CRISABOROLE

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

15,699 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CRISABOROLE

CRISABOROLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for CRISABOROLE include DRUG INEFFECTIVE, APPLICATION SITE PAIN, BURNING SENSATION, OFF LABEL USE, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CRISABOROLE.

Top Adverse Reactions

DRUG INEFFECTIVE1,957 reports
APPLICATION SITE PAIN1,415 reports
BURNING SENSATION985 reports
OFF LABEL USE746 reports
CONDITION AGGRAVATED699 reports
PRURITUS624 reports
RASH597 reports
PAIN526 reports
ECZEMA447 reports
DERMATITIS ATOPIC421 reports
ERYTHEMA370 reports
PRODUCT USE IN UNAPPROVED INDICATION333 reports
DRUG HYPERSENSITIVITY258 reports
DRY SKIN250 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION241 reports
APPLICATION SITE ERYTHEMA234 reports
SKIN BURNING SENSATION231 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE219 reports
PRODUCT USE ISSUE203 reports
SKIN EXFOLIATION175 reports
URTICARIA148 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION146 reports
HYPERSENSITIVITY143 reports
APPLICATION SITE PRURITUS139 reports
SKIN DISORDER139 reports
TREATMENT FAILURE121 reports
PRODUCT DOSE OMISSION ISSUE114 reports
EYE IRRITATION108 reports
DERMATITIS105 reports
DISCOMFORT104 reports
SKIN IRRITATION101 reports
INTENTIONAL PRODUCT MISUSE90 reports
INJECTION SITE PAIN89 reports
SKIN DISCOLOURATION89 reports
SKIN FISSURES84 reports
SLEEP DISORDER83 reports
APPLICATION SITE SWELLING78 reports
EYELID IRRITATION72 reports
BLISTER69 reports
PSORIASIS66 reports
PAIN IN EXTREMITY65 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION65 reports
SWELLING65 reports
FATIGUE64 reports
OCULAR HYPERAEMIA64 reports
COVID 1963 reports
APPLICATION SITE BURN62 reports
ARTHRALGIA60 reports
DRUG EFFECT INCOMPLETE59 reports
SKIN HAEMORRHAGE59 reports
DRY EYE58 reports
EYE SWELLING58 reports
ILLNESS57 reports
EYE PRURITUS56 reports
HEADACHE56 reports
RASH ERYTHEMATOUS55 reports
PERIPHERAL SWELLING53 reports
APPLICATION SITE IRRITATION52 reports
SWELLING FACE51 reports
NAUSEA49 reports
PARAESTHESIA49 reports
FEELING ABNORMAL48 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION47 reports
STRESS47 reports
ASTHMA46 reports
APPLICATION SITE RASH45 reports
DIARRHOEA45 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE44 reports
MALAISE44 reports
SCRATCH44 reports
THERAPEUTIC RESPONSE DECREASED43 reports
INSOMNIA42 reports
PAIN OF SKIN41 reports
RASH PRURITIC41 reports
EYE PAIN40 reports
RASH MACULAR40 reports
FALL37 reports
INFECTION37 reports
INFLAMMATION37 reports
NASOPHARYNGITIS37 reports
PYREXIA37 reports
CRYING36 reports
DRUG INTOLERANCE36 reports
THERAPEUTIC RESPONSE UNEXPECTED36 reports
DIZZINESS35 reports
ORAL HERPES35 reports
DYSPNOEA34 reports
ALOPECIA33 reports
ABDOMINAL DISCOMFORT32 reports
APPLICATION SITE DISCOLOURATION32 reports
INJECTION SITE SWELLING32 reports
THERAPEUTIC PRODUCT EFFECT DECREASED32 reports
ACNE31 reports
COUGH31 reports
DERMATITIS CONTACT31 reports
SCAB31 reports
THERAPEUTIC RESPONSE SHORTENED31 reports
EYE DISORDER30 reports
SKIN LESION30 reports
VISUAL IMPAIRMENT30 reports

Report Outcomes

Out of 9,400 classified reports for CRISABOROLE:

Serious 7.4%Non-Serious 92.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,420 (65.4%)
Male2,864 (34.5%)
Unknown6 (0.1%)

Reports by Age

Age 3224 reports
Age 2213 reports
Age 4165 reports
Age 5159 reports
Age 12127 reports
Age 6121 reports
Age 8118 reports
Age 14115 reports
Age 1114 reports
Age 13112 reports
Age 60110 reports
Age 15108 reports
Age 55105 reports
Age 63105 reports
Age 7104 reports
Age 10103 reports
Age 18103 reports
Age 61103 reports
Age 64103 reports
Age 62102 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CRISABOROLE?

This profile reflects 15,699 FDA FAERS reports that mention CRISABOROLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CRISABOROLE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, APPLICATION SITE PAIN, BURNING SENSATION, OFF LABEL USE, CONDITION AGGRAVATED, PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CRISABOROLE?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with CRISABOROLE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.