What the label lists and what reports show
Crisaborole side effects
Crisaborole's FDA label: “The most common adverse reaction occurring in ≥1% in subjects is application site pain.” FAERS holds 9,540 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 application site pain (1,416 reports).
- No generic listed
Check it at the source: the crisaborole FDA label on DailyMed (effective September 23, 2025, 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 EUCRISA?EUCRISA may cause side effects. • Allergic reactions. EUCRISA may cause allergic reactions at or near the application site or at a distant site which may be serious. Stop using EUCRISA and get medical help right away if you have any symptoms of an allergic reaction including: o trouble breathing or throat tightness o hives o chest tightness o itching o feeling faint o swelling of your face, eyelids, lips, mouth, tongue or throat o redness The most common side effect of EUCRISA is application site pain, such as burning or stinging. This is not the only possible side effect of EUCRISA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, NDA207695 (Anacor Pharms Inc), as published by Pfizer Laboratories Div Pfizer Inc, effective September 23, 2025 (SPL set 609b77de-1ca3-4783-b8f5-01a9c0f1d77d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction occurring in ≥1% in subjects is application site pain.
From the label: adverse reactions, continuedThe most common adverse reaction occurring in ≥1% in subjects is application site pain. ( 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 1012 subjects 2 to 79 years of age with mild to moderate atopic dermatitis were treated with EUCRISA twice daily for 4 weeks. The adverse reaction reported by ≥1% of EUCRISA-treated subjects is listed in Table 1. Table 1: Adverse Reaction Occurring in ≥1% of Subjects in Atopic Dermatitis Trials through Week 4 Adverse Reaction EUCRISA Twice Daily N=1012 n (%) Vehicle Twice Daily N=499 n (%) Application site pain Refers to skin sensations such as burning or stinging. 45 (4) 6 (1) Less common (<1%) adverse reactions in subjects treated with EUCRISA included contact urticaria [see Warnings and Precautions (5.1) ]. …
Source: FDA drug label, NDA207695 (Anacor Pharms Inc), as published by Pfizer Laboratories Div Pfizer Inc, effective September 23, 2025 (SPL set 609b77de-1ca3-4783-b8f5-01a9c0f1d77d), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,540 reports list crisaborole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 155 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 2018 (2,074, against a median of 676 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 17 reactions below, 4 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?
- Crisaborole: 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