What the label lists and what reports show
Abrocitinib side effects
Abrocitinib's FDA label: “Most common adverse events (≥1% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension …” FAERS holds 3,840 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (238 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CIBINQO?CIBINQO may cause serious side effects. See " What is the most important information I should know about CIBINQO? " The most common side effects of CIBINQO include: • See " What is the most important information I should know about CIBINQO ." • common cold • nausea • headache • herpes simplex including cold sores • increased blood level of creatine phosphokinase • dizziness • urinary tract infection • tiredness • acne • vomiting • mouth and throat pain • flu • stomach flu • bacterial skin infection (impetigo) • high blood pressure • allergic skin rash to something you came into contact with • stomach-area pain • shingles • low platelet count Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with CIBINQO. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse events (≥1% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact.
Table 3. Adverse Reactions from Placebo-Controlled Trials Reported in ≥1% of CIBINQO Treated Subjects with Moderate to Severe Atopic Dermatitis and at Higher Rate than Placebo for up to 16 Weeks
| Reaction | CIBINQO 200 mg N=590 n (% Study size adjusted percentages ) | CIBINQO 100 mg N=608 n (% ) | Placebo N=342 n (% ) |
|---|---|---|---|
| Nasopharyngitis | 51 (8.7) | 75 (12.4) | 27 (7.9) |
| Nausea | 86 (14.5) | 37 (6.0) | 7 (2.1) |
| Headache | 46 (7.8) | 36 (6.0) | 12 (3.5) |
| Herpes simplex Herpes simplex also includes oral herpes, ophthalmic herpes, herpes… | 25 (4.2) | 20 (3.3) | 6 (1.8) |
| Increased blood creatine phosphokinase | 17 (2.9) | 14 (2.3) | 5 (1.5) |
| Dizziness | 17 (2.9) | 11 (1.8) | 3 (0.9) |
| Urinary tract infection | 13 (2.2) | 10 (1.7) | 4 (1.2) |
| Fatigue | 8 (1.3) | 10 (1.6) | 2 (0.5) |
| Acne | 28 (4.7) | 10 (1.6) | 0 (0.0) |
| Vomiting | 19 (3.2) | 9 (1.5) | 3 (0.9) |
| Impetigo | 3 (0.5) | 9 (1.5) | 1 (0.3) |
| Oropharyngeal pain | 6 (1.0) | 8 (1.4) | 2 (0.6) |
| Hypertension | 5 (0.8) | 7 (1.2) | 2 (0.7) |
| Influenza | 6 (1.1) | 7 (1.2) | 0 (0.0) |
| Gastroenteritis | 8 (1.3) | 7 (1.1) | 2 (0.6) |
| Dermatitis contact | 3 (0.5) | 6 (1.1) | 1 (0.3) |
| Abdominal pain upper | 11 (1.9) | 4 (0.6) | 0 (0.0) |
| Abdominal discomfort | 7 (1.2) | 3 (0.5) | 1 (0.3) |
| Herpes zoster | 7 (1.2) | 2 (0.3) | 0 (0.0) |
| Thrombocytopenia | 9 (1.5) | 0 (0.0) | 0 (0.0) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Mortality [see Warnings and Precautions (5.2) ] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] • Major Adverse Cardiovascular Events [see Warnings and Precautions (5.4) ] • Thrombosis [see Warnings and Precautions (5.5) ] • Laboratory Abnormalities [see Warnings and Precautions (5.7) ] Most common adverse events (≥1% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact. ( 6.1 ) Most common adverse reactions (≥1% with CIBINQO 200 mg and greater than CIBINQO 100 mg) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, 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?
3,840 reports list abrocitinib among the medicines taken, 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. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Abrocitinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions