Casodex Side Effects

Generic name: bicalutamide

Note: This document contains side effect information about bicalutamide. Some of the dosage forms listed on this page may not apply to the brand name Casodex.

Some side effects of Casodex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bicalutamide: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking bicalutamide (the active ingredient contained in Casodex) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain, cough or trouble breathing;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• fever, chills, body aches, flu symptoms;

• pale skin, easy bruising or bleeding;

• blood in your urine; or

• nausea, pain in your upper stomach, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• hot flashes;

• breast pain or swelling;

• weakness, dizziness;

• back pain, pelvic pain, joint or muscle pain;

• increased nighttime urination;

• upset stomach, vomiting, diarrhea or constipation;

• weight changes;

• impotence, loss of interest in sex, or trouble having an orgasm;

• dizziness, headache; or

• sore throat, runny nose or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bicalutamide: oral tablet

Other

Unless otherwise noted, all data below refer to patients treated concurrently with bicalutamide (the active ingredient contained in Casodex) 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 (the active ingredient contained in Casodex) 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 (the active ingredient contained in Casodex) 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 (the active ingredient contained in Casodex) 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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