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Abiraterone Side Effects

In Summary

Commonly reported side effects of abiraterone include: decreased serum potassium, increased serum aspartate aminotransferase, increased serum triglycerides, fluid retention, and hypokalemia. Other side effects include: hypertension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to abiraterone: oral tablet

Along with its needed effects, abiraterone 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 abiraterone:

More common
  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • bone fracture
  • chest pain or discomfort
  • convulsions
  • decreased urine
  • difficult, burning, or painful urination
  • dizziness
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • frequent urge to urinate
  • headache
  • increased need to urinate
  • increased thirst
  • increased urge to urinate during the night
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or swelling in the arms or legs without any injury
  • passing urine more often
  • pounding in the ears
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • slow heartbeat
  • sudden sweating
  • swelling
  • swelling with pits or depressions on the skin
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • waking to urinate at night
Less common
  • Abdominal or stomach pain or tenderness
  • arm, back, or jaw pain
  • chest tightness or heaviness
  • clay colored stools
  • cool, sweaty skin
  • dark urine
  • decreased appetite
  • decreased urine output
  • difficulty with breathing
  • dilated neck veins
  • extreme fatigue
  • fever
  • headache
  • irregular breathing
  • itching skin or rash
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • weakness
  • weight gain
  • yellow eyes or skin
Rare
  • Darkening of the skin
  • diarrhea
  • mental depression

Some side effects of abiraterone 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
  • Acid or sour stomach
  • belching
  • body aches or pain
  • chills
  • cough
  • difficulty with moving
  • ear congestion
  • heartburn
  • indigestion
  • joint pain
  • loss of voice
  • muscle cramps or spasms
  • muscle or bone pain
  • muscle stiffness
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • stomach discomfort or upset
  • swelling or stiffness of the joints

For Healthcare Professionals

Applies to abiraterone: oral tablet

Endocrine

Uncommon (0.1% to 1%): Adrenocortical insufficiency[Ref]

Hepatic

Very common (10% or more): Elevated ALT (up to 41.9%), elevated AST (up to 37.3%)
Common (1% to 10%): Elevated total bilirubin
Postmarketing reports: Fulminant hepatitis, acute liver failure and death[Ref]

Cardiovascular

Very common (10% or more): Hot flush (up to 22.3%), hypertension (up to 21.6%)
Common (1% to 10%): Arrhythmia, chest pain/chest discomfort, angina pectoris, atrial fibrillation, tachycardia, myocardial infarction/ischemia, cardiac failure (e.g., congestive heart failure, left ventricular dysfunction, decreased ejection fraction)
Frequency not reported: QT prolongation[Ref]

Musculoskeletal

Very common (10% or more): Joint swelling/discomfort (up to 30.3%), muscle discomfort (up to 26.2%), contusion (up to 13.3%)
Common (1% to 10%): Groin pain, fractures, falls
Postmarketing reports: Rhabdomyolysis, myopathy[Ref]

Hematologic

Very common (10% or more): Lymphopenia (up to 38.2%), anemia[Ref]

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 62.5%), hyperglycemia (up to 56.6%), hypernatremia (up to 32.8%), hypokalemia (up to 28.3%), fluid retention/edema (up to 26.7%), hypophosphatemia (up to 23.8%), elevated alkaline phosphatase, hypercholesterolemia[Ref]

Renal

Frequency not reported: Renal failure[Ref]

Other

Very common (10% or more): Fatigue (up to 39.1%)
Common (1% to 10%): Sepsis, pyrexia[Ref]

Respiratory

Very common (10% or more): Cough (up to 17.3%), upper respiratory tract infection (up to 12.7%), dyspnea (up to 11.8%), nasopharyngitis (up to 10.7%)
Postmarketing reports: Non-infectious pneumonitis, allergic alveolitis[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 12%), hematuria (up to 10.3%)
Common (1% to 10%): Urinary frequency, nocturia[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13.5%)[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 23.1%), diarrhea (up to 21.6%), dyspepsia (up to 11.1%), vomiting[Ref]

Dermatologic

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

References

1. "Product Information. Zytiga (abiraterone)." Centocor Inc, Malvern, PA.

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

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