SARILUMAB

N/A

Manufactured by Sanofi-Aventis U.S. LLC

183,830 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SARILUMAB

SARILUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. The most commonly reported adverse reactions for SARILUMAB include DRUG INEFFECTIVE, PAIN, ARTHRALGIA, RHEUMATOID ARTHRITIS, JOINT SWELLING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SARILUMAB.

Top Adverse Reactions

DRUG INEFFECTIVE5,591 reports
PAIN5,313 reports
ARTHRALGIA4,655 reports
RHEUMATOID ARTHRITIS4,395 reports
JOINT SWELLING4,362 reports
CONDITION AGGRAVATED3,580 reports
FATIGUE3,334 reports
RASH3,212 reports
ALOPECIA2,969 reports
ABDOMINAL DISCOMFORT2,906 reports
HEPATIC ENZYME INCREASED2,858 reports
SYSTEMIC LUPUS ERYTHEMATOSUS2,780 reports
PEMPHIGUS2,721 reports
HAND DEFORMITY2,643 reports
GLOSSODYNIA2,625 reports
SYNOVITIS2,621 reports
SWELLING2,609 reports
PERICARDITIS2,589 reports
ARTHROPATHY2,558 reports
INFUSION RELATED REACTION2,549 reports
HYPERSENSITIVITY2,542 reports
WOUND2,526 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE2,522 reports
DRUG INTOLERANCE2,449 reports
OFF LABEL USE2,288 reports
DISCOMFORT2,254 reports
MATERNAL EXPOSURE DURING PREGNANCY2,097 reports
HEADACHE2,076 reports
PRODUCT USE IN UNAPPROVED INDICATION2,074 reports
DUODENAL ULCER PERFORATION2,016 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,976 reports
HELICOBACTER INFECTION1,957 reports
TREATMENT FAILURE1,931 reports
RHEUMATOID FACTOR POSITIVE1,912 reports
CONTRAINDICATED PRODUCT ADMINISTERED1,909 reports
NAUSEA1,880 reports
PRODUCT USE ISSUE1,852 reports
MUSCULOSKELETAL STIFFNESS1,848 reports
BLISTER1,833 reports
BLOOD CHOLESTEROL INCREASED1,718 reports
NASOPHARYNGITIS1,653 reports
PERIPHERAL SWELLING1,643 reports
MOBILITY DECREASED1,636 reports
TYPE 2 DIABETES MELLITUS1,612 reports
DIARRHOEA1,604 reports
HYPERTENSION1,601 reports
DRUG HYPERSENSITIVITY1,597 reports
PRURITUS1,595 reports
MALAISE1,585 reports
PAIN IN EXTREMITY1,572 reports
THERAPEUTIC PRODUCT EFFECT DECREASED1,536 reports
INFECTION1,485 reports
STOMATITIS1,472 reports
PSORIATIC ARTHROPATHY1,464 reports
INJURY1,459 reports
DYSPNOEA1,449 reports
RHEUMATIC FEVER1,447 reports
URTICARIA1,436 reports
ABDOMINAL PAIN UPPER1,425 reports
CONFUSIONAL STATE1,425 reports
VOMITING1,422 reports
HYPOAESTHESIA1,394 reports
LOWER RESPIRATORY TRACT INFECTION1,373 reports
FOLLICULITIS1,360 reports
FIBROMYALGIA1,356 reports
WEIGHT INCREASED1,355 reports
LIVER INJURY1,349 reports
IMPAIRED HEALING1,339 reports
IRRITABLE BOWEL SYNDROME1,334 reports
PNEUMONIA1,323 reports
DIZZINESS1,317 reports
GAIT DISTURBANCE1,240 reports
MUSCLE INJURY1,239 reports
GASTROINTESTINAL DISORDER1,229 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES1,205 reports
SINUSITIS1,181 reports
CONTUSION1,166 reports
DECREASED APPETITE1,164 reports
INTENTIONAL PRODUCT USE ISSUE1,154 reports
PYREXIA1,151 reports
SWOLLEN JOINT COUNT INCREASED1,131 reports
ASTHENIA1,074 reports
ILL DEFINED DISORDER1,053 reports
WHEEZING1,036 reports
GAIT INABILITY1,033 reports
SLEEP DISORDER1,005 reports
OSTEOARTHRITIS987 reports
INFLAMMATION984 reports
OEDEMA935 reports
DEPRESSION932 reports
CHEST PAIN930 reports
DRY MOUTH915 reports
JOINT RANGE OF MOTION DECREASED894 reports
MIGRAINE885 reports
DYSPEPSIA882 reports
HIP ARTHROPLASTY870 reports
KNEE ARTHROPLASTY870 reports
INJECTION SITE ERYTHEMA862 reports
BURSITIS843 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE832 reports

Report Outcomes

Out of 23,677 classified reports for SARILUMAB:

Serious 43.0%Non-Serious 57.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female17,963 (83.8%)
Male3,459 (16.1%)
Unknown1 (0.0%)

Reports by Age

Age 431,290 reports
Age 59703 reports
Age 44651 reports
Age 40558 reports
Age 62552 reports
Age 61507 reports
Age 63500 reports
Age 60488 reports
Age 58461 reports
Age 57459 reports
Age 64438 reports
Age 56391 reports
Age 55385 reports
Age 54361 reports
Age 66350 reports
Age 48320 reports
Age 68313 reports
Age 67311 reports
Age 53309 reports
Age 65306 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with SARILUMAB?

This profile reflects 183,830 FDA FAERS reports that mention SARILUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SARILUMAB?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PAIN, ARTHRALGIA, RHEUMATOID ARTHRITIS, JOINT SWELLING, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SARILUMAB?

Labeling and FAERS entries often list Sanofi-Aventis U.S. LLC in connection with SARILUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.