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Note: This document contains side effect information about ezetimibe / simvastatin. Some of the dosage forms listed on this page may not apply to the brand name Vytorin.
Applies to ezetimibe / simvastatin: oral tablet
Along with its needed effects, ezetimibe/simvastatin 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 / simvastatin:
Incidence not known
Some side effects of ezetimibe / simvastatin 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:
Applies to ezetimibe / simvastatin: oral tablet
The more commonly reported adverse effects have included headache, increased ALT, myalgia, upper respiratory tract infection, and diarrhea.
Common (1% to 10%): Diarrhea
Common (1% to 10%): Diarrhea, abdominal pain, nausea
Postmarketing reports: Pancreatitis
Common (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain, pancreatitis, anorexia, vomiting, gastritis
Very rare (less than 0.01%): Protein losing enteropathy
Common (1% to 10%): Myalgia, extremity pain
Very rare (less than 0.01%): Tendon rupture (one case)
Frequency not reported: Back pain
Postmarketing reports: Muscle cramps
Common (1% to 10%): Back pain, arthralgia
Postmarketing reports: Myalgia, elevated creatine phosphokinase, rare reports of myopathy/rhabdomyolysis
Uncommon (0.1% to 1%): Myopathy, rhabdomyolysis
Frequency not reported: Elevations in creatine kinase, dermatomyositis, arthralgia, myalgia
Simvastatin has been associated with rare cases of severe myopathy and rhabdomyolysis. This is accompanied by elevations in creatine kinase, myoglobinuria, and proteinuria, as well as renal failure. Experience with HMG-CoA reductase inhibitors indicates that concomitant use with gemfibrozil, niacin, cyclosporine, or erythromycin may increase the incidence and the severity of musculoskeletal side effects.
A case of spontaneous biceps tendon rupture developed in a patient after 4 months of treatment with ezetimibe-simvastatin. Upon rechallenge 2 months later, the patient developed pain in the contralateral arm overlying the biceps tendon. Following discontinuation of ezetimibe-simvastatin, pain resolved 2 weeks later. Inhibition of matrix metalloproteinases has been suggested as the contributing factor in the development of tendon rupture.
Frequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis
Persistent elevations in liver function tests three times normal values are reported in up to 1.5% of patients on simvastatin in clinical trials. In one study, this led to the discontinuation of simvastatin in 0.6% of patients. In other patients, elevations in liver function tests were transient and returned to normal with continued simvastatin therapy.
Common (1% to 10%): Increased ALT
Frequency not reported: Increased AST
Postmarketing reports: Elevations in liver transaminases, hepatitis, cholelithiasis, cholecystitis
Common (1% to 10%): Elevations in liver function tests
Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty changes in the liver, cirrhosis, fulminant hepatic necrosis
Postmarketing reports: Hepatic failure, jaundice
Frequency not reported: Eczematous, pruritic rash, toxic epidermal necrolysis, photosensitivity, purpura, erythema multiforme, photosensitivity, purpura, alopecia
Postmarketing reports: A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails)
Frequency not reported: Influenza
Common (1% to 10%): Viral infection
Very rare (less than 0.01%): Lupus-like syndrome
Frequency not reported: Positive ANA, ESR increase, polymyalgia rheumatica, vasculitis
Rare (0.01% to 0.1%): Immune-mediated necrotizing myopathy (IMNM)
Common (1% to 10%): Upper respiratory tract infection
Frequency not reported: Interstitial lung disease causing breathing problems including persistent cough and/or shortness of breath or fever
Common (1% to 10%): Coughing
Frequency not reported: Sinusitis
Frequency not reported: Sinusitis, pharyngitis
Common (1% to 10%): Angina
Frequency not reported: Atrial fibrillation, edema
Frequency not reported: Gynecomastia, thyroid function abnormalities
Frequency not reported: Erectile dysfunction, impotence, urinary tract infections
Postmarketing reports: Epistaxis (one report), anemia
Postmarketing reports: Thrombocytopenia
Frequency not reported: Hemolytic anemia, thrombocytopenia, leukopenia (possibly manifestations of a hypersensitivity reaction)
A 65-year-old male with hereditary hemorrhagic telangiectasia (HHT) who had a history of minimal epistaxis began to experience profuse epistaxis 8 to 10 weeks after starting ezetimibe-simvastatin, The patient had been treated with simvastatin 20 mg alone for 9 years without any adverse effects. Two months after starting combination therapy with ezetimibe-simvastatin he noticed epistaxis that increased from a few drops every other day to profuse bleeding for 20 to 30 minutes daily. The patient reported initiation of ezetimibe-simvastatin as the only change in his treatment regimen in the past year. When he stopped ezetimibe-simvastatin, his epistaxis decreased. After six weeks without ezetimibe-simvastatin, he had only one moderate nose bleed. Four months later, the patient's hemoglobin was stable. He then started simvastatin 40 mg monotherapy. The profound epistaxis returned and the patient discontinued the medication. It remains unclear whether the patient's accelerated epistaxis was due to the combination therapy or the double dosage of simvastatin.
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported. In addition, an apparent hypersensitivity syndrome has been reported rarely that has included one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.
Postmarketing reports: Angioedema, anaphylaxis, rash, urticaria
Rare (less than 0.1%): Erythema multiforme, Stevens-Johnson syndrome, anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, dyspnea
Postmarketing reports: Hypersensitivity reactions
A case of memory loss possibly related to simvastatin use has been reported. The patient developed gradual memory loss following 12 months of simvastatin therapy. He was switched to pravastatin, and within a month his memory was intact. Rechallenge with simvastatin was not performed.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reports have been generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Common (1% to 10%): Headache
Frequency not reported: Confusion, fatigue
Postmarketing reports: Dizziness, paraesthesia
Frequency not reported: Cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy
Postmarketing reports: Cognitive impairment
Frequency not reported: Progression of cataracts, ophthalmoplegia
Frequency not reported: Liver, thyroid, and lung adenomas and carcinomas
Frequency not reported: Depression, suicidal thoughts, delusions, paranoia, agitation, decreased libido, anxiety, insomnia
Frequency not reported: Increases in HbA1c and fasting serum glucose levels
Frequency not reported: Fatigue, asthenia
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