55/100 · Moderate
Manufactured by Alchemee, LLC
Adapalene Safety Profile: Common Skin Irritations and Mild to Moderate Reactions
416,192 FDA adverse event reports analyzed
Last updated: 2026-05-12
ADAPALENE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alchemee, LLC. Based on analysis of 416,192 FDA adverse event reports, ADAPALENE has a safety score of 55 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ADAPALENE include DRUG INEFFECTIVE, DRY SKIN, SKIN BURNING SENSATION, ACNE, ERYTHEMA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADAPALENE.
Adapalene has a safety concern score of 55 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 416,192 adverse event reports for this medication, which is primarily manufactured by Alchemee, Llc.
The most commonly reported adverse events include Drug Ineffective, Dry Skin, Skin Burning Sensation. Of classified reports, 0.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are skin-related, with dry skin and skin burning sensation being the most common.
The safety profile is generally mild to moderate, with serious reactions accounting for only 0.6% of reports. The reaction diversity is high, with over 100 distinct reactions reported.
Patients taking Adapalene should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Adapalene should be used with caution in individuals with sensitive skin, as it may exacerbate skin conditions. Patients should be advised to discontinue use if they experience severe or persistent skin reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Adapalene received a safety concern score of 55/100 (elevated concern). This is based on a 0.6% serious event ratio across 178,147 classified reports. The score accounts for 416,192 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 122,669, Male: 34,451, Unknown: 75. The most frequently reported age groups are age 15 (7,625 reports), age 14 (7,293 reports), age 16 (6,265 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 178,147 classified reports for ADAPALENE:
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 reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Adapalene should be used with caution in individuals with sensitive skin, as it may exacerbate skin conditions. Patients should be advised to discontinue use if they experience severe or persistent skin reactions.
If you are taking Adapalene, here are important things to know. The most commonly reported side effects include drug ineffective, dry skin, skin burning sensation, acne, erythema. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Use Adapalene as directed to minimize the risk of skin irritation and dryness. Discontinue use if you experience severe or persistent skin reactions and consult your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Adapalene, and no major safety concerns have been identified. However, patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 416,192 adverse event reports associated with Adapalene. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Adapalene include Drug Ineffective, Dry Skin, Skin Burning Sensation, Acne, Erythema. By volume, the top reported reactions are: Drug Ineffective (51,276 reports), Dry Skin (44,990 reports), Skin Burning Sensation (41,633 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Adapalene.
Out of 178,147 classified reports, 1,102 (0.6%) were classified as serious and 177,045 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Adapalene break down by patient sex as follows: Female: 122,669, Male: 34,451, Unknown: 75. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Adapalene adverse events are: age 15: 7,625 reports, age 14: 7,293 reports, age 16: 6,265 reports, age 13: 6,149 reports, age 17: 4,709 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Adapalene adverse event reports is Alchemee, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Adapalene include: Skin Irritation, Skin Exfoliation, Inappropriate Schedule Of Product Administration, Rash, Overdose. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Adapalene to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Adapalene has a safety concern score of 55 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of reported reactions are skin-related, with dry skin and skin burning sensation being the most common.
Key safety signals identified in Adapalene's adverse event data include: Dry skin is the most frequently reported reaction, indicating potential skin barrier disruption.. Skin burning sensation and skin irritation are also common, suggesting potential local irritation.. A significant number of reports involve skin exfoliation and skin discoloration, which may be concerning for long-term use.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Adapalene should be used with caution in individuals with sensitive skin, as it may exacerbate skin conditions. Patients should be advised to discontinue use if they experience severe or persistent skin reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Adapalene.
Use Adapalene as directed to minimize the risk of skin irritation and dryness. Discontinue use if you experience severe or persistent skin reactions and consult your healthcare provider.
Adapalene has 416,192 adverse event reports on file with the FDA. The safety profile is generally mild to moderate, with serious reactions accounting for only 0.6% of reports. The volume of reports for Adapalene reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Adapalene, and no major safety concerns have been identified. However, patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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