Alglucosidase Alfa side effects: what 2,392 FDA adverse event reports show

Alglucosidase Alfa · Lumizyme · 55 reaction terms · 1,344 drug–reaction co-reports · data 2026-09-14

Drug class

Hydrolytic Lysosomal Glycogen-specific Enzyme

FDA label (Established Pharmacologic Class)

Brand names

Lumizyme

openFDA label

Who reports

2,392 reports · 38% serious · 116 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency). LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency). ( 1 )

FDA label, Indications and Usage

What it is

Alglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme encoded by the predominant of nine observed haplotypes of the human acid α-glucosidase (GAA) gene. Alglucosidase alfa is produced by recombinant DNA technology in a Chinese hamster ovary cell line.

FDA label, Description section

Boxed warning

HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE See full prescribing information for complete boxed warning.

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 33 strongest signals

Labeled adverse reaction 5Labeled (related wording) 4Reporting / coding artifact 12Lab value / disease marker 3Not in label — unassessed 9

What the badges mean

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. 22 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	32	27.3 19.3–38.5ROR 27.6 · χ² 781 / p 3e-172	26.8 EB05 19.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial data cached
Device related infection	29	16.5 11.5–23.7ROR 16.7 · χ² 407 / p 1e-90	16.2 EB05 11.7 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 25.7	no trial data cached
Device occlusion	24	15.1 10.2–22.6ROR 15.3 · χ² 303 / p 4e-68	14.7 EB05 10.1 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=6 · ♀ 30% (drug 53%)	no trial data cached
Infusion related reaction (reaction during infusion)	83	11.0 8.9–13.6ROR 11.4 · χ² 748 / p 5e-165	10.8 EB05 8.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Inappropriate schedule of product administration	204	10.1 8.9–11.5ROR 11.0 · χ² 1,681 / p <1e-300	10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6	no trial data cached
Aspiration	12	9.7 5.5–17.1ROR 9.8 · χ² 85 / p 1e-20	8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Respiratory distress	28	8.9 6.2–12.9ROR 9.0 · χ² 188 / p 3e-43	8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.7	no trial data cached
Blood creatine phosphokinase increased	27	8.1 5.6–11.8ROR 8.2 · χ² 161 / p 3e-37	7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 7.6	no trial data cached
Oxygen saturation decreased	47	7.4 5.6–9.8ROR 7.5 · χ² 254 / p 2e-57	7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 10.0	no trial data cached
Body temperature increased	17	7.3 4.5–11.7ROR 7.3 · χ² 86 / p 9e-21	6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.8	no trial data cached
Respiratory tract infection	21	7.1 4.6–10.9ROR 7.1 · χ² 104 / p 1e-24	6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Infusion site pain	10	6.9 3.7–12.8ROR 6.9 · χ² 44 / p 1e-11	5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Product preparation error	16	6.8 4.2–11.0ROR 6.8 · χ² 73 / p 6e-18	5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Gastroenteritis viral	13	6.3 3.7–10.8ROR 6.3 · χ² 53 / p 2e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Respiratory disorder	21	6.1 4.0–9.4ROR 6.2 · χ² 85 / p 1e-20	5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.6	no trial data cached
Pneumothorax	11	6.1 3.4–11.0ROR 6.1 · χ² 42 / p 5e-11	5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Muscular weakness	67	5.2 4.1–6.5ROR 5.3 · χ² 222 / p 1e-50	5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Urticaria (hives)	87	4.6 3.7–5.6ROR 4.7 · χ² 242 / p 7e-55	4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.1	no trial data cached
Femur fracture	16	4.5 2.8–7.4ROR 4.5 · χ² 40 / p 1e-10	4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Illness	49	4.3 3.2–5.6ROR 4.3 · χ² 120 / p 3e-28	4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Heart rate increased	45	4.0 3.0–5.3ROR 4.0 · χ² 98 / p 2e-23	3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Ear infection	12	4.0 2.3–7.0ROR 4.0 · χ² 24 / p 6e-7	3.5 EB05 2.2 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 1.8	no trial data cached
