Casodex Side Effects

Generic Name: bicalutamide

Please note - some side effects for Casodex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Casodex - for the Consumer

Casodex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Casodex:

Back, pelvic, stomach, or general body pain; constipation; decreased sexual ability; diarrhea; dizziness; frequent urination, especially at night; gas; headache; hot flashes; nausea; stomach upset; sweating; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; difficulty swallowing; unusual hoarseness); black or bloody stools; blurred vision or other vision changes; bone pain; breast growth or pain; changes in the amount of urine produced; chest pain; dark or bloody urine; fainting; fever, chills, or persistent sore throat; flu-like symptoms; increased hunger, thirst, or urination; joint pain, stiffness, or swelling; loss of appetite; mental or mood changes (eg, anxiety, depression); muscle aches or weakness; numbness or tingling of the skin; severe or persistent cough; severe or persistent dizziness, drowsiness, or headache; severe or persistent nausea or stomach pain; shortness of breath; swelling of the ankles, legs, or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; weight change; yellowing of the skin or eyes.

Casodex Side Effects - for the Professional

Casodex

In patients with advanced prostate cancer treated with Casodex in combination with an LHRH analogue, the most frequent adverse experience 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 analogue, the following adverse experiences with an incidence of 5% or greater, regardless of causality, have been reported.

Other adverse experiences (greater than or equal to 2%, but less than 5%) reported in the Casodex-LHRH analogue 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 analogue treated and flutamide-LHRH analogue treated patients.

Postmarketing Experience:

Uncommon cases of hypersensitivity reactions, including angioneurotic edema and urticaria, and uncommon cases of interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, have been reported with Casodex.

Side Effects by Body System

Other

Unless otherwise noted, all data below refer to patients treated concurrently with bicalutamide and a luteinizing hormone-releasing hormone (LHRH) analogue (goserelin acetate or leuprolide acetate).

Cardiovascular

Cardiovascular system side effects include the most frequently encountered side effect, hot flashes, which has been reported in approximately 49% of treated patients. Hypertension has also been reported.

General

General side effects are also very common and have included generalized pain (27%), back pain (15%), asthenia (15%), pelvic pain (13%), and infection (10%). Abdominal and chest pain, headache, and flu syndrome have also been reported.

Gastrointestinal

Gastrointestinal effects are common and have included constipation (17%), nausea (11%), and diarrhea (10%). Flatulence and vomiting have also been reported.

Hepatic

Hepatic side effects including severe liver injury leading to hospitalization and death have been reported rarely. Hepatitis or marked increases in liver enzymes leading to drug discontinuation have been reported in approximately 1% of bicalutamide patients. One case of fulminant hepatic failure associated with bicalutamide use has also been reported.

Increased values in liver enzyme tests include increased AST, ALT, or both. This effect has occurred in approximately 6% of treated patients.

Genitourinary

Genitourinary side effects are somewhat common and include nocturia, hematuria, urinary tract infection, impotence, and urinary incontinence.

Metabolic

Metabolic effects are somewhat common and include peripheral edema, hyperglycemia, and weight loss.

Hematologic

Hematologic side effects include anemia (7%) and decreased white blood cell counts.

Renal

Renal side effects including new or worsened renal insufficiency (as measured by elevated BUN and creatinine) have been reported.

Musculoskeletal

Musculoskeletal complaints include bone pain. This may be due to underlying disease.

Nervous system

Nervous system side effects including dizziness, paresthesia, and insomnia have been reported.

Respiratory

Respiratory system side effects including dyspnea have been reported. Uncommon cases of interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis have been reported with the use of bicalutamide. One case of pneumonitis has also been reported.

Dermatologic

Dermatologic side effects including rash and sweating have been reported.

Endocrine

Bicalutamide has not been approved for use as monotherapy.

In one phase II clinical trial with bicalutamide used as a single agent, breast tenderness, breast swelling, and hot flashes were reported in 63.4%, 52.5%, and 23.6% of treated patients, respectively.

Another phase II clinical trial with bicalutamide used as a single agent reported breast pain, and gynecomastia in 76% and 60% of treated patients, respectively. This study also showed generalized pain in 30% of treated patients, hot flashes in 28%, pelvic pain in 26%, and libido decrease and impotence, both at 25%.

Endocrine system side effects including gynecomastia (38%) and breast pain (39%) have been reported with the use of bicalutamide as a single agent. Several cases of decreases in prostate specific antigen (PSA) after withdrawal of bicalutamide therapy (referred to as antiandrogen withdrawal syndrome) have been reported.

Hypersensitivity

Hypersensitivity side effects including angioneurotic edema and urticaria have been reported.

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