Bicalutamide Side Effects

Not all side effects for bicalutamide may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bicalutamide: oral tablet

Along with its needed effects, bicalutamide 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
  • congestion
  • cough or hoarseness
  • cough producing mucus
  • difficult or labored breathing
  • dizziness
  • dryness or soreness of the throat
  • fever or chills
  • headache
  • lower back or side pain
  • nervousness
  • painful or difficult urination
  • pounding in the ears
  • rapid weight gain
  • runny nose
  • shortness of breath
  • 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
  • wheezing
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 while urinating
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • change in bowel habits
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • 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
  • fast or irregular heartbeat
  • fever
  • irregular breathing
  • joint stiffness or swelling
  • lightheadedness
  • loss of appetite
  • lump or swelling in the abdomen
  • nausea
  • no blood pressure or pulse
  • noisy breathing
  • pain in the neck
  • pain or discomfort in the arms, jaw, back, or neck
  • painful blisters on 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 heart
  • sunken eyes
  • swelling of the face, fingers, feet, or lower legs
  • 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
  • Hives or welts
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • skin rash

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
  • Acid or sour stomach
  • 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
  • lack or loss of strength
  • leg cramps
  • loss in sexual ability, desire, drive, or performance
  • loss of strength or energy
  • muscle aching or cramping
  • muscle pain or weakness
  • nervousness
  • pain in the pelvis
  • pain or tenderness around the eyes and cheekbones
  • passing of gas
  • sleepiness or unusual drowsiness
  • stomach pain, fullness, or discomfort
  • 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 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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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