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Bicalutamide (Bicalutamide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Bicalutamide 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 (57)
Death (4)
Life Threatening Events (12)
Disability (10)

Reports by Reaction Type

Oedema Peripheral (7)Cardiomegaly (6)Cardiac Failure Congestive (6)Dyspnoea (6)Dilatation Ventricular (5)Prostate Cancer (5)Scotoma (5)Vision Blurred (5)Drug Interaction (4)Interstitial Lung Disease (4)Visual Impairment (4)Pain (3)

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

Possible Bicalutamide side effects in 86 year old male

Reported by a physician from United Kingdom on 2012-08-27

Patient: 86 year old male, weighing 89.0 kg (195.8 pounds)

Reactions: Haematuria, International Normalised Ratio Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Warfarin Sodium
    Administration route: Oral
    Indication: Aortic Valve Replacement

Bicalutamide
    Dosage: 50 mg, qd
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-08-01

Other drugs received by patient: Bendroflumethiazide; Nicorandil; Atorvastatin; Bisoprolol Fumarate; Tamsulosin HCL



Possible Bicalutamide side effects in 74 year old male

Reported by a physician from Finland on 2012-08-27

Patient: 74 year old male

Reactions: Ectopic Acth Syndrome, Metabolic Alkalosis, Prostate Cancer, Hyperglycaemia, Pain, General Physical Health Deterioration, Delirium, Hypokalaemia, Cushing's Syndrome, Leukocytosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Leuprolide Acetate
    Indication: Product Used FOR Unknown Indication

Bicalutamide
    Indication: Product Used FOR Unknown Indication

Bicalutamide

Leuprolide Acetate

Other drugs received by patient: Bisoprolol Fumarate; Glimepiride; Atorvastatin; Metformin HCL; Tramadol HCL; Losartan Potassium; Warfarin Sodium; Felodipine; Potassium Chloride



Possible Bicalutamide side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-09

Patient: 80 year old male

Reactions: Weight Increased, Fatigue, Hyperglycaemia, Hypogonadism, Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient: Triptorelin



Possible Bicalutamide side effects in 83 year old male

Reported by a physician from Japan on 2012-08-01

Patient: 83 year old male

Reactions: Interstitial Lung Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Leuprolide Acetate
    Indication: Prostate Cancer
    Start date: 2012-03-05
    End date: 2012-03-05

Bicalutamide
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-03-05
    End date: 2012-03-05

Other drugs received by patient: Warfarin Potassium; Olmesartan Medoxomil; Allopurinol; Teprenone; Simvastatin



Possible Bicalutamide side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: male

Reactions: Pain, Oedema Peripheral

Drug(s) suspected as cause:
Bicalutamide



Possible Bicalutamide side effects in male

Reported by a physician from Greece on 2012-07-25

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Vertigo, Arteriovenous Fistula Thrombosis, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-01-04

Bicalutamide
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-05-02

Other drugs received by patient: Erythropoetin; Iron; Sevelamer; Triptorelin; L-Carnitine; Lantus; Calcium Carbonate



Possible Bicalutamide side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: male

Reactions: Drug Interaction, Thrombocytopenia

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient possibly interacting with the suspect drug:
Leuprolide Acetate
    Dosage: 22.5 mg every 12 weeks
    Indication: Prostate Cancer

Sunitinib Malate
    Indication: Prostate Cancer



Possible Bicalutamide side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: male

Reactions: Drug Interaction, Neutropenia

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient possibly interacting with the suspect drug:
Sunitinib Malate
    Indication: Prostate Cancer

Leuprolide Acetate
    Dosage: 22.5 mg every 12 weeks
    Indication: Prostate Cancer



Possible Bicalutamide side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: male

Reactions: Drug Interaction, Neutropenia

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient possibly interacting with the suspect drug:
Leuprolide Acetate
    Dosage: 22.5 mg every 12 weeks
    Indication: Prostate Cancer

Sunitinib Malate
    Indication: Prostate Cancer



Possible Bicalutamide side effects in 84 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: 84 year old male, weighing 86.3 kg (189.9 pounds)

