Cangrelor side effects: what 399 FDA adverse event reports show

Cangrelor · Kengreal · 8 reaction terms · 57 drug–reaction co-reports · data 2026-09-14

Drug class

P2Y12 Platelet Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Kengreal

openFDA label

Who reports

399 reports · 72% serious · 84 with death outcome · 35% female

openFDA FAERS counts, all years, deduplication not applied

Used for

KENGREAL is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor .

FDA label, Indications and Usage

What it is

KENGREAL is a direct-acting P2Y 12 platelet receptor inhibitor that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation.

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 6 strongest signals

Labeled (related wording) 1Reporting / coding artifact 2Not in label — unassessed 3

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.
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. 2 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
Cardiogenic shock	15	55.3 33.6–90.9ROR 57.4 · χ² 746 / p 1e-164	51.8 EB05 33.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 44.3	no trial data cached
Haemorrhage intracranial	10	35.0 19.0–64.6ROR 35.9 · χ² 298 / p 6e-67	33.0 EB05 19.1 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 28.2	no trial data cached
Ventricular fibrillation	7	33.0 15.9–68.9ROR 33.6 · χ² 187 / p 9e-43	30.3 EB05 15.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.6	no trial data cached
Eosinophilia	8	24.1 12.1–47.8ROR 24.5 · χ² 155 / p 8e-36	22.3 EB05 11.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Incorrect product administration duration	6	15.5 7.0–34.4ROR 15.8 · χ² 68 / p 9e-17	12.0 EB05 4.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Product preparation error	5	12.7 5.3–30.3ROR 12.8 · χ² 43 / p 3e-11	8.4 EB05 3.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious n=1	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
Cardiogenic shock	15	55.3 33.6–90.9ROR 57.4 · χ² 746 / p 1e-164	51.8 EB05 33.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 44.3	no trial data cached
Haemorrhage intracranial	10	35.0 19.0–64.6ROR 35.9 · χ² 298 / p 6e-67	33.0 EB05 19.1 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 28.2	no trial data cached
Eosinophilia	8	24.1 12.1–47.8ROR 24.5 · χ² 155 / p 8e-36	22.3 EB05 11.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Ventricular fibrillation	7	33.0 15.9–68.9ROR 33.6 · χ² 187 / p 9e-43	30.3 EB05 15.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.6	no trial data cached
Incorrect product administration duration	6	15.5 7.0–34.4ROR 15.8 · χ² 68 / p 9e-17	12.0 EB05 4.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Product preparation error	5	12.7 5.3–30.3ROR 12.8 · χ² 43 / p 3e-11	8.4 EB05 3.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Product complaint	3	6.3 2.0–19.5ROR 6.4 · χ² 9 / p 0.002	3.7 EB05 1.4 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious n=3	no trial data cached
Drug level decreased	3	15.4 5.0–47.6ROR 15.5 · χ² 27 / p 9e-8	8.1 EB05 2.3 · IC025 +0.3 3/3 methods agree	Reporting / coding artifact	serious PRR 15.3	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Cangrelor?

In FDA FAERS, the most frequently co-reported reaction terms for Cangrelor are cardiogenic shock, haemorrhage intracranial, eosinophilia, ventricular fibrillation. 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 Cangrelor have an FDA boxed warning?

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

Do FAERS signals prove that Cangrelor 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 88b434fa-8891-4fd5-9d86-7ea64667c08f, effective 20251021; matched on openfda.generic_name.exact:"CANGRELOR")
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, 8 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.