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, 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 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 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: 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 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 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 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 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 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 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 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 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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