Pharmacologic class (EPC) · 6 drug pages

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

17,202 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.

17,202
reports across the class: 0.1% of all reports; 1,054
reports, 12 months to June 2026: 1,100 in the 12 months before; 63.8%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Hydrolytic lysosomal glycosaminoglycan-specific enzyme is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 17,202 adverse event reports received by FDA, 0.1% of the database, from February 2004 to June 2026.

1,054 reports arrived in the 12 months to June 2026, close to the 1,100 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 63.8% of the class's reports are marked serious, 10.6% record death among the outcomes and 35.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are pyrexia (13.1%), cough (6.1%) and pneumonia (5.9%). 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
VimizimElosulfase alfa	brand	5,369	430	40.4%	Pyrexia
NaglazymeGalsulfase	brand	3,827	201	65.9%	Pyrexia
AldurazymeLaronidase	brand	3,228	128	70.6%	Pyrexia
Idursulfase	generic	2,170	133	96.2%	Product dose omission issue
ElapraseIdursulfase	brand	1,785	51	78.8%	Infusion related reaction
Laronidase	generic	823	111	62.5%	Pyrexia

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

Pyrexiafever13.1%2,250
Coughcough6.1%1,053
Pneumonialung infection5.9%1,008
Dyspnoeashortness of breath5.1%873
Vomitingbeing sick4.8%823
Malaisegeneral feeling of being unwell4.2%721
Product dose omission issuea dose was missed3.4%584
Headachehead pain3.4%578
Influenzaflu3.3%563
Infusion related reactiona reaction during or soon after an infusion3.3%561
Fatiguetiredness3.3%560
Nasopharyngitisa cold3.2%556
Painpain, site not specified3.2%551
Inappropriate schedule of product administrationthe product was taken at the wrong times3.1%533
Deaththe patient died; cause not stated by this term3.1%529
Oxygen saturation decreased2.7%473
Covid-19COVID-19 infection2.5%435
Urticariahives2.4%411
Diarrhoealoose or frequent stools2.4%410
Nauseafeeling sick2.4%405
Seizurea fit or convulsion2.2%386
Poor venous access2.2%376
Falla fall2%343
Rashskin rash1.9%334
Weight increasedweight gain1.9%329

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.6%1,820

Life-threatening2.4%411

Hospitalisation (initial or prolonged)35.5%6,113

Disability2%345

Congenital anomaly0.2%36

Other serious36.3%6,241

Not serious36.2%6,225

Patient age

Under 22.3%404

2 to 1122.8%3,920

12 to 1712.2%2,098

18 to 4415.1%2,589

45 to 641.7%289

65 to 740.1%20

75 and over0%4

Age not given45.8%7,878

Who reported

Physician17.6%3,033

Pharmacist1.3%228

Other health professional15.3%2,638

Lawyer0%0

Consumer or non-health professional64.7%11,133

Not given1%170

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 glycosaminoglycan-specific enzyme reports

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

Vimizim, Naglazyme, Aldurazyme, Idursulfase, Elaprase and Laronidase. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

17,202 reports through June 2026, 1,054 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 (13.1%), cough (6.1%), pneumonia (5.9%), dyspnoea (5.1%) and vomiting (4.8%).

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.