Vytorin Side Effects
Generic Name: ezetimibe / simvastatin
Note: This page contains side effects data for the generic drug ezetimibe / simvastatin. It is possible that some of the dosage forms included below may not apply to the brand name Vytorin.
It is possible that some side effects of Vytorin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to ezetimibe / simvastatin: oral tablet
As well as its needed effects, ezetimibe / simvastatin may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking ezetimibe / simvastatin, check with your doctor immediately:Incidence not known
- Abdominal or stomach fullness
- darkened urine
- fast heartbeat
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- redness of the skin
- shortness of breath
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble breathing or swallowing
- yellow eyes or skin
Some ezetimibe / simvastatin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:Less common
- Body aches or pain
- difficulty with breathing
- difficulty with moving
- ear congestion
- general feeling of discomfort or illness
- loss of voice
- muscle aches and pains or cramping
- muscle stiffness
- nasal congestion
- pain in the arms or legs
- runny nose
- sore throat
- swollen joints
- trouble sleeping
- unusual tiredness or weakness
For Healthcare Professionals
Applies to ezetimibe / simvastatin: oral tablet
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
Very rare (less than 0.01%): Protein losing enteropathy
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.
Very rare (less than 0.01%): Tendon rupture (one case)
Common (1% to 10%): Back pain, arthralgia
Postmarketing reports: Myalgia, elevated creatine phosphokinase, rare reports of myopathy/rhabdomyolysis
Frequency not reported: Elevations in creatine kinase, myopathy, dermatomyositis, rhabdomyolysis, arthralgia, myalgia
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.
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
Frequency not reported: Eczematous, pruritic rash, toxic epidermal necrolysis, photosensitivity, purpura, erythema multiforme, photosensitivity, purpura, alopecia
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
Frequency not reported: Upper respiratory tract infection, 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, pharyngitis
Common (1% to 10%): Angina
Frequency not reported: Gynecomastia, thyroid function abnormalities, increases in HbA1c and fasting serum glucose levels
Frequency not reported: Erectile dysfunction, impotence
A patient who had taken lovastatin and pravastatin on different occasions developed reversible impotence. The impotence resolved within 2 weeks after the HMG-CoA reductase inhibitor was discontinued.
Postmarketing reports: Epistaxis in a 65-year-old male
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.
Postmarketing reports: Angioedema, anaphylaxis, rash, urticaria
Rare (less than 0.1%): Erythema multiforme, Stevens-Johnson syndrome, anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, dyspnea
Frequency not reported: Headache, confusion, fatigue
Postmarketing reports: Dizziness, paraesthesia
Frequency not reported: Cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy
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.
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
More about Vytorin (ezetimibe / simvastatin)
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