Zetia (Ezetimibe) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

ZETIA has been evaluated for safety in more than 4700 patients in clinical trials. Clinical studies of ZETIA (administered alone or with an HMG-CoA reductase inhibitor) demonstrated that ZETIA was generally well tolerated. The overall incidence of adverse events reported with ZETIA was similar to that reported with placebo, and the discontinuation rate due to adverse events was also similar for ZETIA and placebo.

Monotherapy

Adverse experiences reported in >/=2% of patients treated with ZETIA and at an incidence greater than placebo in placebo-controlled studies of ZETIA, regardless of causality assessment, are shown in Table 8.

The frequency of less common adverse events was comparable between ZETIA and placebo.

Combination with an HMG-CoA Reductase Inhibitor

ZETIA has been evaluated for safety in combination studies in more than 2000 patients.

In general, adverse experiences were similar between ZETIA administered with HMG-CoA reductase inhibitors and HMG-CoA reductase inhibitors alone. However, the frequency of increased transaminases was slightly higher in patients receiving ZETIA administered with HMG-CoA reductase inhibitors than in patients treated with HMG-CoA reductase inhibitors alone. (See PRECAUTIONS, Liver Enzymes.)

Clinical adverse experiences reported in >/=2% of patients and at an incidence greater than placebo in four placebo-controlled trials where ZETIA was administered alone or initiated concurrently with various HMG-CoA reductase inhibitors, regardless of causality assessment, are shown in Table 9.

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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ZETIA

Possible Zetia side effects / adverse reactions in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2007-01-05

Patient: 51 year old male

Reactions: Tendon Disorder, Drug Interaction

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2004-12-01

Pravastatin Sodium
    Administration route: Oral
    Start date: 2000-01-01

Possible Zetia side effects / adverse reactions in 57 year old female

Reported by a consumer/non-health professional from United States on 2007-01-08

Patient: 57 year old female

Reactions: Urinary Tract Infection, Flatulence, Heart Rate Increased, Tachycardia, Abdominal Distension, Myocardial Infarction

Suspect drug(s):
Zetia

Other drugs received by patient: Lipitor

Possible Zetia side effects / adverse reactions in 55 year old female

Reported by a physician from France on 2007-01-16

Patient: 55 year old female

Reactions: Musculoskeletal Pain, Cholecystitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Other drugs received by patient: Pravastatin Sodium; Lorazepam; Levocetirizine Hydrochloride; Tetrazepam; Piroxicam Betadex