What the label lists and what reports show
Sutimlimab side effects
Sutimlimab's FDA label: “Most common adverse reactions in the CADENZA study (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon.” FAERS holds 311 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 haemoglobin decreased (23 reports).
- No generic listed
Check it at the source: the sutimlimab FDA label on DailyMed (effective March 2, 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 ENJAYMO?ENJAYMO can cause serious side effects, including: See " What is the most important information I should know about ENJAYMO? " Infusion-related reactions. Treatment with ENJAYMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if you have an infusion-related reaction and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may mean you are having an infusion-related reaction, including: shortness of breath decrease in blood pressure chest discomfort rapid heartbeat nausea injection site reaction flushing headache dizziness rash itchy skin Risk of autoimmune disease. ENJAYMO may increase your risk for developing an autoimmune disease such as SLE. […]
Source: FDA drug label, Recordati Rare Diseases, Inc., effective March 2, 2026 (SPL set 0a25363a-7781-d9f8-cb1c-be22987bf03b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in the CADENZA study (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon.
Table 4: Adverse Reactions (≥15%) in Patients Receiving ENJAYMO in the CARDINAL Study
| Adverse Reaction/Body System | n (%) (N=24) Please note: if a subject has multiple events in a grouped term the subject is only… The following terms were combined for the analysis: INFECTIONS AND INFESTATIONS |
|---|---|
| Urinary tract infection Urinary Tract Infection includes cystitis, urosepsis | 9 (38%) |
| Respiratory tract infection Respiratory tract infection includes upper respiratory tract… | 6 (25%) |
| Bacterial infection Bacterial infection includes Escherichia urinary tract infection,… | 6 (25%) |
| Nasopharyngitis | 5 (21%) |
| Viral infection Viral infection includes oral herpes, herpes zoster, respiratory tract… | 5 (21%) |
| Dizziness Dizziness includes dizziness postural and vertigo | 7 (29%) |
| Headache | 5 (21%) |
| Fatigue Fatigue includes asthenia, malaise, mental fatigue | 8 (33%) |
| Peripheral edema Peripheral edema includes peripheral swelling | 6 (25%) |
| Pyrexia | 5 (21%) |
| Arthralgia | 6 (25%) |
| Hypertension Hypertension includes, blood pressure increased, essential hypertension | 6 (25%) |
| Acrocyanosis | 5 (21%) |
| Nausea | 6 (25%) |
| Abdominal pain Abdominal pain includes abdominal pain upper, abdominal tenderness | 5 (21%) |
| Cough Cough includes productive cough | 6 (25%) |
| Infusion-related reaction Infusion related reaction includes stress cardiomyopathy,… | 4 (17%) |
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 clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Risk of Autoimmune Disease [see Warnings and Precautions (5.3) ] Recurrent Hemolysis After ENJAYMO Discontinuation [see Warnings and Precautions (5.4) ] Most common adverse reactions in the CADENZA study (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. The most common adverse reactions in the CARDINAL study (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 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. …
Source: FDA drug label, Recordati Rare Diseases, Inc., effective March 2, 2026 (SPL set 0a25363a-7781-d9f8-cb1c-be22987bf03b), via openFDA; the full label on DailyMed
What do FAERS reports show?
311 reports list sutimlimab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 51 are coded as a death and 67 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 20 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.
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?
- Sutimlimab: 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