Prescription medicine
Imiglucerase Brand names: Cerezyme
Imiglucerase (Cerezyme) is a prescription medicine with an FDA approval on record since 1994. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the imiglucerase FDA label on DailyMed (effective August 27, 2026, Genzyme Corporation); the BLA 20367 record on Drugs@FDA; every imiglucerase label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; 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 CEREZYME 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 CEREZYME 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. ( 5.1 ) Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. […]
Used for
From the label: indications and usageCEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients.
Forms and strengths
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- May 23, 1994 Cerezyme, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 4,703 through July 30, 2026
What is imiglucerase used for?
From the label: indications and usageCEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. CEREZYME is a hydrolytic lysosomal glucocerebrosidase-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients.
FDA pharmacologic class: Hydrolytic Lysosomal Glucocerebroside-specific Enzyme.
Source: FDA drug label (Cerezyme), Genzyme Corporation, effective August 27, 2026 (SPL set df60f030-866b-4374-a31f-8ae3f6b45c38), via openFDA; the full label on DailyMed
Is there a generic for imiglucerase (Cerezyme)?
No generic imiglucerase is approved (Drugs@FDA, October 8, 2026).
- 1994 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the imiglucerase label say about other medicines?
The imiglucerase label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name imiglucerase. 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 | … anaphylaxis) occurs, discontinue CEREZYME and immediately initiate appropriate medical treatment, including use of epinephrine. |
Other labels that name imiglucerase
Source: FDA drug label (Cerezyme), Genzyme Corporation, effective August 27, 2026 (SPL set df60f030-866b-4374-a31f-8ae3f6b45c38), via openFDA; the full label on DailyMed
What do FAERS reports show for imiglucerase?
The FDA Adverse Event Reporting System holds 4,703 reports that list imiglucerase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 820 are coded as a death and 1,460 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 glucocerebroside-specific enzymes
- the pharmacologic class, with prices and generics
- Imiglucerase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other