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Apalutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 20, 2020.

For the Consumer

Applies to apalutamide: oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, apalutamide 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 apalutamide:

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • constipation
  • depressed mood
  • difficulty with moving
  • dizziness
  • dry skin and hair
  • falls
  • feeling cold
  • hair loss
  • headache
  • hoarseness or husky voice
  • joint pain
  • muscle cramp, pain, and stiffness
  • nervousness
  • pain in the arms or legs
  • pounding in the ears
  • rapid weight gain
  • slow or fast heartbeat
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weight gain

Less common

  • Bloody urine
  • chest pain or discomfort
  • decreased urine output
  • dilated neck veins
  • extreme tiredness or weakness
  • irregular breathing or heartbeat
  • nausea
  • pain in the shoulders, arms, jaw, or neck
  • tightness in the chest
  • troubled breathing
  • vomiting

Side effects not requiring immediate medical attention

Some side effects of apalutamide 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

  • Decreased appetite
  • decreased weight
  • diarrhea
  • feeling of warmth
  • itching, skin rash
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to apalutamide: oral tablet

General

The most frequently reported side effects are fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, appetite decreased, fracture, and peripheral edema.[Ref]

Hematologic

Very common (10% or more): Anemia (70%), leukopenia (47%), lymphopenia (41%)[Ref]

Metabolic

Very common (10% or more): Hypercholesterolemia (76%), hyperglycemia (70%), hypertriglyceridemia (67%), hyperkalemia (32%), appetite disorder (appetite decreased, early satiety, hypophagia) (12%)[Ref]

Genitourinary

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

Other

Very common (10% or more): Fatigue/asthenia (39%), fall (16%), edema (peripheral edema, generalized edema, edema, edema genital, penile edema, peripheral swelling, scrotal edema, lymphedema, swelling, localized edema) (11%)[Ref]

Cardiovascular

Very common (10% or more): Hypertension (25%), hot flush (14%)

Common (1% to 10%): Ischemic heart disease, heart failure

Frequency not reported: Myocardial infarction, cardiopulmonary arrest[Ref]

Dermatologic

Very common (10% or more): Rash (maculopapular rash, generalized rash, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, and rash vesicular) (24%)

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

Endocrine

Very common (10% or more): Thyroid stimulating hormone elevated

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

Gastrointestinal

Very common (10% or more): Diarrhea (20%), nausea (18%)[Ref]

Nervous system

Uncommon (0.1% to 1%): Seizure

Frequency not reported: Cerebral hemorrhage[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (16%), fracture (e.g., rib fracture, lumbar vertebral fracture, spinal compression fracture, spinal fracture, foot fracture, hip fracture, humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, tibia fracture) (12%)[Ref]

Immunologic

Frequency not reported: Infection[Ref]

References

1. "Product Information. Erleada (apalutamide)." Janssen Biotech, Inc., Horsham, PA, PA.

Frequently asked questions

Further information

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.