Pallor	11	3.5 2.0–6.4ROR 3.5 · χ² 18 / p 1e-5	3.2 EB05 1.9 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 5.1	no trial data cached
Unevaluable event	29	3.4 2.3–4.8ROR 3.4 · χ² 46 / p 6e-12	3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Therapeutic response decreased	23	3.3 2.2–5.0ROR 3.4 · χ² 36 / p 1e-9	3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Throat tightness	10	3.2 1.7–6.0ROR 3.3 · χ² 13 / p 1e-4	2.9 EB05 1.7 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 2.1	no trial data cached
Exposure during pregnancy	23	3.2 2.2–4.9ROR 3.3 · χ² 34 / p 3e-9	3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9 · ♀ 100% (drug 53%)	no trial data cached
Product storage error	32	3.2 2.3–4.6ROR 3.3 · χ² 48 / p 3e-12	3.1 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Hospitalisation	55	3.2 2.4–4.1ROR 3.2 · χ² 80 / p 2e-19	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Hip fracture	11	3.0 1.7–5.4ROR 3.0 · χ² 13 / p 2e-4	2.7 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 4.6	no trial data cached
Disease progression	40	3.0 2.2–4.0ROR 3.0 · χ² 51 / p 5e-13	2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Flushing	34	2.9 2.1–4.1ROR 2.9 · χ² 41 / p 7e-11	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.2	no trial data cached
Product dose omission	17	2.3 1.4–3.6ROR 2.3 · χ² 11 / p 6e-4	2.2 EB05 1.5 · IC025 +0.3	Reporting / coding artifact	serious PRR 3.3	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
Inappropriate schedule of product administration	204	10.1 8.9–11.5ROR 11.0 · χ² 1,681 / p <1e-300	10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6	no trial data cached
Urticaria (hives)	87	4.6 3.7–5.6ROR 4.7 · χ² 242 / p 7e-55	4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.1	no trial data cached
Infusion related reaction (reaction during infusion)	83	11.0 8.9–13.6ROR 11.4 · χ² 748 / p 5e-165	10.8 EB05 8.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Muscular weakness	67	5.2 4.1–6.5ROR 5.3 · χ² 222 / p 1e-50	5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Hospitalisation	55	3.2 2.4–4.1ROR 3.2 · χ² 80 / p 2e-19	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Incorrect dose administered	50	1.9 1.5–2.6ROR 2.0 · χ² 22 / p 1e-6	1.9 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 0.7	no trial data cached
Illness	49	4.3 3.2–5.6ROR 4.3 · χ² 120 / p 3e-28	4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Oxygen saturation decreased	47	7.4 5.6–9.8ROR 7.5 · χ² 254 / p 2e-57	7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 10.0	no trial data cached
Heart rate increased	45	4.0 3.0–5.3ROR 4.0 · χ² 98 / p 2e-23	3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Disease progression	40	3.0 2.2–4.0ROR 3.0 · χ² 51 / p 5e-13	2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Flushing	34	2.9 2.1–4.1ROR 2.9 · χ² 41 / p 7e-11	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.2	no trial data cached
Product storage error	32	3.2 2.3–4.6ROR 3.3 · χ² 48 / p 3e-12	3.1 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Poor venous access	32	27.3 19.3–38.5ROR 27.6 · χ² 781 / p 3e-172	26.8 EB05 19.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial data cached
Unevaluable event	29	3.4 2.3–4.8ROR 3.4 · χ² 46 / p 6e-12	3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Device related infection	29	16.5 11.5–23.7ROR 16.7 · χ² 407 / p 1e-90	16.2 EB05 11.7 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 25.7	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=83, PRR 11.0
Respiratory tract infection — n=21, PRR 7.1
Muscular weakness — n=67, PRR 5.2

✓ 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 Alglucosidase Alfa?

In FDA FAERS, the most frequently co-reported reaction terms for Alglucosidase Alfa are urticaria, infusion related reaction, muscular weakness, oxygen saturation decreased, heart rate increased, flushing. 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 Alglucosidase Alfa have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE See full prescribing information for complete boxed warning.

Do FAERS signals prove that Alglucosidase 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 d6bfbc45-2d34-439e-8aad-59ee2d53d4df, effective 20250110; matched on openfda.generic_name.exact:"ALGLUCOSIDASE 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, 55 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.