hospitalization or cardiovascular death (primary outcome) among patients with type 2 diabetes receiving rosiglitazone add-on therapy (n=2220) compared with active control (n=2227); however, there was a significant difference in the incidence of CHF (secondary endpoint). Patients randomized were those who had failed metformin or sulfonylurea monotherapy; mean age: 58 years; 52% male. Following randomization to add-on rosiglitazone or active control (add-on metformin for those inadequately controlled on sulfonylurea or add-on sulfonylurea for those inadequately controlled on metformin) patients were treated to a target glycosylated hemoglobin (HbA1c) of 7% or less. Heart failure was reported in 61 patients receiving add-on rosiglitazone and 29 patients receiving active control.

In a retrospective analysis of 42 clinical trials (mean duration 6 months), rosiglitazone was associated with an increased risk of myocardial ischemia compared with combined active or placebo control (2% versus 1.53%). These events included angina pectoris, angina dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, and coronary artery disorder. There was an increased risk with combination insulin therapy and in patients receiving nitrates for known coronary heart disease.

Cardiovascular Events in Patients with NYHA Class I and II Heart Failure:

An increased risk of cardiovascular events was observed in a 52-week trial in patients with NYHA Class I and II Heart Failure who were receiving rosiglitazone (n=110) compared with placebo (n=114). These events included: cardiovascular deaths (5% vs 4%), worsening CHF (6% vs 4%), new or worsening edema (25% vs 9%), new or worsening dyspnea (26% vs 17%), increases in CHF medication (33% vs 18%), and cardiovascular hospitalization (19% vs 13%).

Edema:

Dose-related edema was reported in rosiglitazone clinical trials. In patients receiving rosiglitazone 8 mg in combination with a sulfonylurea, the incidence of edema was 12.4%. In rosiglitazone monotherapy trials, edema was reported in 4.8% of patients (dose not specified). Healthy volunteers receiving rosiglitazone 8 mg once daily for 8 weeks experienced a statistically significant increase in median plasma volume compared with placebo.

Concomitant Administration with Insulin:

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 CHF occurred at a rate of 1% for insulin alone, 2% (4 mg) and 3% (8 mg) for insulin in combination with rosiglitazone. The coadministration of rosiglitazone and insulin is not recommended.^[Ref]

Hematologic

• Common (1% to 10%): Anemia
• Frequency not reported: Decrease in WBC counts^[Ref]

Anemia was reported in 1.9% of patients receiving rosiglitazone as monotherapy. In combination therapy with metformin, a sulfonylurea, or metformin plus a sulfonylurea, the incidence of anemia was 7.1%, 2.3%, and 6.7%, respectively. Laboratory findings have shown dose-related decreases in hemoglobin and hematocrit; mean decreases in hemoglobin were 1 g/dL and up to 3.3% in hematocrit. These changes primarily occurred during the first 3 months or following a dose increase. They may be related to increased plasma volume.^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hyperbilirubinemia, ALT elevations
• Postmarketing reports: Hepatitis, hepatic enzyme elevations greater than 3 times the upper limit of normal, hepatic failure^[Ref]

Metabolic

• Common (1% to 10%): Hyperglycemia, hypoglycemia, hypocholesterolemia
• Uncommon (0.1% to 1%): Weight gain
• Frequency not reported: Increases in waist and hip circumference^[Ref]

The mechanism of weight gain is unclear, although it probably is due to a combination of fluid retention and fat accumulation. In the ADOPT monotherapy trial, median weight change at 4 years was plus 3.5 kg.^[Ref]

Endocrine

• Frequency not reported: Resumption of ovulation in premenopausal, anovulatory women, hormonal imbalance^[Ref]

Hypersensitivity

• Postmarketing reports: Anaphylactic reaction, urticaria, angioedema^[Ref]

Dermatologic

• Postmarketing reports: Rash, pruritus, urticaria, angioedema, Stevens-Johnson syndrome^[Ref]

Ocular

• Postmarketing reports: Diabetic macular edema with decreased visual acuity^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, sinusitis
• Frequency not reported: Dyspnea
• Postmarketing reports: Pulmonary edema, pleural effusions^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain
• Frequency not reported: Fractures^[Ref]

Long-term clinical trials have shown an increased incidence of bone fracture in patients receiving drug compared with glyburide or metformin. This increased incidence appeared after the first year and persisted during the trials. The majority of fractures were observed in women and occurred in the upper arm, hand, and foot.^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea^[Ref]

Other

• Common (1% to 10%): Injury, fatigue^[Ref]

Further information

Rosiglitazone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer