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Idursulfase Side Effects

The most commonly reported side effects of idursulfase include pyrexia, product dose omission issue, and inappropriate schedule of product administration, based on 3,887 FDA adverse event reports from 2006 to 2025.

Idursulfase side effects

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

1
Pyrexia14.7%570
2
Product Dose Omission Issue12.0%468
3
Inappropriate Schedule Of Product Administration9.9%385
4
Infusion Related Reaction8.0%311
5
Cough7.4%286
6
Pneumonia6.6%256
7
Death6.4%247
8
Dyspnoea5.9%230
9
Influenza5.5%215
10
Covid-195.3%205
11
Seizure5.2%202
12
Malaise4.8%187
13
Product Availability Issue4.8%186
14
Poor Venous Access4.7%183
15
Nasopharyngitis4.6%179

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

Report severity

88.6%Serious3,444 reports
55.0%Hospitalizations2,138 reports
17.2%Fatal669 reports

Seriousness is determined by the reporter, not by OpenClaim.

Idursulfase drug interactions

Other drugs that appear in adverse event reports alongside idursulfase. 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
Diphenhydramine0.4%14
2
Prednisolone0.3%12
3
Acetaminophen0.3%11
4
Lorazepam0.3%10
5
Fexofenadine-hydrochloride0.2%9
6
Dexamethasone0.2%8
7
Sirolimus0.2%8
8
Tacrolimus0.2%8
9
Methotrexate0.1%5
10
Ofatumumab0.1%5
11
Sodium-chloride0.1%5
12
Risperidone0.1%5
13
Methylprednisolone0.1%4
14
Valproate-sodium<0.1%3
15
Carbamazepine<0.1%3

Taken alongside

1
Acetaminophen11.5%446
2
Diphenhydramine7.8%305
3
Albuterol6.9%270
4
Ibuprofen5.1%197
5
Heparin4.9%191
6
Risperidone4.5%174
7
Epinephrine4.5%173
8
Sodium-chloride4.2%164
9
Amoxicillin3.9%150
10
Cetirizine-hydrochloride3.7%143
11
Lidocaine3.6%139
12
Budesonide3.5%137
13
Fluticasone3.3%130
14
Levetiracetam3.2%123
15
Hydrocortisone3.1%121

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 idursulfase side effects

1.0% of idursulfase adverse event reports involve female patients and 84.5% involve male patients. The largest age group is child at 45%. These figures reflect who reports side effects, not underlying risk.

Sex

Female1.0%
Male84.5%
Unknown14.4%

Age group

< 22.4%
2–1145.3%
12–1728.1%
18–6423.9%
65+0.2%

What is idursulfase used for

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

Anticoagulant TherapyBronchiectasisColitis UlcerativeEnzyme AbnormalityEnzyme SupplementationFabry^s DiseaseFabry^s DiseaseGaucher^s DiseaseGaucher^s Disease Type IGaucher^s DiseaseHereditary AngioedemaHypotensionHaemophagocytic LymphohistiocytosisHypertriglyceridaemiaImmune Tolerance Induction

Showing 15 of 38 indications

Idursulfase brand names and reporting trend

Idursulfase is sold under the brand name Elaprase.

Brand names

Elaprase7,362

Quarterly reports (20062025)

20062010201520202025

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

Taking idursulfase with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.