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Yonsa Side Effects

Generic Name: abiraterone

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

For the Consumer

Applies to abiraterone: oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, abiraterone (the active ingredient contained in Yonsa) 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
  • bone pain
  • chest pain or discomfort
  • decreased urine
  • difficult, burning, or painful urination
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • frequent urge to urinate
  • headache
  • 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
  • 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
  • seizures
  • slow heartbeat
  • sudden sweating
  • swelling
  • swelling with pits or depressions on the skin
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • waking to urinate at night

Less common

  • Arm, back, or jaw pain
  • chest tightness or heaviness
  • clay-colored stools
  • cool, sweaty skin
  • dark urine
  • decreased urine output
  • difficulty with breathing
  • dilated neck veins
  • extreme tiredness or weakness
  • fever
  • irregular breathing
  • itching skin or rash
  • stomach pain or tenderness
  • sweating
  • weakness
  • weight gain
  • yellow eyes or skin

Rare

Incidence not known

  • Chills
  • cough
  • general feeling of discomfort or illness
  • irregular heartbeat, recurrent
  • muscle spasms or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • nausea
  • stomach pain, continuing
  • thickening of bronchial secretions
  • unpleasant breath odor
  • vomiting of blood

Side effects not requiring immediate medical attention

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

  • Belching
  • body aches or pain
  • difficulty with moving
  • ear congestion
  • heartburn
  • indigestion
  • joint pain
  • loss of voice
  • runny or stuffy 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.

2. "Product Information. Yonsa (abiraterone)." Sun Pharmaceutical Industries, Cranbury, NJ.

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.

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