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Crisaborole
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- Active ingredient
- Crisaborole 20 mg/1 g
- Reference brand
- Eucrisa
- Drug class
- Phosphodiesterase 4 Inhibitor
- Dosage form
- Ointment
- Route
- Topical
- Prescription status
- Rx (prescription)
- Marketed in the U.S.
- Since 2017
- Label revision date
- September 23, 2025
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Active ingredient
- Crisaborole 20 mg/1 g
- Reference brand
- Eucrisa
- Drug class
- Phosphodiesterase 4 Inhibitor
- Dosage form
- Ointment
- Route
- Topical
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Marketed in the U.S.
- Since 2017
- Label revision date
- September 23, 2025
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
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Drug Overview
Eucrisa (also known as Staquis) is a topical ointment that contains 2% crisaborole, which is used to treat mild to moderate atopic dermatitis, a common skin condition characterized by itchy and inflamed skin. Crisaborole works as a phosphodiesterase-4 (PDE-4) inhibitor, which helps to increase levels of a substance called cyclic adenosine monophosphate (cAMP) in the skin cells. While the exact way it helps with atopic dermatitis isn't fully understood, it is designed to reduce inflammation and improve skin condition.
This ointment is suitable for both adults and children aged 3 months and older. It is applied directly to the affected areas of the skin, providing a localized treatment to help manage symptoms associated with atopic dermatitis.
Uses
If you are looking for a treatment for mild to moderate atopic dermatitis (a type of skin inflammation), Eucrisa and Staquis are both options available as ointments. Eucrisa is suitable for adults and children aged 3 months and older, while Staquis is indicated for patients aged 2 years and older.
These medications work by inhibiting an enzyme called phosphodiesterase 4, which helps reduce inflammation and relieve symptoms associated with atopic dermatitis. If you are pregnant or planning to become pregnant, it's important to discuss the use of these treatments with your healthcare provider, as the potential benefits and risks should be carefully considered.
Dosage and Administration
To use Eucrisa ointment, apply a thin layer to the affected areas of your skin twice a day. Once you notice improvement, you may reduce the application to once daily. Remember, this ointment is for topical use only, so do not apply it to your eyes, mouth, or inside the vagina.
What to Avoid
You should avoid using this ointment if you have a known hypersensitivity (allergic reaction) to crisaborole or any of its ingredients. Additionally, be cautious about potential misuse or abuse of medications, as they can lead to dependence (a condition where you rely on a substance). Always consult with your healthcare provider if you have any concerns or questions regarding your treatment.
Side Effects
You may experience some common side effects when using Eucrisa ointment, such as pain at the application site, which occurs in more than 1% of users. It's important to be aware of hypersensitivity reactions; if you notice any signs of an allergic reaction, such as rash or swelling, stop using the product immediately and seek appropriate medical care.
Additionally, if you have a known allergy to crisaborole or any of its ingredients, you should not use this ointment. While studies have shown no significant cancer-related findings from topical use, there were some benign tumors observed in animal studies, though their relevance to humans is unclear. Overall, no effects on fertility were noted in animal studies with high doses of crisaborole.
Warnings and Precautions
If you experience any signs of an allergic reaction, such as rash, itching, or swelling, stop using Eucrisa ointment immediately and seek appropriate medical treatment. It's important to monitor for these hypersensitivity reactions while using the product. There are no specific laboratory tests or additional precautions mentioned, but always consult your doctor if you have concerns or experience unusual symptoms.
Overdose
If you accidentally use too much Eucrisa ointment, there is no specific information about what to do in case of an overdose. However, if you experience any unusual symptoms or reactions after using the ointment, it’s important to contact your healthcare provider for advice. Always seek medical help if you feel unwell or if you have concerns about your health after using any medication.
Pregnancy Use
Available data on the use of Eucrisa (crisaborole) during pregnancy is limited, and it does not provide enough information to determine a clear risk for major birth defects, miscarriage, or other adverse outcomes for you or your baby. In animal studies, no harmful effects were observed in pregnant rats and rabbits when given doses up to three times the maximum recommended human dose (MRHD) during critical periods of development. However, it's important to note that all pregnancies carry some inherent risk of complications, including a 2% to 4% chance of major birth defects and a 15% to 20% chance of miscarriage in the general population.
While crisaborole did not show adverse effects on fetal development at certain doses, high doses did lead to maternal toxicity and associated complications in animal studies. Therefore, if you are pregnant or planning to become pregnant, it's essential to discuss the use of Eucrisa with your healthcare provider to weigh the potential benefits and risks.
