What the label lists and what reports show
Galsulfase side effects
Galsulfase's FDA label: “The most common adverse reactions (≥10%) are: rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea.” FAERS holds 3,826 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (414 reports).
- No generic listed
- Boxed warning
Check it at the source: the galsulfase FDA label on DailyMed (effective September 18, 2024, BioMarin Pharmaceutical Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥10%) are: rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea.
Table 1: Adverse Reactions that Occurred in the Placebo-Controlled Trial in at least 2 Patients More in the NAGLAZYME Group than in the Placebo Group
| MedDRA Preferred Term | NAGLAZYME (n = 19) No. Patients (%) | Placebo (n = 20 One of the 20 patients in the placebo group dropped out after Week 4… No. Patients (%) |
|---|---|---|
| All | 19 (100) | 20 (100) |
| Abdominal Pain | 9 (47) | 7 (35) |
| Ear Pain | 8 (42) | 4 (20) |
| Arthralgia | 8 (42) | 5 (25) |
| Pain | 6 (32) | 1 (5) |
| Conjunctivitis | 4 (21) | 0 |
| Dyspnea | 4 (21) | 2 (10) |
| Rash | 4 (21) | 2 (10) |
| Chills | 4 (21) | 0 |
| Chest Pain | 3 (16) | 1 (5) |
| Pharyngitis | 2 (11) | 0 |
| Areflexia | 2 (11) | 0 |
| Corneal Opacity | 2 (11) | 0 |
| Gastroenteritis | 2 (11) | 0 |
| Hypertension | 2 (11) | 0 |
| Malaise | 2 (11) | 0 |
| Nasal Congestion | 2 (11) | 0 |
| Umbilical Hernia | 2 (11) | 0 |
| Hearing Impairment | 2 (11) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedSerious and/or clinically significant adverse reactions described elsewhere in labeling include: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Reactions [see Warnings and Precautions ( 5.2 )] Risk of Acute Cardiorespiratory Failure [see Warnings and Precautions ( 5.2 )] Acute Respiratory Complications Associated with Administration [see Warnings and Precautions ( 5.4 )] Infusion Reactions [see Warnings and Precautions ( 5.5 )] Spinal or Cervical Cord Compression [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (≥10%) are: rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea. The most common adverse reactions requiring interventions are infusion-related reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact: BioMarin Pharmaceutical Inc. at 1-866-906-6100 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 observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, BioMarin Pharmaceutical Inc., effective September 18, 2024 (SPL set 59341250-deac-ed71-3823-a4f5d64dbd77), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,826 reports list galsulfase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 348 are coded as a death and 1,414 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. Of the 24 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Galsulfase: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions