Zetia Side Effects

March 8, 2025/Andrew Le

Taking Zetia can lead to serious side effects that worry many patients. You may face risks like allergic reactions, liver damage, and muscle problems. These issues can be dangerous if you do not spot the warning signs. 

Some patients have reported breathing problems and swelling, while others have faced severe liver injury or muscle pain. This situation can feel frightening, and you may wonder if you are at risk. But knowing what to watch for can help you act quickly and safely. 

In this article, you will learn how to identify these signs.

🔑 Key Takeaways

➤ Some patients have had allergic reactions with breathing problems and swelling.

➤ Your liver might show signs of damage if you experience yellowing skin or dark urine.

➤ Muscle pain and weakness can happen and may require quick attention.

➤ You should contact your doctor if you have trouble swallowing or notice unusual swelling.

➤ Cases of pancreatitis and low platelet counts have been reported.

Serious Side Effects

When you take Zetia, you need to know that serious side effects can occur. Some patients have reported allergic reactions, liver damage, and muscle issues. While not everyone will experience them, you must know the signs.

Allergic Reactions

Zetia can sometimes trigger allergic reactions. You might experience:

  • Breathing problems
  • Wheezing
  • Racing heart
  • Swelling of the face, lips, mouth, tongue, or throat that can cause trouble swallowing
  • Skin rash, hives, or angioedema
  • Flushing and swollen lymph nodes
  • Throat tightness or difficulty breathing

The FDA added warnings about hypersensitivity reactions with Zetia. According to Worst Pills, cases of angioedema were reported with Zetia use. Although the report focused on several adverse events, it noted that allergic reactions such as angioedema can be serious.

One case adds to this concern. They described a 90-year-old African American patient who developed facial and oral swelling and throat tightness after taking 10 mg of Zetia. Her symptoms began a few hours after dosing and resolved within 48 hours after treatment. 

Liver Damage

Liver damage is another serious concern with Zetia. Some individuals have reported:

  • Nausea
  • Vomiting
  • Stomach pain
  • Fever
  • Weakness
  • Loss of appetite
  • Itching
  • Light-colored stool
  • Dark urine
  • Yellowing of the skin and eyes
  • Elevated liver enzymes and hepatitis
  • Inflammation of the gallbladder (cholecystitis) or formation of gallstones (cholelithiasis)

According to one case, a 59-year-old man on ezetimibe monotherapy developed severe liver injury. His lab tests showed ALT at 300 U/L, AST at 129 U/L, and ALP at 1344 U/L. He experienced abdominal pain, anorexia, and intense itching, and he needed treatment with prednisone and azathioprine. 

Similarly, another case reported a 56-year-old woman who developed serious hepatitis after 4 months of using 10 mg daily of Zetia. Her symptoms included jaundice and pruritus, and her total bilirubin reached 602 μmol/L. These cases remind you to be alert for signs of liver damage when taking Zetia.

Muscle Damage

Muscle-related issues can be serious. Patients have reported unexplained muscle pain, weakness, or tenderness. Some also experience:

  • Muscle cramps
  • Dark-colored urine
  • Muscle spasms and neck pain
  • Generalized myalgia with elevated creatine phosphokinase
  • In rare cases, these symptoms may progress to myopathy or even rhabdomyolysis, a severe condition involving rapid muscle breakdown

According to one study, a 42-year-old woman on ezetimibe monotherapy developed muscle pain and had creatine kinase (CK) levels rise from 132 U/L at baseline to 280 U/L on a 10 mg dose. 

After a washout period, when she took 5 mg, her CK again went up to 236 U/L. In another case, a man on atorvastatin plus Zetia saw his CK reach 606 U/L, and he had muscle pain as well. 

Similarly, another case reported a patient who developed muscle pain and elevated CK levels 16 days after adding Zetia to his atorvastatin. His symptoms improved and CK levels normalized 12 days after stopping Zetia. 

These examples show that both Zetia alone and when combined with statins may lead to serious muscle issues.

Other Serious Effects

In addition to the above, Zetia may rarely lead to other serious effects. Some patients have experienced:

  • Pancreatitis, which causes severe abdominal pain and vomiting
  • Thrombocytopenia, a low platelet count that may increase the risk of bleeding

In a 2009 Medsafe update from New Zealand, prescribers were advised to consider that Zetia, with or without a statin, may trigger pancreatitis. You should seek help immediately if you experience severe stomach pain or vomiting.

Another rare effect is thrombocytopenia—a very low platelet count that can raise your risk of bleeding. One study described a 72-year-old man who developed immune thrombocytopenia soon after starting an Zetia/simvastatin combination. 

His platelet count dropped, but it returned to normal after stopping the medication. Always contact your doctor if you notice signs of unusual bruising or bleeding.

