Prescription medication · IL-6 Receptor Antagonist

sarilumab

Also sold as Kevzara. Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough.

Data updated 2026-05-15

23,683
FDA reportsModerately reported
5
InteractionsFew interactions
$1852.54
Brand price (NADAC)

What the data shows

sarilumab (Kevzara) is a prescription IL-6 Receptor Antagonist, reported at a middle-of-the-pack volume (23,683 FDA reports), with 5 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

sarilumab (Kevzara) is a prescription IL-6 Receptor Antagonist. Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough.

Kevzara is a medicine that can help treat rheumatoid arthritis, polymyalgia rheumatica and polyarticular juvenile idiopathic arthritis. It works by blocking a protein in your body that causes inflammation.

Drug Pricing (NADAC)

Brand Price

$1852.54/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

Compare with Another Drug → Full Side Effects Report →

What it does

Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough.

Common side effects

Low white blood cell count (neutropenia), Increased liver enzyme levels, Redness at the injection site

Key warnings

Kevzara can increase your risk of serious infections that could lead to hospitalization or death.

The sections below are summarized in plain English from sarilumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Kevzara is an interleukin-6 (IL-6) receptor antagonist. This means it blocks the IL-6 receptor. By blocking this receptor, Kevzara reduces inflammation in your body.

Side Effects (from patient reports)

Based on 23,683 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for sarilumab, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for sarilumab each year to the FDA Adverse Event Reporting System (FAERS).

02,0004,0006,000 20152016201720182019202020212022202320242025 4,803

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where sarilumab sits

sarilumab has more FDA adverse-event reports than 59% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is sarilumab; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 23,683 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2015–2025.

Total Reports

23,683

Reports Mentioning Death

2,313

9.8% of reports — not proof of cause

Hospitalization Reports

4,047

Top Indication

Rheumatoid Arthritis

Gender Distribution

Female 17,963 (84%)
Male 3,459 (16%)

Age Distribution

0–17 53
18–44 3,620
45–64 7,520
65–74 2,758
75+ 1,631

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 PAIN 5,313
3 ARTHRALGIA 4,655
4 RHEUMATOID ARTHRITIS 4,395
5 JOINT SWELLING 4,362
6 CONDITION AGGRAVATED 3,580
7 FATIGUE 3,334
8 RASH 3,212
9 ALOPECIA 2,969
10 ABDOMINAL DISCOMFORT 2,906
11 HEPATIC ENZYME INCREASED 2,858
12 SYSTEMIC LUPUS ERYTHEMATOSUS 2,780
13 PEMPHIGUS 2,721
14 HAND DEFORMITY 2,643
15 GLOSSODYNIA 2,625
16 SYNOVITIS 2,621

Reactions in Death Reports

SYSTEMIC LUPUS ERYTHEMATOSUS 1,016
DUODENAL ULCER PERFORATION 1,014
ABDOMINAL DISCOMFORT 994
PEMPHIGUS 978
TYPE 2 DIABETES MELLITUS 975
PERICARDITIS 971
RHEUMATOID ARTHRITIS 966
ALOPECIA 950
HAND DEFORMITY 943
BLOOD CHOLESTEROL INCREASED 938

Reactions in Hospitalization Reports

RHEUMATOID ARTHRITIS 1,464
ABDOMINAL DISCOMFORT 1,402
ALOPECIA 1,321
SYSTEMIC LUPUS ERYTHEMATOSUS 1,319
ARTHRALGIA 1,297
HEPATIC ENZYME INCREASED 1,293
DUODENAL ULCER PERFORATION 1,288
FATIGUE 1,263
PERICARDITIS 1,263
HELICOBACTER INFECTION 1,256

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Kevzara can increase your risk of serious infections that could lead to hospitalization or death. Tell your doctor if you have an active infection before starting Kevzara. Your doctor should test you for tuberculosis (TB) before you start Kevzara. If you get a serious infection, your doctor will stop Kevzara treatment until the infection is controlled.

Known Drug Interactions

Exercise caution when co-administering KEVZARA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.

Mechanism: Sarilumab can make your body process atorvastatin more quickly than usual. This can make the atorvastatin less effective at lowering your cholesterol.

moderate lovastatin

Exercise caution when co-administering KEVZARA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.

Mechanism: Sarilumab speeds up the way your body gets rid of lovastatin. This reduces the amount of medicine in your system, making it less effective.

Upon initiation or discontinuation of KEVZARA, in patients being treated with CYP substrate medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., theophylline) and adjust the individual dose of the medicinal product as needed.

Mechanism: Sarilumab can change how quickly your body breaks down warfarin, which can affect how much your blood is thinned. This could lead to your blood being too thick or too thin.

7 DRUG INTERACTIONS 7.1 Use with Other Drugs Population pharmacokinetic analyses did not detect any effect of methotrexate (MTX) on sarilumab clearance.

Mechanism: Methotrexate does not affect how the body processes or removes sarilumab.

Upon initiation or discontinuation of KEVZARA, in patients being treated with CYP substrate medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., theophylline) and adjust the individual dose of the medicinal product as needed.

Mechanism: Sarilumab can change how the liver breaks down theophylline, which might change the amount of medicine in your blood.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

What should I tell my doctor before taking Kevzara?
Tell your doctor if you have any infections, liver problems, or have had TB.
Can I take Kevzara with other medicines?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will my doctor monitor me while I'm taking Kevzara?
Your doctor will do blood tests to check your white blood cell count, liver function, and cholesterol levels.
Can I get vaccines while taking Kevzara?
Avoid live vaccines while taking Kevzara.
What are the signs of a serious infection?
Signs include fever, cough, shortness of breath, weight loss, night sweats, diarrhea, or stomach pain.
What should I do if I have side effects?
Tell your doctor about any side effects you experience while taking Kevzara.
Can Kevzara affect my cholesterol?
Yes, Kevzara can increase your cholesterol levels.
Is it safe to take Kevzara if I have diabetes?
Talk to your doctor about the risks and benefits of taking Kevzara if you have diabetes.
How is Kevzara supplied?
Kevzara comes in pre-filled syringes and pre-filled pens.
What if I accidentally leave Kevzara out of the refrigerator?
If needed, you can store Kevzara at room temperature up to 77°F (25°C) for up to 14 days.
What are the common side effects of sarilumab?
The registry lists Low white blood cell count (neutropenia), Increased liver enzyme levels, Redness at the injection site, Upper respiratory infections, Urinary tract infections among the most-reported FAERS reaction terms for sarilumab. The compiled record contains 23,683 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does sarilumab interact with other medications?
The registry has 5 documented interaction rows for sarilumab. Notable source-record pairings include atorvastatin, lovastatin, warfarin. These rows are not a complete medication review.
What drug class is sarilumab?
sarilumab belongs to the IL-6 Receptor Antagonist drug class. It requires a prescription (Rx). Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough.
What pregnancy or breastfeeding source fields are listed for sarilumab?
The FDA label for sarilumab contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Other drugs grouped near sarilumab - same-class peers and common alternatives.

Compare sarilumab vs abatacept side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for sarilumab: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Medication Guides

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What the FDA Data Shows for sarilumab

The FDA label for sarilumab (sold under brand names such as Kevzara) classifies it as a prescription-only medication in the IL-6 Receptor Antagonist class. Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough. Official labeling lists 8 commonly reported side effects, including Low white blood cell count (neutropenia), Increased liver enzyme levels, Redness at the injection site.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 23,683 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: May 16, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page