Applies to ezetimibe / rosuvastatin: oral tablet.
Serious side effects
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
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
- Confusion
- forgetfulness
- memory loss
- nightmares
- problems with memory
- sleeplessness
- swelling of the breasts or breast soreness in both females and males
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]
