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Vytorin

Last reviewed on RxList: 10/9/2020
Vytorin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vytorin?

Vytorin (ezetimibe and simvastatin) is a combination of a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and an HMG-CoA reductase inhibitor (also called a "statin") used to treat high blood cholesterol.

What Are Side Effects of Vytorin?

Common side effects of Vytorin include:

Vytorin may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor if you have any of these symptoms during treatment with Vytorin and if these symptoms persist after your doctor stops this drug:

  • muscle pain/tenderness/weakness (especially with fever or unusual tiredness), or
  • changes in the amount of urine.

Dosage for Vytorin

Vytorin is administered in oral tablet form in the evenings once per day.

What Drugs, Substances, or Supplements Interact with Vytorin?

Numerous other drugs may interact with Vytorin. Vytorin should not be combined with drugs that decrease its elimination, such as erythromycin, ketoconazole, itraconazole, and clarithromycin.

Vytorin During Pregnancy and Breastfeeding

Vytorin should not be taken by pregnant women or nursing mothers.

Additional Information

Our Vytorin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

How to Lower Your Cholesterol & Save Your Heart See Slideshow
Vytorin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • unexplained muscle pain, tenderness, or weakness;
  • fever, unusual tiredness;
  • upper stomach pain, loss of appetite;
  • dark colored urine; or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;
  • muscle pain;
  • abnormal liver function tests;
  • diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vytorin (Ezetimibe and Simvastatin)

QUESTION

What is cholesterol? See Answer
Vytorin Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • habdomyolysis and myopathy [see WARNINGS AND PRECAUTIONS]
  • Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

VYTORIN

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the VYTORIN (ezetimibe and simvastatin) placebo-controlled clinical trials database of 1420 patients (age range 20-83 years, 52% women, 87% Caucasians, 3% Blacks, 5% Hispanics, 3% Asians) with a median treatment duration of 27 weeks, 5% of patients on VYTORIN and 2.2% of patients on placebo discontinued due to adverse reactions.

The most common adverse reactions in the group treated with VYTORIN that led to treatment discontinuation and occurred at a rate greater than placebo were:

  • Increased ALT (0.9%)
  • Myalgia (0.6%)
  • Increased AST (0.4%)
  • Back pain (0.4%)

The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in controlled clinical trials were: headache (5.8%), increased ALT (3.7%), myalgia (3.6%), upper respiratory tract infection (3.6%), and diarrhea (2.8%).

VYTORIN has been evaluated for safety in more than 10,189 patients in clinical trials.

Table 2 summarizes the frequency of clinical adverse reactions reported in ≥2% of patients treated with VYTORIN (n=1420) and at an incidence greater than placebo, regardless of causality assessment, from four placebo-controlled trials.

Table 2*: Clinical Adverse Reactions Occurring in ≥2% of Patients Treated with VYTORIN and at an Incidence Greater than

Body System/Organ Class Adverse ReactionPlacebo
(%)
n=371
Ezetimibe 10 mg
(%)
n=302
Simvastatin
(%)
n=1234
VYTORIN
(%)
n=1420
Body as a whole – general disorders
  Headache5.46.05.95.8
Gastrointestinal system disorders
  Diarrhea2.25.03.72.8
Infections and infestations
  Influenza0.81.01.92.3
  Upper respiratory tract infection2.75.05.03.6
Musculoskeletal and connective tissue disorders
  Myalgia2.42.32.63.6
  Pain in extremity1.33.02.02.3
*Includes two placebo-controlled combination studies in which the active ingredients equivalent to VYTORIN were coadministered and two placebo-controlled studies in which VYTORIN was administered.
All doses.

Study Of Heart And Renal Protection

In SHARP, 9270 patients were allocated to VYTORIN 10/20 mg daily (n=4650) or placebo (n=4620) for a median follow-up period of 4.9 years. The proportion of patients who permanently discontinued study treatment as a result of either an adverse event or abnormal safety blood result was 10.4% vs. 9.8% among patients allocated to VYTORIN and placebo, respectively. Comparing those allocated to VYTORIN vs. placebo, the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum CK >10 times ULN) was 0.2% vs. 0.1% and the incidence of rhabdomyolysis (defined as myopathy with a CK >40 times ULN) was 0.09% vs. 0.02%, respectively. Consecutive elevations of transaminases (>3 X ULN) occurred in 0.7% vs. 0.6%, respectively. Patients were asked about the occurrence of unexplained muscle pain or weakness at each study visit: 21.5% vs. 20.9% patients ever reported muscle symptoms in the VYTORIN and placebo groups, respectively. Cancer was diagnosed during the trial in 9.4% vs. 9.5% of patients assigned to VYTORIN and placebo, respectively.

Ezetimibe

Other adverse reactions reported with ezetimibe in placebo-controlled studies, regardless of causality assessment:

Musculoskeletal system disorders: arthralgia;
Infections and infestations: sinusitis;
Body as a whole – general disorders: fatigue.

Simvastatin

In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with simvastatin (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase [CK] >10 times upper limit of normal [ULN]) in patients on 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis (defined as myopathy with a CK >40 times ULN) in patients on 80 mg/day was approximately 0.4% compared with 0% for patients on 20 mg/day. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment. In this trial, patients were carefully monitored and some interacting medicinal products were excluded.

Other adverse reactions reported with simvastatin in placebo-controlled clinical studies, regardless of causality assessment:

Cardiac disorders: atrial fibrillation;
Ear and labyrinth disorders: vertigo;
Gastrointestinal disorders: abdominal pain, constipation, dyspepsia, flatulence, gastritis;
Skin and subcutaneous tissue disorders: eczema, rash;
Endocrine disorders: diabetes mellitus;
Infections and infestations: bronchitis, sinusitis, urinary tract infections;
Body as a whole – general disorders: asthenia, edema/swelling;
Psychiatric disorders: insomnia.

Laboratory Tests

Marked persistent increases of hepatic serum transaminases have been noted [see WARNINGS AND PRECAUTIONS]. Elevated alkaline phosphatase and γ-glutamyl transpeptidase have been reported. About 5% of patients taking simvastatin had elevations of CK levels of 3 or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported in postmarketing experience for VYTORIN or ezetimibe or simvastatin: pruritus; alopecia; erythema multiforme; a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails); dizziness; muscle cramps; myalgia; arthralgia; pancreatitis; paresthesia; peripheral neuropathy; vomiting; nausea; anemia; erectile dysfunction; interstitial lung disease; myopathy/rhabdomyolysis [see WARNINGS AND PRECAUTIONS]; hepatitis/jaundice; fatal and non-fatal hepatic failure; depression; cholelithiasis; cholecystitis; thrombocytopenia; elevations in liver transaminases; elevated creatine phosphokinase.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see WARNINGS AND PRECAUTIONS].

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.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Read the entire FDA prescribing information for Vytorin (Ezetimibe and Simvastatin)

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