Avandia

The most common side effects of Avandia in clinical trials were cold-like symptoms and headaches. Avandia has a few other mild side effects that may last for a short time.

These mild side effects rarely require medical treatment.

Mild, common Avandia side effects are less severe than the major risks listed below, but they can still impact your quality of life. If they don’t go away or bother you, make sure to tell your doctor.

Avandia’s most serious side effects, such as congestive heart failure and heart attacks, affect the heart. These side effects are rarer but also more serious and may require emergency medical care.

Older adults and those with pre-existing heart conditions are at a significantly higher risk of heart complications.

Bone fracture risk is higher in women and in people who have used Avandia for over a year.

Avandia has a black box warning for congestive heart failure, and the drug can cause new heart failure or make pre-existing heart failure worse.

As of October 2025, heart attack, congestive heart failure, stroke and coronary artery disease were the most common Avandia (rosiglitazone) side effects reported to the U.S. Food and Drug Administration. These four conditions account for 89.4% of all Avandia adverse events reported to the FDA.

A 2007 article by cardiologist Steven Nissen and Kathy Wolski of the Cleveland Clinic first exposed Avandia’s association with heart-related severe side effects. Other studies have linked the drug to liver failure and an increased risk of pregnancy.

Of the more than 93,000 adverse events reported to the FDA, the agency classifies over 87% as “serious.”

Disclaimer: Reports submitted to the FDA do not necessarily indicate that the drug caused an adverse event. It is important to consult with a healthcare professional before changing your medication.

After Avandia was linked to heart-related side effects, its popularity plummeted. Due to these risks, the FDA temporarily imposed a restricted access program called Risk Evaluation and Mitigation Strategy (REMS) in 2011, severely limiting its prescription.

Other side effects of Avandia include bone fractures, liver toxicity, edema, weight gain, vision problems and unexpected pregnancy risks.

“In my clinical practice, the most worrisome adverse effects of Avandia are congestive heart failure, myocardial infarction and liver problems,” Dr. Michael McKinney, primary physician of the medical weight loss center Healthy Outlook, told Drugwatch.

Manufacturer GlaxoSmithKline allocated billions of dollars to resolve thousands of Avandia lawsuits, alleging that the company concealed the risks of heart attack and cardiac death from the public.

Less common adverse effects may include swelling, hypertension, upper respiratory tract infection, headache, back pain, high blood sugar, fatigue, sinusitis, diarrhea and low blood sugar.

Avandia remains on the market in the United States.

FDA warnings and restrictions on Advandia have fueled the medication’s plummeting popularity. In 2007, the FDA required a black box warning about its potential to cause or worsen congestive heart failure.

Avandia can cause or worsen congestive heart failure in some patients.

Source: Avandia Prescribing Information

The FDA’s REMS that restricted the amount of prescriptions, negative reports and increased medical skepticism drastically reduced Avandia’s use in treating type 2 diabetes.

“The basic plot of the rosiglitazone story quickly became obvious to the advisory committee: a new ‘wonder drug,’ approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from industry, had caused undue harm to patients,” Dr. Clifford J. Rosen, the joint committee chair, wrote in
The New England Journal of Medicine. “The rosiglitazone story thus carries lessons for scientists, practitioners, and regulators alike.”

The FDA discontinued their REMS in 2015 after manufacturers updated the label warnings about heart failure and provided educational training to doctors about its risks. Health professionals must monitor patients for rapid weight gain, breathing issues and swelling.

“I equip my clients with knowledge about the signs of heart failure such as difficulty in breathing and swelling in their lower extremities while stressing the importance of seeking immediate medical attention should any of these symptoms occur,” McKinney said.

Did Avandia Cause Heart Attacks?

While there is still controversy about whether Avandia caused heart attacks, a 2007 meta-analysis in the New England Journal of Medicine (NEJM) linked Avandia to a 43% increased risk of heart attacks. The study also found a 64% increased risk of death from cardiovascular causes among Avandia users.

If you are taking Avandia, make sure you watch out for the signs of a heart attack.

In 2010, the FDA restricted Avandia prescriptions because of the 2007 study. However, in 2013, the FDA determined that follow-up data for rosiglitazone didn’t show it increased the risk of heart attack more than the standard Type 2 diabetes drugs metformin and sulfonylurea.

Avandia showed an increased incidence of bone fractures in clinical trials, according to the drug’s label.

Long-term trials found increased bone fracture risk in patients taking Avandia, especially women. Unlike typical osteoporosis sites which are in the spine, hips and wrist, fractures caused by Avandia often occur in the upper arm, hand and foot.

This fracture risk persisted beyond the first year of treatment. Patients should monitor and maintain bone health while on Avandia.

Long-term trials showed an increased rate of bone fracture in more than 200 patients, particularly women, who took Avandia.

Source: Avandia Prescribing Information

In a study published in the Archives of Internal Medicine, Swiss researchers found that patients with diabetes on thiazolidinediones, the drug class Avandia belongs to, had double the odds of fractures compared to patients who did not use these drugs. Those who took the drugs for over a year had an even higher risk of bone fracture, especially in the hip and wrist. The study compared the records of 1,020 patients with diabetes with fractures against a control group of people with diabetes who did not have fractures.

“This analysis provides further evidence of a possible association between long-term use of [the drugs] and fractures, particularly of the hip and wrist, in patients with diabetes mellitus,” the authors wrote.

Avandia’s label warns of possible liver toxicity and against prescribing it to people with a history of liver problems. It also instructs doctors to check patients’ liver before and while on the drug.

A study in the journal LiverTox concluded that while Avandia is linked to rare instances of liver injury, it has a much lower rate of liver enzyme elevation and clinically apparent liver injury compared to troglitazone — an antidiabetic and anti-inflammatory drug in the same drug class. Most liver issues resolved after stopping the medication, though there have been reports of fatal cases, according to the study.

Evidence suggests Avandia can cause severe liver damage.

Source: Pharmacoepidemiology & Drug Safety

Another case series in Pharmacoepidemiology & Drug Safety suggested that rosiglitazone and pioglitazone (Actos) may cause liver problems, citing 21 cases of drug-associated liver failure reported to the FDA between 1997 and 2006.

“This is the largest case series of liver failure associated with rosiglitazone or pioglitazone reported to date, strengthening the evidence that these drugs can cause severe hepatotoxicity [liver damage],” the authors wrote.

Doctors should be cautious about continuing treatment in patients with mild liver enzyme elevations and monitor them closely.

The FDA’s position on Avandia’s safety has changed over the years because of studies on the drug‘s cardiovascular safety. At first, the FDA restricted the drug’s use because of the increased risk of heart attacks.

However, the organization reversed its decision after more data failed to show that Avandia had more heart risks than metformin.

Avandia was never recalled in the U.S. but was banned in Europe. The FDA label still warns of significant risk for cardiovascular events, though it is only for heart failure and no longer for heart attacks.

If you suspect you are experiencing side effects from Avandia (rosiglitazone), it’s important to act promptly and responsibly — this includes speaking to your doctor or seeking emergency care if needed.

You may also consider reporting serious side effects to the FDA MedWatch. This database helps track adverse events related to drugs and medical devices.

After studies linked Avandia to an increased risk of heart attack and death, people filed thousands of lawsuits against GSK for concealing information that Avandia could cause heart attacks and strokes. 

GSK paid $3 billion to the Justice Department over allegations that it unlawfully marketed several of its drugs, including Avandia. GSK also reportedly settled over 10,000 claims for $700 million in 2011. 

Learn more about Avandia lawsuits over heart risks.

Because there are many Avandia alternatives, the right treatment for you depends on your heart health, the side effects of each alternative, the cost and insurance coverage, the type of diabetes you have and the effectiveness of each drug.

“I consider alternatives such as metformin, DPP-4 inhibitors, like sitagliptin, or GLP-1 receptor agonists, such as liraglutide, for patients at higher risk of the severe side effects of Avandia,” McKinney told Drugwatch.

“The choice to go for other medication depends on the patient’s total profile, including their cardiovascular risks, kidney functionality and personal choices,” McKinney said.

“Metformin is always my first option because it has an improved safety record compared with other oral agents and clinical outcome trials show that it reduces macrovascular complications in diabetics.”

A frank conversation with your doctor can help them determine your best alternative.