45/100 · Moderate
Manufactured by Alchemee, LLC
Salicylic Acid Adverse Events: Mild to Moderate Skin Irritation and Sensitivity
126,851 FDA adverse event reports analyzed
Last updated: 2026-05-12
SALICYLIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alchemee, LLC. Based on analysis of 126,851 FDA adverse event reports, SALICYLIC ACID has a safety score of 45 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 SALICYLIC ACID include DRUG INEFFECTIVE, DRY SKIN, ERYTHEMA, ACNE, SKIN BURNING SENSATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SALICYLIC ACID.
Salicylic Acid has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 126,851 adverse event reports for this medication, which is primarily manufactured by Alchemee, Llc.
The most commonly reported adverse events include Drug Ineffective, Dry Skin, Erythema. Of classified reports, 4.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are mild to moderate, primarily skin-related.
Dry skin and skin irritation are the most common reactions. Serious adverse events are relatively rare, comprising only 4.1% of reports.
Patients taking Salicylic Acid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Salicylic acid can cause skin irritation and burning sensations; consumers should avoid contact with eyes and other sensitive areas. Consult a healthcare provider if symptoms persist or worsen. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Salicylic Acid received a safety concern score of 45/100 (moderate concern). This is based on a 4.1% serious event ratio across 52,422 classified reports. The score accounts for 126,851 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 35,065, Male: 13,255, Unknown: 16. The most frequently reported age groups are age 15 (3,175 reports), age 14 (3,146 reports), age 13 (2,608 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 52,422 classified reports for SALICYLIC ACID:
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.
Salicylic acid can cause skin irritation and burning sensations; consumers should avoid contact with eyes and other sensitive areas. Consult a healthcare provider if symptoms persist or worsen.
If you are taking Salicylic Acid, here are important things to know. The most commonly reported side effects include drug ineffective, dry skin, erythema, acne, skin burning sensation. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the recommended usage instructions carefully to minimize the risk of adverse reactions. Do not use salicylic acid on broken or irritated skin. 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 salicylic acid, and no major safety concerns have been identified. However, consumers should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 126,851 adverse event reports associated with Salicylic Acid. 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 Salicylic Acid include Drug Ineffective, Dry Skin, Erythema, Acne, Skin Burning Sensation. By volume, the top reported reactions are: Drug Ineffective (13,777 reports), Dry Skin (12,764 reports), Erythema (12,315 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Salicylic Acid.
Out of 52,422 classified reports, 2,174 (4.1%) were classified as serious and 50,248 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 Salicylic Acid break down by patient sex as follows: Female: 35,065, Male: 13,255, Unknown: 16. 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 Salicylic Acid adverse events are: age 15: 3,175 reports, age 14: 3,146 reports, age 13: 2,608 reports, age 16: 2,572 reports, age 17: 1,832 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 Salicylic Acid 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 Salicylic Acid 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 Salicylic Acid 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.
Salicylic Acid has a safety concern score of 45 out of 100 (moderate 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 adverse events are mild to moderate, primarily skin-related.
Key safety signals identified in Salicylic Acid's adverse event data include: Skin burning sensation and skin exfoliation are key signals indicating potential severe skin reactions.. Overdose and underdose issues highlight the importance of proper usage instructions.. Alopecia and skin hyperpigmentation are less common but notable safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Salicylic acid can cause skin irritation and burning sensations; consumers should avoid contact with eyes and other sensitive areas. Consult a healthcare provider if symptoms persist or worsen. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Salicylic Acid.
Follow the recommended usage instructions carefully to minimize the risk of adverse reactions. Do not use salicylic acid on broken or irritated skin.
Salicylic Acid has 126,851 adverse event reports on file with the FDA. Dry skin and skin irritation are the most common reactions. The volume of reports for Salicylic Acid reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of salicylic acid, and no major safety concerns have been identified. However, consumers should report any adverse reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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