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.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$88.88/unit
Generic Available
No
ELI LILLY AND CO
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
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.
How to Take It
Take Olumiant exactly as your doctor tells you. You can take it with or without food. Try to take it at the same time each day. Do not break, crush, or chew the tablet.
This is a plain-language summary of baricitinib's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Olumiant may harm your unborn baby. It is not known if Olumiant passes into breast milk, so talk to your doctor about the best way to feed your baby if you take Olumiant.
This is a plain-language summary of baricitinib's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of baricitinib's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Olumiant at room temperature, away from moisture and heat.
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
- COVID-19
COVID-19
439 reports
- Rheumatoid arthritis
Rheumatoid arthritis
352 reports
- Blood clot in the lung
Blood clot in the lung
294 reports
- Pneumonia
Pneumonia
264 reports
- Headache
Headache
253 reports
- Shingles
Shingles
237 reports
- Death
Death
235 reports
- Nausea
Nausea
226 reports
- Blood clot in a deep vein
Blood clot in a deep vein
213 reports
- Tiredness
Tiredness
183 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.
Reports over time
Adverse-event reports filed for baricitinib each year to the FDA Adverse Event Reporting System (FAERS).
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) 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?
How long does it take for Olumiant to work?
Can I take Olumiant with other medicines?
What are the symptoms of a serious infection?
Can Olumiant cause cancer?
What should I do if I get pregnant while taking Olumiant?
Can Olumiant affect my cholesterol?
Will Olumiant cure my rheumatoid arthritis?
Can I get vaccines while taking Olumiant?
What tests will I need while taking Olumiant?
What are the common side effects of baricitinib?
What drug class is baricitinib?
Is baricitinib safe during pregnancy?
Related Medications in JAK Inhibitor
Other drugs grouped near baricitinib - same-class peers and common alternatives.
abatacept
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acetaminophen
Tylenol
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acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
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acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
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Humira
Idacio is a medicine that blocks a protein called TNF.
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: May 10, 2022
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages