What the label lists and what reports show
Sarilumab side effects
Sarilumab's FDA label: “Most common adverse reactions are: Rheumatoid Arthritis (incidence ≥3 %): neutropenia, increased ALT, injection site erythema, upper respiratory infections and urinary tract infections.” FAERS holds 26,260 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 pain (5,975 reports).
- No generic listed
- Boxed warning
Check it at the source: the sarilumab FDA label on DailyMed (effective February 27, 2026, Sanofi-Aventis U.S. LLC); 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 KEVZARA?KEVZARA can cause serious side effects, including: See " What is the most important information I should know about KEVZARA? " Serious allergic reactions. Serious allergic reactions can happen with KEVZARA. Get medical attention right away if you or your child have any of the following signs of a serious allergic reaction: shortness of breath or trouble breathing swelling of the lips, tongue, or face chest pain feeling dizzy or faint moderate or severe stomach (abdominal) pain or vomiting Common side effects of KEVZARA include: injection site redness injection site itching upper respiratory tract infection urinary tract infection nasal congestion, sore throat, and runny nose These are not all of the possible side effects of KEVZARA. 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, Sanofi-Aventis U.S. LLC, effective February 27, 2026 (SPL set 827bc01c-d379-4266-a18c-c7f904b76af3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: Rheumatoid Arthritis (incidence ≥3 %): neutropenia, increased ALT, injection site erythema, upper respiratory infections and urinary tract infections.
Table 3: Common Adverse Reactions Adverse reactions occurring in 2% or more in the 150 mg KEVZARA + DMARD or 200 mg KEVZARA + DMARD groups and greater than observed in Placebo + DMARD in Adults with Moderately to…
| Adverse Reactions | Placebo + DMARD (N=579) | KEVZARA 150 mg + DMARD (N=579) | KEVZARA 200 mg + DMARD (N=582) |
|---|---|---|---|
| Neutropenia | 0.2% | 7% | 10% |
| Alanine aminotransferase increased | 2% | 5% | 5% |
| Injection site erythema | 0.9% | 5% | 4% |
| Injection site pruritus | 0.2% | 2% | 2% |
| Upper respiratory tract infection | 2% | 4% | 3% |
| Urinary tract infection | 2% | 3% | 3% |
| Hypertriglyceridemia | 0.5% | 3% | 1% |
| Leukopenia | 0% | 0.9% | 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 following serious adverse reactions are described elsewhere in labeling: Serious infections [see Warnings and Precautions (5.1) ] Neutropenia, thrombocytopenia, elevated liver enzymes, lipid abnormalities [see Warnings and Precautions (5.2) ] Gastrointestinal perforation [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypersensitivity reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions are: Rheumatoid Arthritis (incidence ≥3 %): neutropenia, increased ALT, injection site erythema, upper respiratory infections and urinary tract infections. ( 6.1 ) Polymyalgia Rheumatica (incidence ≥ 5%): neutropenia, leukopenia and injection site pruritus. ( 6.1 ) Polyarticular Juvenile Idiopathic Arthritis: nasopharyngitis, neutropenia, upper respiratory tract infection and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective February 27, 2026 (SPL set 827bc01c-d379-4266-a18c-c7f904b76af3), via openFDA; the full label on DailyMed
What do FAERS reports show?
26,260 reports list sarilumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,540 are coded as a death and 4,422 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 21 reactions below, 4 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?
- Sarilumab: 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