Summary

Commonly reported side effects of bicalutamide include: abdominal pain, nausea, and mastalgia. Other side effects include: flu-like symptoms, gynecomastia, vomiting, and anorexia. Continue reading for a comprehensive list of adverse effects.

Applies to bicalutamide: oral tablets.

Side effects include:

Combined therapy with LHRH analog: hot flashes, pain (including abdominal, back, and pelvic pain), asthenia, constipation, infection, nausea, dyspnea, diarrhea.

Gynecomastia and breast pain frequent if bicalutamide used as monotherapy.

For Healthcare Professionals

Applies to bicalutamide: oral tablet.

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]

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]

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]

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]