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 50 year old male

Reported by a physician from Australia on 2007-06-13

Patient: 50 year old male weighing 80.0 kg (176.0 pounds)

Reactions: Ischaemia, Hepatitis Acute, Anaemia, Cardiac Output Decreased, Cardiac Disorder, Hepatic Enzyme Increased, Death, Renal Failure, Hepatomegaly, Chronic Hepatic Failure

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Coversyl (Perindopril Erbumine)
    Administration route: Oral
    Start date: 2004-08-19

Lasix
    Indication: Ischaemia
    Start date: 2003-01-01

Lasix
    Indication: Left Ventricular Failure
    Start date: 2003-01-01

Lipitor
    Administration route: Oral
    Start date: 2003-01-01
    End date: 2004-09-27

Zetia
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-08-01
    End date: 2004-09-27

Zetia
    Administration route: Oral
    Indication: Coronary Artery Disease
    Start date: 2004-08-01
    End date: 2004-09-27

Other drugs received by patient: Clopidogrel Bisulfate; Carvedilol; [composition Unspecified]

Possible Zetia side effects / adverse reactions in 50 year old male

Reported by a physician from Australia on 2007-06-22

Patient: 50 year old male weighing 80.0 kg (176.0 pounds)

Reactions: Ischaemia, Hepatitis Acute, Anaemia, Cardiac Output Decreased, Hepatic Enzyme Increased, Death, Renal Failure, Hepatomegaly, Chronic Hepatic Failure

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Coversyl (Perindopril Erbumine)
    Administration route: Oral
    Start date: 2004-08-19

Lasix
    Indication: Ischaemia
    Start date: 2003-01-01

Lasix
    Indication: Left Ventricular Failure
    Start date: 2003-01-01

Lipitor
    Administration route: Oral
    Start date: 2003-01-01
    End date: 2004-09-27

Zetia
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-08-01
    End date: 2004-09-27

Zetia
    Administration route: Oral
    Indication: Coronary Artery Disease
    Start date: 2004-08-01
    End date: 2004-09-27

Other drugs received by patient: Clopidogrel Bisulfate; Carvedilol; [composition Unspecified]

Possible Zetia side effects / adverse reactions in 64 year old male

Reported by a individual with unspecified qualification from Japan on 2009-04-01

Patient: 64 year old male

Reactions: Cardiac Disorder, Arrhythmia

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Other drugs received by patient: Acetanol; Sigmart; Zocor; Pirmenol Hydrochloride