Drug · FAERS side-effect profile with label screen

Antihemophilic Factor (Recombinant) side effects: what 1,316 FDA adverse event reports show

Antihemophilic Factor (Recombinant), Fc-Vwf-Xten Fusion Protein-Ehtl · 20 reaction terms · 1,009 drug–reaction co-reports · data 2026-09-14

Drug class

Recombinant dna-derived, factor viii concentrate

FDA label, Indications wording of the closest related product

Label matched

Antihemophilic Factor (Recombinant), Fc-Vwf-Xten Fusion Protein-Ehtl (Altuviiio)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,316 reports · 22% serious · 3 with death outcome · 5% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperati.

FDA label, Indications and Usage

What it is

ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection.

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 19 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 14

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. 1 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	531	81.2 76.0–86.8ROR 135.3 · χ² 41,985 / p <1e-300	80.6 EB05 75.0 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 41.9	no trial data cached
Ligament sprain	36	58.3 42.2–80.4ROR 59.9 · χ² 1,963 / p <1e-300	56.4 EB05 42.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Joint injury	61	45.5 35.6–58.2ROR 47.7 · χ² 2,606 / p <1e-300	44.8 EB05 36.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	no trial data cached
Limb injury	76	44.8 36.0–55.7ROR 47.4 · χ² 3,203 / p <1e-300	44.2 EB05 36.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 33.3	no trial data cached
Post procedural haemorrhage	26	35.5 24.3–52.0ROR 36.2 · χ² 836 / p 4e-184	34.6 EB05 24.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 55.1	no trial data cached
Head injury	45	22.7 17.0–30.3ROR 23.5 · χ² 912 / p 1e-200	22.5 EB05 17.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Poor venous access	13	20.1 11.7–34.5ROR 20.2 · χ² 217 / p 3e-49	19.3 EB05 11.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Epistaxis (nosebleed)	58	12.3 9.6–15.8ROR 12.8 · χ² 594 / p 2e-131	12.1 EB05 9.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Skin laceration	8	11.8 5.9–23.5ROR 11.9 · χ² 69 / p 6e-17	9.1 EB05 4.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 22.1	no trial data cached
Internal haemorrhage	8	11.1 5.6–22.2ROR 11.2 · χ² 64 / p 6e-16	8.5 EB05 4.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.2	no trial data cached
Gingival bleeding	9	10.5 5.5–20.1ROR 10.5 · χ² 68 / p 8e-17	8.2 EB05 4.2 · IC025 +1.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 13.5	no trial data cached
Tooth extraction	7	8.9 4.3–18.7ROR 9.0 · χ² 42 / p 5e-11	6.4 EB05 3.1 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Product dose omission in error	15	8.9 5.4–14.7ROR 9.0 · χ² 97 / p 3e-23	7.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Contusion	52	8.6 6.6–11.2ROR 8.9 · χ² 344 / p 5e-77	8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Skin haemorrhage	7	7.7 3.7–16.2ROR 7.8 · χ² 35 / p 2e-9	5.5 EB05 2.8 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Back injury	5	7.3 3.1–17.6ROR 7.4 · χ² 21 / p 2e-6	4.8 EB05 2.2 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Injury	31	7.0 4.9–9.9ROR 7.1 · χ² 153 / p 2e-35	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Upper limb fracture	6	4.8 2.1–10.6ROR 4.8 · χ² 14 / p 8e-5	3.7 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious PRR 4.7	no trial data cached
Product storage error	11	2.0 1.1–3.6ROR 2.0 · χ² 5 / p 0.015	1.9 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 10.2	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	531	81.2 76.0–86.8ROR 135.3 · χ² 41,985 / p <1e-300	80.6 EB05 75.0 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 41.9	no trial data cached
Limb injury	76	44.8 36.0–55.7ROR 47.4 · χ² 3,203 / p <1e-300	44.2 EB05 36.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 33.3	no trial data cached
Joint injury	61	45.5 35.6–58.2ROR 47.7 · χ² 2,606 / p <1e-300	44.8 EB05 36.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	no trial data cached
Epistaxis (nosebleed)	58	12.3 9.6–15.8ROR 12.8 · χ² 594 / p 2e-131	12.1 EB05 9.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Contusion	52	8.6 6.6–11.2ROR 8.9 · χ² 344 / p 5e-77	8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Head injury	45	22.7 17.0–30.3ROR 23.5 · χ² 912 / p 1e-200	22.5 EB05 17.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Ligament sprain	36	58.3 42.2–80.4ROR 59.9 · χ² 1,963 / p <1e-300	56.4 EB05 42.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Injury	31	7.0 4.9–9.9ROR 7.1 · χ² 153 / p 2e-35	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Post procedural haemorrhage	26	35.5 24.3–52.0ROR 36.2 · χ² 836 / p 4e-184	34.6 EB05 24.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 55.1	no trial data cached
Product dose omission in error	15	8.9 5.4–14.7ROR 9.0 · χ² 97 / p 3e-23	7.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Poor venous access	13	20.1 11.7–34.5ROR 20.2 · χ² 217 / p 3e-49	19.3 EB05 11.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Product storage error	11	2.0 1.1–3.6ROR 2.0 · χ² 5 / p 0.015	1.9 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 10.2	no trial data cached
Gingival bleeding	9	10.5 5.5–20.1ROR 10.5 · χ² 68 / p 8e-17	8.2 EB05 4.2 · IC025 +1.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 13.5	no trial data cached
Internal haemorrhage	8	11.1 5.6–22.2ROR 11.2 · χ² 64 / p 6e-16	8.5 EB05 4.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.2	no trial data cached
Skin laceration	8	11.8 5.9–23.5ROR 11.9 · χ² 69 / p 6e-17	9.1 EB05 4.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 22.1	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.

Ligament sprain — n=36, PRR 58.3
Joint injury — n=61, PRR 45.5
Limb injury — n=76, PRR 44.8
Head injury — n=45, PRR 22.7
Epistaxis — n=58, PRR 12.3
Contusion — n=52, PRR 8.6
Injury — n=31, PRR 7.0

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 Antihemophilic Factor (Recombinant)?

In FDA FAERS, the most frequently co-reported reaction terms for Antihemophilic Factor (Recombinant) are haemorrhage, limb injury, joint injury, epistaxis, contusion, head injury. 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 Antihemophilic Factor (Recombinant) have an FDA boxed warning?

No. The FDA label retrieved for Antihemophilic Factor (Recombinant) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Antihemophilic Factor (Recombinant) 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 01411972-df40-4ccf-88f0-d3220e5abda9, effective 20260223; matched on openfda.generic_name.exact:"ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTL")
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, 20 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.