Lactation Use
There is currently no information available regarding the presence of EUCRISA (an ointment used for skin conditions) in human breast milk or its effects on breastfed infants. While EUCRISA is absorbed into the body, the lack of clinical data means we cannot clearly determine the risks it may pose to a breastfeeding child. As you consider using EUCRISA, it's important to weigh the developmental and health benefits of breastfeeding against your need for the medication and any potential effects it may have on your infant or your underlying health condition.
Pediatric Use
You can use Eucrisa ointment for treating mild to moderate atopic dermatitis (a type of skin condition) in children aged 3 months and older. It is applied twice daily, and its safety and effectiveness have been confirmed through several studies involving children from 3 months to 17 years old. However, please note that the safety and effectiveness of Eucrisa have not been established for infants younger than 3 months. Always consult your child's healthcare provider for personalized advice and recommendations.
Geriatric Use
When using Eucrisa (an ointment for skin conditions), it's important to note that clinical studies did not include enough participants aged 65 and older to determine if older adults respond differently than younger individuals. Therefore, if you are an older adult or a caregiver, it's advisable to consult with a healthcare provider before starting this treatment to ensure it is appropriate for your specific needs. Always follow your doctor's recommendations regarding dosage and application.
Renal Impairment
If you have kidney problems, it's important to be aware that some medications may require dosage adjustments or special monitoring. In the case of Eucrisa, an ointment used for skin conditions, there is currently no specific information regarding its use in patients with renal impairment. This means that no dosage adjustments or safety considerations have been established for those with kidney issues. Always consult your healthcare provider for personalized advice and to ensure safe use of any medication.
Hepatic Impairment
If you have liver problems, it's important to know that there is no specific information available regarding the use of Eucrisa ointment in patients with hepatic impairment (liver issues). This means that there are no dosage adjustments or special monitoring guidelines provided for those with liver conditions. Always consult your healthcare provider for personalized advice and to ensure the safe use of any medication.
Drug Interactions
When using Eucrisa ointment, there are no known interactions with other medications or laboratory tests. However, it's always important to discuss all medications, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, as your provider can help identify any potential issues based on your individual health needs.
Storage and Handling
To ensure the effectiveness of Eucrisa ointment, store it at a temperature between 20°C and 25°C (68°F and 77°F). It is acceptable for the temperature to briefly range from 15°C to 30°C (59°F to 86°F). Always keep the tube tightly closed when not in use to prevent contamination and maintain the ointment's quality.
For disposal, follow local regulations for medication disposal, as it is important to avoid flushing it down the toilet or pouring it down the drain unless specifically instructed.
FAQ
What is EUCRISA?
EUCRISA is a topical ointment that contains 2% crisaborole and is used for the treatment of mild to moderate atopic dermatitis in patients aged 3 months and older.
What is Staquis?
Staquis is a topical ointment containing 2% crisaborole, indicated for the treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.
How does crisaborole work?
Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor, which increases intracellular cyclic adenosine monophosphate (cAMP) levels, although the exact therapeutic mechanism for atopic dermatitis is not well defined.
How should I apply EUCRISA?
Apply a thin layer of EUCRISA to the affected areas twice daily. Once you achieve a clinical effect, you may consider reducing the application to once daily.
How should I use Staquis?
Staquis is for topical use only. Apply it as directed and do not use it for ophthalmic, oral, or intravaginal purposes.
What are the common side effects of EUCRISA?
The most common side effect is application site pain, which occurs in 1% or more of subjects.
What are the common side effects of Staquis?
Common side effects include application site pain, erythema (redness), pruritus (itching), vesicles, and rash.
Are there any serious side effects associated with Staquis?
Yes, serious allergic reactions, including anaphylaxis, have been reported. If you experience severe reactions, seek medical help immediately.
Are there any contraindications for using EUCRISA?
Yes, EUCRISA is contraindicated in individuals with known hypersensitivity to crisaborole or any component of the formulation.
Can I use Staquis during pregnancy?
Crisaborol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies in pregnant women.
Can EUCRISA be used during pregnancy?
Available data are insufficient to inform a drug-associated risk for major birth defects or miscarriage. However, animal studies showed no adverse developmental effects at doses up to 3 times the maximum recommended human dose.
Is it safe to use EUCRISA while breastfeeding?
There is no information on the presence of EUCRISA in human milk or its effects on a breastfed infant, so the benefits of breastfeeding should be weighed against the mother's need for the medication.
Is Staquis safe for children?
