Velaglucerase Alfa side effects: what 2,049 FDA adverse event reports show

Velaglucerase Alfa · Vpriv · 88 reaction terms · 2,183 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

Vpriv

openFDA label

Who reports

2,049 reports · 84% serious · 279 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. ( 1 )

FDA label, Indications and Usage

What it is

Velaglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme produced by gene activation technology in a human fibroblast cell line. Velaglucerase alfa is a glycoprotein of 497 amino acids and a molecular weight of approximately 63 kDa.

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 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 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 3Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 27

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.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 48 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	66	65.8 51.9–83.6ROR 68.0 · χ² 4,126 / p <1e-300	64.3 EB05 52.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=57	no trial data cached
Weight fluctuation	37	36.5 26.5–50.2ROR 37.1 · χ² 1,237 / p 3e-271	35.7 EB05 27.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=37 · ♀ 32% (drug 56%)	no trial data cached
Insurance issue	49	33.9 25.7–44.7ROR 34.7 · χ² 1,526 / p <1e-300	33.4 EB05 26.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 39.1 · 73% consumer	no trial data cached
Product availability issue	64	29.3 23.0–37.3ROR 30.2 · χ² 1,718 / p <1e-300	29.0 EB05 23.5 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 40.4 · 80% consumer	no trial data cached
Pregnancy	46	23.3 17.5–31.0ROR 23.8 · χ² 959 / p 6e-211	23.1 EB05 18.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.3 · ♀ 100% (drug 56%)	no trial data cached
Splenomegaly	19	16.6 10.6–26.0ROR 16.8 · χ² 263 / p 2e-59	16.1 EB05 10.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Infusion related reaction (reaction during infusion)	102	15.8 13.1–19.1ROR 16.6 · χ² 1,404 / p <1e-300	15.7 EB05 13.3 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.7	no trial data cached
Bone pain	89	15.6 12.7–19.1ROR 16.2 · χ² 1,199 / p 5e-263	15.5 EB05 12.9 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.5	no trial data cached
Infusion site pain	16	12.8 7.9–20.9ROR 12.9 · χ² 163 / p 1e-37	11.8 EB05 7.1 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious n=13	no trial data cached
Inappropriate schedule of product administration	212	12.3 10.8–14.0ROR 13.6 · χ² 2,202 / p <1e-300	12.2 EB05 10.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 19.1	no trial data cached
Inability to afford medication	11	11.5 6.4–20.7ROR 11.5 · χ² 95 / p 1e-22	9.6 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Blood pressure abnormal	21	10.9 7.1–16.6ROR 11.0 · χ² 178 / p 6e-41	9.9 EB05 6.5 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 10.8 · ♀ 33% (drug 56%)	no trial data cached
Body height decreased	11	10.4 5.8–18.8ROR 10.5 · χ² 84 / p 2e-20	8.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Hepatomegaly	10	10.4 5.6–19.3ROR 10.4 · χ² 76 / p 2e-18	8.3 EB05 4.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Product prescribing error	23	9.9 6.6–14.9ROR 10.1 · χ² 176 / p 2e-40	9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6 · 78% consumer	no trial data cached
Covid-19	167	9.7 8.4–11.2ROR 10.4 · χ² 1,299 / p 1e-284	9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Wrist fracture	11	9.4 5.2–16.9ROR 9.4 · χ² 74 / p 3e-18	7.5 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Upper limb fracture	18	9.2 5.8–14.6ROR 9.3 · χ² 124 / p 5e-29	8.0 EB05 5.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Abortion spontaneous	36	9.2 6.6–12.7ROR 9.3 · χ² 254 / p 2e-57	8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.2 · ♀ 100% (drug 56%)	no trial data cached
Osteonecrosis (bone death)	29	9.0 6.2–12.9ROR 9.1 · χ² 197 / p 4e-45	8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Exposure during pregnancy	54	8.9 6.8–11.6ROR 9.1 · χ² 371 / p 5e-83	8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0 · ♀ 100% (drug 56%)	no trial data cached
Body temperature increased	16	8.0 4.9–13.0ROR 8.1 · χ² 91 / p 7e-22	6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.8	no trial data cached
Rib fracture	16	8.0 4.9–13.0ROR 8.0 · χ² 91 / p 8e-22	6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Femur fracture	24	7.9 5.3–11.8ROR 8.0 · χ² 138 / p 3e-32	7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Sciatica	12	7.7 4.4–13.6ROR 7.8 · χ² 64 / p 6e-16	6.3 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Blood pressure fluctuation	17	7.2 4.5–11.6ROR 7.3 · χ² 85 / p 1e-20	6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 6.3	no trial data cached
Product dose omission issue	198	7.1 6.2–8.1ROR 7.8 · χ² 1,049 / p 2e-230	7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 16.2	no trial data cached
