OpenClaim

Sebelipase Side Effects

The most commonly reported side effects of sebelipase include pyrexia, diarrhoea, and off label use, based on 633 FDA adverse event reports from 2016 to 2025. 4.3% of reports found the drug to be ineffective.

Sebelipase side effects

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

1
Pyrexia9.3%59
2
Diarrhoea7.1%45
3
Off Label Use7.1%45
4
Vomiting6.6%42
5
Drug Ineffective4.3%27
6
Headache4.1%26
7
Low Density Lipoprotein Increased3.5%22
8
Malaise3.5%22
9
Infusion Related Reaction3.0%19
10
Fatigue3.0%19
11
Weight Increased2.8%18
12
Blood Cholesterol Increased2.8%18
13
Cough2.7%17
14
Nausea2.7%17
15
Abdominal Distension2.5%16

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

Report severity

42.2%Serious267 reports
20.9%Hospitalizations132 reports
7.1%Fatal45 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sebelipase drug interactions

Other drugs that appear in adverse event reports alongside sebelipase. 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
Dexamethasone0.9%6
2
Etoposide0.8%5
3
Cyclosporine0.6%4
4
Meropenem0.6%4
5
Methylene-blue0.6%4
6
Epinephrine0.6%4
7
Vasopressin0.6%4
8
Hydrocortisone0.6%4
9
Rosuvastatin0.6%4
10
Budesonide0.5%3
11
Acetaminophen0.5%3
12
Vancomycin0.5%3
13
Sirolimus0.3%2
14
Diphenhydramine0.3%2
15
Famotidine0.3%2

Taken alongside

1
Diphenhydramine10.9%69
2
Epinephrine10.6%67
3
Acetaminophen8.8%56
4
Heparin8.4%53
5
Sodium-chloride7.1%45
6
Ammonium6.8%43
7
Famotidine4.9%31
8
Hydrocortisone4.6%29
9
Lidocaine4.4%28
10
Methylprednisolone4.1%26
11
Ibuprofen3.6%23
12
Ergocalciferol3.6%23
13
Atorvastatin-calcium3.5%22
14
Albuterol3.0%19
15
Ranitidine2.7%17

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 sebelipase side effects

42.0% of sebelipase adverse event reports involve female patients and 49.8% involve male patients. The largest age group is child at 35%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.0%
Male49.8%
Unknown8.2%

Age group

< 234.4%
2–1135.4%
12–178.4%
18–6421.2%
65+0.6%

What is sebelipase used for

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

Body Fat DisorderC3 GlomerulopathyDyslipidaemiaEnzyme AbnormalityEnzyme SupplementationFabry^s DiseaseHistiocytosis HaematophagicHypophosphatasiaHaemophagocytic LymphohistiocytosisLipid Metabolism DisorderLipidosisLysosomal Acid Lipase DeficiencyLipid Metabolism DisorderLipidosisLipids Abnormal

Showing 15 of 23 indications

Sebelipase brand names and reporting trend

Sebelipase is sold under the brand name Kanuma.

Brand names

Kanuma75

Quarterly reports (20162025)

2016202020242025

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

Taking sebelipase with another medication?

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