85/100 · Critical
Manufactured by A2A Integrated Pharmaceuticals, LLC
Highly Reported Adverse Reactions for Cool Relief Gel with Aloe
229,196 FDA adverse event reports analyzed
Last updated: 2026-05-12
COOL RELIEF GEL WITH ALOE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by A2A Integrated Pharmaceuticals, LLC. Based on analysis of 229,196 FDA adverse event reports, COOL RELIEF GEL WITH ALOE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for COOL RELIEF GEL WITH ALOE include OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, CONDITION AGGRAVATED, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COOL RELIEF GEL WITH ALOE.
Cool Relief Gel With Aloe has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 229,196 adverse event reports for this medication, which is primarily manufactured by A2a Integrated Pharmaceuticals, Llc.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Fatigue. Of classified reports, 83.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are non-serious, but the volume of reports is substantial.
Fatigue, nausea, and rash are among the most frequently reported side effects. Serious reactions, such as pneumonia and death, are also reported but less frequently. The reaction diversity is high, indicating a wide range of potential side effects.
Patients taking Cool Relief Gel With Aloe should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but users should avoid off-label use and ensure proper application to prevent adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cool Relief Gel With Aloe received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,581 classified reports. The score accounts for 229,196 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 32,032, Male: 23,627, Unknown: 130. The most frequently reported age groups are age 43 (1,429 reports), age 44 (1,197 reports), age 40 (1,043 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,581 classified reports for COOL RELIEF GEL WITH ALOE:
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.
No specific drug interactions are noted, but users should avoid off-label use and ensure proper application to prevent adverse reactions.
If you are taking Cool Relief Gel With Aloe, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, fatigue, condition aggravated, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Do not use the product off-label or for conditions not approved by the FDA. Report any adverse reactions to the manufacturer or the FDA. 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 has not issued specific warnings for Cool Relief Gel with Aloe, but users should report any adverse reactions to the manufacturer or FDA.
The FDA has received approximately 229,196 adverse event reports associated with Cool Relief Gel With Aloe. 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 Cool Relief Gel With Aloe include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Nausea. By volume, the top reported reactions are: Off Label Use (8,923 reports), Drug Ineffective (7,048 reports), Fatigue (5,579 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cool Relief Gel With Aloe.
Out of 63,581 classified reports, 53,039 (83.4%) were classified as serious and 10,542 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 Cool Relief Gel With Aloe break down by patient sex as follows: Female: 32,032, Male: 23,627, Unknown: 130. 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 Cool Relief Gel With Aloe adverse events are: age 43: 1,429 reports, age 44: 1,197 reports, age 40: 1,043 reports, age 60: 838 reports, age 65: 838 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 Cool Relief Gel With Aloe adverse event reports is A2a Integrated Pharmaceuticals, 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 Cool Relief Gel With Aloe include: Rash, Pain, Headache, Diarrhoea, Arthralgia. 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 Cool Relief Gel With Aloe 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.
Cool Relief Gel With Aloe has a safety concern score of 85 out of 100 (high 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 non-serious, but the volume of reports is substantial.
Key safety signals identified in Cool Relief Gel With Aloe's adverse event data include: Frequent reports of rash and skin reactions suggest potential dermatological issues.. Multiple reports of serious conditions like pneumonia and death indicate significant safety concerns.. A wide range of reactions, including gastrointestinal and respiratory issues, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but users should avoid off-label use and ensure proper application to prevent adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cool Relief Gel With Aloe.
Do not use the product off-label or for conditions not approved by the FDA. Report any adverse reactions to the manufacturer or the FDA.
Cool Relief Gel With Aloe has 229,196 adverse event reports on file with the FDA. Fatigue, nausea, and rash are among the most frequently reported side effects. The volume of reports for Cool Relief Gel With Aloe reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for Cool Relief Gel with Aloe, but users should report any adverse reactions to the manufacturer or FDA. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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