What the label lists and what reports show
Remibrutinib side effects
Remibrutinib's FDA label: “The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain.” FAERS holds 972 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 petechiae (145 reports).
- No generic listed
Check it at the source: the remibrutinib FDA label on DailyMed (effective March 23, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of RHAPSIDO?RHAPSIDO may cause serious side effects, including: Risk of bleeding. Bleeding may happen while being treated with RHAPSIDO. Your healthcare provider will monitor you for signs and symptoms of bleeding and may stop your treatment if bleeding happens. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider right away if you get any signs or symptoms of bleeding, such as: bruising, or red or purple skin marks pink or brown urine headache, dizziness, confusion, or feeling weak red or black stools that look like tar The most common side effects with RHAPSIDO may include nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, abdominal pain. These are not all the possible side effects of RHAPSIDO. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective March 23, 2026 (SPL set e5e89bff-6ced-4165-acc5-fb13136b3a3d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain.
Table 1 Adverse Reactions with RHAPSIDO with Incidence ≥3% and More Common than Placebo in Adult Patients with CSU (REMIX-1 and REMIX-2)
| Adverse Reaction | RHAPSIDO (N = 606) n (%) | Placebo (N = 306) n (%) |
|---|---|---|
| Nasopharyngitis a | 67 (11%) | 27 (9%) |
| Bleeding b | 55 (9%) | 6 (2%) |
| Headache c | 41 (7%) | 19 (6%) |
| Nausea | 18 (3%) | 5 (2%) |
| Abdominal Pain d | 18 (3%) | 6 (2%) |
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, continuedThe most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 drug reaction (ADR) rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of RHAPSIDO was based on a pooled safety population from two identical clinical trials of 52 weeks duration, REMIX-1 and REMIX-2 [see Clinical Studies (14)]. The pooled safety population consisted of 912 adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and who received RHAPSIDO 25 mg orally twice daily (N=606) or placebo (N=306) for 24 weeks during the double-blind, controlled treatment period of the trial. Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than the placebo group from the pooled safety population (REMIX-1 and REMIX-2) during the 24-week blinded, placebo-controlled treatment period are shown in Table 1.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective March 23, 2026 (SPL set e5e89bff-6ced-4165-acc5-fb13136b3a3d), via openFDA; the full label on DailyMed
What do FAERS reports show?
972 reports list remibrutinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 22 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 18 reactions below, 6 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?
- Remibrutinib: 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