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Bicalutamide (Bicalutamide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

In patients with advanced prostate cancer treated with Bicalutamide Tablets, USP in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%).

In the multicenter, double-blind, controlled clinical trial comparing Bicalutamide Tablets, USP 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analog, the following adverse reactions with an incidence of 5% or greater, regardless of causality, have been reported.

Table 1. Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality
Body System
  Adverse Reaction
Treatment Group
Number of Patients (%)
Bicalutamide Tablets, USP
Plus LHRH Analog
(n=401)
Flutamide
Plus LHRH Analog
(n=407)
Body as a Whole
  Pain (General) 142 (35) 127 (31)
  Back Pain 102 (25) 105 (26)
  Asthenia 89 (22) 87 (21)
  Pelvic Pain 85 (21) 70 (17)
  Infection 71 (18) 57 (14)
  Abdominal Pain 46 (11) 46 (11)
  Chest Pain 34 (8) 34 (8)
  Headache 29 (7) 27 (7)
  Flu Syndrome 28 (7) 30 (7)
Cardiovascular
  Hot Flashes 211 (53) 217 (53)
  Hypertension 34 (8) 29 (7)
Digestive
  Constipation 87 (22) 69 (17)
  Nausea 62 (15) 58 (14)
  Diarrhea 49 (12) 107 (26)
  Increased Liver Enzyme Test 30 (7) 46 (11)
  Dyspepsia 30 (7) 23 (6)
  Flatulence 26 (6) 22 (5)
  Anorexia 25 (6) 29 (7)
  Vomiting 24 (6) 32 (8)
Hemic and Lymphatic
  Anemia 45 (11) 53 (13)
Metabolic and Nutritional
  Peripheral Edema 53 (13) 42 (10)
  Weight Loss 30 (7) 39 (10)
  Hyperglycemia 26 (6) 27 (7)
  Alkaline Phosphatase Increased 22 (5) 24 (6)
  Weight Gain 22 (5) 18 (4)
Musculoskeletal
  Bone Pain 37 (9) 43 (11)
  Myasthenia 27 (7) 19 (5)
  Arthritis 21 (5) 29 (7)
  Pathological Fracture 17 (4) 32 (8)
Nervous System
  Dizziness 41 (10) 35 (9)
  Paresthesia 31 (8) 40 (10)
  Insomnia 27 (7) 39 (10)
  Anxiety 20 (5) 9 (2)
  Depression 16 (4) 33 (8)
Respiratory System
  Dyspnea 51 (13) 32 (8)
  Cough Increased 33 (8) 24 (6)
  Pharyngitis 32 (8) 23 (6)
  Bronchitis 24 (6) 22 (3)
  Pneumonia 18 (4) 19 (5)
  Rhinitis 15 (4) 22 (5)
Skin and Appendages
  Rash 35 (9) 30 (7)
  Sweating 25 (6) 20 (5)
Urogenital
  Nocturia 49 (12) 55 (14)
  Hematuria 48 (12) 26 (6)
  Urinary Tract Infection 35 (9) 36 (9)
  Gynecomastia 36 (9) 30 (7)
  Impotence 27 (7) 35 (9)
  Breast Pain 23 (6) 15 (4)
  Urinary Frequency 23 (6) 29 (7)
  Urinary Retention 20 (5) 14 (3)
  Urinary Impaired 19 (5) 15 (4)
  Urinary Incontinence 15 (4) 32 (8)

Other adverse reactions (greater than or equal to 2%, but less than 5%) reported in the Bicalutamide Tablets, USP-LHRH analog treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality.

Body as a Whole: Neoplasm; Neck Pain; Fever; Chills; Sepsis; Hernia; Cyst

Cardiovascular: Angina Pectoris; Congestive Heart Failure; Myocardial Infarct; Heart Arrest; Coronary Artery Disorder; Syncope

Digestive: Melena; Rectal Hemorrhage; Dry Mouth; Dysphagia; Gastrointestinal Disorder; Periodontal Abscess; Gastrointestinal Carcinoma

Metabolic and Nutritional: Edema; BUN Increased; Creatinine Increased; Dehydration; Gout; Hypercholesteremia

Musculoskeletal: Myalgia; Leg Cramps

Nervous: Hypertonia; Confusion; Somnolence; Libido Decreased; Neuropathy; Nervousness

Respiratory: Lung Disorder; Asthma; Epistaxis; Sinusitis

Skin and Appendages: Dry Skin; Alopecia; Pruritus; Herpes Zoster; Skin Carcinoma; Skin Disorder

Special Senses: Cataract specified

Urogenital: Dysuria; Urinary Urgency; Hydronephrosis; Urinary Tract Disorder

Abnormal Laboratory Test Values:

Laboratory abnormalities including elevated AST, ALT, bilirubin, BUN, and creatinine and decreased hemoglobin and white cell count have been reported in both Bicalutamide Tablets, USP-LHRH analog treated and flutamide-LHRH analog treated patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Bicalutamide Tablets, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Uncommon cases of hypersensitivity reactions, including angioneurotic edema and urticaria have been seen [see Contraindications]. Cases of interstitial lung disease (some fatal), including interstitial pneumonitis and pulmonary fibrosis, have been reported with Bicalutamide Tablets, USP. Interstitial lung disease has been reported most often at doses greater than 50 mg. A few cases of fatal hepatic failure have been reported.

Reduction in glucose tolerance, manifesting as diabetes or a loss of glycemic control in those with pre-existing diabetes, has been reported during treatment with LHRH agonists.



REPORTS OF SUSPECTED BICALUTAMIDE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Bicalutamide. The information is not vetted and should not be considered as verified clinical evidence.

Possible Bicalutamide side effects / adverse reactions in 50 year old male

Reported by a physician from United Kingdom on 2011-10-21

Patient: 50 year old male

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

Adverse event resulted in: disablity

Suspect drug(s):
Bicalutamide

Other drugs received by patient: Albuterol; Tamsulosin HCL



Possible Bicalutamide side effects / adverse reactions in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-26

Patient: 63 year old male

Reactions: Impaired Driving Ability, Visual Impairment, Vision Blurred, Scotoma

Suspect drug(s):
Bicalutamide



Possible Bicalutamide side effects / adverse reactions in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-27

Patient: 63 year old male

Reactions: Visual Impairment, Vision Blurred, Scotoma

Suspect drug(s):
Bicalutamide



See index of all Bicalutamide side effect reports >>

Drug label data at the top of this Page last updated: 2010-11-16

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