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Zetia (Ezetimibe) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zetia (Ezetimibe) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (322)
Death (16)
Life Threatening Events (19)
Disability (37)

Reports by Reaction Type

Myalgia (38)Pain in Extremity (31)Fatigue (27)Arthralgia (25)Asthenia (24)Dyspnoea (22)Constipation (21)Nausea (21)Drug Ineffective (20)Back Pain (20)Vomiting (20)Pain (17)

Below are a few examples of reports where side effects / adverse reactions may be related to Zetia (Ezetimibe). For a complete list or a specific selection of reports, please use the links above.

Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Clavicle Fracture, Joint Swelling, Fall, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 62 year old female

Reactions: Allergic Oedema, Drug Tolerance Increased, Urticaria, Psoriasis, Musculoskeletal Discomfort, DRY Eye, Angle Closure Glaucoma

Drug(s) suspected as cause:
Humira
    Indication: Psoriasis

Lipitor
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-01

Lotrel
    Indication: Product Used FOR Unknown Indication

Zetia
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-13

Other drugs received by patient: Losartan Potassium; Potassium; Nopalea; Amlodipine; Carvedilol; Celexa



Possible Zetia side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 62 year old female

Reactions: Pharyngeal Oedema, Drug Effect Decreased, Urticaria, Psoriasis, Musculoskeletal Discomfort, DRY Eye, Angle Closure Glaucoma

Drug(s) suspected as cause:
Humira
    Indication: Psoriasis

Lipitor
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-01

Lotrel
    Indication: Product Used FOR Unknown Indication

Zetia
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-13

Other drugs received by patient: Amlodipine; Celexa; Carvedilol; Losartan Potassium; Nopalea; Potassium



Possible Zetia side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 67 year old female, weighing 93.0 kg (204.6 pounds)

Reactions: Pancreatitis

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Dizziness, Blood Glucose Fluctuation

Drug(s) suspected as cause:
Janumet XR
    Administration route: Oral
    Indication: Diabetes Mellitus

Zetia

Other drugs received by patient: Pepcid; Toprol-XL; Spironolactone



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Myalgia

Drug(s) suspected as cause:
Zetia
    Indication: Hypertriglyceridaemia

Zetia
    Dosage: unk
    Administration route: Oral
    Indication: Hypercholesterolaemia



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: International Normalised Ratio Increased

Drug(s) suspected as cause:
Zetia

Other drugs received by patient: Coumadin



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Myalgia

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Breast Tenderness

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Malaise, Pain

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Pain in Extremity

Drug(s) suspected as cause:
Zetia

Other drugs received by patient: Metoprolol Tartrate; Amlodipine; Vitamins (Unspecified)



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Bone Pain, Blood Cholesterol Increased

Drug(s) suspected as cause:
Crestor
    Dosage: unk unk, qd
    Indication: Blood Cholesterol Increased

Zetia
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2012-01-01

Other drugs received by patient: Nexium; Synthroid



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective, Pain in Extremity, Asthenia

Drug(s) suspected as cause:
Welchol
    Indication: Blood Cholesterol Increased

Zetia
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2010-01-01

Other drugs received by patient: Vagifem



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective, Pain, Muscular Weakness, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Wrong Technique in Drug Usage Process, Myopathy

Drug(s) suspected as cause:
Zetia

Other drugs received by patient: Metformin



Possible Zetia side effects in 67 year old male

Reported by a physician from United States on 2012-08-21

Patient: 67 year old male, weighing 89.0 kg (195.8 pounds)

Reactions: Ileus, Orthostatic Hypotension, non-Small Cell Lung Cancer, Failure To Thrive, Constipation, Disease Progression

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

Drug(s) suspected as cause:
Aspirin
    Dosage: 80 mg, daily, tablet
    Administration route: Oral
    Indication: Cardiovascular Event Prophylaxis
    End date: 2011-11-05

Benzonatate
    Dosage: 100 mg, as needed
    Administration route: Oral
    Indication: Cough
    End date: 2011-11-05

Coreg
    Dosage: 3.125 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-10-10

Crizotinib
    Dosage: 250 mg, 2x/day
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-06-03
    End date: 2011-10-24

Fluzone
    Dosage: 1 df, single, injection
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Dosage: unk, tablet
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-11-05