Common Side Effects

These effects are usually mild and temporary, and they often get better on their own. 

Gastrointestinal Issues

Many patients taking Zetia experience gastrointestinal symptoms that are typically mild and temporary. You might notice:

  • Diarrhea
  • Abdominal pain
  • Nausea
  • Flatulence
  • Dyspepsia or a dry mouth

These effects usually improve as your body adjusts to the medication.

🤔 Did You Know?

According to one study, when Zetia was used with statins in 18 trials involving over 14,000 patients, there was no significant increase in gastrointestinal adverse events. 

Upper Respiratory Symptoms

Mild upper respiratory symptoms are also common with Zetia. You may experience:

  • Sore throat
  • Runny or stuffy nose
  • Sinus infections
  • Coughing
  • Ear congestion
  • Nasopharyngitis or even a mild case of influenza

Although these symptoms can be annoying, they tend to resolve on their own over time.

For example, similar mild symptoms were observed in a phase 3 trial (the GAUSS‑4 trial) in Japanese patients with statin intolerance. While patients on Zetia experienced diarrhea in about 9.5% of cases, those on a comparable therapy showed nasopharyngitis in 12.5% of cases during the double‑blind period and 29% during the open‑label extension. 

This finding shows upper respiratory symptoms are common with lipid‑lowering treatments like Zetia.

Musculoskeletal Complaints

Zetia can cause mild musculoskeletal discomfort. Many users report:

  • Joint pain
  • General body aches
  • Discomfort in the arms or legs
  • Back pain 

These symptoms are generally not severe and often subside as treatment continues. 

For example, in the GAUSS‑2 trial of statin‑intolerant patients, musculoskeletal side effects were reported in 23% of those on Zetia. In that study, muscle pain was noted in 18% of patients taking Zetia compared to only 8% in those on an alternative treatment. 

General Systemic Symptoms

Some patients experience a range of general symptoms while taking Zetia. Common complaints include:

  • Headaches
  • Dizziness
  • Feelings of fatigue or unusual tiredness
  • Sweating 
  • Trouble sleeping

These systemic effects are usually mild and transient. 

In clinical trials, headache was seen in 4.8% of patients on Zetia versus 4.7% on placebo. Fatigue occurred in 2.4% of users compared to 1.9% with placebo, and dizziness in 2.3% versus 2.1%. 

These small differences were not statistically significant, showing that these symptoms are uncommon and similar to what you’d see with placebo. If you have persistent or bothersome symptoms, it’s a good idea to talk with your healthcare provider.

Final Words

Zetia comes with risks that you must take seriously. This medicine can cause problems with your breathing, liver, and muscles. Some patients have seen severe allergic reactions that led to swelling and breathing trouble. 

Your health is at stake, so you must stay alert for any unusual changes. It is important to keep an eye on your symptoms and speak with your doctor if anything feels off.

Frequently Asked Questions

Should I stop taking Zetia if I have side effects?

It is important to contact your doctor to help make this decision. They can help decide if you should continue or change your treatment.

What should I do if I get diarrhea or joint pain?

If these side effects bother you or last too long, tell your doctor. They might suggest ways to ease your symptoms.

How long do these side effects last?

Mild side effects can last a few days to weeks. If they do not go away or worsen, contact your doctor.

Sources

  • Public Citizen’s Health Research Group. (2004, December). A review of Ezetimibe (ZETIA) and Ezetimibe with Simvastatin (VYTORIN) for cholesterol lowering. Worst Pills, Best Pills. Retrieved from https://www.worstpills.org/newsletters/view/353
  • Castellote, J., Ariza, J., Rota, R., Girbau, A., & Xiol, X. (2008). Serious drug-induced liver disease secondary to ezetimibe. World Journal of Gastroenterology, 14(32), 5098–5099. https://doi.org/10.3748/wjg.14.5098.
  • Simard, C., & Poirier, P. (2006). Ezetimibe-associated myopathy in monotherapy and in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. The Canadian Journal of Cardiology, 22(2), 141–144. https://doi.org/10.1016/s0828-282x(06)70253-7.
  • Kashani, A., Sallam, T., Bheemreddy, S., Mann, D. L., Wang, Y., & Foody, J. M. (2008). Review of side-effect profile of combination ezetimibe and statin therapy in randomized clinical trials. American Journal of Cardiology, 101(11), 1606–1613. https://doi.org/10.1016/j.amjcard.2008.01.041.
  • Koba, S., Inoue, I., Cyrille, M., Lu, C., Inomata, H., Shimauchi, J., & Kajinami, K. (2020). Evolocumab vs. ezetimibe in statin-intolerant hyperlipidemic Japanese patients: Phase 3 GAUSS-4 trial. Journal of Atherosclerosis and Thrombosis, 27(5), 471–484. https://doi.org/10.5551/jat.50963.
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