Bicalutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 25, 2023.

Applies to bicalutamide: oral tablet.

Serious side effects of bicalutamide

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
• 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

Other side effects of bicalutamide

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.

General

In patients with advanced prostate cancer treated with this drug in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%).^[Ref]

Cardiovascular

• Very common (10% or more): Hot flashes (53%)
• Common (1% to 10%): Chest pain, hypertension, angina pectoris, congestive heart failure, myocardial infarction, coronary arrest, coronary artery disorder, syncope^[Ref]

Other

• Very common (10% or more): Pain (35%), asthenia (22%), peripheral edema (13%)
• Common (1% to 10%): Weight loss, weight gain, fever, chills, hernia, cyst^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (22%), pelvic pain (21%), nausea (15%), diarrhea (12%), abdominal pain (11%)
• Common (1% to 10%): Dyspepsia, flatulence, vomiting, melena, rectal hemorrhage, dry mouth, dysphagia, GI disorder, periodontal abscess, GI carcinoma^[Ref]

Hepatic

• Common (1% to 10%): Increased liver enzyme test, alkaline phosphatase increased, elevated AST, elevated ALT, elevated bilirubin

Genitourinary

• Very common (10% or more): Nocturia (12%), hematuria (12%)
• Common (1% to 10%): Urinary tract infection, gynecomastia, impotence, breast pain, urinary frequency, urinary retention, urinary impaired, urinary incontinence, decreased libido, dysuria, urinary urgency, hydronephrosis, urinary tract disorder^[Ref]

Metabolic

• Common (1% to 10%): Anorexia, hyperglycemia, bone pain, myasthenia, edema, BUN Increased, creatinine increased, dehydration, gout, hypercholesteremia^[Ref]

Hematologic

• Very common (10% or more): Anemia (11%)
• Common (1% to 10%): Decreased hemoglobin, decreased white cell count
• Postmarketing reports: Increased PT/INR due to interaction between coumarin anticoagulants and this drug; serious bleeding reported^[Ref]

Renal

• Common (1% to 10%): Elevated creatinine^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (25%)
• Common (1% to 10%): Paresthesia, neck pain, leg cramps, myalgia^[Ref]

Nervous system

• Common (1% to 10%): Headache, neuropathy, hypertonia^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (13%)
• Common (1% to 10%): Cough, pharyngitis, bronchitis, pneumonia, rhinitis
• Uncommon (0.1% to 1%): Lung disorder, asthma, epistaxis, sinusitis
• Postmarketing reports: Interstitial lung disease (sometimes fatal) including interstitial pneumonitis and pulmonary fibrosis, most often at doses greater than 50 mg^[Ref]

Dermatologic

• Common (1% to 10%): Rash, sweating, dry skin, alopecia, pruritus, herpes zoster, skin carcinoma, skin disorder
• Postmarketing reports: Photosensitivity^[Ref]

Immunologic

• Very common (10% or more): Infection (18%)
• Common (1% to 10%): Influenza syndrome^[Ref]

Ocular

• Common (1% to 10%): Specified cataract^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, anxiety, depression, confusion, somnolence, nervousness^[Ref]

Oncologic

• Common (1% to 10%): Neoplasm^[Ref]

Further information

Bicalutamide side effects can vary depending on the individual. 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.

Medical Disclaimer