Abrocitinib
Abrocitinib is a once-daily JAK inhibitor pill used to treat refractory, moderate-to-severe atopic dermatitis (eczema) in adults and teens 12 and older.
🧬 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 →
Abrocitinib (Cibinqo) is a once-daily JAK inhibitor that blocks JAK1, an enzyme behind inflammation and itch signaling. It is a specialist choice, on the U.S. market since about 2020, for moderate-to-severe atopic dermatitis (eczema) in people 12 and older when other whole-body treatments have not worked or are not suitable. Most people tolerate it reasonably well, with nausea, headache, acne and cold sores the side effects most often noticed. Its boxed warning, the FDA's strongest, covers serious infections, death, cancer, major heart events and blood clots, with higher risk in current or past smokers, so report fever, a painful blistering rash, leg swelling or chest pain promptly.
Clinical pearls
- Expect blood counts and a cholesterol check about four weeks after starting, and blood counts again after any dose increase.
- Avoid antiplatelet medicines other than low-dose aspirin for the first three months of treatment because of bleeding risk.
- Get vaccines up to date before starting, including the shingles vaccine, and avoid live vaccines before, during and after treatment.
- Skin cancer was seen in trials, so use broad-spectrum sunscreen and protective clothing, and limit time in strong sun.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Cibinqo has a boxed warning, the FDA's strongest warning, about serious infections, death, cancer, heart problems, and blood clots.
- Serious infections: These include TB, fungal, viral, and bacterial infections that can lead to hospitalization or death. The most common serious ones were herpes simplex, shingles, and pneumonia. You will be tested for TB before and during treatment. Treatment is stopped if a serious infection develops.
- Death, cancer, heart events, and clots: In a large study of another JAK inhibitor in rheumatoid arthritis patients 50 and older with heart risk factors, there were more deaths, cancers (including lymphoma and lung cancer), major heart events (heart attack, stroke, cardiovascular death), and blood clots than with TNF blockers. Cibinqo is not approved for rheumatoid arthritis, but similar problems have occurred with Cibinqo.
- Higher risk: Current or past smokers have extra risk of cancer and heart problems.
- What to do: Stop Cibinqo and get help if you have a heart attack, stroke, or signs of a blood clot. Avoid it if you are at risk for clots.
Patient information guide A plain-language walkthrough of Abrocitinib, written from its FDA label.
What Abrocitinib is used for
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Abrocitinib treats one condition:
- Refractory, moderate-to-severe atopic dermatitis (eczema) in adults and children 12 and older, when other systemic medicines, including biologics, have not worked well or are not advisable (Cibinqo tablets).
- It is not recommended with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
How Abrocitinib works
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Abrocitinib is a JAK inhibitor. It reversibly blocks JAK1, an enzyme involved in inflammation signaling, by occupying the spot where the enzyme's energy source (ATP) normally binds.
Exactly how blocking specific JAK enzymes leads to improvement is not known.
Abrocitinib dosage
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Cibinqo is a tablet taken by mouth once a day, with or without food. Your prescriber chooses the dose and may change it based on response, kidney function, CYP2C19 status, or other medicines. Always follow the label and your prescriber's instructions.
- Before starting: TB test, hepatitis screening, and a complete blood count.
- A blood count is recommended 4 weeks after starting and 4 weeks after any dose increase.
Dosing details from the FDA-approved label
From the Abrocitinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (adults with atopic dermatitis per label text)
- 100 mg orally once daily
- Patients not responding to 100 mg once daily
- 200 mg orally once daily
- Moderate renal impairment
- 50 mg once daily, or 100 mg once daily for those patients who are not responding to 50 mg once daily
- Renal impairment adjustment
- CYP2C19 poor metabolizer
- 50 mg once daily, or 100 mg once daily for those patients who are not responding to 50 mg once daily
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. ( 2.1 ) • Recommended dosage is 100 mg orally once daily. ( 2.2 ) • 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily. ( 2.2 ) • Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. ( 2.3 ) • CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. ( 2.4 ) • For dosage modifications for certain adverse reactions, see Full Prescribing Information. ( 2.6 ) 2.1 Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation Perform the following tests and evaluations prior to CIBINQO initiation: • Tuberculosis (TB) infection evaluation – CIBINQO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of CIBINQO [see Warnings and Precautions (5.1) ] . • Viral hepatitis screening in accordance with clinical guidelines – CIBINQO initiation is not recommended in patients with active hepatitis B or hepatitis C [see Warnings and Precautions (5.1) ] . • A complete blood count (CBC) – CIBINQO initiation is not recommended in patients with a platelet count <150,000/mm 3 , an absolute lymphocyte count <500/mm 3 , an absolute neutrophil count <1,000/mm 3 , or a hemoglobin value <8 g/dL [see Warnings and Precautions (5.7) ] . Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to CIBINQO initiation [see Warnings and Precautions (5.8) ] . 2.2 Recommended Dosage The recommended dosage is 100 mg once daily. If an adequate response is not achieved with CIBINQO 100 mg once daily, consider increasing the dosage to 200 mg once daily. Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily. Use the lowest efficacious dosage to maintain response. CIBINQO can be used with or without topical corticosteroids. If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case, skip the missed dose.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Abrocitinib side effects
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Common side effects seen in studies include:
Common side effects
- Cold-like symptoms (nasopharyngitis)
- Nausea
- Headache
- Herpes simplex (cold sores)
- Dizziness
- Acne
- Urinary tract infection
- Vomiting
- Fatigue
- Raised blood creatine phosphokinase (a muscle enzyme)
When to get medical help
- Signs of infection such as fever, cough, painful skin rash or blisters (shingles), or symptoms of TB. Call your doctor promptly.
