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Zejula (Niraparib tosylate): Uses, Side Effects and Dosage

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Prescription (Rx)
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100 mg, 200 mg, 300 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Zejula

What is the most important information I should know about ZEJULA?

ZEJULA may cause serious side effects including:

  • Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with ZEJULA.
  • Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include:
  • weakness
  • feeling tired
  • weight loss
  • frequent infections
  • fever
  • shortness of breath
  • blood in urine or stool
  • bruising or bleeding more easily

  1. Your healthcare provider will do blood tests to check your blood cell counts:

    1. o before treatment with ZEJULA.
    2. o weekly for the first month of treatment with ZEJULA.
    3. o every month for the next 11 months, then as needed during treatment with ZEJULA.
  2. • High blood pressure. High blood pressure is common during treatment with ZEJULA and can become serious. Your healthcare provider will check your blood pressure and heart rate at least weekly for the first 2 months, then monthly for the first year and as needed thereafter during your treatment with ZEJULA.
  3. • Posterior reversible encephalopathy syndrome (PRES). PRES is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure with or without high blood pressure, please contact your healthcare provider.

See “What are the possible side effects of ZEJULA?” for more information about side effects.

What is ZEJULA?

ZEJULA is a prescription medicine used to treat adults for:

  • maintenance treatment of advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called homologous recombination deficiency (HRD). ZEJULA is used after the cancer has responded (complete or partial response) to treatment with first-line platinum-based chemotherapy.
  • maintenance treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) abnormal BRCA gene that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.

Your healthcare provider will perform a test to make sure that ZEJULA is right for you.

It is not known if ZEJULA is safe and effective in children.

Before taking ZEJULA, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have liver problems.
  • have high blood pressure.

  • are pregnant or plan to become pregnant. ZEJULA can harm your unborn baby and may cause loss of pregnancy (miscarriage).

    • If you are able to become pregnant, your healthcare provider should perform a pregnancy test before you start treatment with ZEJULA.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after the last dose of ZEJULA. Talk to your healthcare provider about birth control methods that may be right for you.
    • Tell your healthcare provider right away if you become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if ZEJULA passes into your breast milk. Do not breastfeed during treatment with ZEJULA and for 1 month after the last dose of ZEJULA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take ZEJULA?

  • Take ZEJULA exactly as your healthcare provider tells you to.
  • Take ZEJULA 1 time each day, at the same time each day.

  • ZEJULA may be taken with or without food.

  • ZEJULA tablets should be swallowed whole. Do not chew, crush, or split ZEJULA tablets before swallowing.
  • Taking ZEJULA at bedtime may help relieve any nausea symptoms you may have.
  • Do not stop taking ZEJULA without first talking with your healthcare provider.
  • If you miss a dose of ZEJULA, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose.
  • If you vomit after taking a dose of ZEJULA, do not take an extra dose. Take your next dose at your scheduled time.
  • If you take too much ZEJULA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of ZEJULA?

ZEJULA may cause serious side effects, including:

  • See “What is the most important information I should know about ZEJULA?”

The most common side effects of ZEJULA include:

  • nausea
  • tiredness
  • constipation
  • pain in your muscles and back
  • pain in the stomach area
  • vomiting
  • loss of appetite
  • trouble sleeping
  • headache
  • shortness of breath
  • rash
  • diarrhea
  • cough
  • dizziness
  • changes in the amount or color of your urine
  • urinary tract infection
  • low levels of magnesium in the blood

Your healthcare provider may change your dose, temporarily stop treatment, or permanently stop treatment with ZEJULA if you have certain side effects.

These are not all the possible side effects of ZEJULA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZEJULA?

  • Store ZEJULA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store ZEJULA tablets in the original bottle.

Keep ZEJULA and all medicines out of the reach of children.

General information about the safe and effective use of ZEJULA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZEJULA for a condition for which it was not prescribed. Do not give ZEJULA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ZEJULA that is written for health professionals.

What are the ingredients in ZEJULA?

Active ingredient: niraparib.

Inactive ingredients:

Core tablet: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide.

Film-coating: Opadry II Gray (100 mg), Opadry II Blue (200 mg), or Opadry II Green (300 mg).

For more information about ZEJULA, call 1-888-825-5249.

Trademarks are owned by or licensed to the GSK group of companies. Opadry is a trademark owned by or licensed to its respective owner and is not owned by or licensed to the GSK group of companies. The maker of Opadry is not affiliated with and does not endorse the GSK group of companies or its products.

Manufactured for:

GlaxoSmithKline, Durham, NC 27701

©2026 GSK group of companies or its licensor.

ZJT:3PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: March/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 214876 · View the label on DailyMed

Revision date stated in the text: March 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Zejula

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Poly(ADP-Ribose) Polymerase Inhibitor
Active ingredient Niraparib tosylate
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GLAXOSMITHKLINE
FDA approval NDA 214876New Drug Application (NDA) Approved April 26, 2023
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg – 30 in 1 bottle NDC 0173-0909-13
200 mg – 30 in 1 bottle NDC 0173-0912-13
200 mg – 30 in 1 bottle NDC 0173-0912-61
300 mg – 30 in 1 bottle NDC 0173-0915-13
300 mg – 30 in 1 bottle NDC 0173-0915-61

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.