Anti-Inhibitor Coagulant Complex side effects: what 1,102 FDA adverse event reports show

Anti-Inhibitor Coagulant Complex · Feiba · 19 reaction terms · 613 drug–reaction co-reports · data 2026-09-14

Drug class

Anti-inhibitor coagulant complex

FDA label, Indications wording

Brand names

Feiba

openFDA label

Who reports

1,102 reports · 96% serious · 151 with death outcome · 14% female

openFDA FAERS counts, all years, deduplication not applied

Used for

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FDA label, Indications and Usage

What it is

FEIBA (Anti-Inhibitor Coagulant Complex) is a freeze-dried sterile human plasma fraction with factor VIII inhibitor bypassing activity to be reconstituted for intravenous administration. Factor VIII inhibitor bypassing activity is expressed in arbitrary units.

FDA label, Description section

Boxed warning

EMBOLIC and THROMBOTIC EVENTS Thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

FDA 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 15 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 6

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
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	285	52.0 47.1–57.5ROR 69.8 · χ² 14,240 / p <1e-300	51.7 EB05 46.9 · IC025 +5.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 36.9 · 78% consumer	no trial data cached
Therapy partial responder	32	40.5 28.8–57.0ROR 41.7 · χ² 1,192 / p 2e-261	39.6 EB05 29.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 29.5 · 97% consumer	no trial data cached
Treatment failure	132	30.6 26.1–36.0ROR 34.7 · χ² 3,765 / p <1e-300	30.5 EB05 26.4 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 35.4	no trial data cached
Disseminated intravascular coagulation	19	25.6 16.4–40.0ROR 26.1 · χ² 425 / p 9e-95	25.0 EB05 16.9 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.4	no trial data cached
Haematoma	31	22.7 16.0–32.1ROR 23.3 · χ² 622 / p 2e-137	22.4 EB05 16.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Gingival bleeding	13	18.1 10.5–31.1ROR 18.3 · χ² 193 / p 3e-44	17.2 EB05 10.1 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 16.3	no trial data cached
Thrombotic microangiopathy	9	17.7 9.2–33.9ROR 17.8 · χ² 125 / p 2e-29	16.0 EB05 7.7 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 10.6	no trial data cached
Joint injury	17	15.1 9.4–24.3ROR 15.4 · χ² 211 / p 5e-48	14.4 EB05 9.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Device related infection	12	14.8 8.4–26.0ROR 15.0 · χ² 141 / p 8e-33	13.5 EB05 7.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1	no trial data cached
Post procedural haemorrhage	8	13.0 6.5–26.0ROR 13.1 · χ² 77 / p 7e-19	10.4 EB05 4.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7	no trial data cached
Poor venous access	7	12.9 6.2–27.0ROR 13.0 · χ² 65 / p 3e-16	9.9 EB05 4.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Ischaemic stroke	9	9.6 5.0–18.4ROR 9.7 · χ² 61 / p 3e-15	7.4 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Limb injury	13	9.1 5.3–15.7ROR 9.2 · χ² 86 / p 8e-21	7.6 EB05 4.5 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.5	no trial data cached
Haemorrhage intracranial	6	7.6 3.4–16.9ROR 7.6 · χ² 28 / p 6e-8	5.2 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Drug effective for unapproved indication	6	3.9 1.8–8.7ROR 3.9 · χ² 10 / p 7e-4	3.2 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious n=3	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	285	52.0 47.1–57.5ROR 69.8 · χ² 14,240 / p <1e-300	51.7 EB05 46.9 · IC025 +5.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 36.9 · 78% consumer	no trial data cached
Treatment failure	132	30.6 26.1–36.0ROR 34.7 · χ² 3,765 / p <1e-300	30.5 EB05 26.4 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 35.4	no trial data cached
Therapy partial responder	32	40.5 28.8–57.0ROR 41.7 · χ² 1,192 / p 2e-261	39.6 EB05 29.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 29.5 · 97% consumer	no trial data cached
Haematoma	31	22.7 16.0–32.1ROR 23.3 · χ² 622 / p 2e-137	22.4 EB05 16.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Disseminated intravascular coagulation	19	25.6 16.4–40.0ROR 26.1 · χ² 425 / p 9e-95	25.0 EB05 16.9 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.4	no trial data cached
Joint injury	17	15.1 9.4–24.3ROR 15.4 · χ² 211 / p 5e-48	14.4 EB05 9.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Limb injury	13	9.1 5.3–15.7ROR 9.2 · χ² 86 / p 8e-21	7.6 EB05 4.5 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.5	no trial data cached
Gingival bleeding	13	18.1 10.5–31.1ROR 18.3 · χ² 193 / p 3e-44	17.2 EB05 10.1 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 16.3	no trial data cached
Device related infection	12	14.8 8.4–26.0ROR 15.0 · χ² 141 / p 8e-33	13.5 EB05 7.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1	no trial data cached
Ischaemic stroke	9	9.6 5.0–18.4ROR 9.7 · χ² 61 / p 3e-15	7.4 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Thrombotic microangiopathy	9	17.7 9.2–33.9ROR 17.8 · χ² 125 / p 2e-29	16.0 EB05 7.7 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 10.6	no trial data cached
Post procedural haemorrhage	8	13.0 6.5–26.0ROR 13.1 · χ² 77 / p 7e-19	10.4 EB05 4.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7	no trial data cached
Poor venous access	7	12.9 6.2–27.0ROR 13.0 · χ² 65 / p 3e-16	9.9 EB05 4.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Drug effective for unapproved indication	6	3.9 1.8–8.7ROR 3.9 · χ² 10 / p 7e-4	3.2 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious n=3	no trial data cached
Haemorrhage intracranial	6	7.6 3.4–16.9ROR 7.6 · χ² 28 / p 6e-8	5.2 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	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.

Haematoma — n=31, PRR 22.7

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 Anti-Inhibitor Coagulant Complex?

In FDA FAERS, the most frequently co-reported reaction terms for Anti-Inhibitor Coagulant Complex are haemorrhage, haematoma, disseminated intravascular coagulation, joint injury, limb injury, gingival bleeding. 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 Anti-Inhibitor Coagulant Complex have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: EMBOLIC and THROMBOTIC EVENTS Thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

Do FAERS signals prove that Anti-Inhibitor Coagulant Complex 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 752604e5-4ea2-44f4-83ed-1569373f6412, effective 20251127; matched on openfda.generic_name.exact:"ANTI-INHIBITOR COAGULANT COMPLEX")
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, 19 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.