Reactions: International Normalised Ratio Increased, Anaemia

Drug(s) suspected as cause:
Bicalutamide
    Dosage: 5-7 tab every day po
    Administration route: Oral
    Indication: Pain
    Start date: 2000-01-01
    End date: 2012-03-29

Abiraterone



Possible Bicalutamide side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-11

Patient: 65 year old male

Reactions: Hypotension, Dizziness, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicalutamide



Possible Bicalutamide side effects in male

Reported by a consumer/non-health professional from Hungary on 2012-06-28

Patient: male

Reactions: Blood Chromogranin A Increased, Drug Interaction

Drug(s) suspected as cause:
Omeprazole
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bicalutamide
    Dosage: 150 mg, unknown
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2012-04-05



Possible Bicalutamide side effects in male

Reported by a individual with unspecified qualification from United States on 2012-06-25

Patient: male

Reactions: Neurotoxicity

Drug(s) suspected as cause:
Goserelin
    Dosage: total of 2 years
    Indication: Prostate Cancer

Avastin
    Dosage: for weeks1 through 8
    Indication: Prostate Cancer

Avastin
    Dosage: after completion of radiation therapy was continued for 12 weeks

Bicalutamide
    Dosage: total of 16 weeks
    Indication: Prostate Cancer



Possible Bicalutamide side effects in male

Reported by a physician from United States on 2012-06-25

Patient: male

Reactions: Prostatitis, Haematuria, Sepsis, Prostatic Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: for weeks1 through 8
    Indication: Prostate Cancer

Bicalutamide
    Dosage: total of 16 weeks
    Indication: Prostate Cancer

Goserelin
    Dosage: total of 2 years
    Indication: Prostate Cancer

Avastin
    Dosage: after completion of radiation therapy was continued for 12 weeks



Possible Bicalutamide side effects in male

Reported by a individual with unspecified qualification from United States on 2012-06-25

Patient: male

Reactions: Rectal Haemorrhage, Hyponatraemia, Rash, Cognitive Disorder, Hepatic Enzyme Increased, Fatigue, Proteinuria, Urinary Retention, Hypertension

Drug(s) suspected as cause:
Avastin
    Dosage: for weeks1 through 8
    Indication: Prostate Cancer

Avastin
    Dosage: after completion of radiation therapy was continued for 12 weeks

Goserelin
    Dosage: total of 2 years
    Indication: Prostate Cancer

Bicalutamide
    Dosage: total of 16 weeks
    Indication: Prostate Cancer



Possible Bicalutamide side effects in male

Reported by a physician from United States on 2012-06-15

Patient: male, weighing 58.5 kg (128.7 pounds)

Reactions: Sleep Disorder, Constipation

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2012-04-24

Chantix
    Dosage: unk
    Administration route: Oral
    End date: 2012-05-13

Bicalutamide
    Dosage: 50 mg daily
    Administration route: Oral
    Indication: Feeling Hot

Metformin HCL
    Dosage: 500 mg, 2x/day
    Indication: Diabetes Mellitus

Other drugs received by patient: Eligard; Paroxetine; Simvastatin



Possible Bicalutamide side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: male, weighing 107.0 kg (235.4 pounds)

Reactions: Prostate Cancer, Blood Triglycerides Increased, Hypertension, Blood Glucose Increased

Drug(s) suspected as cause:
Lipitor
    Dosage: unk
    Indication: Blood Cholesterol Increased
    Start date: 1993-01-01
    End date: 2012-01-01

Viagra
    Dosage: unk

Sutent
    Dosage: 25 mg, daily
    Indication: Prostate Cancer

Bicalutamide
    Dosage: 50 mg, daily
    Indication: Prostate Cancer
    Start date: 2011-04-01
    End date: 2012-01-01



Possible Bicalutamide side effects in male

Reported by a physician from Japan on 2012-05-21

Patient: male

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Bicalutamide
    Dosage: dose unknown
    Administration route: Oral

