Summary

Commonly reported side effects of niraparib include: anemia, asthenia, constipation, cough, decreased hemoglobin, decreased neutrophils, decreased platelet count, decreased white blood cell count, dizziness, dyspnea, fatigue, headache, hypertension, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, insomnia, mucositis, nasopharyngitis, nausea, neutropenia, palpitations, skin rash, stomatitis, thrombocytopenia, vomiting, decreased appetite, dysgeusia, and xerostomia. Other side effects include: hypertensive crisis. Continue reading for a comprehensive list of adverse effects.

Applies to niraparib: oral capsule, oral tablet.

Serious side effects of Niraparib

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
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Chest pain
• swollen glands

Incidence not known

• Agitation
• back pain
• change in consciousness
• drowsiness
• enlarged pupils
• general feeling of discomfort or illness
• increased sensitivity of the eyes to light
• increased sensitivity of the skin to sunlight
• increased sweating, possibly with fever or cold, clammy skin
• irritability
• mood or mental changes
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness or other discoloration of the skin
• seeing, hearing, or feeling things that are not there
• seizures
• severe sunburn
• skin rash
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• thickening of bronchial secretions
• tightness in the chest
• vomiting

Other side effects of Niraparib

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
• 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

For Healthcare Professionals

Applies to niraparib: oral capsule, oral tablet.

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]