Pharmacologic class (EPC) · 2 drug pages

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

2,843 reports list a drug in this class as a suspect or interacting product, 2010–2026.

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.

2,843
reports across the class: 0% of all reports; 300
reports, 12 months to June 2026: 316 in the 12 months before; 28.5%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Hydrolytic lysosomal glycogen-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 2,843 adverse event reports received by FDA, 0% of the database, from October 2010 to June 2026.

300 reports arrived in the 12 months to June 2026, close to the 316 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 28.5% of the class's reports are marked serious, 2.9% record death among the outcomes and 17% record hospitalisation, as reported.

Across the class the reactions recorded most often are inappropriate schedule of product administration (7.9%), off label use (7.1%) and drug specific antibody present (7%). 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
LumizymeAlglucosidase alfa	brand	2,000	100	33%	Inappropriate schedule of product administration
NexviazymeAvalglucosidase alfa-ngpt	brand	843	200	17.9%	Drug specific antibody present

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

Inappropriate schedule of product administrationthe product was taken at the wrong times7.9%225
Off label useused for a purpose or in a way not on the label7.1%201
Drug specific antibody present7%200
Pyrexiafever5.5%157
Dyspnoeashortness of breath4.2%119
Weight increasedweight gain3.8%109
Falla fall3.3%94
Weight decreasedweight loss3.3%94
Malaisegeneral feeling of being unwell3.3%93
Fatiguetiredness3.1%87
Pneumonialung infection3%84
Infusion related reactiona reaction during or soon after an infusion2.8%81
Rashskin rash2.8%81
Urticariahives2.7%77
Illness2.5%72
Painpain, site not specified2.3%66
Headachehead pain2.1%61
Condition aggravatedthe condition being treated got worse2%58
Incorrect dose administeredthe wrong dose was given2%58
Astheniaweakness or lack of energy1.9%55
Pruritusitching1.9%54
Vomitingbeing sick1.9%53
Covid-19COVID-19 infection1.8%52
Nauseafeeling sick1.8%51
Hospitalisationadmission to hospital1.7%49

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

Death2.9%83

Life-threatening0.6%17

Hospitalisation (initial or prolonged)17%483

Disability0.7%21

Congenital anomaly0.1%2

Other serious15.8%450

Not serious71.5%2,033

Patient age

Under 26%171

2 to 1117.2%488

12 to 174.9%139

18 to 4416.9%480

45 to 6417.6%501

65 to 745.7%163

75 and over1.8%52

Age not given29.9%849

Who reported

Physician36.4%1,035

Pharmacist9.1%259

Other health professional28.1%799

Lawyer0%0

Consumer or non-health professional26.2%745

Not given0.2%5

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 glycogen-specific enzyme reports

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

Lumizyme and Nexviazyme. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,843 reports through June 2026, 300 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?

inappropriate schedule of product administration (7.9%), off label use (7.1%), drug specific antibody present (7%), pyrexia (5.5%) and dyspnoea (4.2%).

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.