Prescription medicine
Abrocitinib Brand names: Cibinqo
Abrocitinib (Cibinqo) is a prescription medicine with an FDA approval on record since 2022. No generic is listed; pharmacies paid $197.09 per Cibinqo 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the abrocitinib FDA label on DailyMed (effective September 9, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 213871 record on Drugs@FDA; every abrocitinib label on DailyMed.
Highlights of the record
FDA label of September 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS,.
and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning.
Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. ( 5.1 )
Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. CIBINQO is not approved for use in RA patients. ( 5.2 )
Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 )
MACE has occurred with CIBINQO. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 )
Thrombosis has occurred with CIBINQO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. […]
Used for
From the label: indications and usageCIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 14, 2022 Cibinqo, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 14, 2036 Cibinqo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $197.09 per tablet Cibinqo 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,840 through July 30, 2026
What is abrocitinib used for?
From the label: indications and usageCIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. […]
Conditions named in the indications of abrocitinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Janus Kinase Inhibitor.
Source: FDA drug label (Cibinqo), Pfizer Laboratories Div Pfizer Inc, effective September 9, 2026 (SPL set 3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258), via openFDA; the full label on DailyMed
What does the patient leaflet for abrocitinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CIBINQO?CIBINQO may cause serious side effects, including: 1. Serious infections CIBINQO is a medicine that affects your immune system. CIBINQO can lower the ability of your immune system to fight infections. Some people have had serious infections while taking CIBINQO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. • Your healthcare provider should test you for TB before starting treatment with CIBINQO. • Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with CIBINQO. You should not start taking CIBINQO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting CIBINQO, tell your healthcare provider if you: • are being treated for an infection • have had an infection that does not go away or that keeps coming back • have diabetes, chronic lung disease, HIV, or a weak immune system • have TB or have been in close contact with someone with TB • have had shingles (herpes zoster) • have had hepatitis B or hepatitis C • live or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain kinds of fungal infections. These infections may happen or become more severe if you use CIBINQO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. […]
From the patient leaflet: How should I store CIBINQO?Store CIBINQO at room temperature between 68°F to 77°F (20°C to 25°C). • Store CIBINQO in the original package. • The container has a child resistant closure. Keep CIBINQO and all medicines out of the reach of children.
Source: FDA drug label (Cibinqo), Pfizer Laboratories Div Pfizer Inc, effective September 9, 2026 (SPL set 3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258), via openFDA; the full label on DailyMed
Is there a generic for abrocitinib (Cibinqo)?
No generic abrocitinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Cibinqo tablets: the compound patent runs to January 14, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for abrocitinib (Cibinqo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $197.09 per Cibinqo 100 mg tablet, up 4% from $189.33 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cibinqo 100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cibinqo 100 mg tablet | Brand | $197.09 per tablet | $5,912.77 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the abrocitinib label say about other medicines?
The abrocitinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name abrocitinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | CONTRAINDICATIONS CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment [see Warnings and Precautions (5.7), Drug Interactions (7.2), and Clinical Pharmacology (12.2) ]. |
Other labels that name abrocitinib
Source: FDA drug label (Cibinqo), Pfizer Laboratories Div Pfizer Inc, effective September 9, 2026 (SPL set 3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258), via openFDA; the full label on DailyMed
What do FAERS reports show for abrocitinib?
The FDA Adverse Event Reporting System holds 3,840 reports that list abrocitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 65 are coded as a death and 391 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (1,189, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other janus kinase inhibitors
- the pharmacologic class, with prices and generics
- Abrocitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other