Avandia
Avandia (rosiglitazone) has common, mild side effects such as headaches and cold-like symptoms. But it’s also linked to serious side effects such as heart attacks. Avandia has a black box warning for congestive heart failure.
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- Last update: August 21, 2025
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What Is Avandia?
Avandia is the brand name for rosiglitazone, a prescription medication used to manage blood sugar in adults with Type 2 diabetes. It works by improving the body’s sensitivity to insulin, which helps lower blood glucose levels.
Avandia is part of the thiazolidinedione (TZD) class of drugs, which is the same class as Actos (pioglitazone). It was developed and originally marketed by GlaxoSmithKline (GSK) and received FDA approval in 1999. Its usage in the U.S. peaked around 2006.
What Are the Most Common Side Effects of 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.
- Swelling (edema), weight gain
- Fatigue and tiredness
- Headache
- Upper respiratory tract infections (such as colds)
- Back or joint pain
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.
Serious Health Risks Linked to Avandia
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.
- Heart attack (myocardial infarction)
- Congestive heart failure
- Bone fractures (hand, arm or foot)
- Liver problems or failure
- Macular edema (swelling behind the eye)
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.
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.
- Chest pain or pressure
- Shortness of breath
- Sudden fatigue or weakness
- Pain in the arms, legs, back, neck, jaw or stomach
- Vomiting or nausea
- Feeling lightheaded
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.
What Did the FDA Say About Avandia?
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.
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2007
Issued a black box warning, highlighting the cardiovascular risks associated with Avandia.
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2010
Implemented strict usage restrictions via a Risk Evaluation and Mitigation Strategy (REMS), limiting Avandia’s use primarily to patients who could not control their diabetes with other medications.
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2013
Lifted most restrictions after a reanalysis, including the black box warning, though the drug’s cardiovascular risk profile remains controversial.
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.
What To Do If You’re Experiencing Side Effects
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.
- 1. Contact Your Doctor — Do Not Discontinue on Your Own
- Do not stop Avandia without talking to your healthcare provider. Stopping abruptly may affect your blood sugar control. Describe your symptoms clearly so your doctor can assess the urgency and decide on the next steps.
- 2. Get Cardiac Screening
- If you have any symptoms like chest pain, shortness of breath, swelling or irregular heartbeat, your doctor may recommend tests such as:
- – Electrocardiogram (ECG) to check heart rhythm and possible damage
- – Exercise stress test to evaluate heart function under exertion
- – Lipid panel to monitor cholesterol and related cardiovascular risks
- 3. Discuss Safer Alternatives for Type 2 Diabetes
- There are many other medications approved for Type 2 diabetes that may have a safer profile for you. Ask your doctor if switching to a different diabetes medication might benefit you.
- 4. Monitor for Signs of Fluid Retention and Chest Pain
- – Keep track of daily weight, any new swelling (especially in feet, ankles or legs), trouble breathing or chest pain.
- – Report any rapid increase in weight, swelling or breathing difficulties immediately, as these may signal heart failure or fluid overload.
You may also consider reporting serious side effects to the FDA MedWatch. This database helps track adverse events related to drugs and medical devices.
How Avandia Heart Risks Led to Lawsuits
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.
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