Xtandi Side Effects

Generic name: enzalutamide

Note: This document contains side effect information about enzalutamide. Some of the dosage forms listed on this page may not apply to the brand name Xtandi.

Some side effects of Xtandi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to enzalutamide: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking enzalutamide (the active ingredient contained in Xtandi) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using enzalutamide and call your doctor at once if you have:

• seizure (black-out or convulsions);

• severe low back pain, trouble walking or standing up;

• pain or weakness in your lower body, severe and worsening numbness or tingly feeling;

• sudden loss of bladder or bowel control;

• fever, cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;

• red or pink urine; or

• increased blood pressure (severe headache, blurred vision, buzzing in your ears, confusion, chest pain, uneven heartbeats).

Common side effects may include:

• anxiety, dizziness, headache, sleep problems (insomnia);

• feeling weak or tired;

• back pain, joint or muscle pain, muscle weakness;

• flushing (warmth, redness, hot feeling);

• numbness, burning pain, or prickly feeling under your skin;

• swelling in your hands or feet;

• diarrhea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to enzalutamide: oral capsule

Cardiovascular

Very common (10% or more): Hot flush (20.3%), peripheral edema (15.4%)
Common (1% to 10%): Hypertension (6.4%)

Dermatologic

Common (1% to 10%): Pruritus (3.8%), dry skin (3.5%)

Gastrointestinal

Very common (10% or more): Diarrhea (21.8%)

Genitourinary

Common (1% to 10%): Hematuria (6.9%), pollakiuria (4.8%)

Hematologic

Very common (10% or more): Neutropenia (15%)
Uncommon (0.1% to 1%): Thrombocytopenia (0.5%)
Frequency not reported: Small increases in mean QTc interval

Hepatic

Very common (10% or more): Elevations in ALT (10%)
Common (1% to 10%): Elevations in bilirubin (3%)

Musculoskeletal

Very common (10% or more): Back pain (26.4%), arthralgia (20.5%), musculoskeletal pain (15%)
Common (1% to 10%): Muscular weakness (9.8%), musculoskeletal stiffness (2.6%)

Nervous system

Very common (10% or more): Headache (12.1%)
Common (1% to 10%): Dizziness, includes vertigo (9.5%), spinal cord compression and cauda equina syndrome (7.4%), paresthesia (6.6%), mental impairment, includes amnesia, memory impairment, cognitive disorder, and disturbance in attention (4.3%), hypoesthesia (4%)

Other

Very common (10% or more): Asthenic conditions, including asthenia and fatigue (50.6%)
Common (1% to 10%): Falls (4.6%), non-pathologic fractures (4%)

Psychiatric

Common (1% to 10%): Insomnia (8.8%), anxiety (6.5%), hallucinations (1.6%)

Respiratory

Very common (10% or more): Upper respiratory tract infection, includes nasopharyngitis, sinusitis, rhinitis, pharyngitis, and laryngitis (10.9%)
Common (1% to 10%): Lower respiratory tract and lung infection, includes pneumonia, and bronchitis (8.5%), epistaxis (3.3%)

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