OpenClaim

Galsulfase Side Effects

The most commonly reported side effects of galsulfase include pyrexia, pneumonia, and cough, based on 3,730 FDA adverse event reports from 2007 to 2025.

#1 Reported: PyrexiaAll side effects ↓Top Co-Medication: PregabalinDrug interactions ↓42% of Reports Are ChildDemographics ↓

Galsulfase side effects

Percentages show how often each reaction appears relative to total reports for galsulfase.

1
Pyrexia10.7%398
2
Pneumonia6.6%245
3
Cough5.7%213
4
Dyspnoea4.8%180
5
Spinal Cord Compression3.4%126
6
Vomiting3.1%116
7
Oxygen Saturation Decreased3.1%114
8
Fatigue2.7%102
9
Headache2.3%86
10
Pain2.3%85
11
Nasopharyngitis2.3%84
12
Influenza2.2%82
13
Death2.1%80
14
Rhinorrhoea1.9%72
15
Fall1.9%70

These are voluntary reports and do not establish that galsulfase caused these reactions.

Report severity

66.0%Serious2,462 reports
36.8%Hospitalizations1,372 reports
9.0%Fatal336 reports

Seriousness is determined by the reporter, not by OpenClaim.

Galsulfase drug interactions

Other drugs that appear in adverse event reports alongside galsulfase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Pregabalin0.2%6
2
Diphenhydramine0.1%5
3
Propofol<0.1%3
4
Diazepam<0.1%2
5
Warfarin<0.1%2
6
Sevoflurane<0.1%2
7
Methylphenidate<0.1%1
8
Fluconazole<0.1%1
9
Duloxetine-hydrochloride<0.1%1
10
Levetiracetam<0.1%1
11
Oxycodone<0.1%1
12
Alcohol<0.1%1
13
Medroxyprogesterone-acetate<0.1%1
14
Lacosamide<0.1%1
15
Albuterol<0.1%1

Taken alongside

1
Diphenhydramine8.6%319
2
Acetaminophen8.4%314
3
Epinephrine6.0%224
4
Loratadine4.6%170
5
Heparin4.3%160
6
Furosemide4.2%157
7
Lidocaine3.9%144
8
Enalapril-maleate2.9%108
9
Prilocaine2.7%99
10
Albuterol2.4%91
11
Ammonium2.4%89
12
Sodium-chloride2.3%84
13
Ibuprofen2.2%81
14
Spironolactone2.1%77
15
Methylprednisolone1.9%71

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports galsulfase side effects

41.2% of galsulfase adverse event reports involve female patients and 34.6% involve male patients. The largest age group is child at 42%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.2%
Male34.6%
Unknown24.2%

Age group

< 21.8%
2–1141.9%
12–1723.0%
18–6433.0%
65+0.4%

What is galsulfase used for

Conditions and purposes for which patients were taking galsulfase when the adverse event was reported.

Foetal Exposure During PregnancyLipid Metabolism DisorderLipidosisLipidosisMetabolic DisorderMucopolysaccharidosisMucopolysaccharidosis IvMucopolysaccharidosis ViMucopolysaccharidosisMucopolysaccharidosis IMucopolysaccharidosis IiMucopolysaccharidosis IvMucopolysaccharidosis ViNiemann-pick DiseaseParaganglion Neoplasm Benign

Showing 15 of 19 indications

Galsulfase brand names and reporting trend

Quarterly reports (2007–2025)

20072010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking galsulfase with another medication?

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