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Casodex (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 CASODEX in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%).

In the multicenter, double-blind, controlled clinical trial comparing CASODEX 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 (%)
CASODEX 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)

Muscoloskeletal

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 CASODEX-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 CASODEX-LHRH analog treated and flutamide-LHRH analog treated patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CASODEX. 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 CASODEX. 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 CASODEX SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Casodex side effects / adverse reactions in 74 year old male

Reported by a physician from United States on 2011-10-03

Patient: 74 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Radiotherapy
    Indication: Prostate Cancer

Casodex
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2010-12-27

Lupron
    Indication: Prostate Cancer
    Start date: 2010-12-29

Taxotere
    Indication: Prostate Cancer

Other drugs received by patient: Lasix; Phenazopyridine HCL TAB; Mucinex; Aspirin; Albuterol Sulfate; Flonase; Lisinopril; Dakin; Coreg; Potassium Cloride; Lexapro; Multaq; Zofran; Advair Diskus 100/50; Flomax



Possible Casodex side effects / adverse reactions in 66 year old male

Reported by a physician from Japan on 2011-10-03

Patient: 66 year old male

Reactions: Interstitial Lung Disease

Suspect drug(s):
Leuprolide Acetate
    Indication: Prostate Cancer
    Start date: 2011-01-01

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



Possible Casodex side effects / adverse reactions in 74 year old male

Reported by a physician from Japan on 2011-10-17

Patient: 74 year old male weighing 61.0 kg (134.2 pounds)

Reactions: Hepatitis Fulminant

Adverse event resulted in: life threatening event

Suspect drug(s):
Zoladex
    Start date: 2011-08-26

Casodex
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2011-06-03
    End date: 2011-06-17

Zoladex
    Indication: Prostate Cancer
    Start date: 2011-06-03

Other drugs received by patient: Zolpidem; Vesturit; Norvasc



See index of all Casodex side effect reports >>

Drug label data at the top of this Page last updated: 2009-11-30

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