Vytorin

[ezetimibe/simvastatin]

Side Effects & Drug Interactions
ADVERSE REACTIONS

VYTORIN has been evaluated for safety in more than 3800 patients in clinical trials. VYTORIN was generally well tolerated.

Table 5 summarizes the frequency of clinical adverse experiences reported in =2% of patients treated with VYTORIN (n=1236) and at an incidence greater than placebo regardless of causality assessment from three similarly designed, placebo-controlled trials.

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Table 5*

Clinical Adverse Events Occurring in =2% of Patients Treated with VYTORIN and at an Incidence Greater than Placebo,
Regardless of Causality
Body System/Organ Class
Placebo
Ezetimibe
10 mg
Simvastatin**
VYTORIN**
Adverse Event (%) (%) (%) (%)
n=311 n=302 n=1234 n=1236
Body as a whole - general disorders
Headache 6.4 6.0 5.9 6.8
Infection and infestations
Influenza 1.0 1.0 1.9 2.6
Upper respiratory tract infection 2.6 5.0 5.0 3.9
Musculoskeletal and connective tissue disorders
Myalgia 2.9 2.3 2.6 3.5
Pain in extremity 1.3 3.0 2.0 2.3
*
Includes two placebo-controlled combination studies in which the active ingredients equivalent to VYTORIN were coadministered and one placebo controlled study in which VYTORIN was administered.
**All doses.

Ezetimibe

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

Body as a whole –

general disorders: fatigue;

Gastrointestinal system disorders:

abdominal pain, diarrhea;

Infection and infestations:

infection viral, pharyngitis, sinusitis;

Musculoskeletal system disorders:

arthralgia, back pain;

Respiratory system disorders:

coughing.

Post-marketing Experience

The following adverse reactions have been reported in post-marketing experience, regardless of causality assessment:

Hypersensitivity reactions, including angioedema and rash; pancreatitis; nausea; cholelithiasis; cholecystitis.

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