Lower limb fracture	13	7.0 4.1–12.0ROR 7.0 · χ² 61 / p 3e-15	5.8 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Treatment noncompliance	36	6.8 4.9–9.4ROR 6.9 · χ² 172 / p 1e-39	6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.5 · 78% consumer	no trial data cached
Ankle fracture	10	6.6 3.6–12.3ROR 6.6 · χ² 42 / p 4e-11	5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Cholelithiasis	20	6.2 4.0–9.7ROR 6.3 · χ² 83 / p 4e-20	5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Epilepsy	17	5.7 3.6–9.2ROR 5.7 · χ² 61 / p 2e-15	5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Gout	10	5.7 3.1–10.6ROR 5.7 · χ² 34 / p 2e-9	4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Bone disorder	10	5.6 3.0–10.3ROR 5.6 · χ² 33 / p 4e-9	4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.7	no trial data cached
Hepatic cirrhosis	10	5.5 3.0–10.2ROR 5.5 · χ² 32 / p 7e-9	4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial data cached
Road traffic accident	22	5.4 3.6–8.2ROR 5.4 · χ² 74 / p 3e-18	4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.9 · 73% consumer	no trial data cached
Influenza	56	5.1 4.0–6.6ROR 5.2 · χ² 183 / p 6e-42	4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Localised infection	12	5.1 2.9–8.9ROR 5.1 · χ² 35 / p 1e-9	4.3 EB05 2.7 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Limb injury	13	4.9 2.9–8.4ROR 4.9 · χ² 37 / p 7e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Weight increased (weight gain)	106	4.9 4.0–5.9ROR 5.1 · χ² 326 / p 4e-73	4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	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
Inappropriate schedule of product administration	212	12.3 10.8–14.0ROR 13.6 · χ² 2,202 / p <1e-300	12.2 EB05 10.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 19.1	no trial data cached
Product dose omission issue	198	7.1 6.2–8.1ROR 7.8 · χ² 1,049 / p 2e-230	7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 16.2	no trial data cached
Covid-19	167	9.7 8.4–11.2ROR 10.4 · χ² 1,299 / p 1e-284	9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Weight increased (weight gain)	106	4.9 4.0–5.9ROR 5.1 · χ² 326 / p 4e-73	4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Infusion related reaction (reaction during infusion)	102	15.8 13.1–19.1ROR 16.6 · χ² 1,404 / p <1e-300	15.7 EB05 13.3 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.7	no trial data cached
Bone pain	89	15.6 12.7–19.1ROR 16.2 · χ² 1,199 / p 5e-263	15.5 EB05 12.9 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.5	no trial data cached
Poor venous access	66	65.8 51.9–83.6ROR 68.0 · χ² 4,126 / p <1e-300	64.3 EB05 52.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=57	no trial data cached
Product availability issue	64	29.3 23.0–37.3ROR 30.2 · χ² 1,718 / p <1e-300	29.0 EB05 23.5 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 40.4 · 80% consumer	no trial data cached
No adverse event	58	3.3 2.6–4.3ROR 3.4 · χ² 94 / p 2e-22	3.3 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Influenza	56	5.1 4.0–6.6ROR 5.2 · χ² 183 / p 6e-42	4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Exposure during pregnancy	54	8.9 6.8–11.6ROR 9.1 · χ² 371 / p 5e-83	8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0 · ♀ 100% (drug 56%)	no trial data cached
Insurance issue	49	33.9 25.7–44.7ROR 34.7 · χ² 1,526 / p <1e-300	33.4 EB05 26.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 39.1 · 73% consumer	no trial data cached
Pregnancy	46	23.3 17.5–31.0ROR 23.8 · χ² 959 / p 6e-211	23.1 EB05 18.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.3 · ♀ 100% (drug 56%)	no trial data cached
Incorrect dose administered	43	2.0 1.5–2.6ROR 2.0 · χ² 19 / p 5e-6	1.9 EB05 1.5 · IC025 +0.4	Reporting / coding artifact	serious PRR 4.5	no trial data cached
Illness	41	4.2 3.1–5.7ROR 4.2 · χ² 96 / p 5e-23	4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 76% consumer	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.

Poor venous access — n=66, PRR 65.8
Weight fluctuation — n=37, PRR 36.5
Insurance issue — n=49, PRR 33.9
Pregnancy — n=46, PRR 23.3
Covid-19 — n=167, PRR 9.7
Abortion spontaneous — n=36, PRR 9.2
Osteonecrosis — n=29, PRR 9.0
Femur fracture — n=24, PRR 7.9
Cholelithiasis — n=20, PRR 6.2
Road traffic accident — n=22, PRR 5.4

✓ 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 Velaglucerase Alfa?

In FDA FAERS, the most frequently co-reported reaction terms for Velaglucerase Alfa are covid-19, weight increased, infusion related reaction, bone pain, poor venous access, influenza. 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 Velaglucerase 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 and after extended duration of therapy.

Do FAERS signals prove that Velaglucerase 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 ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf, effective 20241126; matched on openfda.generic_name.exact:"VELAGLUCERASE 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, 88 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.