- Symptoms of a blood clot: leg swelling or pain, sudden shortness of breath, or chest pain. Get medical help right away.
- Symptoms of a heart attack or stroke, such as chest pain, weakness on one side, or trouble speaking. Get emergency help.
- A new or changing skin growth, or any new cancer diagnosis.
- Signs of low blood sugar if you have diabetes.
- Unusual bleeding or bruising, which can happen if platelet counts drop.
Abrocitinib warnings and precautions
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- Serious infections including TB, shingles, and pneumonia. Avoid use with an active serious infection.
- Blood clots in the legs and lungs, and heart events such as heart attack and stroke. Smokers and people with heart risk factors are at higher risk.
- Cancer, including lymphoma and skin cancer. Limit sun exposure.
- Lab changes: lower platelets and lymphocytes and higher cholesterol and other blood fats.
- Low blood sugar in people with diabetes.
- Vaccines: avoid live vaccines around treatment.
Abrocitinib interactions
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Several medicines change abrocitinib levels or are affected by it.
- Antiplatelet drugs (except low-dose aspirin): not allowed in the first 3 months because of bleeding risk with low platelets.
- Strong CYP2C19 inhibitors: raise levels, so a lower dose is used.
- Drugs blocking both CYP2C19 and CYP2C9: avoid, since they raise levels.
- CYP2C19 or CYP2C9 inducers: avoid, since they can reduce effectiveness.
- P-gp substrates and CYP2C19-sensitive drugs: abrocitinib can raise their levels, so monitoring or dose changes may be needed.
Interactions listed in the FDA-approved label
From the Abrocitinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong inhibitors of CYP2C19: Increases the combined exposure of abrocitinib and its two active metabolites, M1 and M2, which may increase the adverse reactions of CIBINQO. Dosage reduction is recommended: 50 mg once daily, or 100 mg once daily for those patients who are not responding to 50 mg once daily.
- Strong or moderate inhibitors of both CYP2C19 and CYP2C9: Increases the exposure of abrocitinib and its two active metabolites, M1 and M2, which may increase the adverse reactions of CIBINQO. Avoid concomitant use.
- Strong or moderate CYP2C19 or CYP2C9 inducers: Decreases the combined exposure of abrocitinib and its two active metabolites, M1 and M2, which may result in loss of or reduced clinical response. Avoid concomitant use.
- Certain P-gp substrates: CIBINQO increases plasma concentrations of P-gp substrates and may result in adverse reactions of the substrate where minimal increases in concentration may lead to serious adverse reactions. Monitor appropriately or modify the dosage of the P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities. Refer to the Prescribing Information of the P-gp substrate.
- Certain CYP2C19 substrates: CIBINQO is a moderate inhibitor of CYP2C19 and may increase plasma concentrations of drugs primarily metabolized by CYP2C19, which may result in adverse reactions. Caution should be exercised with CYP2C19 sensitive substrates where small concentration changes may lead to serious or life-threatening toxicities.
- Antiplatelet therapy drugs: Concomitant use may increase the risk of bleeding with thrombocytopenia. CIBINQO is contraindicated in patients taking antiplatelet drugs, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Strong Inhibitors of CYP2C19 : The recommended dosage is 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. ( 2.5 , 7.1 ) • Moderate to Strong Inhibitors of Both CYP2C19 and CYP2C9, or Strong or Moderate CYP2C19 or CYP2C9 Inducers : Avoid concomitant use. ( 7.1 ) • Certain P-gp Substrates or Certain CYP2C19 Substrates : Monitor or titrate dosage of P-gp substrates or CYP2C19 substrates where small concentration changes may lead to serious or life-threatening toxicities. ( 7.2 ) 7.1 Effects of Other Drugs on CIBINQO Table 4 includes drugs with clinically significant drug interactions affecting CIBINQO. Table 4. Clinically Significant Drug Interactions Affecting CIBINQO Strong CYP2C19 Inhibitors Clinical Impact Concomitant use of CIBINQO with strong CYP2C19 inhibitors increases the combined exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO [see Clinical Pharmacology (12.3) ]. Intervention Dosage reduction of CIBINQO is recommended when concomitantly used with strong CYP2C19 inhibitors [see Dosage and Administration (2.5) ]. Strong or Moderate Inhibitors of both CYP2C19 and CYP2C9 Clinical Impact Concomitant use of CIBINQO with drugs that are strong or moderate inhibitors of both CYP2C19 and CYP2C9 increases the exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO [ Clinical Pharmacology (12.3) ]. Intervention Avoid concomitant use of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9 . Strong or Moderate CYP2C19 or CYP2C9 Inducers Clinical Impact Concomitant use of CIBINQO with strong or moderate CYP2C19 or CYP2C9 inducers decreases the combined exposure of abrocitinib and its two active metabolites, M1 and M2, which may result in loss of or reduced clinical response [see Clinical Pharmacology (12.3) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Abrocitinib
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- Do not use with active TB, active hepatitis B or C, or an active serious infection.
