Pharmacologic class (EPC) · 3 drug pages

Hydrolytic lysosomal glucocerebroside-specific enzyme: adverse event reports filed with FDA

6,362 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

6,362
reports across the class: 0% of all reports; 316
reports, 12 months to June 2026: 345 in the 12 months before; 74.5%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Hydrolytic lysosomal glucocerebroside-specific enzyme is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 6,362 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

316 reports arrived in the 12 months to June 2026, close to the 345 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 74.5% of the class's reports are marked serious, 16.6% record death among the outcomes and 35% record hospitalisation, as reported.

Across the class the reactions recorded most often are fatigue (4.7%), pyrexia (4.6%) and death (4.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
CerezymeImiglucerase	brand	4,348	198	70%	Pyrexia
Velaglucerase alfa	generic	1,189	97	95%	Inappropriate schedule of product administration
VprivVelaglucerase alfa	brand	825	21	68.6%	Infusion related reaction

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Fatiguetiredness4.7%299
Pyrexiafever4.6%292
Deaththe patient died; cause not stated by this term4.4%278
Product dose omission issuea dose was missed4.2%269
Falla fall4.1%264
Inappropriate schedule of product administrationthe product was taken at the wrong times4%253
Weight increasedweight gain3.8%239
Pneumonialung infection3.7%235
Covid-19COVID-19 infection3.5%220
Malaisegeneral feeling of being unwell3.5%220
Bone painbone pain3.3%209
Weight decreasedweight loss3.1%200
Arthralgiajoint pain3.1%199
Headachehead pain3%191
Exposure during pregnancythe medicine was taken during pregnancy2.9%186
Dyspnoeashortness of breath2.8%178
Nauseafeeling sick2.7%171
Painpain, site not specified2.6%165
Dizzinesslight-headedness or unsteadiness2.5%156
Abdominal painstomach or belly pain2.4%155
Coughcough2.3%149
Pain in extremitypain in an arm or leg2.3%149
Infusion related reactiona reaction during or soon after an infusion2.2%142
Vomitingbeing sick2.2%141
Back painback pain2%130

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death16.6%1,056

Life-threatening2.4%154

Hospitalisation (initial or prolonged)35%2,224

Disability1.9%119

Congenital anomaly0.2%10

Other serious45.8%2,912

Not serious25.5%1,623

Patient age

Under 22.8%176

2 to 119.8%624

12 to 175.1%324

18 to 4419.7%1,254

45 to 6414.2%901

65 to 746.8%435

75 and over6.1%389

Age not given35.5%2,259

Who reported

Physician41.3%2,626

Pharmacist2.8%181

Other health professional19.7%1,251

Lawyer0%0

Consumer or non-health professional35.3%2,246

Not given0.9%58

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Hydrolytic lysosomal glucocerebroside-specific enzyme reports

Which drugs are in the Hydrolytic lysosomal glucocerebroside-specific enzyme class on this site?

Cerezyme, Velaglucerase alfa and Vpriv. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

6,362 reports through June 2026, 316 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

fatigue (4.7%), pyrexia (4.6%), death (4.4%), product dose omission issue (4.2%) and fall (4.1%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.