Levofloxacin
    Dosage: 750 mg/ d5w 150 ml q24h, ivpb
    Start date: 2011-10-15
    End date: 2011-10-18

Levothyroxine Sodium
    Dosage: 50 ug, 1x/day,
    Administration route: Oral
    Indication: Hypothyroidism
    End date: 2011-11-05

Meropenem
    Dosage: 1 gram in 50 ml ns q8h, ivpb
    Start date: 2011-10-15
    End date: 2011-10-19

Potassium Chloride
    Dosage: 20 meq, 1x/day, tablet
    Administration route: Oral
    Indication: Supplementation Therapy
    End date: 2011-11-05

Vancomycin HCL
    Dosage: 1750 mg, once, ivpb
    Start date: 2011-10-15
    End date: 2011-10-15

Vancomycin HCL
    Dosage: 1500 mg, 2x/day, ivpb
    Start date: 2011-10-15
    End date: 2011-10-16

Zetia
    Dosage: 10 mg, 1x/day, tablet
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-11-05

Zocor
    Dosage: 40 mg, 1x/day, tablet
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-11-05



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Myalgia

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a pharmacist from United States on 2012-08-14

Patient:

Reactions: NO Adverse Event, Overdose

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a physician from Japan on 2012-08-10

Patient:

Reactions: Drug Eruption

Drug(s) suspected as cause:
Zetia

Other drugs received by patient: Doxazosin Mesylate



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Hepatic Enzyme Increased

Drug(s) suspected as cause:
Zetia

Other drugs received by patient: Levothyroxine Sodium; Loratadine; Veramyst; Vitamin D; Fluticasone Propionate



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Adverse Event, Brain Neoplasm

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Adverse Event, Brain Neoplasm

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Hypotension, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Pain in Extremity, Oedema Peripheral, Musculoskeletal Pain, Pain

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in 67 year old male

Reported by a physician from United States on 2012-08-09

Patient: 67 year old male, weighing 89.1 kg (196.0 pounds)

Reactions: Death, Ileus, Orthostatic Hypotension, Constipation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aspirin
    Indication: Prophylaxis
    End date: 2011-11-05

Benzonatate
    Indication: Cough
    End date: 2011-11-05

Coreg
    Indication: Hyperlipidaemia
    End date: 2011-10-10

Crizotinib
    Dosage: 250mg twice per day
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-06-03
    End date: 2011-10-24

Fluzone
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Indication: Hypertension

Levothyroxine Sodium
    Dosage: 50mcg per day
    Indication: Hypothyroidism
    End date: 2011-11-05

Potassium Chloride
    Dosage: 20meq per day
    Administration route: Oral
    End date: 2011-11-05

Zetia
    Dosage: 10meq per day
    Indication: Hyperlipidaemia
    Start date: 2011-11-05

Zocor
    Dosage: 40mg per day
    Indication: Hyperlipidaemia
    End date: 2011-11-05



Possible Zetia side effects in 68 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-09

Patient: 68 year old female, weighing 66.2 kg (145.6 pounds)

Reactions: Confusional State, Anxiety, Dyspnoea, Palpitations, Dementia, Pain, Amnesia, Cardiac Disorder

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2002-01-01
    End date: 2011-01-01

Omeprazole
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-02-01
    End date: 2012-04-01

Omeprazole
    Administration route: Oral
    Start date: 2012-07-01

Zetia



Possible Zetia side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female, weighing 70.3 kg (154.7 pounds)

Reactions: Myalgia, Fatigue, Nausea, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Zetia



Possible Zetia side effects in 67 year old male

Reported by a physician from United States on 2012-08-08

Patient: 67 year old male, weighing 89.0 kg (195.8 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Aspirin
    Indication: Cardiovascular Event Prophylaxis
    End date: 2011-11-05

Benzonatate
    Indication: Cough
    End date: 2011-11-05

Coreg
    Indication: Hypertension
    End date: 2011-10-10

Fluzone
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Indication: Hypertension
    End date: 2011-11-05

Levothyroxine Sodium
    Indication: Hypothyroidism
    End date: 2011-11-05

Potassium Chloride
    Indication: Supplementation Therapy
    End date: 2011-11-05

Zetia
    End date: 2011-11-05

Zocor
    End date: 2011-11-05

Other drugs received by patient: Investigational Drug

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