Crestor: Side Effects, Risks, FDA Warnings & Lawsuit Information

Crestor is a drug used to help you lower cholesterol. However, patients taking the medication may be at an increased risk of diabetes, muscle issues and more. These potential side effects have led to scrutiny and legal repercussions.

Before using Crestor, it’s important to understand the medication’s benefits and risks, along with regulations and litigation. If you have been adversely impacted by taking Crestor, you may be eligible to file a lawsuit.

Crestor is a statin that contains rosuvastatin as its active ingredient. Like other statins, the medication helps lower cholesterol levels and slows the buildup of plaque in your arteries.

Cholesterol is an integral component of your blood, supporting your bodily functions. However, if cholesterol levels rise, bad cholesterol can create plaque in your arteries. As it builds up, you become at risk of heart attack, heart disease and stroke.

AstraZeneca, Crestor’s manufacturer, reports that, along with diet, Crestor has helped lower bad cholesterol, known as low-density lipoprotein (LDL) cholesterol, by approximately 55% when using a 20-milligram dose.

However, despite the benefits of Crestor, it may come with safety risks.

While Crestor can help lower cholesterol, it could come with common and serious side effects. These can range from fatigue and headaches to diabetes and muscle problems.

Since 2003, Crestor patients have reported 43,912 adverse reactions to the U.S. Food & Drug Administration’s (FDA) Adverse Event Reporting System (FAERS). More than half of these cases were serious.

Common Crestor Side Effects

Crestor’s label identifies headaches, nausea and muscle pain, known as myalgia, as the most common side effects seen in patients. These issues generally resolve within a few days or weeks as the body adjusts to the medication.

You should monitor and report any side effects to your doctor to ensure your symptoms aren’t signs of another issue.

Serious Crestor Side Effects

In rare cases, serious side effects of Crestor can include cognitive issues, liver damage, Type 2 diabetes and more.

Alert your doctor immediately if you experience any side effects while taking Crestor.

Cognitive Impairment

There have been reports of cognitive impairment, including memory loss and confusion, associated with statin use. For example, a case study published in Pharmacotherapy revealed that a patient taking rosuvastatin experienced short-term memory loss while taking the drug.

Additionally, a survey conducted by Pharmacotherapy found that cognitive issues caused by statins can vary based on potency.

These side effects are generally reversible when you stop taking the medication. However, you should talk to your doctor if you experience significant changes in memory or cognitive function while on Crestor.

Liver Damage

Crestor can cause liver damage, indicated by elevated liver enzymes. A 2022 study published in the Journal of Clinical and Translational Hepatology states that statins have been associated with mild liver dysfunction as well as liver injuries with autoimmune features.

While rare, liver damage is a serious side effect of Crestor. Talk to your doctor immediately if you are taking Crestor and notice yellowing of your skin or eyes, as these issues could indicate liver problems.

Myopathy

Crestor has been linked to an increased risk of myopathy. This is a muscle disorder in which your muscle fibers do not function properly. Symptoms include muscle pain, tenderness and weakness.

According to Dr. Kevin Huffman, a board-certified bariatric physician and CEO of Ambari Nutrition, a study published in the Journal of the American College of Cardiology found an increased risk of myopathy among statin patients taking higher doses.

“It’s not controversial that higher doses of rosuvastatin, Crestor’s active ingredient, are associated with these risks,” Huffman told Drugwatch.

A separate study in Pharmacological Research found that up to 30% of patients taking statins developed skeletal muscle-associated symptoms, depending on the statin used and the patients being treated.

Rhabdomyolysis

Crestor’s label warns about the risk of rhabdomyolysis. This is a condition in which your muscles break down and the byproducts are released into your bloodstream. It may cause kidney damage.

Studies have shown that the incidence of rhabdomyolysis is higher in patients taking Crestor compared to some other statins. This elevated risk underscores the importance of careful patient selection and monitoring by health care providers.

Seek immediate medical attention if you experience unexplained muscle pain, dark urine, tenderness or weakness. These could be early signs of rhabdomyolysis.

Type 2 Diabetes

Studies have shown that the statin class of drugs, which includes Crestor, can increase your risk of Type 2 diabetes. For example, a study published in Frontiers in Endocrinology found a 46% greater risk of Type 2 diabetes in participants taking statins.

A separate study in the Archives of Internal Medicine found that statin use increased the risk of new-onset diabetes in postmenopausal women by 71%.

