Galsulfase side effects: what 3,819 FDA adverse event reports show
Drug class
Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Brand names
Naglazyme
Who reports
3,819 reports · 66% serious · 348 with death outcome · 54% female
Used for
NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. NAGLAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. ( 1 )
What it is
NAGLAZYME is a formulation of galsulfase, which is a purified human enzyme that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Galsulfase (glycosaminoglycan N .
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.
Causality screen of the 40 strongest signals
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. 56 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Carpal tunnel syndrome | 46 | 18.0 13.5–24.0ROR 18.2 · χ² 720 / p 6e-159 | 17.8 EB05 13.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 80% consumer | no trial data cached |
| Device related infection | 48 | 17.1 12.9–22.7ROR 17.3 · χ² 710 / p 1e-156 | 16.9 EB05 13.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 14.3 | no trial data cached |
| Poor venous access | 32 | 17.0 12.1–24.1ROR 17.2 · χ² 466 / p 1e-103 | 16.8 EB05 12.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 48 | 16.7 12.6–22.2ROR 16.9 · χ² 693 / p 5e-153 | 16.6 EB05 12.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 · 74% consumer | no trial data cached |
| Sleep apnoea syndrome | 58 | 16.7 12.9–21.5ROR 16.9 · χ² 837 / p 3e-184 | 16.5 EB05 13.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.4 | no trial data cached |
| Mitral valve incompetence | 33 | 16.0 11.4–22.5ROR 16.2 · χ² 449 / p 7e-100 | 15.7 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Ear infection | 66 | 13.7 10.8–17.4ROR 13.9 · χ² 761 / p 9e-168 | 13.5 EB05 10.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 73% consumer | no trial data cached |
| Oxygen saturation decreased | 129 | 12.7 10.7–15.0ROR 13.1 · χ² 1,379 / p <1e-300 | 12.6 EB05 10.8 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 11.5 · 71% consumer | no trial data cached |
| Secretion discharge | 28 | 12.4 8.6–18.0ROR 12.5 · χ² 283 / p 9e-64 | 11.9 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · 96% consumer | no trial data cached |
| Bronchospasm (airway tightening) | 30 | 11.5 8.1–16.4ROR 11.6 · χ² 277 / p 2e-62 | 10.9 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · 71% consumer | no trial data cached |
| Respiratory disorder | 62 | 11.3 8.9–14.5ROR 11.5 · χ² 574 / p 3e-127 | 11.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 · 72% consumer | no trial data cached |
| Obstructive airways disorder | 22 | 10.8 7.1–16.4ROR 10.9 · χ² 186 / p 1e-42 | 9.9 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Tachypnoea | 25 | 10.1 6.9–15.0ROR 10.2 · χ² 196 / p 6e-45 | 9.3 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Respiratory distress | 48 | 9.5 7.2–12.6ROR 9.6 · χ² 358 / p 3e-80 | 9.1 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.3 | no trial data cached |
| Spinal operation | 19 | 8.6 5.5–13.5ROR 8.7 · χ² 120 / p 3e-28 | 7.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 | no trial data cached |
| Scratch | 16 | 8.5 5.2–13.8ROR 8.5 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Knee operation | 14 | 7.9 4.7–13.4ROR 7.9 · χ² 78 / p 6e-19 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Pulmonary hypertension | 30 | 7.9 5.5–11.2ROR 7.9 · χ² 173 / p 8e-40 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Respiratory tract infection | 35 | 7.4 5.3–10.3ROR 7.5 · χ² 187 / p 6e-43 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 71% consumer | no trial data cached |
| Scab | 15 | 7.3 4.4–12.0ROR 7.3 · χ² 75 / p 3e-18 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Cardiomegaly | 15 | 6.6 4.0–11.0ROR 6.7 · χ² 66 / p 2e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Pyrexia (fever) | 414 | 6.6 6.0–7.2ROR 7.2 · χ² 1,976 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 84% consumer | no trial data cached |
| Rhinorrhoea (runny nose) | 77 | 6.6 5.3–8.2ROR 6.7 · χ² 358 / p 5e-80 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 83% consumer | no trial data cached |
| Device occlusion | 16 | 6.3 3.9–10.3ROR 6.3 · χ² 66 / p 2e-16 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Body temperature increased | 23 | 6.2 4.1–9.3ROR 6.2 · χ² 94 / p 1e-22 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 · 74% consumer | no trial data cached |
| Pharyngitis streptococcal | 12 | 6.1 3.5–10.7ROR 6.1 · χ² 46 / p 6e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Viral infection | 34 | 5.6 4.0–7.8ROR 5.7 · χ² 124 / p 4e-29 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 80% consumer | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 46 | 5.5 4.1–7.3ROR 5.5 · χ² 164 / p 9e-38 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Complication associated with device | 13 | 5.4 3.1–9.3ROR 5.4 · χ² 42 / p 4e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Nasal congestion (stuffy nose) | 55 | 5.2 4.0–6.7ROR 5.2 · χ² 180 / p 2e-41 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 78% consumer | no trial data cached |
