Pharmacologic class (EPC) · 2 drug pages

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

9,110 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.

9,110
reports across the class: 0% of all reports; 652
reports, 12 months to June 2026: 558 in the 12 months before; 51.7%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 9,110 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

652 reports arrived in the 12 months to June 2026, up 17% from 558 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 51.7% of the class's reports are marked serious, 7.7% record death among the outcomes and 27.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are pyrexia (5.6%), pain (5.6%) and malaise (5.4%). 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
FabrazymeAgalsidase beta	brand	8,437	551	50%	Pyrexia
Agalsidase beta	generic	673	101	72.7%	Fatigue

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

Pyrexiafever5.6%513
Painpain, site not specified5.6%506
Malaisegeneral feeling of being unwell5.4%490
Chillschills or shivering5.1%466
Nauseafeeling sick5%457
Fatiguetiredness4.6%422
Dyspnoeashortness of breath4.6%417
Headachehead pain4.1%373
Vomitingbeing sick4%363
Weight decreasedweight loss3.7%336
Pain in extremitypain in an arm or leg3.4%312
Infusion related reactiona reaction during or soon after an infusion3.2%289
Dizzinesslight-headedness or unsteadiness3%273
Weight increasedweight gain2.9%266
Condition aggravatedthe condition being treated got worse2.9%265
Coughcough2.8%253
Chest painchest pain2.7%246
Cerebrovascular accidentstroke2.7%245
Diarrhoealoose or frequent stools2.4%223
Illness2.4%217
Atrial fibrillationan irregular heart rhythm2.3%205
Drug specific antibody present2.2%200
Pruritusitching2.2%196
Falla fall2.1%195
Paraesthesiatingling or pins and needles2%181

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death7.7%699

Life-threatening1.7%154

Hospitalisation (initial or prolonged)27.1%2,467

Disability1.2%111

Congenital anomaly0%3

Other serious29.4%2,681

Not serious48.3%4,399

Patient age

Under 20.1%11

2 to 112.7%242

12 to 175.1%468

18 to 4428.5%2,597

45 to 6429.6%2,700

65 to 745.3%483

75 and over1.2%113

Age not given27.4%2,496

Who reported

Physician39.8%3,628

Pharmacist4%360

Other health professional22.7%2,066

Lawyer0%3

Consumer or non-health professional32.8%2,990

Not given0.7%63

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 neutral glycosphingolipid-specific enzyme reports

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

Fabrazyme and Agalsidase beta. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

9,110 reports through June 2026, 652 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?

pyrexia (5.6%), pain (5.6%), malaise (5.4%), chills (5.1%) and nausea (5%).

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.