Hydrolytic Lysosomal Glucocerebroside-specific Enzyme side effects compared: 3 drugs, 7,318 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Imiglucerase (Cerezyme) | 4,703 | 70% | 820 | boxed | Cyanosis; Pulmonary hypertension; Respiratory disorder | Bone pain; Convulsion |
| Velaglucerase Alfa (Vpriv) | 2,049 | 84% | 279 | boxed | Infusion related reaction; Bone pain; Infusion site pain | Covid-19; Weight increased |
| Taliglucerase Alfa (Elelyso) | 566 | 72% | 49 | boxed | – | Infusion related reaction |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Osteonecrosis | 3/3 | 11.2 | 124 | 0/3 members' labels |
| Poor venous access | 2/3 | 46.0 | 126 | 0/2 members' labels |
| Weight fluctuation | 2/3 | 21.0 | 50 | 0/2 members' labels |
| Splenomegaly | 2/3 | 21.0 | 85 | 0/2 members' labels |
| Infusion related reaction | 2/3 | 17.5 | 136 | 1/2 members' labels |
| Pregnancy | 2/3 | 14.8 | 74 | 0/2 members' labels |
| Bone pain | 2/3 | 13.4 | 236 | 1/2 members' labels |
| Hepatomegaly | 2/3 | 12.9 | 44 | 0/2 members' labels |
| Infusion site pain | 2/3 | 9.0 | 31 | 2/2 members' labels |
| Bone disorder | 2/3 | 8.6 | 58 | 1/2 members' labels |
| Abortion spontaneous | 2/3 | 8.5 | 106 | 0/2 members' labels |
| Epilepsy | 2/3 | 7.4 | 79 | 0/2 members' labels |
| Femur fracture | 2/3 | 6.8 | 64 | 0/2 members' labels |
| Wrist fracture | 2/3 | 6.7 | 22 | 0/2 members' labels |
| Upper limb fracture | 2/3 | 6.7 | 37 | 0/2 members' labels |
| Hepatic cirrhosis | 2/3 | 5.2 | 31 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which hydrolytic lysosomal glucocerebroside-specific enzyme has the most FDA adverse event reports?
Imiglucerase has the most FAERS co-reports in this class (4,703), followed by Velaglucerase Alfa (2,049). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across hydrolytic lysosomal glucocerebroside-specific enzyme drugs?
Reaction terms flagged in at least half of the 3 members include osteonecrosis, poor venous access, weight fluctuation, splenomegaly, infusion related reaction. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.