Baricitinib
Baricitinib is a JAK inhibitor used to treat moderately to severely active rheumatoid arthritis, severe alopecia areata, and COVID-19 in hospitalized adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Olumiant carries a Boxed Warning — the FDA's most serious safety alert. There are five major risks to know about:
- Serious infections: Olumiant suppresses the immune system, raising the risk of severe bacterial, fungal, viral, and opportunistic infections — including tuberculosis — that can lead to hospitalization or death. You must be tested for latent TB before starting (except for COVID-19). Do not take Olumiant if you have active TB.
- Higher risk of death: In a large study of a related drug (another JAK inhibitor) compared to TNF blockers in rheumatoid arthritis patients, there was a higher overall death rate, including from sudden cardiac events.
- Cancer risk: Lymphoma and lung cancers occurred at a higher rate with a related JAK inhibitor compared to TNF blockers, especially in current or past smokers.
- Major cardiovascular events (MACE): Heart attack, stroke, and cardiovascular death occurred more often with a related JAK inhibitor versus TNF blockers in RA patients aged 50+ with cardiovascular risk factors. Stop Olumiant immediately if you have a heart attack or stroke.
- Blood clots (thrombosis): Clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), and arteries have occurred with Olumiant — some fatal. Seek emergency care if you have sudden leg pain, swelling, chest pain, or shortness of breath.
📖 Baricitinib: Patient Information Guide
A plain-language walkthrough of Baricitinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Baricitinib is used for
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Baricitinib is approved for three distinct conditions in adults, all involving an overactive immune system.
- Rheumatoid arthritis (RA): Olumiant tablets are used in adults with moderately to severely active RA whose disease didn't improve enough with at least one TNF blocker medication.
- Severe alopecia areata: Olumiant tablets are approved for adults with severe alopecia areata — a condition where the immune system attacks hair follicles, causing significant hair loss.
- COVID-19: Olumiant tablets are used in hospitalized adults with COVID-19 who need supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation — a machine that supports heart and lung function).
How Baricitinib works
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Baricitinib is a JAK inhibitor — it blocks specific enzymes inside immune cells called Janus kinases (JAK1, JAK2, and TYK2). These enzymes normally pass along signals from the body's immune messengers (cytokines), triggering inflammation and immune activity. By blocking JAK enzymes, baricitinib interrupts this signaling chain and reduces the overactive immune response that drives joint inflammation in rheumatoid arthritis, hair follicle damage in alopecia areata, and dangerous immune overactivation in severe COVID-19.
In the lab, baricitinib showed the greatest blocking effect at JAK1 and JAK2. However, exactly which JAK enzyme is most responsible for its therapeutic effect isn't fully established yet.
How Baricitinib is taken (dosage)
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Baricitinib is taken as a tablet by mouth, once daily. It can be taken with or without food — eating doesn't meaningfully change how much of the medication reaches your bloodstream. The body reaches steady, stable drug levels within about 2 to 3 days of starting treatment.
- Your dose will be tailored to your condition, kidney function, and any other medications you take — particularly if you use probenecid, which raises baricitinib levels.
- Blood tests (blood counts, liver enzymes, cholesterol) are done before and during treatment to guide dosing and check for side effects.
- Do not adjust or stop your dose without talking to your prescriber first.
Baricitinib side effects in detail
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The most commonly reported side effects vary by condition but include:
- Upper respiratory tract infections (colds, sinus infections)
- Nausea
- Herpes simplex (cold sores, oral or genital herpes)
- Herpes zoster (shingles)
- Headache
- Acne and folliculitis (inflamed hair follicles)
- Elevated cholesterol and triglycerides (high lipid levels)
- Urinary tract infections
- Elevated liver enzymes (seen on blood tests)
- Fatigue
Serious reactions — including severe infections, blood clots, heart attack, stroke, and allergic reactions — require immediate medical attention. Contact your doctor right away if you develop fever, sudden chest pain, leg swelling, or signs of an allergic reaction such as hives or facial swelling.
