Drug · FAERS side-effect profile with label screen
Niraparib side effects: what 22,064 FDA adverse event reports show
Drug class
Poly (adp-ribose) polymerase (parp) inhibitor
FDA label, Indications wording
Brand names
Zejula
openFDA label
Who reports
22,064 reports · 66% serious · 1,428 with death outcome · 98% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-lin.
FDA label, Indications and Usage
What it is
Niraparib is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Likely indication confounding 9Reporting / coding artifact 4Lab value / disease marker 12Not in label — unassessed 14
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,027 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Carbohydrate antigen 125 increased | 1,848 | 1,118.4 1,046.7–1,194.9ROR 1,220.5 · calibrated p 2e-18 ✓ | 507.6 EB05 488.5 · IC025 +8.7 3/3 methods agree | Lab value / disease marker | serious n=1,410 · 85% consumer | not reported in cached trials |
| Computerised tomogram pelvis abnormal | 10 | 1,040.9 423.0–2,561.4ROR 1,041.4 · calibrated p 6e-13 ✓ | 254.2 EB05 147.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Eastern cooperative oncology group performance status | 36 | 602.2 396.3–915.2ROR 603.2 · calibrated p 9e-14 ✓ | 307.1 EB05 231.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=27 · 81% consumer | not reported in cached trials |
| Carbohydrate antigen 125 | 10 | 468.4 219.3–1,000.6ROR 468.6 · calibrated p 5e-11 ✓ | 196.2 EB05 113.9 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=7 | not reported in cached trials |
| Ovarian cancer recurrent | 495 | 427.4 384.6–474.9ROR 437.2 · calibrated p 3e-13 ✓ | 290.5 EB05 269.7 · IC025 +7.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=491 | not reported in cached trials |
| Ovarian epithelial cancer recurrent | 11 | 239.6 123.6–464.7ROR 239.8 · calibrated p 4e-9 ✓ | 143.9 EB05 85.8 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=11 | not reported in cached trials |
| Recurrent cancer | 774 | 224.8 208.0–242.8ROR 232.9 · calibrated p 1e-10 ✓ | 180.7 EB05 170.2 · IC025 +7.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=771 · 72% consumer | not reported in cached trials |
| Drug monitoring procedure not performed | 257 | 160.5 140.7–183.1ROR 162.4 · calibrated p 3e-9 ✓ | 135.8 EB05 122.4 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=179 · 89% consumer | not reported in cached trials |
| Scan abnormal | 53 | 159.6 119.3–213.6ROR 160.0 · calibrated p 5e-9 ✓ | 130.2 EB05 103.4 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=41 · 89% consumer | not reported in cached trials |
| Lymph nodes scan abnormal | 18 | 159.1 96.5–262.1ROR 159.2 · calibrated p 2e-8 ✓ | 119.2 EB05 79.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=15 | not reported in cached trials |
| Lymphangioleiomyomatosis | 15 | 151.1 87.6–260.6ROR 151.2 · calibrated p 4e-8 ✓ | 112.1 EB05 72.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Liver scan abnormal | 22 | 148.3 94.6–232.4ROR 148.4 · calibrated p 2e-8 ✓ | 115.5 EB05 80.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=19 · 100% consumer | not reported in cached trials |
| Positron emission tomogram abnormal | 85 | 133.4 106.3–167.3ROR 133.9 · calibrated p 2e-8 ✓ | 113.9 EB05 95.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=65 · 88% consumer | not reported in cached trials |
| Eastern cooperative oncology group performance status worsened | 127 | 108.2 90.1–129.9ROR 108.8 · calibrated p 8e-8 ✓ | 95.7 EB05 82.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=103 · 89% consumer | not reported in cached trials |
| Coronavirus test positive | 94 | 94.4 76.4–116.6ROR 94.8 · calibrated p 2e-7 ✓ | 84.4 EB05 71.0 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=59 · 85% consumer | not reported in cached trials |
| Intentional underdose | 658 | 94.3 87.2–102.1ROR 97.2 · calibrated p 1e-7 ✓ | 85.6 EB05 80.2 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=434 · 85% consumer | not reported in cached trials |
| Computerised tomogram abnormal | 180 | 81.3 69.9–94.6ROR 82.0 · calibrated p 6e-7 ✓ | 74.3 EB05 65.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=146 · 85% consumer | not reported in cached trials |
| Ovarian cancer metastatic | 65 | 79.6 61.8–102.5ROR 79.8 · calibrated p 9e-7 ✓ | 72.0 EB05 58.4 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=63 | not reported in cached trials |
| Tumour marker increased | 360 | 76.9 69.1–85.5ROR 78.1 · calibrated p 7e-7 ✓ | 70.8 EB05 64.9 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=254 · 80% consumer | not reported in cached trials |
