Olaparib
Olaparib is a PARP inhibitor, a targeted cancer medicine used for certain ovarian, breast, pancreatic and prostate cancers linked to BRCA or related gene changes.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Olaparib (Lynparza) is a targeted medicine for certain ovarian, breast, pancreatic and prostate cancers chosen by a gene test; it blocks PARP, an enzyme cells use to repair DNA, which pushes cancer cells with faulty BRCA or related repair genes past the point of survival, and it has been on the U.S. market for over a decade. Most people tolerate it fairly well, though nausea, tiredness and anemia (low red blood cells) are common. Rarely it can cause serious, sometimes fatal, harm to blood counts (including MDS/AML, blood and bone marrow cancers), lungs, clotting or liver, so keep every blood test and promptly report a new cough, breathlessness, fever or swollen leg.
Clinical pearls
- Swallow the tablets whole, with or without food, and never chew, crush, dissolve or split them.
- If you miss a dose, skip it and take the next one at its usual time rather than doubling up.
- Check before starting fluconazole, itraconazole, rifampicin or efavirenz, because they can push olaparib levels too high or too low.
- Use effective contraception for 6 months after the last dose (women) or 3 months (men, who also should not donate sperm).
Patient information guide A plain-language walkthrough of Olaparib, written from its FDA label.
What Olaparib is used for
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Olaparib is used for several cancers in adults, chosen by gene testing. Lynparza tablets are indicated for:
- First-line maintenance treatment of BRCA-mutated advanced ovarian, fallopian tube or primary peritoneal cancer after response to platinum chemotherapy.
- Maintenance treatment with bevacizumab for HRD-positive advanced ovarian, fallopian tube or primary peritoneal cancer after response to platinum chemotherapy.
- Maintenance treatment of BRCA-mutated recurrent ovarian, fallopian tube or primary peritoneal cancer after response to platinum chemotherapy.
- Adjuvant (after-surgery or after-chemotherapy) treatment of germline BRCA-mutated, HER2-negative, high-risk early breast cancer.
- Treatment of germline BRCA-mutated, HER2-negative metastatic breast cancer after chemotherapy.
- First-line maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma.
- Treatment of HRR gene-mutated metastatic castration-resistant prostate cancer after enzalutamide or abiraterone.
- Treatment with abiraterone and prednisone or prednisolone for BRCA-mutated metastatic castration-resistant prostate cancer.
How Olaparib works
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Olaparib blocks PARP enzymes (PARP1, PARP2 and PARP3). These enzymes help cells repair damaged DNA.
Tumors with BRCA or other homologous recombination repair gene problems have trouble fixing DNA. When PARP is blocked, DNA damage builds up and cancer cells die. In prostate cancer, PARP also affects androgen receptor activity.
Olaparib dosage
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Lynparza tablets are taken by mouth twice a day, with or without food. Swallow them whole.
- If you miss a dose, take your next dose at the regular time.
- Treatment length depends on the cancer. It may continue until the disease progresses or side effects become unacceptable.
- Your doctor may pause treatment or lower the dose for side effects, kidney problems, or certain interacting drugs.
- For prostate cancer, you also need a GnRH analog or prior bilateral orchiectomy.
Dosing details from the FDA-approved label
From the Olaparib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- First-line maintenance treatment of BRCA-mutated advanced ovarian cancer
- 300 mg taken orally twice daily, with or without food
- Continue until disease progression, unacceptable toxicity, or completion of 2 years of treatment
- Patients with a complete response at 2 years should stop treatment; patients with evidence of disease at 2 years who can derive further benefit can be treated beyond 2 years
- First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab
- 300 mg taken orally twice daily, with or without food
- Continue until disease progression, unacceptable toxicity, or completion of 2 years of treatment
- Bevacizumab 15 mg/kg every three weeks
- Bevacizumab given for a total of 15 months including the period given with chemotherapy and as maintenance
- Adjuvant treatment of germline BRCA-mutated HER2-negative high risk early breast cancer
- 300 mg taken orally twice daily, with or without food
- Continue for a total of 1 year, or until disease recurrence or unacceptable toxicity, whichever occurs first
- Patients with hormone receptor positive HER2-negative breast cancer should continue concurrent endocrine therapy
- Germline or somatic BRCA-mutated recurrent ovarian cancer, germline BRCA-mutated HER2-negative metastatic breast cancer, germline BRCA-mutated metastatic pancreatic adenocarcinoma, and HRR gene-mutated metastatic castration-resistant prostate cancer
- 300 mg taken orally twice daily, with or without food
- Continue until disease progression or unacceptable toxicity
- Patients with mCRPC should also receive a GnRH analog concurrently or should have had bilateral orchiectomy
- BRCA-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone
- 300 mg taken orally twice daily, with or without food
- Continue until disease progression or unacceptable toxicity
- Abiraterone 1000 mg taken orally once daily with prednisone or prednisolone 5 mg orally twice daily
- Patients should also receive a GnRH analog concurrently or should have had bilateral orchiectomy
- Dose reduction for adverse reactions
- Recommended dose reduction is 250 mg taken twice daily
- If a further reduction is required, 200 mg taken twice daily
- Concomitant use with a strong CYP3A inhibitor (if use cannot be avoided)
- 100 mg twice daily
- After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the dose taken prior to the inhibitor
- Concomitant use with a moderate CYP3A inhibitor (if use cannot be avoided)
- 150 mg twice daily
- After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the dose taken prior to the inhibitor
- Moderate renal impairment (CLcr 31-50 mL/min)
- 200 mg orally twice daily
- Renal impairment adjustment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Recommended dosage is 300 mg taken orally twice daily with or without food. See Full Prescribing Information for the recommended duration. (2.2) • Patients receiving Lynparza for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.2) • For moderate renal impairment (CLcr 31-50 mL/min), reduce Lynparza dosage to 200 mg orally twice daily. (2.5) 2.1 Patient Selection Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics . Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1). Table 1 Biomarker Testing for Patient Selection Where testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available. Indication Biomarker Sample type Tumor Blood Plasma (ctDNA) First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer BRCA1 m, BRCA2 m X X First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab BRCA1 m, BRC A2m and/or genomic instability X Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer BRCA1 m, BRCA2 m X X Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer gBRCA1 m , gBRCA2 m X g BRCA m HER2-negative metastatic breast cancer gBRCA1 m, gBRCA2 m X First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma gBRCA1 m, gBRCA2 m X Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m X g BRCA1 m, g BRCA2 m X ATM m , BRCA1 m, BRCA2 m X BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone BRCA1 m, BRCA2 m X X X 2.2 Recommended Dosage The recommended dosage of Lynparza is 300 mg taken orally twice daily, with or without food. If a patient misses a dose of Lynparza, instruct patient to take their next dose at its scheduled time.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Olaparib side effects
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Common side effects seen in studies include:
Common side effects
- Nausea
- Tiredness or weakness
- Anemia (low red blood cells)
- Vomiting
- Diarrhea
- Decreased appetite
- Headache
- Changes in taste
- Anemia and low white blood cell or platelet counts
- Headache and dizziness
- Indigestion
When to get medical help
- Call your doctor if you have new or worsening cough, shortness of breath or fever. These can be signs of pneumonitis (lung inflammation).
- Get medical help for signs of a blood clot in the leg or lung, or a pulmonary embolism (a clot in the lungs).
- Tell your doctor about signs of liver problems, since liver injury has occurred.
- Report ongoing low blood counts or symptoms that could point to serious blood problems such as MDS/AML (blood and bone marrow cancers).
- Tell your doctor right away if you become pregnant or think you might be.
Olaparib warnings and precautions
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- MDS/AML: Serious blood and bone marrow cancers occurred in about 1.2% of patients, and many cases were fatal. Blood counts are checked before treatment and monthly.
- Pneumonitis: Lung inflammation occurred in about 1% of patients, and some cases were fatal. New cough, shortness of breath or fever needs prompt attention.
- Blood clots: Venous thromboembolism, including pulmonary embolism, occurred. It was seen in 8% of patients with prostate cancer in studies.
- Liver injury: Severe and potentially fatal cases have occurred. Liver tests are checked before and during treatment.
- Pregnancy: Lynparza can cause fetal harm.
Olaparib interactions
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Some drugs change olaparib levels in your body.
- Strong or moderate CYP3A inhibitors can raise olaparib levels and side effect risk. Avoid them, or your doctor may reduce the dose.
- Strong or moderate CYP3A inducers can lower olaparib levels and may make it less effective. Avoid them.
- Other anticancer drugs that suppress blood counts can add to and prolong that effect.
Interactions listed in the FDA-approved label
From the Olaparib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong or moderate CYP3A inhibitors: Coadministration can increase olaparib concentrations, which may increase the risk for adverse reactions. Avoid coadministration. If it must be coadministered, reduce the Lynparza dose (100 mg twice daily with a strong inhibitor; 150 mg twice daily with a moderate inhibitor).
- Strong or moderate CYP3A inducers: Concomitant use decreased olaparib exposure, which may reduce Lynparza efficacy. Avoid coadministration.
