Taliglucerase Alfa side effects: what 566 FDA adverse event reports show

Taliglucerase Alfa · Elelyso · 6 reaction terms · 71 drug–reaction co-reports · data 2026-09-14

Drug class

Hydrolytic Lysosomal Glucocerebroside-specific Enzyme

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Elelyso

openFDA label

Who reports

566 reports · 72% serious · 49 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease ( 1 ).

FDA label, Indications and Usage

What it is

Taliglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme produced by recombinant DNA technology using plant cell culture (carrot). Taliglucerase alfa is a monomeric glycoprotein enzyme containing 4 N-linked glycosylation sites (kDa=60.8).

FDA label, Description section

Boxed warning

HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life‑threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

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 6 strongest signals

Labeled (related wording) 1Not in label — unassessed 5

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.
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. 0 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
Poor venous access	7	25.1 12.0–52.5ROR 25.4 · χ² 139 / p 2e-32	22.9 EB05 10.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Retinal detachment	6	24.2 10.9–53.6ROR 24.4 · χ² 111 / p 3e-26	21.2 EB05 8.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.6	no trial data cached
Infusion related reaction (reaction during infusion)	34	19.1 13.8–26.4ROR 20.2 · χ² 566 / p 2e-125	18.9 EB05 14.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Infusion site pain	6	17.4 7.9–38.6ROR 17.6 · χ² 77 / p 8e-19	14.0 EB05 5.2 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Sneezing	8	13.3 6.7–26.4ROR 13.4 · χ² 79 / p 3e-19	10.7 EB05 4.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Osteonecrosis (bone death)	10	11.2 6.0–20.7ROR 11.4 · χ² 83 / p 4e-20	9.1 EB05 4.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	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
Infusion related reaction (reaction during infusion)	34	19.1 13.8–26.4ROR 20.2 · χ² 566 / p 2e-125	18.9 EB05 14.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Osteonecrosis (bone death)	10	11.2 6.0–20.7ROR 11.4 · χ² 83 / p 4e-20	9.1 EB05 4.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Sneezing	8	13.3 6.7–26.4ROR 13.4 · χ² 79 / p 3e-19	10.7 EB05 4.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Poor venous access	7	25.1 12.0–52.5ROR 25.4 · χ² 139 / p 2e-32	22.9 EB05 10.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Infusion site pain	6	17.4 7.9–38.6ROR 17.6 · χ² 77 / p 8e-19	14.0 EB05 5.2 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Retinal detachment	6	24.2 10.9–53.6ROR 24.4 · χ² 111 / p 3e-26	21.2 EB05 8.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.6	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.

Infusion related reaction — n=34, PRR 19.1

✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.

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 Taliglucerase Alfa?

In FDA FAERS, the most frequently co-reported reaction terms for Taliglucerase Alfa are infusion related reaction, osteonecrosis, sneezing, poor venous access, infusion site pain, retinal detachment. 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 Taliglucerase Alfa have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life‑threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Do FAERS signals prove that Taliglucerase Alfa 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 fa3cbd5d-677c-4b19-9032-d9182cb69a83, effective 20251229; matched on openfda.generic_name.exact:"TALIGLUCERASE ALFA")
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, 6 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.