Imiglucerase: uses, dosing, side effects & brands
Imiglucerase is a medicine sold in the U.S. under one brand, for gaucher disease, liver diseases and splenic diseases. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Gaucher Disease, Liver Diseases and Splenic Diseases
- Available as
- Injectable
- Sold as
- Cerezyme
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How imiglucerase is dosed
From the FDA label for Cerezyme (application BLA020367). Other imiglucerase products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer CEREZYME under the supervision of a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. ( 2.1 ) The recommended dosage is 2.5 units/kg three times a week to 60 units/kg once every two weeks administered intravenously. ( 2.2 ) Titrate the dosage based on disease severity and therapeutic goals for the patient. ( 2.2 ) See the full prescribing information for dosage modifications due to hypersensitivity reactions and/or IARs. ( 2.3 ) See the full prescribing information for preparation and administration instructions. ( 2.4 , 2.5 ) 2.1 Recommendations Prior to CEREZYME Treatment Administer CEREZYME under the supervision of a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ] . Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Warnings and Precautions (5.1) ] . For patients who experience hypersensitivity reactions to CEREZYME, premedicate with antihistamines and/or corticosteroids. Monitor patients for the occurrence of new hypersensitivity reactions [see Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage and Administration Ensure physicians knowledgeable in the management of patients with Gaucher disease…
Imiglucerase side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions [see Warnings and Precautions (5.2) ] Adverse reactions reported in adults and pediatric patients include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials and Postmarketing Experience The following adverse reactions associated with the use of imiglucerase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. See Table 2 for adverse reactions occurring in adults and pediatric patients treated with CEREZYME in clinical trials and the postmarketing setting. Table 2: Adverse Reactions in Adults and Pediatric Patients Treated with CEREZYME Adverse Reactions Nervous system disorders dizziness, headache Cardiac disorders tachycardia Vascular disorders cyanosis, Signs and symptoms suggestive of hypersensitivity reactions including anaphylaxis [see…
Who shouldn’t take imiglucerase
None. None. ( 4 )
Every imiglucerase product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Cerezyme.
Imiglucerase and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for imiglucerase: levels in milk, effects in breastfed infants, and the drugs it would consider insteadImiglucerase is a synthetic form of beta-glucocerebrosidase, which is a normal component of human milk. After therapeutic use of imiglucerase, breastmilk levels are lower than those of normal mothers. Additionally, absorption by the infant is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. International panels of clinicians that treat Gaucher’s disease recommend breastfeeding with enzyme replacement therapy such as imiglucerase. Consider limiting the duration of breastfeeding to about 6 months to avoid excessive bone loss in the nursing mother.[3–5]
National Institute of Child Health and Human Development, record revised May 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about imiglucerase
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 258 reports naming imiglucerase, and the FDA flagged 68% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue22 reports
- pyrexia22 reports
- exposure during pregnancy17 reports
- cough14 reports
- seizure14 reports
- bone pain13 reports
- dyspnoea13 reports
- malaise13 reports
Read these as a signal, not a rate. A report does not mean imiglucerase caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is imiglucerase?
Imiglucerase is a hydrolytic lysosomal glucocerebrosidase-specific enzyme.
Can you take imiglucerase with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run imiglucerase against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does imiglucerase come in?
Across the brands we track, imiglucerase is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic imiglucerase?
We do not currently list a generic-labelled imiglucerase product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Imiglucerase: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/imiglucerase
- MLA
- “Imiglucerase: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/imiglucerase.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for imiglucerase on DailyMed (NIH) ↗ — including its boxed warning in full.