Idarucizumab side effects: what 1,428 FDA adverse event reports show

Idarucizumab · Praxbind · 28 reaction terms · 818 drug–reaction co-reports · data 2026-09-14

Drug class

Humanized Monoclonal Antibody Fragment

FDA label (Established Pharmacologic Class)

Brand names

Praxbind

openFDA label

Who reports

1,428 reports · 97% serious · 894 with death outcome · 44% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody .

FDA label, Indications and Usage

What it is

Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Using recombinant expression tec.

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 24 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 21

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.
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.
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. 4 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
Haemorrhage intracranial	67	65.9 52.1–83.2ROR 69.1 · χ² 4,199 / p <1e-300	64.4 EB05 52.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 38.8 · 97% clinician	no trial data cached
Ischaemic stroke	45	37.1 27.8–49.4ROR 38.2 · χ² 1,541 / p <1e-300	36.5 EB05 28.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 21.8 · 98% clinician	no trial data cached
Multiple organ dysfunction syndrome	62	32.7 25.6–41.7ROR 34.1 · χ² 1,872 / p <1e-300	32.3 EB05 26.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 95% clinician	no trial data cached
Cerebral haemorrhage	79	32.5 26.2–40.3ROR 34.4 · χ² 2,380 / p <1e-300	32.2 EB05 26.7 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 97% clinician	no trial data cached
Coagulopathy	31	27.4 19.4–38.9ROR 28.0 · χ² 763 / p 3e-168	27.0 EB05 19.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.9 · 94% clinician	no trial data cached
Cardiogenic shock	22	22.7 15.0–34.3ROR 23.0 · χ² 434 / p 1e-96	22.2 EB05 15.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Post procedural haemorrhage	17	21.4 13.3–34.4ROR 21.7 · χ² 310 / p 9e-70	20.9 EB05 13.6 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.1	no trial data cached
Rebound effect	15	19.4 11.7–32.2ROR 19.6 · χ² 244 / p 2e-55	18.8 EB05 11.7 · IC025 +2.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 18.4	no trial data cached
Brain oedema	15	17.5 10.6–28.9ROR 17.6 · χ² 216 / p 3e-49	16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Cerebral infarction	29	17.4 12.2–25.0ROR 17.8 · χ² 433 / p 2e-96	17.2 EB05 12.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.3 · 93% clinician	no trial data cached
Subarachnoid haemorrhage	12	17.3 9.8–30.3ROR 17.4 · χ² 168 / p 1e-38	16.2 EB05 9.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Haemorrhage	119	16.7 14.1–19.9ROR 18.2 · χ² 1,751 / p <1e-300	16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0 · 95% clinician	no trial data cached
Melaena (black stool)	25	16.7 11.3–24.6ROR 16.9 · χ² 352 / p 6e-79	16.3 EB05 11.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 96% clinician	no trial data cached
Shock	24	15.5 10.4–23.0ROR 15.7 · χ² 310 / p 9e-70	15.0 EB05 10.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · ♀ 22% (drug 44%) · 96% clinician	no trial data cached
Subdural haematoma	14	14.3 8.5–24.1ROR 14.5 · χ² 160 / p 5e-37	13.2 EB05 7.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Gastrointestinal haemorrhage	81	14.2 11.5–17.5ROR 14.9 · χ² 980 / p 2e-215	14.0 EB05 11.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · 96% clinician	no trial data cached
Hemiparesis	16	13.8 8.5–22.5ROR 13.9 · χ² 177 / p 1e-40	12.8 EB05 7.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Haematoma	21	11.9 7.8–18.1ROR 12.0 · χ² 198 / p 3e-45	11.0 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · 95% clinician	no trial data cached
Upper gastrointestinal haemorrhage	13	11.3 6.6–19.4ROR 11.4 · χ² 112 / p 2e-26	9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Septic shock	33	11.2 8.0–15.7ROR 11.5 · χ² 297 / p 6e-67	10.7 EB05 7.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 100% clinician	no trial data cached
Aphasia (loss of speech)	20	9.7 6.3–15.0ROR 9.8 · χ² 148 / p 3e-34	8.7 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 100% clinician	no trial data cached
