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Zytiga (Abiraterone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zytiga (Abiraterone) 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 (539)
Death (95)
Life Threatening Events (35)
Disability (10)

Reports by Reaction Type

Prostatic Specific Antigen Increased (55)Death (42)Oedema Peripheral (35)Fatigue (32)Pain (26)Drug Ineffective (25)Confusional State (24)Weight Decreased (24)Blood Alkaline Phosphatase Increased (22)Thrombocytopenia (21)Asthenia (19)Weight Increased (18)

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

Possible Zytiga side effects in male

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

Patient: male

Reactions: Coagulopathy, Gastric Ulcer Haemorrhage, International Normalised Ratio Abnormal, Neoplasm Progression, Factor Xiii Deficiency

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

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

Patient: male

Reactions: Nasopharyngitis, Pain in Extremity

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from France on 2012-08-24

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Hepatic Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient: Prednisolone; Zometa; Acetaminophen; Morphine Sulfate



Possible Zytiga side effects in male

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

Patient: male

Reactions: Myocardial Infarction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from Germany on 2012-08-24

Patient: male

Reactions: Prostatic Specific Antigen Increased, Blood Creatine Phosphokinase MB Increased

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from Spain on 2012-08-24

Patient: male

Reactions: Multi-Organ Failure, Death, Renal Failure, Prostate Cancer, Sepsis, Haematuria, Petechiae, Neutropenia, Thrombocytopenia

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

Drug(s) suspected as cause:
Zytiga
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-06-05
    End date: 2012-07-06

Zytiga
    Administration route: Oral
    Start date: 2012-03-16
    End date: 2012-06-05

Other drugs received by patient: Sintrom



Possible Zytiga side effects in male

Reported by a pharmacist from United States on 2012-08-24

Patient: male

Reactions: Diarrhoea, Musculoskeletal Pain, Depression, Arthritis

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in 71 year old male

Reported by a pharmacist from United States on 2012-08-24

Patient: 71 year old male, weighing 81.7 kg (179.6 pounds)

Reactions: Prostatic Specific Antigen Increased, Oedema Peripheral, Abdominal Distension

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

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

Patient: male, weighing 88.0 kg (193.6 pounds)

Reactions: Drug Dose Omission, Diarrhoea, Gastric Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga
    Dosage: 4 tablets each day before breakfast
    Administration route: Oral
    Indication: Prostate Cancer Metastatic

Zytiga
    Administration route: Oral
    Start date: 2011-01-10
    End date: 2012-02-01

Other drugs received by patient: Hydralazine HCL; Amlodipine; Carvedilol; Calcitriol; Glipizide; Prednisone TAB; Nifedipine



Possible Zytiga side effects in male

Reported by a consumer/non-health professional from France on 2012-08-22

Patient: male

Reactions: Myalgia, Pneumonia, Cardiac Failure, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a pharmacist from Germany on 2012-08-22

Patient: male

Reactions: Pancytopenia, Thrombocytopenia

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from Australia on 2012-08-21

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisolone
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2012-02-11

Zytiga
    Administration route: Oral

Zytiga
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2012-02-11
    End date: 2012-06-14

Other drugs received by patient: Lipidil; Acimax; Oxycodone Hydrochloride; Oxycodone Hydrochloride; Eligard; Maxolon



Possible Zytiga side effects in 71 year old male

Reported by a physician from Germany on 2012-08-21

Patient: 71 year old male

Reactions: Oedema, Cardiac Disorder

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from Denmark on 2012-08-21

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: International Normalised Ratio Increased, Drug Interaction

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient possibly interacting with the suspect drug:
Armodafinil
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-14

Armodafinil
    Start date: 2012-06-12

Armodafinil
    Start date: 2012-06-21

Warfarin Sodium
    Indication: Atrial Fibrillation
    End date: 2012-06-29

Other drugs received by patient: Prednisolone



Possible Zytiga side effects in 75 year old male

Reported by a physician from Germany on 2012-08-20

Patient: 75 year old male

Reactions: Retinal Detachment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in 70 year old male

Reported by a physician from United States on 2012-08-20

Patient: 70 year old male

Reactions: Swelling, Metastases To Central Nervous System

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from Germany on 2012-08-17

Patient: male, weighing 110.0 kg (242.0 pounds)

Reactions: Night Sweats, Prostatic Specific Antigen Increased, Pain, Liver Function Test Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Duragesic-100
    Indication: Product Used FOR Unknown Indication

Zytiga
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-01-19
    End date: 2012-07-12

Other drugs received by patient: Ondansetron; Moviprep; Xgeva; Prednisolone; Magnesium



Possible Zytiga side effects in 77 year old male

Reported by a pharmacist from United States on 2012-08-17

Patient: 77 year old male

Reactions: Balance Disorder, Dizziness

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male, weighing 60.3 kg (132.7 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Platelet Count Decreased

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient: Metoprolol Tartrate; Plavix; Vicodin; Cymbalta; MS Contin; Xgeva; Prednisone TAB; Megace; Miralax; Lupron; Vitamin D



Possible Zytiga side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: male

Reactions: Cauda Equina Syndrome, Pulmonary Oedema, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-13

Patient: 79 year old male

Reactions: Nausea, Ileus, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male

Reactions: Blood Alkaline Phosphatase Increased

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male, weighing 79.4 kg (174.6 pounds)

Reactions: Glioblastoma Multiforme, Cataract

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient: Prednisone TAB



Possible Zytiga side effects in

Reported by a pharmacist from United Kingdom on 2012-08-13

Patient:

Reactions: Thrombocytopenia

Drug(s) suspected as cause:
Zytiga



Possible Zytiga side effects in 75 year old male

Reported by a physician from United States on 2012-08-13

Patient: 75 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Docetaxel
    Indication: Prostate Cancer Metastatic
    Start date: 2012-05-01

Prednisone TAB
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2012-05-01

Zytiga
    Administration route: Oral

Zytiga
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2012-05-08



Possible Zytiga side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Confusional State, Fear, Pain, Muscular Weakness, Headache, Weight Increased, Dyspnoea Exertional, Hypokinesia, Fatigue, Oedema Peripheral, Dizziness, Depression, Hypersomnia

Drug(s) suspected as cause:
Lexapro
    Administration route: Oral
    Start date: 2012-01-01

Lexapro
    Administration route: Oral
    Indication: Depression
    End date: 2012-01-01

Prednisone TAB
    Administration route: Oral
    Start date: 2012-01-01

Prednisone TAB
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-01-01

Zytiga
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-04-01



Possible Zytiga side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male

Reactions: Dyspnoea, Fatigue, Pneumonia, Drug Ineffective, Adverse Event

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient: Calcium; Potassium; Prednisone TAB



Possible Zytiga side effects in male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-13

Patient: male

Reactions: Abdominal Pain

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient: Multiple Concomitant Drugs



Possible Zytiga side effects in male

Reported by a pharmacist from United States on 2012-08-13

Patient: male, weighing 66.7 kg (146.7 pounds)

Reactions: Haemoglobin Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zytiga

Other drugs received by patient: Prednisone TAB; Calcium Carbonate; Ferrous Sulfate TAB; Prilosec; Lortab

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