Roszet Side Effects

Generic name: ezetimibe / rosuvastatin

Medically reviewed by Drugs.com. Last updated on Jun 28, 2024.

Note: This document provides detailed information about Roszet.

Applies to ezetimibe / rosuvastatin: oral tablet Side Effects associated with ezetimibe / rosuvastatin. Some dosage forms listed on this page may not apply specifically to the brand name Roszet.

Applies to ezetimibe / rosuvastatin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, including myopathy or immune-mediated necrotizing myopathy (IMNM).

Check with your doctor right away if you have dark urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, major injury, or if you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Roszet

Along with its needed effects, ezetimibe/rosuvastatin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ezetimibe / rosuvastatin:

Other side effects of Roszet

Some side effects of ezetimibe / rosuvastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ezetimibe / rosuvastatin: oral tablet.

General adverse events

The more commonly reported adverse reactions have included myalgia, arthralgia, diarrhea, back pain, influenza, and fatigue.^[Ref]

Musculoskeletal

Rosuvastatin and ezetimibe:

• Uncommon (0.1% to 1%): Arthralgia, myalgia

Rosuvastatin:

• Uncommon (0.1% to 1%): Myalgia, arthralgia, increased creatinine phosphokinase (CPK)
• Postmarketing reports: Myopathy (including myositis), rhabdomyolysis

Ezetimibe:

• Common (1% to 10%): Arthralgia, extremity pain
• Uncommon (0.1% to 1%): Muscle spasms, neck pain
• Postmarketing reports: Increased CPK, myopathy, rhabdomyolysis^[Ref]

Hepatic

Rosuvastatin and ezetimibe:

• Uncommon (0.1% to 1%): Alanine transaminase levels to 3 times the upper limit of normal (3 x ULN) or greater

Rosuvastatin:

• Common (1% to 10%): Serum transaminase elevations to more than 3 x ULN
• Postmarketing reports: Fatal and non-fatal hepatic failure, hepatitis, jaundice

Ezetimibe:

• Uncommon (0.1% to 1%): Elevations in serum transaminases to 3 x ULN or greater
• Postmarketing reports: Hepatitis, cholelithiasis, cholecystitis^[Ref]

Hypersensitivity

Rosuvastatin and ezetimibe:

• Postmarketing reports: Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria

Rosuvastatin:

• Rare (0.01% to 0.1%): Hypersensitivity reactions including angioedema, allergic reaction, urticaria, fever, chills, flushing, malaise, dyspnea

Ezetimibe:

• Postmarketing reports: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria^[Ref]

Immunologic

Rosuvastatin:

• Postmarketing reports: Immune-mediated necrotizing myopathy

Ezetimibe:

• Common (1% to 10%): Influenza^[Ref]

Nervous system

Rosuvastatin and ezetimibe:

• Common (1% to 10%): Headache

Rosuvastatin:

• Common (1% to 10%): Headache
• Frequency not reported: Dizziness
• Postmarketing reports: Peripheral neuropathy, cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion)

Ezetimibe:

• Postmarketing reports: Dizziness, paresthesia, headache^[Ref]

Gastrointestinal

Rosuvastatin and ezetimibe:

• Uncommon (0.1% to 1%): Abdominal distension, abdominal pain, constipation, dry mouth, nausea

Rosuvastatin:

• Common (1% to 10%): Constipation, nausea, abdominal pain
• Rare (0.01% to 0.1%): Pancreatitis

Ezetimibe:

• Common (1% to 10%): Abdominal pain, diarrhea, flatulence
• Uncommon (0.1% to 1%): Gastroesophageal reflux disease
• Postmarketing reports: Pancreatitis^[Ref]

Renal

Rosuvastatin:

• Frequency not reported: Renal failure associated with rhabdomyolysis^[Ref]

Other

Rosuvastatin:

• Common (1% to 10%): Asthenia
• Uncommon (0.1% to 1%): Fatigue

Ezetimibe:

• Common: (1% to 10%): Fatigue

Hematologic

Rosuvastatin:

• Postmarketing reports: Thrombocytopenia

Ezetimibe:

• Postmarketing reports: Thrombocytopenia^[Ref]

Cardiovascular

Rosuvastatin and ezetimibe:

• Uncommon (0.1% to 1%): Peripheral edema

Ezetimibe:

• Uncommon (0.1% to 1%): Hypertension, hot flush, chest pain^[Ref]

Dermatologic

Rosuvastatin and ezetimibe:

• Uncommon (0.1% to 1%): Allergic dermatitis, eczema, skin exfoliation

Rosuvastatin:

• Uncommon (0.1% to 1%): Skin exfoliation, pruritus, rash, urticaria

Ezetimibe:

• Postmarketing reports: Erythema multiforme^[Ref]

Psychiatric

Rosuvastatin and ezetimibe:

• Postmarketing reports: Depression

Rosuvastatin:

• Postmarketing reports: Depression, sleep disorders (including insomnia and nightmares)

Ezetimibe:

• Postmarketing reports: Depression^[Ref]

Endocrine

Rosuvastatin:

• Postmarketing reports: Gynecomastia, thyroid function abnormalities^[Ref]

Metabolic

Rosuvastatin:

• Common (1% to 10%): Diabetes mellitus
• Frequency not reported: Increases in HbA1c and fasting serum glucose levels

Ezetimibe:

• Uncommon (0.1% to 1%): Decreased appetite

Genitourinary

Rosuvastatin:

• Frequency not reported: Dipstick-positive proteinuria and microscopic hematuria

Respiratory

Rosuvastatin:

• Postmarketing reports: Interstitial lung disease

Ezetimibe:

• Common (1% to 10%): Upper respiratory tract infection, sinusitis
• Uncommon (0.1% to 1%): Cough
• Frequency not reported: Nasopharyngitis^[Ref]

See also:

Further information

Roszet 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