Circulatory collapse	10	8.6 4.6–15.9ROR 8.6 · χ² 60 / p 6e-15	6.7 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Haematemesis (vomiting blood)	14	8.1 4.8–13.6ROR 8.2 · χ² 80 / p 2e-19	6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Peritonitis	11	7.8 4.3–14.1ROR 7.9 · χ² 59 / p 9e-15	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	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
Haemorrhage	119	16.7 14.1–19.9ROR 18.2 · χ² 1,751 / p <1e-300	16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0 · 95% clinician	no trial data cached
Gastrointestinal haemorrhage	81	14.2 11.5–17.5ROR 14.9 · χ² 980 / p 2e-215	14.0 EB05 11.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · 96% clinician	no trial data cached
Cerebral haemorrhage	79	32.5 26.2–40.3ROR 34.4 · χ² 2,380 / p <1e-300	32.2 EB05 26.7 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 97% clinician	no trial data cached
Haemorrhage intracranial	67	65.9 52.1–83.2ROR 69.1 · χ² 4,199 / p <1e-300	64.4 EB05 52.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 38.8 · 97% clinician	no trial data cached
Multiple organ dysfunction syndrome	62	32.7 25.6–41.7ROR 34.1 · χ² 1,872 / p <1e-300	32.3 EB05 26.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 95% clinician	no trial data cached
Ischaemic stroke	45	37.1 27.8–49.4ROR 38.2 · χ² 1,541 / p <1e-300	36.5 EB05 28.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 21.8 · 98% clinician	no trial data cached
Septic shock	33	11.2 8.0–15.7ROR 11.5 · χ² 297 / p 6e-67	10.7 EB05 7.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 100% clinician	no trial data cached
Coagulopathy	31	27.4 19.4–38.9ROR 28.0 · χ² 763 / p 3e-168	27.0 EB05 19.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.9 · 94% clinician	no trial data cached
Cerebral infarction	29	17.4 12.2–25.0ROR 17.8 · χ² 433 / p 2e-96	17.2 EB05 12.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.3 · 93% clinician	no trial data cached
Melaena (black stool)	25	16.7 11.3–24.6ROR 16.9 · χ² 352 / p 6e-79	16.3 EB05 11.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 96% clinician	no trial data cached
Shock	24	15.5 10.4–23.0ROR 15.7 · χ² 310 / p 9e-70	15.0 EB05 10.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · ♀ 22% (drug 44%) · 96% clinician	no trial data cached
Cardiogenic shock	22	22.7 15.0–34.3ROR 23.0 · χ² 434 / p 1e-96	22.2 EB05 15.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Haematoma	21	11.9 7.8–18.1ROR 12.0 · χ² 198 / p 3e-45	11.0 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · 95% clinician	no trial data cached
Aphasia (loss of speech)	20	9.7 6.3–15.0ROR 9.8 · χ² 148 / p 3e-34	8.7 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 100% clinician	no trial data cached
Post procedural haemorrhage	17	21.4 13.3–34.4ROR 21.7 · χ² 310 / p 9e-70	20.9 EB05 13.6 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.1	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.

Haemorrhage intracranial — n=67, PRR 65.9
Ischaemic stroke — n=45, PRR 37.1
Multiple organ dysfunction syndrome — n=62, PRR 32.7
Cerebral haemorrhage — n=79, PRR 32.5
Coagulopathy — n=31, PRR 27.4
Cardiogenic shock — n=22, PRR 22.7
Cerebral infarction — n=29, PRR 17.4
Melaena — n=25, PRR 16.7
Shock — n=24, PRR 15.5
Gastrointestinal haemorrhage — n=81, PRR 14.2

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 Idarucizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Idarucizumab are haemorrhage, gastrointestinal haemorrhage, cerebral haemorrhage, haemorrhage intracranial, multiple organ dysfunction syndrome, ischaemic stroke. 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 Idarucizumab have an FDA boxed warning?

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

Do FAERS signals prove that Idarucizumab 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 c7400f8a-dcf4-a6df-6d07-983081b1bf34, effective 20240123; matched on openfda.generic_name.exact:"IDARUCIZUMAB")
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, 28 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.