Bicalutamide Side Effects

Brand Names: Casodex

Please note - some side effects for Bicalutamide 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 Bicalutamide - for the Consumer

Bicalutamide

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 Bicalutamide:

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.

Bicalutamide Side Effects - for the Professional

Bicalutamide

Adverse reactions that occurred in more than 10% of patients receiving Bicalutamide plus an LHRH-A were: hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia and anemia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.