Drugs › Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme
Generic name
Agalsidase beta: adverse event reports filed with FDA
673 reports list it as a suspect or interacting product, 2013–2026. Class: Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme.
- 673
- reports as suspect product
- 0% of all reports · about 52 a year
- 101
- reports, 12 months to June 2026
- 54 in the 12 months before
- 72.7%
- marked serious by the reporter
- 51.7% across the class
- 3.6%
- record death among outcomes, as reported
- 24 reports · not verified by FDA
673 adverse event reports received by FDA list agalsidase beta, a generic name as a suspect or interacting product, from September 2013 to June 2026. A further 17 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 101 reports listed it, up 87% from 54 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 52 reports a year and 0% of the 20,646,523 reports in the database, and 7.4% of the reports for the hydrolytic lysosomal neutral glycosphingolipid-specific enzyme class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded fatigue (15.6%), pain (15.3%) and malaise (14.9%). A report can list several reactions, so shares add to more than 100%; 312 different terms appear across these reports. Fatigue is recorded in 15.6% of these reports, a larger share than in the median hydrolytic lysosomal neutral glycosphingolipid-specific enzyme drug (9.7%).
72.7% of the reports are marked serious by the reporter (51.7% across the class); 3.6% record death among the outcomes and 32.4% record hospitalisation, as reported. 48.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (35.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Agalsidase beta reports recording the termmedian drug in hydrolytic lysosomal neutral glycosphingolipid-specific enzyme
- Fatiguetiredness15.6%105
- Painpain, site not specified15.3%103
- Malaisegeneral feeling of being unwell14.9%100
- Pain in extremitypain in an arm or leg9.5%64
- Dyspnoeashortness of breath9.2%62
- Pyrexiafever9.2%62
- Dizzinesslight-headedness or unsteadiness8.9%60
- Headachehead pain8.6%58
- Nauseafeeling sick8.3%56
- Vomitingbeing sick8.3%56
- Diarrhoealoose or frequent stools6.7%45
- Condition aggravatedthe condition being treated got worse6.2%42
- Atrial fibrillationan irregular heart rhythm5.8%39
- Weight decreasedweight loss5.8%39
- Chillschills or shivering5.5%37
- Chest painchest pain5.3%36
- Astheniaweakness or lack of energy5.2%35
- Falla fall4.5%30
- Feeling abnormalfeeling odd or not right4.3%29
- Loss of consciousnesspassing out4.3%29
- Hypotensionlow blood pressure4.2%28
- Syncopefainting4.2%28
- Cerebrovascular accidentstroke3.9%26
- Coughcough3.9%26
- Abdominal discomfortstomach discomfort3.7%25
- Burning sensationa burning feeling3.7%25
- Cardiac disorder3.7%25
- Abdominal painstomach or belly pain3.6%24
- Seizurea fit or convulsion3.6%24
Top 30 of 312 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the hydrolytic lysosomal neutral glycosphingolipid-specific enzyme class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 9,110 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 69.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Fabry's disease | 516 | 76.7% |
| Mucopolysaccharidosis | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 673 reports.
In context
| Measure | Agalsidase beta | Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme | All reports |
|---|---|---|---|
| Reports as suspect product | 673 | 9,110 | 20,646,523 |
| Share of that pool | — | 7.4% | 0% |
| Reports, latest 12 months | 101 | — | 1,332,454 |
| Marked serious | 72.7% | 51.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 36 | 77 | 91 |
| Hospitalisation recorded, per 1,000 reports | 324 | 271 | 213 |
| Consumer-filed share | 48.3% | 32.8% | 45.8% |
| Top term, share of reports | Fatigue 15.6% | median 9.7% | 3.7% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the hydrolytic lysosomal neutral glycosphingolipid-specific enzyme class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Fabrazyme | brand | 8,437 | 551 | 50% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Agalsidase beta reports
How many adverse event reports has FDA received for Agalsidase beta?
673 reports list Agalsidase beta as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 101 of them arrived in the latest 12 months. Another 17 list it only as a concomitant medication.
What reactions are recorded in Agalsidase beta reports?
fatigue (15.6%), pain (15.3%), malaise (14.9%), pain in extremity (9.5%) and dyspnoea (9.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Agalsidase beta was responsible.
How serious are the reports?
72.7% are marked serious by the reporter. Among the outcomes recorded, 3.6% of reports include death and 32.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (48.3%), physician (34.6%) and other health professional (15.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Agalsidase beta rising?
101 reports in the 12 months to June 2026, up 87% from 54 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Agalsidase beta was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Agalsidase beta?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Agalsidase beta as a suspect or interacting product; reports listing it only as a concomitant medication (17) are excluded. 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.