Abiraterone / niraparib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 21, 2023.

Applies to abiraterone / niraparib: oral tablet.

Serious side effects

Along with its needed effects, abiraterone/niraparib 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 / niraparib:

More common

• Bladder pain
• bleeding gums
• bloody or cloudy urine
• blurred vision
• body pain
• cough
• coughing up blood
• diarrhea
• difficult, burning, or painful urination
• dizziness
• falls
• fever or chills
• frequent urge to urinate
• headache
• increased menstrual flow or vaginal bleeding
• loss of taste or smell
• lower back or side pain
• muscle pain
• nausea
• nervousness
• nosebleeds
• pale skin
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• slow or fast heartbeat
• sore throat
• stuffy or runny nose
• swelling
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Agitation
• anxiety
• chest pain or tightness
• coma
• confusion
• decreased urine output
• depression
• heart stops
• hostility
• inability to speak
• irritability
• lethargy
• lightheadedness
• muscle twitching
• no breathing
• no pulse or blood pressure
• pain, redness, or swelling in the arm or leg
• pain or swelling in the arms or legs without any injury
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• severe or sudden headache
• slurred speech
• sneezing
• stupor
• swelling of the face, ankles, or hands
• temporary blindness
• unconscious
• weakness in the arm and/or leg on one side of the body, sudden and severe

Incidence not known

• Bone pain
• chest discomfort
• dark urine
• darkening of the skin
• fainting
• increased hunger
• loss of appetite
• mental depression
• nervousness
• nightmares
• problems with vision, speech, or walking
• shakiness
• skin rash
• stomach pain, severe
• swelling of the fingers, hands, feet, or lower legs
• swollen glands
• unusual drowsiness
• yellow eyes or skin

Other side effects

Some side effects of abiraterone / niraparib 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

• Constipation
• decreased appetite
• trouble sleeping

Less common

• Lack or loss of strength

For Healthcare Professionals

Applies to abiraterone / niraparib: oral tablet.

General

The most common adverse reactions occurring in 10% or greater included musculoskeletal pain, fatigue, constipation, hypertension, nausea, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, weight decreased, arrhythmia, fall, and pyrexia.

The most common laboratory abnormalities that worsened from baseline in 10% or greater of patients included hemoglobin decreased, platelets decreased, neutrophils decreased, creatinine increased, potassium decreased, AST increased, ALT increased, and bilirubin increased.^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (33%), hemorrhage (12%), arrhythmia (10%)

Common (1% to 10%): Cerebrovascular accident, deep vein thrombosis

Frequency not reported: Cardiopulmonary arrest, potential for increased pulse rate

Postmarketing reports with individual components in other clinical trials:

-Abiraterone acetate: QT prolongation, Torsades de Pointes

-Niraparib: Hypertensive crisis, hypertension

Dermatologic

Common (1% to 10%): Rash

Endocrine

Adverse reactions reported with abiraterone acetate in other trials: Adrenal insufficiency

Gastrointestinal

Very common (10% or more): Constipation (34%), nausea (33%), vomiting (15%), abdominal pain (12%)

Hematologic

Very common (10% or more): Hemoglobin decreased (67%), lymphocyte decreased (55%), white blood cell count decreased (48%), platelets decreased (37%), neutrophils decreased (32%)

Frequency not reported: Anemia

Adverse reactions reported with individual components of this drug in other trials: Febrile neutropenia

Hepatic

Very common (10% or more): AST increased (up to 20%), ALT increased (up to 18%), bilirubin increased (12%)

Postmarketing reports with abiraterone acetate in other trials: Severe hepatic toxicity, including fulminant hepatitis, acute liver failure, and death

Hypersensitivity

Adverse reactions reported with individual components of this drug in other trials: Anaphylactic reaction

Metabolic

Very common (10% or more): Alkaline phosphatase increased (34%), creatinine increased (30%), potassium increased (25%), potassium decreased (20%), edema (17%), decreased appetite (15%), weight decreased (10%)

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (44%)

Adverse reactions reported with individual components of this drug in other trials: Myopathy, rhabdomyolysis

Oncologic

Adverse reactions reported with niraparib in other clinical trials: Myelodysplastic syndrome/acute myeloid leukemia

Other

Very common (10% or more): Fatigue (43%), COVID-19 (13%), fall (10%), pyrexia (10%)

Frequency not reported: Septic shock, asthenia

Psychiatric

Very common (10% or more): Insomnia (12%)

Renal

Common (1% to 10%): Acute kidney injury

Respiratory

Very common (10% or more): Dyspnea (15%), cough (12%)

Common (1% to 10%): Pulmonary embolism

Frequency not reported: Pneumonia

Adverse reactions reported with individual components of this drug in other trials: Allergic alveolitis

Nervous system

Very common (10% or more): Dizziness (14%), headache (12%)

Adverse reactions reported with individual components of this drug in other trials:

-Niraparib: Posterior reversible encephalopathy

-Abiraterone acetate: Increased risk of fractures and death when used in combination with radium 223 dichloride

Genitourinary

Very common (10% or more): Urinary tract infection (12%)

Frequency not reported: Hematuria

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.

Medical Disclaimer