Staquis is indicated for patients aged 2 years and older, but specific pediatric use information is not provided in the text.
What should I do if I experience hypersensitivity reactions?
If you notice signs of hypersensitivity, discontinue EUCRISA immediately and seek appropriate medical therapy.
What should I do if I experience skin irritation from Staquis?
If you experience skin irritation, such as burning or stinging at the application site, you should consult your doctor.
How should EUCRISA be stored?
Store EUCRISA at 20°C–25°C (68°F–77°F), with excursions permitted between 15°C and 30°C (59°F–86°F). Keep the tube tightly closed.
How should I store Staquis?
Store Staquis at 20°C to 25°C (68°F to 77°F), protecting it from light and keeping the tube tightly closed when not in use.
Uses and Indications
This drug is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients aged 3 months and older. Crisaborol, the active ingredient, is specifically indicated for patients aged 2 years and older.
Limitations of Use
Crisaborol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate and well-controlled studies in pregnant women.
Dosage and Administration
Eucrisa is indicated for topical use only and should not be applied to the eyes, orally, or intravaginally. The recommended dosage is to apply a thin layer of the ointment to the affected areas twice daily. Once a clinical effect is achieved, healthcare professionals may consider reducing the frequency of application to once daily.
Contraindications
Known hypersensitivity to crisaborole or any component of the formulation is a contraindication for use.
Warnings and Precautions
Hypersensitivity reactions may occur with the use of EUCRISA. If any signs or symptoms of hypersensitivity are observed, it is imperative to discontinue the use of EUCRISA immediately and initiate appropriate therapy.
No additional general precautions or laboratory tests are specified in the available data. There are also no instructions regarding the need for emergency medical help or specific directives to stop taking the medication and contact a healthcare provider.
Side Effects
Patients using Eucrisa (crisaborole) ointment may experience several adverse reactions, which can be categorized by frequency and seriousness.
Common Adverse Reactions
Application site pain has been reported in ≥1% of subjects.
Hypersensitivity Reactions
In the event of signs and symptoms of hypersensitivity, it is advised to discontinue the use of Eucrisa immediately and initiate appropriate therapy. Known hypersensitivity to crisaborole or any component of the formulation is a contraindication for use.
Additional Adverse Reactions or Important Notes
In a dermal carcinogenicity study, no crisaborole-related neoplastic findings were observed at topical doses up to 7% crisaborole ointment.
An increased incidence of benign granular cell tumors in the uterus, cervix, and vagina was noted in female rats treated with 300 mg/kg/day of crisaborole in an oral carcinogenicity study; however, the clinical relevance of this finding remains unknown.
Crisaborole has shown no evidence of mutagenic or clastogenic potential based on genotoxicity tests.
No effects on fertility were observed in male or female rats administered oral doses up to 600 mg/kg/day of crisaborole prior to and during early pregnancy.
Drug Interactions
There are no documented drug interactions associated with Eucrisa (ointment). Additionally, there is no information available regarding interactions with laboratory tests. Therefore, healthcare professionals can consider Eucrisa as having a low potential for drug interactions in clinical practice.
Pediatric Use
The safety and effectiveness of EUCRISA (crisaborole) have been established in pediatric patients ages 3 months and older for the topical treatment of mild to moderate atopic dermatitis. EUCRISA is administered twice daily in this age group, supported by data from several clinical trials:
Two 28-day adequate, vehicle-controlled safety and efficacy trials included 1,313 pediatric subjects ages 2 years to 17 years, of whom 874 received EUCRISA.
A 28-day open-label safety and pharmacokinetics trial involved 137 subjects ages 3 months to less than 2 years who received EUCRISA.
An additional trial with an open-label period of up to 8 weeks included 327 pediatric subjects ages 5 months to less than 18 years who received EUCRISA.
The safety and effectiveness of EUCRISA in pediatric patients below the age of 3 months have not been established.
Geriatric Use
Clinical studies of Eucrisa did not include sufficient numbers of subjects aged 65 and over to determine whether elderly patients respond differently from younger patients. Therefore, the safety and efficacy of Eucrisa in geriatric patients have not been established. Caution is advised when prescribing this medication to elderly patients, and careful monitoring may be warranted.
Pregnancy
Available data from case reports regarding the use of Eucrisa (crisaborole) in pregnant patients are insufficient to establish a definitive drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times the maximum recommended human dose (MRHD), respectively.