Hemorrhagic Stroke

Some studies suggest statins could increase your risk of hemorrhagic strokes. This type of stroke is caused by internal bleeding in your brain or skull.

A 2008 study found that statins can decrease the risk of ischemic strokes (strokes caused by a blocked vein or artery) in patients with a history of cerebrovascular disease. However, they increase the risk of hemorrhagic strokes.

Individuals with a history of strokes or those with low cholesterol levels are especially at risk.

Who Is Most at Risk for Crestor Side Effects?

Some people are more at risk of developing Crestor side effects. This can include patients with other conditions, seniors and people on a higher dose of Crestor.

Additionally, people taking certain medications may be at higher risk of side effects. Talk to your doctor if you fall into these categories or if you are currently taking other drugs to see if they may interact adversely with Crestor.

How To Manage or Avoid Crestor Side Effects

Proper management of Crestor side effects involves regular monitoring, lifestyle adjustments and open communication with your doctor.

“You should monitor yourself for unexplained muscle pain, weakness, or tenderness, especially if those symptoms worsen with activity,” Huffman said. “Notify your doctor right away if you experience these symptoms.”

Whether the side effects you experience are barely noticeable or impact your day-to-day functioning, it is essential to keep your doctor informed so they can adjust your medication if needed.

Crestor has encountered pushback since its introduction, with the FDA and international agencies issuing warnings and recalls for the drug.

In 2025, AstraZeneca came under scrutiny again when the Crestor generic version, rosuvastatin, was recalled by the FDA and given a Class II risk level.

The recall specifically applied to drugs produced by Glenmark Pharmaceuticals, Inc., a drug manufacturer in India. It was accused of failing to meet “current good manufacturing practice,” according to the FDA.

The FDA warned patients that the tainted drugs could cause “temporary or medically reversible adverse health consequences.” However, it noted that the likelihood of experiencing serious health issues is “remote.”

Rosuvastatin is just one of 39 generic medications that were recalled, including drugs like propafenone hydrochloride, nitroglycerin and pravastatin. Only 40-milligram tablets in a 30-count bottle were affected for rosuvastatin, but Glenmark Pharmaceuticals’ global distribution meant that countless pharmacies and medical facilities were affected.
You can read all FDA warnings, precautions and drug interactions on the Crestor label insert.

AstraZeneca has faced Crestor litigation. In 2017, the manufacturer’s annual report acknowledged its legal troubles, mentioning the lawsuits the company faced involved health complications like rhabdomyolysis and diabetes.

The report also noted that AstraZeneca had “resolved all active claims with regard to this matter.”

In 2018, AstraZeneca settled a Crestor lawsuit with the state of Texas. The manufacturer agreed to pay $110 million for accusations that it fraudulently marketed Crestor and another drug, Seroquel.

“While we deny the allegations, it is in the best interests of the company to resolve these matters,” AstraZeneca stated.

Affected patients might be eligible to file a lawsuit to seek compensation for expenses like damages from injuries or pain and suffering. Drugwatch can connect you with an attorney for a free case consultation.

Crestor and Lipitor (Atorvastatin) share many of the same side effects and risks. Both have faced regulatory action and civil litigation, with several Lipitor lawsuits filed over the years.

Rosuvastatin is the generic version of Crestor. It is a statin and provides the same benefits as Crestor but at a lower price.

Similar to Crestor, rosuvastatin requires a prescription and is available as a tablet. Rosuvastatin also has the same risks and warnings as Crestor, which is the case when comparing generic and brand-name drugs.

Additionally, like Crestor, the higher your rosuvastatin dose, the greater your odds of developing side effects like rhabdomyolysis.

Some Crestor patients who have been adversely impacted by the medication, along with government entities, have taken legal action against AstraZeneca. Lawsuits allege that the drugmaker:

If you have been adversely impacted by taking Crestor, you might be able to file a Crestor lawsuit.

There is no doubt that AstraZeneca has had a long road with Crestor. In response to regulatory and legal challenges, the manufacturer has taken steps to help mitigate some of the damage.

The company’s website now includes details on patient risks and warnings. It also provides a link where affected patients can report their Crestor side effects directly to AstraZeneca.

In the meantime, if you use Crestor and have had any adverse reactions, you may want to ask your doctor for other ways to treat your symptoms.

Contact a lawyer to discuss your options and determine whether you have cause for a Crestor lawsuit.