Baricitinib warnings and precautions
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- Serious and sometimes fatal infections are the top concern. Baricitinib weakens the immune system, raising the risk of bacterial, fungal, and viral infections — including TB and shingles. You need a TB test before starting (unless being treated for COVID-19), and any active serious infection must be treated before beginning baricitinib.
- Blood clots (thrombosis) — in the legs, lungs, or arteries — have occurred at an increased rate compared to placebo. Some were fatal. Avoid baricitinib if you already have a high clot risk, and stop it immediately if clot symptoms appear.
- Major cardiovascular events — heart attack, stroke, and cardiovascular death — occurred more often with a related JAK inhibitor than with TNF blockers in RA patients aged 50+ who had cardiovascular risk factors. Current or past smokers face additional risk.
- Cancer risk — lymphoma, lung cancers, and other malignancies have been observed. Smokers and former smokers carry extra risk. Periodic skin checks are recommended for those at higher risk of skin cancer.
- Higher mortality: In a large postmarketing study, a related JAK inhibitor was linked to a higher all-cause death rate — including sudden cardiac death — compared to TNF blockers in RA patients.
- Lab abnormalities — including low white blood cell counts, anemia, elevated liver enzymes, and increased cholesterol — are monitored regularly during treatment.
Baricitinib interactions: what it interacts with
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A few medications interact meaningfully with baricitinib and should be discussed with your prescriber:
- Probenecid (used for gout): significantly increases baricitinib blood levels — your prescriber will reduce the baricitinib dose if you take this together.
- Other JAK inhibitors (e.g., tofacitinib, upadacitinib): not studied in combination with baricitinib; concurrent use is not recommended.
- Biologic DMARDs (e.g., adalimumab, etanercept, tocilizumab): not recommended in combination with baricitinib for RA or alopecia areata due to additive immune suppression risk.
- Potent immunosuppressants (azathioprine, cyclosporine): not recommended alongside baricitinib for RA or alopecia areata.
- Live vaccines: should not be given while taking baricitinib — they can cause infection in an immunocompromised person. Get your vaccines up to date before starting treatment.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Baricitinib
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- Tell your doctor about any current or recent infections — baricitinib should not be started during an active serious infection.
- You will need a TB skin or blood test before starting (not required for COVID-19 use); latent TB must be treated first.
- Tell your doctor if you have kidney disease — baricitinib levels build up with reduced kidney function, and dose adjustments are necessary.
- Tell your doctor if you have liver disease — baricitinib is not recommended for RA or alopecia areata patients with severe hepatic (liver) impairment.
- Tell your doctor if you have diabetes — baricitinib can cause hypoglycemia (low blood sugar), and closer glucose monitoring may be needed.
- Tell your doctor if you have a history of blood clots, heart disease, or stroke — baricitinib carries meaningful cardiovascular and thrombosis risks.
- Current or past smokers face a higher risk of cancer and cardiovascular events — your doctor will weigh the risks and benefits for you individually.
- Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding before taking baricitinib.
- Baricitinib is approved for adults; its use in children is not addressed in the FDA label evidence provided.
Baricitinib overdose: if you take too much
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In clinical trials, single doses up to 40 mg and repeated daily doses up to 20 mg for 10 days were given without dose-limiting toxicity. If someone takes too much, the body is expected to clear most of the drug within 24 hours. If an overdose occurs, the person should be monitored for signs of side effects, and any reactions that develop should be treated appropriately — contact Poison Control or seek emergency care.
Pharmacodynamics: what Baricitinib does in the body
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After a dose of baricitinib, the drug starts suppressing key immune signals within about one hour — measurable by how much it reduces a specific immune marker called STAT3 phosphorylation — and that effect largely returns to baseline by 24 hours, consistent with once-daily dosing. In people with rheumatoid arthritis, reductions in C-reactive protein (CRP) — a blood marker of inflammation — appeared within the first week of treatment and were sustained throughout. Baricitinib also causes modest, lasting decreases in certain antibody levels (IgG, IgM, IgA), though these generally stayed within the normal range. Notably, baricitinib does not meaningfully affect heart rhythm (QT interval) even at very high doses.