The background risk of major birth defects in the U.S. general population is estimated to be between 2% to 4%, while the risk of miscarriage is approximately 15% to 20% of clinically recognized pregnancies. All pregnancies inherently carry some risk of birth defects, loss, or other adverse outcomes.
In studies involving pregnant rats, crisaborole did not cause adverse fetal effects at oral doses up to 300 mg/kg/day during organogenesis, which corresponds to 3 times the MRHD based on area under the curve (AUC) comparisons. Additionally, no fetal malformations were noted at doses up to 600 mg/kg/day (13 times the MRHD on an AUC basis) during the same period. However, maternal toxicity was observed at this high dose, leading to decreased fetal body weight and delayed skeletal ossification.
In pregnant rabbits, crisaborole did not produce adverse effects on fetal development at doses up to 100 mg/kg/day (2 times the MRHD on an AUC basis) during organogenesis. Furthermore, in a prenatal/postnatal development study, no adverse effects were noted at doses up to 300 mg/kg/day (3 times the MRHD on an AUC basis). It is important to note that maternal toxicity at the high dose of 600 mg/kg/day in pregnant rats was associated with stillbirths, pup mortality, and reduced pup weights.
Given the limited data and potential risks, healthcare providers should carefully consider the benefits and risks of using crisaborole in pregnant patients.
Lactation
There is currently no information available regarding the presence of EUCRISA (crisaborole) in human milk, nor its effects on breastfed infants or on milk production following topical application in lactating mothers. Although EUCRISA is systemically absorbed, the absence of clinical data during lactation limits the ability to assess the risk it may pose to a breastfed infant.
Healthcare providers should weigh the developmental and health benefits of breastfeeding against the mother's clinical need for EUCRISA. Additionally, potential adverse effects on the breastfed infant from either EUCRISA or the underlying maternal condition should be considered in the decision-making process.
Renal Impairment
Patients with renal impairment have no specific dosage adjustments, monitoring requirements, or safety considerations outlined for the use of Eucrisa (ointment). The absence of information regarding the impact of reduced kidney function suggests that standard dosing may be applicable; however, healthcare providers should exercise clinical judgment when prescribing this medication to patients with compromised renal function.
Hepatic Impairment
Patients with hepatic impairment have no specific dosage adjustments, special monitoring requirements, or precautions outlined for the use of Eucrisa (ointment). The absence of information regarding hepatic impairment suggests that standard dosing may be applicable; however, healthcare providers should exercise clinical judgment when prescribing to this patient population.
Overdosage
In the event of an overdose with Eucrisa ointment, no specific overdosage information is available. However, it is essential to monitor the patient for any unusual symptoms or reactions that may arise from excessive application.
Recommended actions include seeking immediate medical attention if an overdose is suspected. Healthcare professionals should assess the patient's condition and provide supportive care as necessary. Continuous monitoring may be warranted to ensure the patient's safety and well-being.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
In an oral carcinogenicity study conducted in Sprague-Dawley rats, doses of crisaborole (30, 100, or 300 mg/kg/day) were administered once daily. An increased incidence of benign granular cell tumors in the uterus, cervix, and vagina was observed in female rats treated with 300 mg/kg/day, which represents two times the maximum recommended human dose (MRHD) on an area under the curve (AUC) comparison basis. The clinical relevance of this finding remains uncertain. Conversely, a dermal carcinogenicity study in CD-1 mice, where topical doses of crisaborole ointment (2%, 5%, or 7%) were applied once daily, revealed no neoplastic findings at doses up to 7%, equivalent to one times the MRHD on an AUC comparison basis.
Crisaborole demonstrated no evidence of mutagenic or clastogenic potential, as indicated by the results of two in vitro genotoxicity tests (the Ames assay and the human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (the rat micronucleus assay).
Furthermore, no effects on fertility were observed in male or female rats administered oral doses of crisaborole up to 600 mg/kg/day (13 times the MRHD on an AUC comparison basis) prior to and during early pregnancy.
Storage and Handling
Eucrisa is supplied as an ointment. It should be stored at a temperature range of 20°C–25°C (68°F–77°F), with permissible excursions between 15°C–30°C (59°F–86°F). To maintain product integrity, the tube must be kept tightly closed.
Product Labels
The table below lists all FDA-approved prescription labels containing crisaborole. Use it to compare dosage forms, strengths, and approved indications across labels.
More Details | |||||
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Pfizer Laboratories Div Pfizer Inc | Ointment | Topical | 20 mg/1 g | 2017 | |
Indications
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Pharmacia & Upjohn Company LLC | Ointment | Topical | 20 mg/1 g | 2020 | |
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