Skip to Content

Niraparib Side Effects

For the Consumer

Applies to niraparib: oral capsule

Along with its needed effects, 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 niraparib:

More Common

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • chills
  • cough
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever
  • headache
  • lower back or side pain
  • nervousness
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • slow or fast heartbeat
  • sore throat
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less Common

  • Chest pain
  • swollen glands

Some side effects of 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

  • Acid or sour stomach
  • back pain
  • belching
  • bladder pain
  • bloody or cloudy urine
  • change in taste
  • cracked lips
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with swallowing
  • dry mouth
  • fear or nervousness
  • frequent urge to urinate
  • heartburn
  • indigestion
  • lack or loss of strength
  • loss of taste
  • lower back or side pain
  • nausea
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • vomiting

For Healthcare Professionals

Applies to niraparib: oral capsule

General

The most commonly reported adverse reactions (incidence 20% or greater) were

decreased hemoglobin (85%), decreased platelet count (82%), nausea (74%), decreased white blood cell count (66%), thrombocytopenia (61%), fatigue/asthenia (57%), decreased absolute neutrophil count (53%), anemia (50%), constipation (40%), increased AST (36%), vomiting (34%), abdominal pain/distention (33%), neutropenia (30%), increased ALT (28%), insomnia (27%), headache (26%), decreased appetite (25%), nasopharyngitis (23%), rash (21%), diarrhea (20%), dyspnea (20%), hypertension (20%), and mucositis/stomatitis (20%).[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (85%), decreased platelet count (82%), decreased white blood cell count (66%), thrombocytopenia (61%), decreased absolute neutrophil count (53%), anemia (50%), neutropenia (30%), leukopenia (17%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (74%), constipation (40%), vomiting (34%), abdominal pain/distention (33%), diarrhea (20%), mucositis/stomatitis (20%), dyspepsia (18%), dry mouth (10%)[Ref]

Other

Very common (10% or more): Fatigue/asthenia (57%)

Common (1% to 10%): Peripheral edema[Ref]

Hepatic

Very common (10% or more): Increased AST (36%), Increased ALT (28%), AST/ALT elevation (10%)

Common (1% to 10%): Increased gamma-glutamyl transferase, increased blood alkaline phosphatase[Ref]

Psychiatric

Very common (10% or more): Insomnia (27%), anxiety (11%)

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

Nervous system

Very common (10% or more): Headache (26%), dizziness (18%), dysgeusia (10%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (25%)

Common (1% to 10%): Hypokalemia, decreased weight[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (23%), dyspnea (20%), cough (16%)

Common (1% to 10%): Bronchitis, epistaxis[Ref]

Dermatologic

Very common (10% or more): Rash (21%)[Ref]

Cardiovascular

Very common (10% or more): Hypertension (20%), palpitations (10%)

Common (1% to 10%): Tachycardia

Frequency not reported: Hypertensive crisis[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (19%), back pain (18%), arthralgia (13%)[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (13%)[Ref]

Ocular

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

Renal

Common (1% to 10%): Increased blood creatinine[Ref]

Oncologic

Uncommon (0.1% to 1%): Myelodysplastic Syndrome/Acute Myeloid Leukemia[Ref]

References

1. "Product Information. Zejula (niraparib)." Tesaro Inc., Waltham, MA.

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.

Hide