Prescription medicine
Agalsidase beta Brand names: Fabrazyme
Agalsidase beta (Fabrazyme) is a prescription medicine with an FDA approval on record since 2003. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the agalsidase beta FDA label on DailyMed (effective August 22, 2025, Genzyme Corporation); the BLA 103979 record on Drugs@FDA; every agalsidase beta label on DailyMed.
Highlights of the record
FDA label of August 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS.
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue FABRAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur. [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. […]
Used for
From the label: indications and usageFABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
Forms and strengths
- 5 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- April 24, 2003 Fabrazyme, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,189 through July 30, 2026
What is agalsidase beta used for?
From the label: indications and usageFABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. FABRAZYME is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
FDA pharmacologic class: Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme.
Source: FDA drug label (Fabrazyme), Genzyme Corporation, effective August 22, 2025 (SPL set 988513ab-b06f-4dd0-93f7-d2d4531dcce4), via openFDA; the full label on DailyMed
Is there a generic for agalsidase beta (Fabrazyme)?
No generic agalsidase beta is approved (Drugs@FDA, October 8, 2026).
- 2003 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the agalsidase beta label say about other medicines?
The agalsidase beta label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | boxed warning | If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue FABRAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. |
Source: FDA drug label (Fabrazyme), Genzyme Corporation, effective August 22, 2025 (SPL set 988513ab-b06f-4dd0-93f7-d2d4531dcce4), via openFDA; the full label on DailyMed
What do FAERS reports show for agalsidase beta?
The FDA Adverse Event Reporting System holds 9,189 reports that list agalsidase beta among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 699 are coded as a death and 2,485 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hydrolytic lysosomal neutral glycosphingolipid-specific enzymes
- the pharmacologic class, with prices and generics
- Agalsidase beta side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other