What the label lists and what reports show
Ublituximab side effects
Ublituximab's FDA label: “The most common adverse reactions (≥10%) were infusion reactions and upper respiratory tract infections ( 6.1 ).” FAERS holds 3,781 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 infusion related reaction (1,412 reports).
- No generic listed
Check it at the source: the ublituximab FDA label on DailyMed (effective February 19, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BRIUMVI?BRIUMVI may cause serious side effects, including: See " What is the most important information I should know about BRIUMVI? " Liver damage. BRIUMVI may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start BRIUMVI and while you take BRIUMVI if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as: yellowing of the skin and eyes (jaundice) nausea vomiting unusual darkening of the urine feeling tired or weak The most common side effects of BRIUMVI include: Infusion reactions, upper and lower respiratory tract infections, herpes infections, extremity pain, insomnia, and fatigue. See " What is the most important information I should know about BRIUMVI? " These are not all the possible side effects of BRIUMVI. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, TG Therapeutics, Inc., effective February 19, 2026 (SPL set 3a77cd8c-811b-407c-9140-d0c5c26435c2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥10%) were infusion reactions and upper respiratory tract infections ( 6.1 ).
Table 2: Adverse Reactions in Adult Patients with RMS with an Incidence of at least 5% for BRIUMVI and Higher than Teriflunomide from Study 1 and Study 2
| Adverse Reactions | BRIUMVI 450 mg IV The first dose of BRIUMVI was given as an intravenous (IV) infusion of… (N=545) % | Teriflunomide 14 mg PO (N=548) % |
|---|---|---|
| Infusion reactions | 48 | 12 |
| Upper respiratory tract infections Includes the following: nasopharyngitis, upper… | 45 | 41 |
| Lower respiratory tract infections Includes the following: bronchitis, pneumonia,… | 9 | 7 |
| Herpes virus-associated infections Includes several related terms. | 6 | 5 |
| Pain in extremity | 6 | 4 |
| Insomnia | 6 | 3 |
| Fatigue | 5 | 4 |
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 following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Liver Injury [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥10%) were infusion reactions and upper respiratory tract infections ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact TG Therapeutics at 1-877-848-9462 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 reaction 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 clinical practice. In active-controlled clinical trials (Study 1 and Study 2), 545 patients with RMS received BRIUMVI [see Clinical Studies (14) ]. The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Table 2 summarizes the adverse reactions that occurred in RMS trials (Study 1 and Study 2). The most common cause of discontinuation in patients treated with BRIUMVI was infection (1.3%). …
Source: FDA drug label, TG Therapeutics, Inc., effective February 19, 2026 (SPL set 3a77cd8c-811b-407c-9140-d0c5c26435c2), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,781 reports list ublituximab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 449 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. Reports rose sharply in 2025 (1,782, against a median of 10 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 11 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?
- Ublituximab: 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