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 liquid filled

Along with its needed effects, enzalutamide (the active ingredient contained in Xtandi) 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 enzalutamide:

More common
  • Back pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in urine
  • blurred vision
  • chest pain
  • cough
  • cough with mucus
  • difficulty breathing
  • dizziness
  • fever or chills
  • headache
  • loss of bladder control
  • loss of bowel control
  • nervousness
  • no sensation in the legs
  • painful or difficult urination
  • pounding in the ears
  • rapid weight gain
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • tightness in the chest
  • tingling of the hands or feet
  • unable to move legs
  • unusual weight gain or loss
  • wheezing
Less common
  • Confusion or excitement
  • fainting
  • falling
  • lightheadedness
  • loss of memory
  • mental depression or anxiety
  • nightmares or unusually vivid dreams
  • problems with memory or attention span
  • rapid, shallow breathing
  • trouble performing routine tasks
  • Seizures

Some side effects of enzalutamide 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
  • Body aches or pain
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • difficulty in moving
  • dry throat
  • ear congestion
  • feeling of constant movement of self or surroundings
  • feeling of warmth
  • hoarseness
  • joint pain
  • lack or loss of strength
  • loss of voice
  • muscle pain, stiffness, or weakness
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms and occasionally, upper chest
  • sensation of spinning
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • trouble with swallowing
  • trouble sleeping
  • unusual tiredness or weakness
  • voice changes
Less common
  • Bloody nose
  • dry skin
  • frequent urination
  • itching skin
  • pale-colored urine

For Healthcare Professionals

Applies to enzalutamide: oral capsule


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


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


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


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


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


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


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%)


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


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


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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