Rucaparib side effects: what 8,779 FDA adverse event reports show

Rucaparib · Rubraca · 867 reaction terms · 38,884 drug–reaction co-reports · data 2026-09-14

Drug class

Poly (adp-ribose) polymerase (parp) inhibitor

FDA label, Indications wording

Brand names

Rubraca

openFDA label

Who reports

8,779 reports · 43% serious · 505 with death outcome · 93% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

FDA label, Indications and Usage

What it is

Rucaparib is an inhibitor of the mammalian polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme.

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 5Likely indication confounding 3Reporting / coding artifact 8Lab value / disease marker 12Not in label — unassessed 12

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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 827 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Carbohydrate antigen 125 increased	571	476.2 436.3–519.7ROR 509.3 · χ² 224,892 / p <1e-300	391.1 EB05 364.9 · IC025 +8.1 3/3 methods agree	Lab value / disease marker	serious n=275	no trial data cached
Ovarian cancer recurrent	167	278.5 237.5–326.5ROR 283.8 · χ² 41,045 / p <1e-300	242.2 EB05 212.9 · IC025 +6.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=152	no trial data cached
Tumour marker increased	259	135.9 120.1–153.8ROR 140.0 · χ² 32,679 / p <1e-300	127.4 EB05 114.9 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious n=117	no trial data cached
Scan abnormal	16	108.3 65.7–178.7ROR 108.5 · χ² 1,526 / p <1e-300	92.5 EB05 60.4 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=5	no trial data cached
Renal function test abnormal	108	57.5 47.6–69.5ROR 58.2 · χ² 5,801 / p <1e-300	55.6 EB05 47.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=55	no trial data cached
Positron emission tomogram abnormal	12	42.2 23.9–74.7ROR 42.3 · χ² 435 / p 8e-97	39.1 EB05 23.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Ovarian cancer metastatic	13	37.5 21.7–64.8ROR 37.5 · χ² 419 / p 2e-93	35.2 EB05 21.9 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications	serious n=13	no trial data cached
Early satiety	26	33.0 22.4–48.6ROR 33.1 · χ² 765 / p 1e-168	31.9 EB05 22.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Taste disorder	271	32.7 29.1–36.8ROR 33.7 · χ² 8,199 / p <1e-300	32.2 EB05 29.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 33.4	no trial data cached
Blood count abnormal	197	31.0 27.0–35.6ROR 31.7 · χ² 5,617 / p <1e-300	30.5 EB05 27.1 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious PRR 36.1	no trial data cached
Computerised tomogram abnormal	27	28.6 19.6–41.7ROR 28.6 · χ² 683 / p 9e-151	27.7 EB05 20.0 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Malignant neoplasm progression	1,184	28.1 26.6–29.6ROR 32.3 · χ² 30,681 / p <1e-300	27.8 EB05 26.4 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7	no trial data cached
Sunburn	78	25.2 20.2–31.5ROR 25.5 · χ² 1,774 / p <1e-300	24.9 EB05 20.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=27	no trial data cached
Photosensitivity reaction (sun sensitivity)	172	25.2 21.7–29.3ROR 25.7 · χ² 3,938 / p <1e-300	24.9 EB05 21.9 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.0	no trial data cached
Recurrent cancer	41	24.4 18.0–33.2ROR 24.5 · χ² 888 / p 2e-195	23.9 EB05 18.4 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=37	no trial data cached
Red blood cell count decreased	289	24.3 21.7–27.3ROR 25.1 · χ² 6,390 / p <1e-300	24.1 EB05 21.8 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious PRR 23.4	no trial data cached
Blood magnesium decreased	86	24.0 19.4–29.7ROR 24.3 · χ² 1,857 / p <1e-300	23.7 EB05 19.8 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious PRR 25.6	no trial data cached
Therapy partial responder	136	21.8 18.4–25.7ROR 22.1 · χ² 2,650 / p <1e-300	21.5 EB05 18.6 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 15.6	no trial data cached
Mean cell volume increased	22	20.6 13.6–31.4ROR 20.7 · χ² 388 / p 1e-86	20.1 EB05 13.9 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious n=13	no trial data cached
Prescribed underdose	156	18.8 16.1–22.0ROR 19.1 · χ² 2,596 / p <1e-300	18.6 EB05 16.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.8	no trial data cached
Dysgeusia (altered taste)	567	18.3 16.9–19.8ROR 19.5 · χ² 9,198 / p <1e-300	18.1 EB05 16.9 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.8	no trial data cached
Accidental underdose	106	17.5 14.5–21.2ROR 17.7 · χ² 1,622 / p <1e-300	17.3 EB05 14.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=42	no trial data cached
Mean cell haemoglobin increased	12	17.4 9.9–30.7ROR 17.4 · χ² 168 / p 1e-38	16.2 EB05 9.1 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious n=8	no trial data cached
Intentional underdose	50	16.5 12.5–21.8ROR 16.6 · χ² 708 / p 3e-156	16.3 EB05 12.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=19	no trial data cached
Liver function test increased	140	15.8 13.4–18.6ROR 16.0 · χ² 1,912 / p <1e-300	15.6 EB05 13.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Adverse event	571	14.9 13.7–16.1ROR 15.9 · χ² 7,369 / p <1e-300	14.8 EB05 13.8 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 27.3	no trial data cached
Laboratory test abnormal	170	13.8 11.9–16.1ROR 14.1 · χ² 2,005 / p <1e-300	13.7 EB05 12.1 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 15.8	no trial data cached
