DOCOSANOL

N/A

Manufactured by Haleon US Holdings LLC

26,055 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DOCOSANOL

DOCOSANOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for DOCOSANOL include DRUG INEFFECTIVE, ORAL HERPES, CONDITION AGGRAVATED, DRUG ADMINISTRATION ERROR, INCORRECT DRUG ADMINISTRATION DURATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOCOSANOL.

Top Adverse Reactions

DRUG INEFFECTIVE7,010 reports
ORAL HERPES2,446 reports
CONDITION AGGRAVATED1,953 reports
DRUG ADMINISTRATION ERROR1,779 reports
INCORRECT DRUG ADMINISTRATION DURATION803 reports
HERPES SIMPLEX706 reports
INCORRECT PRODUCT ADMINISTRATION DURATION637 reports
LIP SWELLING552 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS550 reports
PRODUCT QUALITY ISSUE539 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION493 reports
APPLICATION SITE PAIN444 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION399 reports
PRODUCT COMPLAINT374 reports
HYPERSENSITIVITY317 reports
SWELLING FACE286 reports
PRODUCT USE IN UNAPPROVED INDICATION252 reports
APPLICATION SITE ERYTHEMA245 reports
APPLICATION SITE IRRITATION230 reports
APPLICATION SITE SWELLING208 reports
PRODUCT USE ISSUE206 reports
EXPIRED PRODUCT ADMINISTERED175 reports
APPLICATION SITE SCAB165 reports
ORAL DISCOMFORT161 reports
RASH155 reports
INTENTIONAL DRUG MISUSE151 reports
LIP PAIN147 reports
CHEILITIS144 reports
PAIN133 reports
LIP DRY126 reports
ERYTHEMA125 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION124 reports
APPLICATION SITE REACTION123 reports
BLISTER117 reports
PRURITUS114 reports
OFF LABEL USE113 reports
BURNING SENSATION103 reports
APPLICATION SITE SCAR101 reports
CHAPPED LIPS101 reports
ACCIDENTAL EXPOSURE TO PRODUCT92 reports
LIP BLISTER91 reports
APPLICATION SITE HAEMORRHAGE88 reports
APPLICATION SITE PARAESTHESIA87 reports
APPLICATION SITE VESICLES87 reports
LIP HAEMORRHAGE87 reports
APPLICATION SITE PRURITUS86 reports
DRUG HYPERSENSITIVITY84 reports
SCAB84 reports
HEADACHE83 reports
APPLICATION SITE DISCOLOURATION81 reports
SCAR80 reports
PRODUCT ADMINISTERED AT INAPPROPRIATE SITE70 reports
APPLICATION SITE DRYNESS68 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION68 reports
DRUG EFFECT LESS THAN EXPECTED67 reports
DIZZINESS64 reports
PARAESTHESIA64 reports
PARAESTHESIA ORAL64 reports
HYPOAESTHESIA ORAL63 reports
DYSPNOEA61 reports
FATIGUE61 reports
HYPOAESTHESIA60 reports
DIARRHOEA59 reports
LIP DISORDER59 reports
NAUSEA58 reports
ORAL PAIN57 reports
THERAPEUTIC PRODUCT EFFECT DELAYED57 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE54 reports
LIP EXFOLIATION50 reports
VOMITING50 reports
APPLICATION SITE BURN46 reports
APPLICATION SITE BLEEDING45 reports
SWELLING45 reports
ASTHENIA43 reports
URTICARIA41 reports
CONSTIPATION40 reports
THERAPEUTIC RESPONSE UNEXPECTED40 reports
SKIN LACERATION39 reports
ADVERSE DRUG REACTION38 reports
LIP DISCOLOURATION38 reports
PRODUCT PACKAGE ASSOCIATED INJURY38 reports
APPLICATION SITE EXFOLIATION37 reports
ARTHRALGIA36 reports
DRY SKIN35 reports
RHINORRHOEA35 reports
WEIGHT DECREASED35 reports
ADVERSE EVENT34 reports
APPLICATION SITE INFECTION32 reports
BACK PAIN32 reports
CHILLS32 reports
DRUG ADMINISTERED AT INAPPROPRIATE SITE32 reports
GAIT DISTURBANCE32 reports
ILL DEFINED DISORDER31 reports
IMPAIRED HEALING31 reports
ABDOMINAL DISCOMFORT30 reports
DRUG EFFECT DELAYED30 reports
EAR PAIN30 reports
ABDOMINAL PAIN29 reports
DYSPHAGIA29 reports
NONSPECIFIC REACTION29 reports

Report Outcomes

Out of 14,469 classified reports for DOCOSANOL:

Serious 1.9%Non-Serious 98.1%

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

Female9,118 (74.6%)
Male3,090 (25.3%)
Unknown18 (0.1%)

Reports by Age

Age 55202 reports
Age 65184 reports
Age 50170 reports
Age 52170 reports
Age 56168 reports
Age 58168 reports
Age 35164 reports
Age 60163 reports
Age 64163 reports
Age 59161 reports
Age 40157 reports
Age 51156 reports
Age 70155 reports
Age 72153 reports
Age 27152 reports
Age 38152 reports
Age 54151 reports
Age 30150 reports
Age 62150 reports
Age 42148 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 DOCOSANOL?

This profile reflects 26,055 FDA FAERS reports that mention DOCOSANOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DOCOSANOL?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, ORAL HERPES, CONDITION AGGRAVATED, DRUG ADMINISTRATION ERROR, INCORRECT DRUG ADMINISTRATION DURATION, HERPES SIMPLEX. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DOCOSANOL?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with DOCOSANOL. 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.