| Malignant peritoneal neoplasm | 43 | 74.2 54.4–101.2ROR 74.3 · calibrated p 2e-6 ✓ | 66.9 EB05 51.7 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=43 · 100% clinician | not reported in cached trials |
| Drug monitoring procedure incorrectly performed | 48 | 73.6 54.9–98.7ROR 73.8 · calibrated p 2e-6 ✓ | 66.6 EB05 52.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=28 · 92% consumer | not reported in cached trials |
| Fallopian tube cancer | 10 | 72.1 37.9–137.1ROR 72.1 · calibrated p 1e-5 ✓ | 59.7 EB05 34.7 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | not reported in cached trials |
| Ovarian cancer | 619 | 68.0 62.8–73.8ROR 70.0 · calibrated p 2e-6 ✓ | 63.4 EB05 59.3 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 55.1 · 96% clinician | not reported in cached trials |
| Fluid replacement | 21 | 62.3 40.0–96.8ROR 62.3 · calibrated p 9e-6 ✓ | 55.6 EB05 38.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 · 81% consumer | not reported in cached trials |
| Tumour marker abnormal | 20 | 60.2 38.3–94.7ROR 60.3 · calibrated p 1e-5 ✓ | 53.9 EB05 36.9 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=14 · 70% consumer | not reported in cached trials |
| Tumour marker decreased | 10 | 55.4 29.3–104.9ROR 55.5 · calibrated p 4e-5 ✓ | 47.9 EB05 27.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Decreased activity | 584 | 54.8 50.4–59.5ROR 56.2 · calibrated p 7e-6 ✓ | 51.7 EB05 48.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 45.5 · 82% consumer | not reported in cached trials |
| Central venous catheter removal | 25 | 53.1 35.5–79.4ROR 53.2 · calibrated p 2e-5 ✓ | 48.6 EB05 34.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=17 · 76% consumer | not reported in cached trials |
| Red blood cell count decreased | 1,352 | 47.1 44.6–49.6ROR 50.1 · calibrated p 1e-5 ✓ | 44.8 EB05 42.9 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 37.7 · 84% consumer | NCT03602859: 1/745 (0.1%) on Niraparib (serious AE) |
| Pelvic neoplasm | 15 | 42.7 25.5–71.6ROR 42.7 · calibrated p 1e-4 ✓ | 39.0 EB05 25.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Mean cell volume abnormal | 20 | 42.4 27.1–66.3ROR 42.4 · calibrated p 8e-5 ✓ | 39.2 EB05 26.8 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=18 | not reported in cached trials |
| White coat hypertension | 23 | 42.2 27.8–64.0ROR 42.2 · calibrated p 8e-5 ✓ | 39.2 EB05 27.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 · 100% consumer | not reported in cached trials |
| Ovarian cancer stage iii | 14 | 39.4 23.1–67.2ROR 39.4 · calibrated p 2e-4 ✓ | 36.1 EB05 22.9 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | not reported in cached trials |
| Mean cell haemoglobin increased | 65 | 38.7 30.2–49.6ROR 38.8 · calibrated p 8e-5 ✓ | 36.8 EB05 29.9 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=57 | not reported in cached trials |
| Platelet count decreased | 4,130 | 38.3 37.2–39.4ROR 46.9 · calibrated p 2e-5 ✓ | 36.8 EB05 35.9 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.4 · 73% consumer | NCT03602859: 28/745 (3.8%) on Niraparib (serious AE) |
| Abdominal cavity drainage | 16 | 37.3 22.6–61.4ROR 37.3 · calibrated p 2e-4 ✓ | 34.6 EB05 22.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Red blood cell count abnormal | 52 | 35.0 26.5–46.1ROR 35.1 · calibrated p 1e-4 ✓ | 33.4 EB05 26.5 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=27 · 80% consumer | NCT03602859: 1/745 (0.1%) on Niraparib (serious AE) |
| Mean cell volume increased | 90 | 34.5 28.0–42.6ROR 34.6 · calibrated p 1e-4 ✓ | 33.1 EB05 27.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=77 · 71% consumer | not reported in cached trials |
| Ovarian cancer stage iv | 14 | 32.6 19.2–55.6ROR 32.6 · calibrated p 4e-4 ✓ | 30.4 EB05 19.2 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | not reported in cached trials |
| Stoma closure | 10 | 32.5 17.3–61.1ROR 32.5 · calibrated p 6e-4 ✓ | 29.8 EB05 17.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Niraparib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT03602859 — A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based (N=1400, PHASE3; 478 AE terms posted; arms: Not Treated; Paclitaxel + Carboplatin + Dostarlimab P; Paclitaxel + Carboplatin + Dostarlimab P; Paclitaxel + Carboplatin + Dostarlimab +)
- NCT03748641 — A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Pre (N=765, PHASE3; 239 AE terms posted; arms: Cohort 1: Niraparib 200 mg + Abiraterone; Cohort 1: Placebo + Abiraterone Acetate ; Cohort 2: Niraparib 200 mg + Abiraterone; Cohort 2: Placebo + Abiraterone Acetate )