- Tell your doctor about smoking, heart disease risk, clot history, cancer history, or diabetes.
- Not recommended with severe kidney disease, end-stage kidney disease, or severe liver impairment.
- Do not breastfeed during treatment and for one day after the last dose.
- Pregnancy data are limited; a pregnancy exposure registry exists. Female fertility may be affected.
- Not established under age 12.
- Adults 65 and older were not studied in large numbers; more stopped treatment in trials.
Abrocitinib overdose
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There is no experience with human overdose and no specific antidote. If you take too much, call Poison Control at 1-800-222-1222 for current advice.
What Abrocitinib does in the body
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Abrocitinib lowers blood markers of inflammation, including hsCRP, IL-31, and TARC, and these return near baseline within 4 weeks of stopping. It also causes a temporary, dose-related drop in platelets, lowest at a median of about 24 days, with partial recovery by 12 weeks even while continuing treatment. At 3 times the maximum dose, it did not meaningfully affect the heart's QT interval.
How your body processes Abrocitinib
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Abrocitinib is well absorbed by mouth and peaks within about 1 hour. A high-fat meal did not have a clinically relevant effect on exposure. It is mainly broken down by liver enzymes (mostly CYP2C19 and CYP2C9) into two active byproducts. Half-lives are about 3 to 5 hours, and steady levels are reached within 48 hours of daily use. Very little leaves in urine unchanged.
How to store Abrocitinib
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Store CIBINQO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in original package.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Abrocitinib
290 supplements and herbal products have documented interactions with Abrocitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 252
- Minor · 35
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.
Abrocitinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Abrocitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is abrocitinib for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take it with my other medicines?
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Is it safe in pregnancy or while breastfeeding?
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Is Abrocitinib available over the counter?
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When was Abrocitinib first available?
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Who makes Abrocitinib?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Abrocitinib on HelloPharmacist
Abrocitinib forms and strengths (how it comes)
Abrocitinib 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Abrocitinib inactive ingredients by manufacturer.
Tablet
How this form is used
- Cibinqo is used for refractory, moderate-to-severe atopic dermatitis in adults and children 12 and older.
- Cibinqo is for people not well controlled on other systemic medicines, including biologics, or who can't use them.
- Cibinqo is taken by mouth once daily.
- Cibinqo may be taken with or without food.
- Cibinqo dosing may be lowered for moderate kidney impairment, CYP2C19 poor metabolizers, or certain interacting drugs.
Abrocitinib on the U.S. market: products, makers and brands
How Abrocitinib 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.
2 companies list 6 Abrocitinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2020. Brand names on the directory include Cibinqo; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (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 Abrocitinib is used (Medicaid data)
A general measure of how commonly Abrocitinib 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 Abrocitinib 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 Abrocitinib prescribed? Of the 1,601 medications we measure, Abrocitinib ranks #1,103 by Medicaid prescriptions — more than 31% of them.
Utilization by Abrocitinib 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.
Other Abrocitinib products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 3 of 13 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 Abrocitinib, 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 3 of 13 listed Abrocitinib NDCs with Medicaid activity.
Compare Abrocitinib products
A representative set of FDA-listed product records for Abrocitinib — 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 | ||||
| 50 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 100 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 200 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 50 mg | Oral | U.S. Pharmaceuticals | NDA | View NDC → |
| 100 mg | Oral | U.S. Pharmaceuticals | NDA | View NDC → |
| 200 mg | Oral | U.S. Pharmaceuticals | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Abrocitinib NDCs →
Abrocitinib 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 Abrocitinib — 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 Abrocitinib 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.
Abrocitinib FDA approval history
How Abrocitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Abrocitinib 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.
The FDA’s enforcement reports list no Abrocitinib recalls since July 2021.
✅No Abrocitinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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 2591476 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2591480In current FDA listingsClinical drug / strength (SCD) 50 MGRxCUI 2591493100 MGRxCUI 2591481200 MGRxCUI 2591489
Look up RxCUI 2591476 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.
Abrocitinib supply and shortage status
Whether Abrocitinib 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.
💵 What Abrocitinib costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 100 mg | $197.09 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Abrocitinib brand names
Abrocitinib is sold under one brand name in the FDA directory — Cibinqo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Abrocitinib: manufacturers and labelers
2 companies list Abrocitinib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Abrocitinib drug class (RxNorm)
Abrocitinib 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 Abrocitinib 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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →