Prescription medication · JAK Inhibitor

baricitinib

Also sold as Olumiant. Olumiant treats rheumatoid arthritis in adults when other medicines have not worked well.

Data updated 2026-05-15

9,259
FDA reportsLightly reported
$88.88
Brand price (NADAC)

baricitinib (Olumiant) is a prescription JAK Inhibitor. Olumiant treats rheumatoid arthritis in adults when other medicines have not worked well.

Olumiant contains baricitinib. It is a medicine that can lower the activity of your immune system.

Drug Pricing (NADAC)

Brand Price

$88.88/unit

Generic Available

No

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

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What it does

Olumiant treats rheumatoid arthritis in adults when other medicines have not worked well.

Common side effects

Upper respiratory tract infections (like common cold), Nausea, Headache

Key warnings

Olumiant can increase your risk of serious infections.

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

How It Works

Olumiant blocks certain enzymes called Janus kinases (JAKs) inside your cells. These enzymes help cause inflammation. By blocking them, Olumiant can reduce inflammation and other symptoms of rheumatoid arthritis and alopecia areata.

Side Effects (from patient reports)

Based on 9,259 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for baricitinib, 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 baricitinib each year to the FDA Adverse Event Reporting System (FAERS).

05001,0001,5002,000 20122014201620182020202220242025 932

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

Where baricitinib sits

baricitinib has more FDA adverse-event reports than 37% 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 baricitinib; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 9,259 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.

Total Reports

9,259

Reports Mentioning Death

866

9.4% of reports — not proof of cause

Hospitalization Reports

3,011

Top Indication

Rheumatoid Arthritis

Gender Distribution

Female 5,641 (67%)
Male 2,741 (33%)

Age Distribution

0–17 184
18–44 1,111
45–64 2,625
65–74 1,623
75+ 1,022

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
3 COVID-19 439
4 RHEUMATOID ARTHRITIS 352
5 PULMONARY EMBOLISM 294
6 PNEUMONIA 264
7 HEADACHE 253
8 HERPES ZOSTER 237
9 DEATH 235
10 NAUSEA 226
11 DEEP VEIN THROMBOSIS 213
12 FATIGUE 183
13 ARTHRALGIA 179
14 WEIGHT INCREASED 179
15 THERAPY INTERRUPTED 178
16 DYSPNOEA 174
17 URINARY TRACT INFECTION 174

Reactions in Death Reports

DEATH 229
COVID-19 80
RESPIRATORY FAILURE 48
CARDIAC ARREST 45
COVID-19 PNEUMONIA 41
SEPSIS 41
PULMONARY EMBOLISM 39
MULTIPLE ORGAN DYSFUNCTION SYNDROME 34
PNEUMONIA 33
SEPTIC SHOCK 28

Reactions in Hospitalization Reports

COVID-19 227
PNEUMONIA 185
RHEUMATOID ARTHRITIS 181
PULMONARY EMBOLISM 154
DEEP VEIN THROMBOSIS 109
DYSPNOEA 99
HERPES ZOSTER 88
PYREXIA 83
ARTHRALGIA 77
URINARY TRACT INFECTION 75

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

Serious Warnings

Olumiant can increase your risk of serious infections. Tell your doctor right away if you have any signs of an infection, such as fever, cough, or body aches. Blood clots in the lungs and legs, some cancers, heart attack, stroke, and death have happened in people taking Olumiant.

Common Questions

What should I tell my doctor before taking Olumiant?
Tell your doctor about all of your medical conditions, including any infections, liver problems, kidney problems, or if you are pregnant or breastfeeding.
How long does it take for Olumiant to work?
It may take several weeks or months before you notice the full effects of Olumiant.
Can I take Olumiant with other medicines?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the symptoms of a serious infection?
Symptoms of a serious infection include fever, cough, body aches, chills, and fatigue.
Can Olumiant cause cancer?
Olumiant may increase your risk of certain types of cancer. Talk to your doctor about this risk.
What should I do if I get pregnant while taking Olumiant?
Tell your doctor right away if you become pregnant while taking Olumiant.
Can Olumiant affect my cholesterol?
Olumiant can increase your cholesterol levels. Your doctor may check your cholesterol levels while you are taking Olumiant.
Will Olumiant cure my rheumatoid arthritis?
Olumiant will not cure rheumatoid arthritis, but it can help to reduce your symptoms.
Can I get vaccines while taking Olumiant?
You should not get live vaccines while taking Olumiant. Talk to your doctor about which vaccines are safe for you.
What tests will I need while taking Olumiant?
Your doctor may do blood tests to check your blood cell counts and liver function while you are taking Olumiant.
What are the common side effects of baricitinib?
The registry lists Upper respiratory tract infections (like common cold), Nausea, Headache, Diarrhea, Herpes zoster (shingles) among the most-reported FAERS reaction terms for baricitinib. The compiled record contains 9,259 FDA adverse-event reports. These counts are not an individual symptom assessment.
What drug class is baricitinib?
baricitinib belongs to the JAK Inhibitor drug class. It requires a prescription (Rx). Olumiant treats rheumatoid arthritis in adults when other medicines have not worked well.
What pregnancy or breastfeeding source fields are listed for baricitinib?
The FDA label for baricitinib contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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

Compare baricitinib vs abatacept side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for baricitinib: 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.

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What the FDA Data Shows for baricitinib

The FDA label for baricitinib (sold under brand names such as Olumiant) classifies it as a prescription-only medication in the JAK Inhibitor class. Olumiant treats rheumatoid arthritis in adults when other medicines have not worked well. Official labeling lists 7 commonly reported side effects, including Upper respiratory tract infections (like common cold), Nausea, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 9,259 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. 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 10, 2022

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