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 5,785 | 7.0 6.9–7.2ROR 9.1 · calibrated p 0.043 ✓ | 7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 82% consumer | NCT03602859: 5/745 (0.7%) on Niraparib (serious AE) |
| Fatigue (tiredness) | 5,233 | 6.4 6.3–6.6ROR 8.1 · calibrated p 0.063 | 6.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 84% consumer | NCT03602859: 1/745 (0.1%) on Niraparib (serious AE) |
| Platelet count decreased | 4,130 | 38.3 37.2–39.4ROR 46.9 · calibrated p 2e-5 ✓ | 36.8 EB05 35.9 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.4 · 73% consumer | NCT03602859: 28/745 (3.8%) on Niraparib (serious AE) |
| Constipation | 4,105 | 18.4 17.9–18.9ROR 22.3 · calibrated p 0.001 ✓ | 18.0 EB05 17.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.8 · 86% consumer | NCT03602859: 6/745 (0.8%) on Niraparib (serious AE) |
| Insomnia (trouble sleeping) | 2,841 | 10.2 9.9–10.6ROR 11.6 · calibrated p 0.019 ✓ | 10.1 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 85% consumer | NCT03602859: 143/745 (19.2%) on Niraparib |
| Blood pressure increased | 2,456 | 15.5 14.9–16.1ROR 17.3 · calibrated p 0.004 ✓ | 15.2 EB05 14.7 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 · 84% consumer | not reported in cached trials |
| Headache | 2,370 | 3.6 3.5–3.7ROR 3.9 · calibrated p 0.393 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 83% consumer | NCT03602859: 2/745 (0.3%) on Niraparib (serious AE) |
| Off label use (used outside approved label) | 2,247 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.759 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 70% consumer | not reported in cached trials |
| Vomiting | 2,035 | 4.1 4.0–4.3ROR 4.5 · calibrated p 0.303 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 81% consumer | NCT03602859: 9/745 (1.2%) on Niraparib (serious AE) |
| Decreased appetite (loss of appetite) | 1,881 | 7.8 7.4–8.1ROR 8.4 · calibrated p 0.057 | 7.7 EB05 7.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 82% consumer | NCT03602859: 2/745 (0.3%) on Niraparib (serious AE) |
| Asthenia (weakness) | 1,856 | 4.7 4.5–4.9ROR 5.0 · calibrated p 0.229 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 83% consumer | NCT03602859: 7/745 (0.9%) on Niraparib (serious AE) |
| Product dose omission issue | 1,855 | 6.2 6.0–6.5ROR 6.7 · calibrated p 0.111 | 6.2 EB05 5.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 85% consumer | not reported in cached trials |
| Carbohydrate antigen 125 increased | 1,848 | 1,118.4 1,046.7–1,194.9ROR 1,220.5 · calibrated p 2e-18 ✓ | 507.6 EB05 488.5 · IC025 +8.7 3/3 methods agree | Lab value / disease marker | serious n=1,410 · 85% consumer | not reported in cached trials |
| Haemoglobin decreased | 1,750 | 16.4 15.7–17.2ROR 17.8 · calibrated p 0.003 ✓ | 16.2 EB05 15.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 80% consumer | NCT03602859: 1/745 (0.1%) on Niraparib (serious AE) |
| Dizziness | 1,602 | 3.1 2.9–3.2ROR 3.2 · calibrated p 0.557 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 82% consumer | NCT03602859: 2/745 (0.3%) on Niraparib (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Eastern cooperative oncology group performance status — n=36, PRR 602.2
- Positron emission tomogram abnormal — n=85, PRR 133.4
- Eastern cooperative oncology group performance status worsened — n=127, PRR 108.2
- Intentional underdose — n=658, PRR 94.3
- Computerised tomogram abnormal — n=180, PRR 81.3
- Fluid replacement — n=21, PRR 62.3
- Decreased activity — n=584, PRR 54.8
- Central venous catheter removal — n=25, PRR 53.1
- White coat hypertension — n=23, PRR 42.2
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Niraparib?
In FDA FAERS, the most frequently co-reported reaction terms for Niraparib are nausea, fatigue, platelet count decreased, constipation, insomnia, blood pressure increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Niraparib have an FDA boxed warning?
No. The FDA label retrieved for Niraparib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Niraparib causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID b7f675e2-159c-490c-b6f4-3f16d9492b7d, effective 20260728; matched on
openfda.generic_name.exact:"NIRAPARIB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,067 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
NIRAPARIB, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.