Laronidase: uses, dosing, side effects & brands
Laronidase is a hydrolytic lysosomal glycosaminoglycan-specific enzyme sold in the U.S. under one brand, for mucopolysaccharidosis i. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Hydrolytic Lysosomal Glycosaminoglycan-Specific Enzyme
- Treats
- Mucopolysaccharidosis I
- Available as
- Injectable
- Sold as
- Aldurazyme
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How laronidase is dosed
From the FDA label for Aldurazyme (application BLA125058). Other laronidase products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For pretreatment recommendations, see Full Prescribing Information. ( 2.1 ) The recommended dosage is 0.58 mg/kg administered once weekly as an intravenous infusion. ( 2.2 ) For dosage and administration modifications due to hypersensitivity reactions or infusion-associated reactions (IARs), see Full Prescribing Information. ( 2.3 ) For instructions on preparation, storage, and administration, see Full Prescribing Information. ( 2.4 , 2.5 , 2.6 ) 2.1 Recommendations Prior to ALDURAZYME Treatment Premedication Prior to ALDURAZYME administration, consider premedicating with antihistamines, with or without antipyretics, 60 minutes before the start of infusion [see Warnings and Precautions (5.1 , 5.4) ]. Medical Support Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration. 2.2 Recommended Dosage and Administration The recommended dosage of ALDURAZYME is 0.58 mg/kg (actual body weight) administered once weekly as an intravenous infusion. ALDURAZYME injection must be diluted with 0.9% Sodium Chloride Injection to a final volume of 50 mL, 100 mL or 250 mL as determined by the patient's body weight and cardiopulmonary condition: Patients with a body weight equal to or greater than 2 kg and less than 4 kg should receive a total volume of 50 mL; patients with a body weight…
Laronidase side effects
Serious and or clinically significant adverse reactions described elsewhere in labeling include: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Acute Respiratory Complications Associated with Administration [see Warnings and Precautions (5.2) ] Acute Cardiorespiratory Failure [see Warnings and Precautions (5.3) ] Infusion-Associated Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥10%) in patients: 6 months of age and older are: infusion reactions (pyrexia, chills, blood pressure increased, tachycardia, and oxygen saturation decreased). ( 6.1 ) 6 years and older are: rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Serious adverse reactions reported with ALDURAZYME treatment during clinical trials were anaphylactic and hypersensitivity reactions. The most common adverse reactions were infusion…
Who shouldn’t take laronidase
None. None. ( 4 )
Every laronidase 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: Aldurazyme.
Laronidase and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for laronidase: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited information from on mother receiving laronidase for mucopolysaccharidosis type I indicates that the drug is not detectable in breastmilk and her breastfed infant suffered no adverse reactions or adverse developmental effects from the drug in milk. The lack of penetration into milk is consistent with its high molecular weight of 82,000 Da. If laronidase is required by the mother, it is not a reason to discontinue breastfeeding. Until more data are available, laronidase should be used with careful monitoring during breastfeeding.
National Institute of Child Health and Human Development, record revised August 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about laronidase
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 844 reports naming laronidase, and the FDA flagged 64% 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:
- pyrexia125 reports
- inappropriate schedule of product administration60 reports
- cough53 reports
- pneumonia53 reports
- fatigue50 reports
- covid-1944 reports
- malaise44 reports
- dyspnoea42 reports
Read these as a signal, not a rate. A report does not mean laronidase 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 laronidase?
Aldurazyme (Laronidase) is a hydrolytic lysosomal glycosaminoglycan-specific enzyme used to treat Mucopolysaccharidosis I.
What kind of drug is laronidase?
The FDA classifies laronidase as a hydrolytic lysosomal glycosaminoglycan-specific enzyme. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take laronidase 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 laronidase 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 laronidase come in?
Across the brands we track, laronidase 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 laronidase?
We do not currently list a generic-labelled laronidase 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). Laronidase: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/laronidase
- MLA
- “Laronidase: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/laronidase.
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 laronidase on DailyMed (NIH) ↗ — including its boxed warning in full.