Radiotherapy	11	13.8 7.6–24.9ROR 13.8 · χ² 117 / p 1e-27	12.1 EB05 6.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Full blood count abnormal	58	13.2 10.2–17.1ROR 13.3 · χ² 639 / p 3e-141	13.0 EB05 10.3 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 11.2 · 95% consumer	no trial data cached
Product dose omission	362	13.1 11.9–14.5ROR 13.6 · χ² 4,032 / p <1e-300	13.0 EB05 11.9 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 27.0	no trial data cached
Platelet count decreased	539	12.1 11.2–13.2ROR 12.9 · χ² 5,500 / p <1e-300	12.1 EB05 11.2 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Red cell distribution width increased	20	11.5 7.4–17.9ROR 11.6 · χ² 181 / p 1e-41	10.6 EB05 6.8 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious n=13	no trial data cached
Small intestinal obstruction	53	10.4 7.9–13.6ROR 10.4 · χ² 437 / p 2e-97	10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	no trial data cached
Product dose omission in error	110	9.8 8.2–11.8ROR 9.9 · χ² 860 / p 2e-189	9.6 EB05 8.2 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 20.0 · 94% consumer	no trial data cached
Nail discolouration	16	9.8 6.0–16.0ROR 9.8 · χ² 117 / p 1e-27	8.5 EB05 5.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Blood creatinine abnormal	14	9.8 5.8–16.5ROR 9.8 · χ² 101 / p 4e-24	8.2 EB05 4.9 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious n=8	no trial data cached
Blood creatinine increased	266	9.7 8.7–11.0ROR 10.0 · χ² 2,077 / p <1e-300	9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5	no trial data cached
Vitamin b12 decreased	11	9.2 5.1–16.6ROR 9.2 · χ² 72 / p 1e-17	7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious n=7	no trial data cached
Blood test abnormal	52	8.9 6.8–11.6ROR 8.9 · χ² 354 / p 2e-79	8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.3	no trial data cached
Constipation	785	8.7 8.1–9.3ROR 9.4 · χ² 5,372 / p <1e-300	8.6 EB05 8.1 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Fatigue (tiredness)	2,551	7.9 7.6–8.1ROR 10.7 · χ² 15,818 / p <1e-300	7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4	no trial data cached
Nausea	2,261	6.9 6.6–7.1ROR 8.9 · χ² 11,726 / p <1e-300	6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.3	no trial data cached
Malignant neoplasm progression	1,184	28.1 26.6–29.6ROR 32.3 · χ² 30,681 / p <1e-300	27.8 EB05 26.4 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7	no trial data cached
Decreased appetite (loss of appetite)	802	8.3 7.8–8.9ROR 9.0 · χ² 5,178 / p <1e-300	8.2 EB05 7.8 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Diarrhoea (diarrhea)	790	2.9 2.7–3.1ROR 3.1 · χ² 1,037 / p 7e-228	2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.2	no trial data cached
Constipation	785	8.7 8.1–9.3ROR 9.4 · χ² 5,372 / p <1e-300	8.6 EB05 8.1 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached
Vomiting	782	4.0 3.7–4.3ROR 4.3 · χ² 1,785 / p <1e-300	4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.2	no trial data cached
Asthenia (weakness)	680	4.3 4.0–4.6ROR 4.6 · χ² 1,764 / p <1e-300	4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5	no trial data cached
Adverse event	571	14.9 13.7–16.1ROR 15.9 · χ² 7,369 / p <1e-300	14.8 EB05 13.8 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 27.3	no trial data cached
Carbohydrate antigen 125 increased	571	476.2 436.3–519.7ROR 509.3 · χ² 224,892 / p <1e-300	391.1 EB05 364.9 · IC025 +8.1 3/3 methods agree	Lab value / disease marker	serious n=275	no trial data cached
Dysgeusia (altered taste)	567	18.3 16.9–19.8ROR 19.5 · χ² 9,198 / p <1e-300	18.1 EB05 16.9 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.8	no trial data cached
Anaemia (low red blood cells)	557	7.0 6.4–7.6ROR 7.4 · χ² 2,870 / p <1e-300	6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.4	no trial data cached
Product dose omission issue	552	4.6 4.3–5.0ROR 4.9 · χ² 1,590 / p <1e-300	4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8	no trial data cached
Platelet count decreased	539	12.1 11.2–13.2ROR 12.9 · χ² 5,500 / p <1e-300	12.1 EB05 11.2 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Drug ineffective (drug did not work)	519	0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.081	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.2 · 77% consumer	no trial data cached

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.

Early satiety — n=26, PRR 33.0
Taste disorder — n=271, PRR 32.7
Computerised tomogram abnormal — n=27, PRR 28.6
Sunburn — n=78, PRR 25.2
Prescribed underdose — n=156, PRR 18.8
Accidental underdose — n=106, PRR 17.5
Intentional underdose — n=50, PRR 16.5
Liver function test increased — n=140, PRR 15.8
Small intestinal obstruction — n=53, PRR 10.4

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 Rucaparib?

In FDA FAERS, the most frequently co-reported reaction terms for Rucaparib are fatigue, nausea, decreased appetite, diarrhoea, constipation, vomiting. 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 Rucaparib have an FDA boxed warning?

No. The FDA label retrieved for Rucaparib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Rucaparib 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 0295d202-1cfe-7659-e063-6294a90a476e, effective 20251231; matched on openfda.generic_name.exact:"RUCAPARIB")
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, field patient.drug.openfda.generic_name.exact, 867 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

Page generated 2026-10-08. 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.