Zoladex
    Indication: Prostate Cancer
    Start date: 2012-04-05



Possible Bicalutamide side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: 66 year old male

Reactions: Lymphadenopathy, Fatigue, Prostatic Specific Antigen Increased, Osteoporosis, Dysuria, Malignant Pleural Effusion, Normochromic Normocytic Anaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Eligard

Bicalutamide

Eligard
    Indication: Prostate Cancer

Other drugs received by patient: Zoledronic; Docetaxel; Calcitriol; Carboplatin



Possible Bicalutamide side effects in 75 year old male

Reported by a physician from United Kingdom on 2012-05-11

Patient: 75 year old male, weighing 67.0 kg (147.4 pounds)

Reactions: LIP Swelling, Dysphagia, Swollen Tongue

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient: Aspirin; Levothyroxine Sodium; Zoladex; Bumetanide; Simvastatin; Amiodarone HCL; Spironolactone; Digoxin; Ranitidine; Warfarin Sodium



Possible Bicalutamide side effects in male

Reported by a pharmacist from Canada on 2012-05-04

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Thrombosis, Pulmonary Embolism, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot
    Indication: Prostate Cancer
    Start date: 2011-04-01

Bicalutamide
    Indication: Prostate Cancer

Chemotherapy
    Indication: Prostate Cancer

Other drugs received by patient: Fraxiparine



Possible Bicalutamide side effects in 75 year old male

Reported by a physician from Japan on 2012-05-04

Patient: 75 year old male

Reactions: Pulmonary Alveolar Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicalutamide
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-04-01
    End date: 2012-04-11

Anplag
    Administration route: Oral
    Indication: Spinal Osteoarthritis
    End date: 2012-04-11

Leuprolide Acetate
    Indication: Prostate Cancer
    Start date: 2012-04-07

Other drugs received by patient: Pramipexole Dihydrochloride; Norvasc; Comtan; Juvela; Carbidopa and Levodopa; Enalapril Maleate; Tambocor; FP OD



Possible Bicalutamide side effects in 85 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-30

Patient: 85 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Incontinence, Joint Swelling, Nipple Pain, Oedema Peripheral, Breast Mass, Urinary Retention, Constipation, Blood Glucose Increased

Drug(s) suspected as cause:
Bicalutamide



Possible Bicalutamide side effects in male

Reported by a pharmacist from Japan on 2012-03-05

Patient: male

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Leuprolide Acetate
    Indication: Product Used FOR Unknown Indication

Bicalutamide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Bicalutamide side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-01

Patient: male

Reactions: Hepatotoxicity

Drug(s) suspected as cause:
Bicalutamide



Possible Bicalutamide side effects in 75 year old male

Reported by a physician from Japan on 2012-02-10

Patient: 75 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Pneumonia Primary Atypical, Condition Aggravated

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

Drug(s) suspected as cause:
Bicalutamide
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2011-12-01
    End date: 2012-01-02

Flivas
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2011-12-01
    End date: 2012-01-02

Other drugs received by patient: Urso / 00465701 /; Amlodipine



Possible Bicalutamide side effects in male

Reported by a pharmacist from Japan on 2012-02-03

Patient: male

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Bicalutamide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Leuprolide Acetate
    Indication: Product Used FOR Unknown Indication



Possible Bicalutamide side effects in 69 year old male

Reported by a pharmacist from United Kingdom on 2012-01-23

Patient: 69 year old male

Reactions: Hepatitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Bicalutamide



Possible Bicalutamide side effects in 50 year old male

Reported by a physician from United Kingdom on 2012-01-17

Patient: 50 year old male

Reactions: Dyspnoea, Dilatation Ventricular, Oedema Peripheral, Cardiac Failure Congestive, Cardiomegaly

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient: Tamsulosin HCL; Albuterol Sulfate Autohaler



Possible Bicalutamide side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-01-11

Patient: 50 year old male

Reactions: Ventricular Dysfunction, Cardiomegaly, Cardiac Failure Congestive

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Bicalutamide

Other drugs received by patient: Tamsulosin HCL; Albuterol Sulfate Autohaler

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