Pharmacologic class (EPC) · 7 drug pages

Poly(ADP-Ribose) polymerase inhibitor: adverse event reports filed with FDA

52,093 reports list a drug in this class as a suspect or interacting product, 2010–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

52,093
reports across the class: 0.3% of all reports; 3,646
reports, 12 months to June 2026: 4,938 in the 12 months before; 72.3%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Poly(ADP-Ribose) polymerase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 52,093 adverse event reports received by FDA, 0.3% of the database, from June 2010 to June 2026.

3,646 reports arrived in the 12 months to June 2026, down 26% from 4,938 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 72.3% of the class's reports are marked serious, 15.4% record death among the outcomes and 20.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (19%), fatigue (18.3%) and death (11.8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ZejulaNiraparib	brand	15,540	499	59.5%	Nausea
LynparzaOlaparib	brand	14,399	968	89.4%	Death
RubracaRucaparib	brand	8,312	81	40.7%	Fatigue
Niraparib	generic	6,482	169	81.7%	Nausea
Olaparib	generic	5,674	1,636	96.8%	Death
TalzennaTalazoparib	brand	893	206	67.5%	Death
Talazoparib	generic	793	87	95.8%	Anaemia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Nauseafeeling sick19%9,885
Fatiguetiredness18.3%9,548
Deaththe patient died; cause not stated by this term11.8%6,136
Constipationconstipation10.2%5,317
Platelet count decreasedlow platelet count9.8%5,129
Malignant neoplasm progression8.8%4,568
Anaemialow red blood cells7.3%3,825
Vomitingbeing sick6.8%3,522
Off label useused for a purpose or in a way not on the label6.6%3,435
Insomniadifficulty sleeping6.3%3,284
Headachehead pain6.2%3,211
Decreased appetitereduced appetite6.2%3,209
Astheniaweakness or lack of energy6.1%3,161
Product dose omission issuea dose was missed5.4%2,789
Carbohydrate antigen 125 increased5.2%2,723
Blood pressure increaseda raised blood pressure reading5.1%2,645
Haemoglobin decreasedlow haemoglobin5%2,630
Diarrhoealoose or frequent stools4.8%2,507
Dizzinesslight-headedness or unsteadiness4.6%2,379
Drug ineffectivethe medicine did not work as expected4.3%2,254
Dyspnoeashortness of breath4.3%2,251
White blood cell count decreasedlow white cell count4%2,062
Neuropathy peripheralnerve damage in hands or feet3.8%1,956
Malaisegeneral feeling of being unwell3.6%1,889
Red blood cell count decreased3.5%1,848

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.4%8,034

Life-threatening3.7%1,944

Hospitalisation (initial or prolonged)20.1%10,464

Disability0.5%272

Congenital anomaly0%15

Other serious50.8%26,451

Not serious27.7%14,447

Patient age

Under 20%7

2 to 110%19

12 to 170.1%37

18 to 442.8%1,443

45 to 6417%8,838

65 to 7412.1%6,288

75 and over7.5%3,902

Age not given60.6%31,559

Who reported

Physician25.3%13,159

Pharmacist2.8%1,434

Other health professional17.6%9,161

Lawyer0%3

Consumer or non-health professional49.5%25,794

Not given4.9%2,542

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Poly(ADP-Ribose) polymerase inhibitor reports

Which drugs are in the Poly(ADP-Ribose) polymerase inhibitor class on this site?

Zejula, Lynparza, Rubraca, Niraparib, Olaparib and Talzenna and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

52,093 reports through June 2026, 3,646 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

nausea (19%), fatigue (18.3%), death (11.8%), constipation (10.2%) and platelet count decreased (9.8%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.