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 57 year old female

Reported by a pharmacist from United States on 2007-01-16

Patient: 57 year old female

Reactions: Guillain-Barre Syndrome, Vitamin B12 Deficiency

Suspect drug(s):
Zetia

Other drugs received by patient: Prevacid; Cyanocobalamin

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

Possible Zetia side effects / adverse reactions in 71 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-16

Patient: 71 year old male

Reactions: Cholelithiasis, Cholestasis, Cholecystitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Possible Zetia side effects / adverse reactions in 84 year old female

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

Patient: 84 year old female

Reactions: Migraine, Headache

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2005-03-09
    End date: 2005-10-20

Zetia
    Administration route: Oral
    Start date: 2005-11-23
    End date: 2005-12-23

Other drugs received by patient: Statin (Unspecified)

Possible Zetia side effects / adverse reactions in 40 year old female

Reported by a physician from United States on 2007-01-17

Patient: 40 year old female

Reactions: Guillain-Barre Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Possible Zetia side effects / adverse reactions in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-17

Patient: 60 year old female

Reactions: Drug Interaction, Epilepsy

Adverse event resulted in: life threatening event

Suspect drug(s):
Zetia

Other drugs received by patient possibly interacting with the suspect drug:
Carbamazepine
    Administration route: Oral
    Indication: Epilepsy

Phenobarbital
    Administration route: Oral
    Indication: Epilepsy

Other drugs received by patient: Zocor; Zocor; Risperidone; Pipamperone Hydrochloride; Periciazine

Possible Zetia side effects / adverse reactions in 59 year old female

Reported by a physician from United States on 2007-01-17

Patient: 59 year old female weighing 97.0 kg (213.4 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Myoglobin Blood Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2006-10-11
    End date: 2006-11-21

Zetia
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2006-10-11
    End date: 2006-11-21

Other drugs received by patient: CO-Diovan; Synthroid

Possible Zetia side effects / adverse reactions in 81 year old male

Reported by a consumer/non-health professional from United States on 2007-01-17

Patient: 81 year old male

Reactions: Muscular Weakness, Cerebrovascular Accident

Suspect drug(s):
Zetia

Other drugs received by patient: Glyburide; Metformin; Hydrochlorothiazide

Possible Zetia side effects / adverse reactions in 49 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-18

Patient: 49 year old male weighing 130.0 kg (286.0 pounds)

Reactions: Rhabdomyolysis, Renal Failure

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Other drugs received by patient: Albuterol; Furosemide; Diltiazem Hydrochloride; Fluticasone Propionate and Salmeterol Xinafoate; Zolpidem Tartrate; Aspirin Lysine; Nitroglycerin; Acetaminophen

Possible Zetia side effects / adverse reactions in 84 year old male

Reported by a pharmacist from Australia on 2007-01-19

Patient: 84 year old male

Reactions: Abdominal Pain, Vomiting, Dyspnoea, Swelling Face, Pain in Extremity, Nausea

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Other drugs received by patient: Amlodipine Besylate; Atenolol; Aspirin

Possible Zetia side effects / adverse reactions in 70 year old female

Reported by a physician from Canada on 2007-01-19

Patient: 70 year old female weighing 63.0 kg (138.6 pounds)

Reactions: Abdominal Pain, Blood Creatine Phosphokinase Increased, Dyspnoea, Rhabdomyolysis, Hyperkalaemia, Hyperphosphataemia, Urinary Tract Infection, General Physical Health Deterioration, Haemoglobin Decreased, Malaise, Renal Tubular Necrosis, Muscle Spasms, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia
    Administration route: Oral
    Start date: 2006-02-01
    End date: 2006-04-01

Zetia
    Administration route: Oral
    Start date: 2006-04-01

Rosuvastatin Calcium
    Administration route: Oral
    Start date: 2005-07-01
    End date: 2006-04-01

Rosuvastatin Calcium
    Administration route: Oral
    Start date: 2005-03-20
    End date: 2005-07-01

Other drugs received by patient: Valsartan; Aspirin; Hydrochlorothiazide; Atenolol; Atenolol; Dimenhydrinate; Aspirin and Caffeine, Citrated and Codeine Phosphate; Aspirin and Caffeine, Citrated and Codeine Phosphate

Possible Zetia side effects / adverse reactions in 75 year old female

Reported by a pharmacist from Australia on 2007-01-19

Patient: 75 year old female weighing 75.0 kg (165.0 pounds)

Reactions: Angioedema, Dyspnoea, Throat Tightness

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Zetia

Other drugs received by patient: Floxacillin; Diltiazem Hydrochloride; Diltiazem Hydrochloride; Aspirin; Dextran 70 and Hypromellose; Nitroglycerin; Cefaclor

Possible Zetia side effects / adverse reactions in 53 year old female

Reported by a physician from Australia on 2007-01-19

Patient: 53 year old female weighing 69.0 kg (151.8 pounds)

Reactions: Pancreatitis Relapsing

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2006-10-01
    End date: 2006-11-01

Zetia
    Administration route: Oral
    Indication: Liver Function Test Abnormal
    Start date: 2006-10-01
    End date: 2006-11-01

Other drugs received by patient: Esomeprazole Magnesium; Butylscopolamine Bromide; Butylscopolamine Bromide; Metoclopramide Hydrochloride; Metoclopramide Hydrochloride

Possible Zetia side effects / adverse reactions in 70 year old female

Reported by a physician from United States on 2007-01-19

Patient: 70 year old female weighing 60.0 kg (132.0 pounds)

Reactions: Autoimmune Hepatitis

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Type IIA Hyperlipidaemia
    Start date: 2004-06-01
    End date: 2005-12-01

Atorvastatin Calcium
    Administration route: Oral
    Indication: Type IIA Hyperlipidaemia
    Start date: 1999-11-01
    End date: 2005-12-01

Atorvastatin Calcium
    Administration route: Oral
    Start date: 2006-02-01
    End date: 2006-03-01

Other drugs received by patient: Azithromycin

Possible Zetia side effects / adverse reactions in 69 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-01-22

Patient: 69 year old female

Reactions: Rhabdomyolysis, Renal Failure Acute

Adverse event resulted in: death

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

Rosuvastatin Calcium
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2004-01-01

Ibuprofen
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2006-04-05

Other drugs received by patient: Spironolactone; Hydrochlorothiazide and Losartan Potassium; Metformin; Rosiglitazone Maleate; Bisoprolol; Aspirin

Possible Zetia side effects / adverse reactions in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-01-22

Patient: 71 year old female weighing 75.0 kg (165.0 pounds)

Reactions: Myalgia, Blood Creatine Phosphokinase Increased, Drug Interaction

Adverse event resulted in: disablity

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2005-11-10
    End date: 2006-01-26

Atorvastatin Calcium
    Indication: Blood Cholesterol Increased
    Start date: 2005-03-18
    End date: 2006-02-24

Other drugs received by patient: Vaseretic; Nifedipine; Doxazosin Mesylate; Venlafaxine Hydrochloride; Omeprazole

Possible Zetia side effects / adverse reactions in 70 year old female

Reported by a physician from United Kingdom on 2007-01-22

Patient: 70 year old female weighing 60.0 kg (132.0 pounds)

Reactions: Autoimmune Hepatitis

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Zetia
    Administration route: Oral
    Indication: Type IIA Hyperlipidaemia
    Start date: 2004-06-01
    End date: 2005-12-01

Atorvastatin Calcium
    Administration route: Oral
    Indication: Type IIA Hyperlipidaemia
    Start date: 1999-11-01
    End date: 2005-12-01

Atorvastatin Calcium
    Administration route: Oral
    Start date: 2006-02-01
    End date: 2006-03-01

Other drugs received by patient: Azithromycin

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

Reported by a pharmacist from Australia on 2007-01-23

Patient: 64 year old female

Reactions: Pruritus Generalised, Dysphagia, Angioedema, Urticaria

Adverse event resulted in: hospitalization

Suspect drug(s):
Zetia

Other drugs received by patient: Omeprazole; Zocor; Zocor