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Roszet Side Effects

Generic name: ezetimibe / rosuvastatin

Medically reviewed by Drugs.com. Last updated on Oct 24, 2022.

Note: This document contains side effect information about ezetimibe / rosuvastatin. Some dosage forms listed on this page may not apply to the brand name Roszet.

Applies to ezetimibe / rosuvastatin: oral tablet.

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:

More common

  • Difficulty in moving
  • joint pain or swelling
  • muscle pain, cramps, spasms, or stiffness

Less common

  • Arm, leg, or back pain
  • bloating
  • body aches or pain
  • chills
  • constipation
  • cough
  • darkened urine
  • diarrhea
  • ear congestion
  • fast heartbeat
  • fever
  • general feeling of discomfort or illness
  • headache
  • hives, itching
  • hoarseness
  • indigestion
  • irritation
  • lack or loss of strength
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • loss of voice
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • redness of the skin
  • runny or stuffy nose
  • shivering
  • sneezing
  • sore throat
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble breathing or swallowing
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, loosening of the skin
  • blood in the urine or stools
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  • clay-colored stools
  • dizziness
  • gaseous stomach pain
  • indigestion
  • light-colored stools
  • muscle tenderness, wasting, or weakness
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach fullness
  • unpleasant breath odor
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • vomiting of blood
  • weakness in the arms, hands, legs, or feet

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:

Less common

  • Pain or tenderness around the eyes and cheekbones

Incidence not known

For Healthcare Professionals

Applies to ezetimibe / rosuvastatin: oral tablet.

General

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Roszet (ezetimibe-rosuvastatin)." Althera Pharmaceuticals LLC (2021):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.