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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.

In Summary

Common side effects of Casodex include: abdominal pain, nausea, and mastalgia. Other side effects include: flu-like symptoms, gynecomastia, vomiting, and anorexia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to bicalutamide: oral tablet

Along with its needed effects, bicalutamide (the active ingredient contained in Casodex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bicalutamide:

More Common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine
  • blurred vision
  • body aches or pain
  • chills
  • congestion
  • cough
  • cough producing mucus
  • difficult or labored breathing
  • dizziness
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • lower back or side pain
  • nervousness
  • painful or difficult urination
  • pounding in the ears
  • rapid weight gain
  • runny nose
  • slow or fast heartbeat
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • tingling of the hands or feet
  • trouble with swallowing
  • unusual weight gain or loss
  • voice changes

Less Common

  • Abnormal growth filled with fluid or semisolid material
  • ankle, knee, or great toe joint pain
  • arm, back, or jaw pain
  • bleeding from the rectum or bloody stools
  • blindness
  • bloody nose
  • burning feeling while urinating
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • change in bowel habits
  • chest pain, discomfort, tightness or heaviness
  • confusion
  • decrease in frequency of urination
  • decrease in urine volume
  • decreased vision
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing or eating
  • dilated neck veins
  • dry mouth
  • fainting
  • irregular breathing or heartbeat
  • joint stiffness or swelling
  • lightheadedness
  • loss of appetite
  • lump or swelling in the abdomen or stomach
  • nausea
  • no blood pressure or pulse
  • noisy breathing
  • pain or discomfort in the arms, jaw, back, or neck
  • painful blisters on the trunk of the body
  • persistent, non-healing sore
  • rapid, shallow breathing
  • reddish patch or irritated area
  • sensation of pins and needles
  • shiny bump
  • stabbing pain
  • stomach discomfort
  • stopping of the heart
  • sunken eyes
  • thirst
  • tumor
  • unconsciousness
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • white, yellow, or waxy scar-like area
  • wrinkled skin
  • yellow skin or eyes

Incidence Not Known

  • Bleeding gums
  • coughing up blood
  • hives or welts, itching, skin rash
  • increased menstrual flow or vaginal bleeding
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • redness of the skin

Some side effects of bicalutamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Belching
  • breast pain
  • constipation
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty with moving
  • dry skin
  • hair loss or thinning of the hair
  • heartburn
  • inability to have or keep an erection
  • indigestion
  • leg cramps
  • loss in sexual ability, desire, drive, or performance
  • loss of strength or energy
  • muscle ache, cramp, pain, or weakness
  • pain in the pelvis
  • pain or tenderness around the eyes and cheekbones
  • passing of gas
  • sleepiness or unusual drowsiness
  • stomach pain or fullness
  • stuffy or runny nose
  • swelling of the breasts or breast soreness in both females and males

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).[Ref]

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.[Ref]

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.[Ref]

Gastrointestinal

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

Hepatic

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

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.[Ref]

Genitourinary

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

Metabolic

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

Hematologic

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

Renal

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

Musculoskeletal

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

Nervous system

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

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.[Ref]

Dermatologic

Dermatologic side effects including rash and sweating have been reported.[Ref]

Endocrine

Endocrine system side effects including gynecomastia (38%) and breast pain (39%) have been reported with the use of bicalutamide (the active ingredient contained in Casodex) 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.[Ref]

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%.[Ref]

Hypersensitivity

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

References

1. Freeman SN, Mainwaring WI, Furr BJ "A possible explanation for the peripheral selectivity of a novel non- steroidal pure antiandrogen, Casodex (ICI 176,334)." Br J Cancer 60 (1989): 664-8

2. Soloway MS, Schellhammer PF, Smith JA, Chodak GW, Vogelzang NJ, Kennealey GT "Bicalutamide in the treatment of advanced prostatic carcinoma: a phase II noncomparative multicenter trial evaluating safety, efficacy and long-term endocrine effects of monotherapy." J Urol 154 (1995): 2110-4

3. Tyrrell CJ "Casodex: a pure non-steroidal anti-androgen used as monotherapy in advanced prostate cancer." Prostate Suppl 4 (1992): 97-104

4. Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G "A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group." Urology 45 (1995): 745-52

5. Newling DW "The response of advanced prostatic cancer to a new non-steroidal antiandrogen: results of a multicenter open phase II study of Casodex. European/Australian Co-operative Group." Eur Urol 18 Suppl 3 (1990): 18-21

6. "Multum Information Services, Inc. Expert Review Panel"

7. "Product Information. Casodex (bicalutamide)." Zeneca Pharmaceuticals, Wilmington, DE.

8. Bennett CL, Raisch DW, Sartor O "Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect." Ann Intern Med 137 (2002): 625

9. Nieh PT "Withdrawal phenomenon with the antiandrogen casodex." J Urol 153 (1995): 1070-2;disc. 1072-3

10. Kolvenbag GJCM, Blackledge GRP "Worldwide activity and safety of bicalutamide: a summary review." Urology 47 Suppl (1996): 70-9

11. Schellhammer PF, Kolvenbag GJ "Serum PSA decline after Casodex withdrawal." Urology 44 (1994): 790-2

12. Small EJ, Carroll PR "Prostate-specific antigen decline after casodex withdrawal: evidence for an antiandrogen withdrawal syndrome." Urology 43 (1994): 408-10

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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