COOL RELIEF GEL WITH ALOE and OFF LABEL USE

Overview

OFF LABEL USE is the #1 most commonly reported adverse reaction for COOL RELIEF GEL WITH ALOE, manufactured by A2A Integrated Pharmaceuticals, LLC. There are 8,923 FDA adverse event reports linking COOL RELIEF GEL WITH ALOE to OFF LABEL USE. This represents approximately 3.9% of all 229,196 adverse event reports for this drug.

Patients taking COOL RELIEF GEL WITH ALOE who experience off label use should discuss this symptom with their healthcare provider to determine whether it may be related to their medication and what alternatives may be available.

Reporting Frequency

OFF LABEL USE8,923 of 229,196 reports

OFF LABEL USE is moderately reported among COOL RELIEF GEL WITH ALOE users, representing a notable but not dominant share of adverse events.

Other Side Effects of COOL RELIEF GEL WITH ALOE

In addition to off label use, the following adverse reactions have been reported for COOL RELIEF GEL WITH ALOE:

DRUG INEFFECTIVE — 7,048 reports
FATIGUE — 5,579 reports
CONDITION AGGRAVATED — 5,223 reports
NAUSEA — 4,692 reports
RASH — 4,587 reports
PAIN — 4,240 reports
HEADACHE — 4,199 reports
DIARRHOEA — 4,193 reports
ARTHRALGIA — 4,049 reports
DYSPNOEA — 4,026 reports

Other Drugs Associated with OFF LABEL USE

The following drugs have also been linked to off label use in FDA adverse event reports:

0XYGEN ABACAVIR SULFATE ABATACEPT ABIRATERONE ACETATE ACALABRUTINIB ACETAMINOPHEN ACETAMINOPHEN 500MG ACETAMINOPHEN AND CODEINE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, ASPIRIN, AND CAFFEINE ACETAMINOPHEN, ASPIRIN, CAFFEINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE ACETAMINOPHEN, CAFFEINE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, IBUPROFEN

Does COOL RELIEF GEL WITH ALOE cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 8,923 FDA reports for COOL RELIEF GEL WITH ALOE. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with COOL RELIEF GEL WITH ALOE?

OFF LABEL USE accounts for approximately 3.9% of all adverse event reports for COOL RELIEF GEL WITH ALOE, making it one of the most commonly reported side effect.

What should I do if I experience OFF LABEL USE while taking COOL RELIEF GEL WITH ALOE?

If you experience off label use while taking COOL RELIEF GEL WITH ALOE, contact your healthcare provider. They can evaluate whether the symptom is related to your medication and discuss potential adjustments to your treatment plan. Do not stop taking prescribed medication without consulting your doctor.