Enzalutamide Side Effects

Not all side effects for enzalutamide 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 enzalutamide: oral capsule liquid filled

In addition to its needed effects, some unwanted effects may be caused by enzalutamide. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
Rare
  • Seizures

Some of the side effects that can occur with enzalutamide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Nervous system

Very common (10% or more): Headache (up to 12.1%), dizziness/vertigo (up to 11.3%)
Common (1% to 10%): Spinal cord compression and cauda equina syndrome, paresthesia, mental impairment disorders, hypoesthesia, dysgeusia, restless legs syndrome
Uncommon (0.1% to 1%): Seizures[Ref]

It is unknown how the drug may lower the seizure threshold; however, it may be related to the drug's ability to inhibit the activity of the GABA-gated chloride channel. The risk of seizure may be related to dose.

Mental impairment disorders included amnesia, memory impairment, cognitive disorder, and disturbance in attention.[Ref]

Cardiovascular

Very common (10% or more): Hot flush (up to 20.3%), peripheral edema (up to 15.4%), hypertension (up to 14.2%)[Ref]

Dermatologic

Common (1% to 10%): Pruritus, dry skin[Ref]

Endocrine

Common (1% to 10%): Gynecomastia[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 23.2%), diarrhea (up to 21.8%)[Ref]

Genitourinary

Common (1% to 10%): Hematuria, pollakiuria[Ref]

Hematologic

Very common (10% or more): Neutropenia (15%)
Common (1% to 10%): Thrombocytopenia
Frequency not reported: Leukopenia[Ref]

Hepatic

Very common (10% or more): ALT elevations (10%)
Common (1% to 10%): Bilirubin elevations[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 18.9%), decreased weight (up to 12.4%)[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 28.6%), arthralgia (up to 21.4%), musculoskeletal pain (up to 15%)
Common (1% to 10%): Muscular weakness, musculoskeletal stiffness[Ref]

Other

Fall-related injuries included non-pathologic fractures, joint injuries, and hematomas.[Ref]

Very common (10% or more): Asthenia/fatigue (up to 50.6%), falls (up to 12.7%)
Common (1% to 10%): Fall-related injuries[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, hallucinations[Ref]

Respiratory

Upper respiratory tract infection included nasopharyngitis, sinusitis, rhinitis, pharyngitis, and laryngitis. Lower respiratory tract and lung infection included pneumonia and bronchitis.[Ref]

Very common (10% or more): Upper respiratory tract infection (up to 16.4%), dyspnea (up to 11%)
Common (1% to 10%): Lower respiratory tract and lung infection, epistaxis[Ref]

References

1. "Product Information. Xtandi (enzalutamide)." Astellas Pharma US, Inc, Deerfield, IL.

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