- Other myelosuppressive anticancer agents, including DNA damaging agents: Clinical studies indicate a potentiation and prolongation of myelosuppressive toxicity.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Strong or moderate CYP3A inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce Lynparza dosage. ( 2.4 , 7.2 , 12.3 ) • Strong or moderate CYP3A inducers: Avoid concomitant use. ( 7.2 , 12.3 ) 7.1 Use with Anticancer Agents Clinical studies of Lynparza with other myelosuppressive anticancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. 7.2 Effect of Other Drugs on Lynparza Strong and Moderate CYP3A Inhibitors Coadministration of CYP3A inhibitors can increase olaparib concentrations, which may increase the risk for adverse reactions [see Clinical Pharmacology (12.3) ] . Avoid coadministration of strong or moderate CYP3A inhibitors. If the strong or moderate inhibitor must be coadministered, reduce the dose of Lynparza [see Dosage and Administration (2.4) ]. Strong and Moderate CYP3A Inducers Concomitant use with a strong or moderate CYP3A inducer decreased olaparib exposure, which may reduce Lynparza efficacy [see Clinical Pharmacology (12.3) ] . Avoid coadministration of strong or moderate CYP3A inducers.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Olaparib
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- Pregnancy: tell your doctor. A pregnancy test is checked before starting, and effective contraception is advised.
- Breastfeeding: not advised during treatment and for one month after the last dose.
- Men with partners who could become pregnant need contraception and should not donate sperm during treatment and for 3 months after.
- Moderate kidney impairment: a lower dose is used. There are no data for severe kidney impairment.
- Liver impairment: no starting dose change for mild or moderate impairment. There are no data for severe impairment.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness were seen.
What Olaparib does in the body
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Olaparib blocks PARP enzymes, which leads to DNA damage and cancer cell death, especially in cells with DNA repair gene deficiencies. In studies, it had no clinically relevant effect on the QT interval, a measure of the heart's electrical timing.
How your body processes Olaparib
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After you swallow olaparib, blood levels peak in about 1.5 hours. A high-fat meal slows absorption but does not significantly change how much is absorbed. The average half-life is about 15 hours.
The liver breaks it down mainly through the CYP3A enzyme. It leaves the body through both urine and feces, mostly as metabolites.
How to store Olaparib
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Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) . Store in original bottle to protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Olaparib
138 supplements and herbal products have documented interactions with Olaparib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 94
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Olaparib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Olaparib — the kind of thing our pharmacy team would talk through with you at the counter.
What is olaparib used for?
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How do I take Lynparza tablets?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take other medicines or supplements with it?
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Is it safe in pregnancy?
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Is Olaparib available over the counter?
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When was Olaparib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Olaparib on HelloPharmacist
Olaparib forms and strengths (how it comes)
Olaparib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Lynparza is used for certain BRCA-mutated or HRD-positive ovarian, fallopian tube or primary peritoneal cancers.
- Lynparza is used for certain gBRCA-mutated HER2-negative breast cancers.
- Lynparza is used for gBRCA-mutated metastatic pancreatic cancer after platinum chemotherapy.
- Lynparza is used for certain metastatic castration-resistant prostate cancers.
- Lynparza tablets are taken by mouth twice a day, with or without food.
- Swallow Lynparza tablets whole. Do not chew, crush, dissolve or divide them.
- If a Lynparza dose is missed, take the next dose at its scheduled time.
- People with metastatic prostate cancer taking Lynparza also need a GnRH analog or a prior bilateral orchiectomy (surgical removal of both testicles).
Olaparib on the U.S. market: products, makers and brands
How Olaparib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 4 Olaparib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2011. Brand names on the directory include Lynparza; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Olaparib is used (Medicaid data)
A general measure of how commonly Olaparib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Olaparib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Olaparib prescribed? Of the 1,601 medications we measure, Olaparib ranks #997 by Medicaid prescriptions — more than 38% of them.
Utilization by Olaparib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
olaparib 150 MG Oral Tablet Most dispensed
Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1942487
olaparib 100 MG Oral Tablet
Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1942482
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Olaparib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 14 listed Olaparib NDCs with Medicaid activity.
Compare Olaparib products
A representative set of FDA-listed product records for Olaparib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
| 150 mg | Oral | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Olaparib NDCs →
Olaparib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Olaparib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Olaparib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Olaparib FDA approval history
How Olaparib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Olaparib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Olaparib recalls since July 2021.
✅No Olaparib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1597582 2 dose forms · 3 strengths
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Dose form (SCDF) Oral Capsule RxCUI 1597586No current FDA listingClinical drug / strength (SCD) 50 MGRxCUI 1597587 -
Dose form (SCDF) Oral Tablet RxCUI 1942481In current FDA listings
Look up RxCUI 1597582 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Olaparib supply and shortage status
Whether Olaparib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Olaparib brand names
Olaparib is sold under one brand name in the FDA directory — Lynparza. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Olaparib: manufacturers and labelers
One company lists Olaparib products with the FDA. By number of product records, the largest are AstraZeneca Pharmaceuticals LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Olaparib drug class (RxNorm)
Olaparib belongs to the Poly(ADP-Ribose) Polymerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Olaparib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →