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Naglazyme Side Effects

Generic name: galsulfase

Medically reviewed by Last updated on Sep 5, 2023.

Note: This document contains side effect information about galsulfase. Some dosage forms listed on this page may not apply to the brand name Naglazyme.

Applies to galsulfase: intravenous solution.

Serious side effects of Naglazyme

Along with its needed effects, galsulfase (the active ingredient contained in Naglazyme) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking galsulfase:

Less common

Incidence not known

Other side effects of Naglazyme

Some side effects of galsulfase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to galsulfase: intravenous solution.


The most frequently reported adverse reactions included rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain, and dyspnea.

The most frequently reported adverse reactions requiring interventions are infusion-related reactions.[Ref]


Frequency not reported: Anaphylaxis/anaphylactoid reaction, allergic reaction[Ref]


Very common (10% or more): Rash (21%), angioedema, urticaria, pruritus

Common (1% to 10%): Erythema[Ref]


Very common (10% or more): Abdominal pain (47%), gastroenteritis (11%), umbilical hernia (11%), nausea, vomiting[Ref]


Very common (10% or more): Infusion reactions (56%), ear pain (42%), pain (32%), chills/rigors (21%), chest pain (16%), malaise (11%), hearing impairment (11%), pyrexia[Ref]

Infusion reactions, which occurred in 56% of patients across 5 clinical studies were defined as adverse reactions occurring during infusions or until the end of the infusion day. Infusion reactions were observed as early as week 1 and as late as week 146 of treatment and occurred during multiple infusions, however, not always in consecutive weeks. The most common signs/symptoms included pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm, and arthralgia.[Ref]


Very common (10% or more): Hypertension (11%)

Common (1% to 10%): Hypotension

Frequency not reported: Pallor, bradycardia, tachycardia, cyanosis, shock[Ref]

Nervous system

Very common (10% or more): Areflexia (11%), headache

Common (1% to 10%): Tremor

Frequency not reported: Paresthesia[Ref]


Very common (10% or more): Dyspnea (21%), pharyngitis (11%), nasal congestion (11%)

Common (1% to 10%): Apnea, cough, respiratory distress, asthma, bronchospasm

Frequency not reported: Laryngeal edema, hypoxia, tachypnea, sleep apnea

Postmarketing reports: Respiratory failure[Ref]


Very common (10% or more): Arthralgia (42%)[Ref]


Very common (10% or more): Conjunctivitis (21%), corneal opacity (11%)[Ref]


Very common (10% or more): Development of antidrug antibodies (98%)[Ref]

During clinical trials, 53 out of 54 patients tested positive for antidrug IgG antibodies within 4 to 8 weeks of treatment. In the placebo controlled study, 19 patients were evaluated for a potential relationship between development of antidrug antibodies to clinical outcome measures. While all 19 patients developed antidrug antibodies, there was no consistent predictive relationship between total antibody titer, neutralizing or IgE antibodies, and infusion-associated reactions, urinary glycosaminoglycan (GAG) levels, or endurance measures.[Ref]


Postmarketing reports: Membranous nephropathy[Ref]


Postmarketing reports: Thrombocytopenia[Ref]


1. Product Information. Naglazyme (galsulfase). BioMarin Pharmaceutical Inc. 2005.

2. EMEA. European Medicines Agency. EPARs. European Union Public Assessment Reports. 2007.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.