What the label lists and what reports show
Sibeprenlimab side effects
Sibeprenlimab's FDA label: “Most common adverse reactions are upper respiratory tract infection and injection site erythema.” FAERS holds 302 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 injection site pain (42 reports).
- No generic listed
Check it at the source: the sibeprenlimab FDA label on DailyMed (effective March 17, 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 VOYXACT?VOYXACT can cause serious side effects, including: immunosuppression and increased risk of infections. VOYXACT weakens your immune system, which may increase your risk of infections. Your healthcare provider will check you for signs and symptoms of infections before you start and during treatment with VOYXACT. Tell your healthcare provider right away if you develop any signs and symptoms of infection during treatment with VOYXACT, including: fever chills feeling tired cough flu-like symptoms aches and pain warm, red, or painful skin The most common side effects of VOYXACT include: upper respiratory tract infection and skin redness at your injection site. These are not all of the possible side effects of VOYXACT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Otsuka America Pharmaceutical, Inc., effective March 17, 2026 (SPL set c8a93b32-0676-4704-86dc-cb65f425c6e5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are upper respiratory tract infection and injection site erythema.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Immunosuppression and Increased Risk of Infections [see Warnings and Precautions (5.1) ] Immunosuppression and Immunization Risks [see Warnings and Precautions (5.2) ] Most common adverse reactions are upper respiratory tract infection and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 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 practice. The safety of VOYXACT was evaluated in a randomized, double-blind, placebo-controlled, clinical study in patients with IgAN (VISIONARY). The median duration of exposure was 44 weeks in the 259 patients treated with VOYXACT and 48 weeks in the 251 patients administered placebo. The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). …
Source: FDA drug label, Otsuka America Pharmaceutical, Inc., effective March 17, 2026 (SPL set c8a93b32-0676-4704-86dc-cb65f425c6e5), via openFDA; the full label on DailyMed
What do FAERS reports show?
302 reports list sibeprenlimab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 26 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 22 reactions below, 3 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.
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?
- Sibeprenlimab: 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