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Remibrutinib Side Effects

The most commonly reported side effects of remibrutinib include petechiae, urticaria, and headache, based on 226 FDA adverse event reports from 2023 to 2025. 10.6% of reports found the drug to be ineffective.

Remibrutinib side effects

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

1
Petechiae15.9%36
2
Urticaria11.1%25
3
Drug Ineffective10.6%24
4
Headache9.3%21
5
Condition Aggravated8.4%19
6
Chronic Spontaneous Urticaria8.4%19
7
Angioedema8.0%18
8
Treatment Failure7.1%16
9
Pruritus7.1%16
10
Mental Disorder Due To A General Medical Condition6.6%15
11
Drug Intolerance6.6%15
12
Contusion6.2%14
13
Cough4.9%11
14
Nausea4.9%11
15
Off Label Use3.1%7

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

Report severity

19.9%Serious45 reports
1.3%Hospitalizations3 reports
0.4%Fatal1 reports

Seriousness is determined by the reporter, not by OpenClaim.

Remibrutinib drug interactions

Other drugs that appear in adverse event reports alongside remibrutinib. 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
Omalizumab18.6%42
2
Cyclosporine7.1%16
3
Methotrexate6.6%15
4
Prednisolone6.6%15
5
Rituximab6.6%15
6
Anakinra6.6%15
7
Tofacitinib6.6%15
8
Dupilumab1.3%3
9
Cetirizine-hydrochloride1.3%3
10
Famotidine0.9%2
11
Fexofenadine-hydrochloride0.9%2
12
Venetoclax0.4%1
13
Amitriptyline-hydrochloride0.4%1
14
Teriflunomide0.4%1
15
Dapsone0.4%1

Taken alongside

1
Cyclosporine2.7%6
2
Prednisone2.2%5
3
Famotidine1.3%3
4
Montelukast-sodium1.3%3
5
Ergocalciferol1.3%3
6
Cetirizine-hydrochloride1.3%3
7
Fexofenadine-hydrochloride1.3%3
8
Dupilumab1.3%3
9
Omalizumab0.9%2
10
Methotrexate0.9%2
11
Amlodipine0.9%2
12
Metformin0.9%2
13
Progesterone0.9%2
14
Epinephrine0.9%2
15
Desloratadine0.4%1

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 remibrutinib side effects

70.4% of remibrutinib adverse event reports involve female patients and 15.9% involve male patients. The largest age group is adult at 82%. These figures reflect who reports side effects, not underlying risk.

Sex

Female70.4%
Male15.9%
Unknown13.7%

Age group

< 20.0%
2–110.0%
12–174.9%
18–6481.7%
65+13.4%

What is remibrutinib used for

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

AngioedemaChronic Spontaneous UrticariaContusionHypersensitivityIdiopathic UrticariaMast Cell Activation SyndromeProduct Used For Unknown IndicationRelapsing Multiple SclerosisUrticariaUrticaria Chronic

Remibrutinib brand names and reporting trend

Remibrutinib is sold under the brand name Rhapsido.

Brand names

Rhapsido53

Quarterly reports (20232025)

202320242025

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

Taking remibrutinib with another medication?

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