Sarilumab

Common brands: Kevzara, Prednisone, Prednisone Delayed Release, Prednisone Tablets, Usp, 10 Mg, Prednisone Tablets, Usp, 20 Mg

Top reporter: Sanofi-Aventis U.S. Llc

Interleukin-6 Receptor Antagonist [EPC]Corticosteroid [EPC]Folate Analog Metabolic Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Vitamin C [EPC]
24,738
Total Reports
17,825
Serious Reports
2,424
Death Reports
30
Reported Reactions
Death Report Ratio: High (9.80%)

Patient Demographics

Male
3,697
Female
18,745

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Sarilumab.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 5,814
6.3%
2 PAIN 5,591
6.1%
3 ARTHRALGIA 4,865
5.3%
4 RHEUMATOID ARTHRITIS 4,509
4.9%
5 JOINT SWELLING 4,441
4.8%
6 CONDITION AGGRAVATED 3,646
4.0%
7 FATIGUE 3,412
3.7%
8 RASH 3,278
3.6%
9 ALOPECIA 3,025
3.3%
10 ABDOMINAL DISCOMFORT 2,967
3.2%
11 HEPATIC ENZYME INCREASED 2,895
3.1%
12 SYSTEMIC LUPUS ERYTHEMATOSUS 2,833
3.1%
13 PEMPHIGUS 2,768
3.0%
14 HAND DEFORMITY 2,690
2.9%
15 GLOSSODYNIA 2,669
2.9%
16 SWELLING 2,657
2.9%
17 SYNOVITIS 2,650
2.9%
18 PERICARDITIS 2,635
2.9%
19 ARTHROPATHY 2,607
2.8%
20 HYPERSENSITIVITY 2,583
2.8%
21 INFUSION RELATED REACTION 2,582
2.8%
22 WOUND 2,582
2.8%
23 ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE 2,554
2.8%
24 DRUG INTOLERANCE 2,505
2.7%
25 OFF LABEL USE 2,366
2.6%
26 DISCOMFORT 2,302
2.5%
27 MATERNAL EXPOSURE DURING PREGNANCY 2,164
2.4%
28 PRODUCT USE IN UNAPPROVED INDICATION 2,162
2.4%
29 HEADACHE 2,127
2.3%
30 DUODENAL ULCER PERFORATION 2,084
2.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.