Pharmacokinetics: how your body processes Baricitinib
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Baricitinib is well absorbed after swallowing a tablet — about 80% of the dose reaches the bloodstream — and peak blood levels are reached in roughly one hour. It can be taken with or without food, as eating causes only a small, clinically unimportant change in absorption. The drug reaches stable levels in the body within 2 to 3 days of once-daily dosing, and its half-life (the time for blood levels to fall by half) is approximately 12 to 16 hours in people with rheumatoid arthritis or alopecia areata. The body clears baricitinib mainly through the kidneys — about 75% leaves in the urine, mostly unchanged — so reduced kidney function meaningfully increases drug exposure and may require dose adjustments.
How to store Baricitinib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children.
📄 Written from Baricitinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Baricitinib
59 supplements and herbal products have documented interactions with Baricitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 46
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Baricitinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Baricitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does baricitinib do, and why was I prescribed it?
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How do I take it, and does it matter if I take it with food?
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What side effects are most likely, and which ones should make me call my doctor?
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I heard baricitinib can cause blood clots. How worried should I be?
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Do I need any tests or vaccines before I start, or while I'm on it?
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Are there any medications I need to avoid while taking baricitinib?
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Is Baricitinib available over the counter?
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When was Baricitinib first available?
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Who makes Baricitinib?
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💬 Answers drafted from Baricitinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Baricitinib on HelloPharmacist
💊 Baricitinib forms and strengths (how it comes)
Baricitinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Olumiant tablets treat moderately to severely active rheumatoid arthritis in adults who haven't responded adequately to at least one TNF blocker
- Olumiant tablets treat severe alopecia areata in adults
- Olumiant tablets treat COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or ECMO
- Olumiant tablets are taken by mouth once daily, with or without food
- Olumiant tablets should not be taken with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine or cyclosporine when used for RA or alopecia areata
- If you also take probenecid, tell your doctor — your Olumiant dose will need to be reduced
- Get recommended vaccines before starting Olumiant, and avoid live vaccines while taking it
📊 Baricitinib on the U.S. market: products, makers and brands
How Baricitinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (4) · Crystal (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Baricitinib is used (Medicaid data)
A general measure of how commonly Baricitinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Baricitinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Baricitinib prescribed? Of the 1,599 medications we measure, Baricitinib ranks #1,002 by Medicaid prescriptions — more than 37% of them.
Utilization by Baricitinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
baricitinib 4 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2588561
Other Baricitinib products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 12 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Baricitinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 16 listed Baricitinib NDCs with Medicaid activity.
🔍 Compare Baricitinib products
A representative set of FDA-listed product records for Baricitinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 1 mg | Oral | Eli Lilly and Company × 4 listings | NDA | View NDC → |
| 2 mg | Oral | Eli Lilly and Company × 4 listings | NDA | View NDC → |
| 4 mg | Oral | Eli Lilly and Company × 4 listings | NDA | View NDC → |
| 4 mg | Oral | Eli Lilly and Company | EMERGENCY USE AUTHORIZATION | View NDC → |
| 1 mg | — | Lilly del Caribe, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 2 mg | — | Lilly del Caribe, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 4 mg | — | Lilly del Caribe, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 5 kg/5 kg | — | Chunghwa Chemical Synthesis & Biotech. Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Eli Lilly Kinsale Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Wisdom Pharmaceutical Co.,Ltd | BULK INGREDIENT | View NDC → |
Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Baricitinib NDCs →
📈 Baricitinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Baricitinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Baricitinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Baricitinib FDA approval history
How Baricitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Baricitinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2047232 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2047240In current FDA listings
Look up RxCUI 2047232 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Baricitinib supply and shortage status
Whether Baricitinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Baricitinib brand names
🏭 Who makes Baricitinib: manufacturers and labelers
Baricitinib drug class (RxNorm)
Baricitinib belongs to the Janus Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Baricitinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Eli Lilly and Company is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.