| Pneumonia (lung infection) | 303 | 5.1 4.6–5.7ROR 5.5 · χ² 1,021 / p 2e-224 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 73% consumer | no trial data cached |
| Hernia | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 56 / p 4e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Cardio-respiratory arrest | 39 | 5.1 3.7–6.9ROR 5.1 · χ² 124 / p 4e-29 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Product dose omission | 58 | 4.8 3.7–6.2ROR 4.9 · χ² 171 / p 2e-39 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 90% consumer | no trial data cached |
| Respiratory failure | 63 | 4.7 3.7–6.0ROR 4.8 · χ² 182 / p 8e-42 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Ear pain | 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 | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Influenza | 91 | 4.5 3.6–5.5ROR 4.5 · χ² 242 / p 7e-55 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 88% consumer | no trial data cached |
| Cough | 226 | 4.4 3.9–5.0ROR 4.6 · χ² 604 / p 1e-133 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 82% consumer | no trial data cached |
| Deafness | 20 | 4.2 2.7–6.5ROR 4.2 · χ² 45 / p 8e-12 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 · 85% consumer | no trial data cached |
| Head injury | 24 | 4.2 2.8–6.2ROR 4.2 · χ² 55 / p 7e-14 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 75% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 414 | 6.6 6.0–7.2ROR 7.2 · χ² 1,976 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 84% consumer | no trial data cached |
| Pneumonia (lung infection) | 303 | 5.1 4.6–5.7ROR 5.5 · χ² 1,021 / p 2e-224 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 73% consumer | no trial data cached |
| Cough | 226 | 4.4 3.9–5.0ROR 4.6 · χ² 604 / p 1e-133 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 82% consumer | no trial data cached |
| Oxygen saturation decreased | 129 | 12.7 10.7–15.0ROR 13.1 · χ² 1,379 / p <1e-300 | 12.6 EB05 10.8 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 11.5 · 71% consumer | no trial data cached |
| Influenza | 91 | 4.5 3.6–5.5ROR 4.5 · χ² 242 / p 7e-55 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 88% consumer | no trial data cached |
| Nasopharyngitis (common cold) | 89 | 2.6 2.2–3.2ROR 2.7 · χ² 90 / p 1e-21 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.0 · 88% consumer | no trial data cached |
| Rhinorrhoea (runny nose) | 77 | 6.6 5.3–8.2ROR 6.7 · χ² 358 / p 5e-80 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 83% consumer | no trial data cached |
| Ear infection | 66 | 13.7 10.8–17.4ROR 13.9 · χ² 761 / p 9e-168 | 13.5 EB05 10.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 73% consumer | no trial data cached |
| Seizure | 63 | 3.0 2.4–3.8ROR 3.0 · χ² 83 / p 4e-20 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 84% consumer | no trial data cached |
| Respiratory failure | 63 | 4.7 3.7–6.0ROR 4.8 · χ² 182 / p 8e-42 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Respiratory disorder | 62 | 11.3 8.9–14.5ROR 11.5 · χ² 574 / p 3e-127 | 11.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 · 72% consumer | no trial data cached |
| Product dose omission | 58 | 4.8 3.7–6.2ROR 4.9 · χ² 171 / p 2e-39 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 90% consumer | no trial data cached |
| Sleep apnoea syndrome | 58 | 16.7 12.9–21.5ROR 16.9 · χ² 837 / p 3e-184 | 16.5 EB05 13.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.4 | no trial data cached |
| Nasal congestion (stuffy nose) | 55 | 5.2 4.0–6.7ROR 5.2 · χ² 180 / p 2e-41 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 78% consumer | no trial data cached |
| Respiratory distress | 48 | 9.5 7.2–12.6ROR 9.6 · χ² 358 / p 3e-80 | 9.1 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.3 | 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.
- Carpal tunnel syndrome — n=46, PRR 18.0
- Poor venous access — n=32, PRR 17.0
- Mitral valve incompetence — n=33, PRR 16.0
- Ear infection — n=66, PRR 13.7
- Secretion discharge — n=28, PRR 12.4
- Obstructive airways disorder — n=22, PRR 10.8
- Tachypnoea — n=25, PRR 10.1
- Respiratory tract infection — n=35, PRR 7.4
- Rhinorrhoea — n=77, PRR 6.6
- Viral infection — n=34, PRR 5.6
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 Galsulfase?
In FDA FAERS, the most frequently co-reported reaction terms for Galsulfase are pyrexia, pneumonia, cough, oxygen saturation decreased, influenza, nasopharyngitis. 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 Galsulfase 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 Galsulfase 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 59341250-deac-ed71-3823-a4f5d64dbd77, effective 20240918; matched on
openfda.generic_name.exact:"GALSULFASE") - 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, fieldpatient.drug.openfda.generic_name.exact, 96 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.