82/100 · Critical
Manufactured by Actavis Pharma, Inc.
Serious Adverse Events Dominate BURN RELIEF Safety Profile
98,034 FDA adverse event reports analyzed
Last updated: 2026-05-12
BURN RELIEF is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 98,034 FDA adverse event reports, BURN RELIEF has a safety score of 82 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 BURN RELIEF include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BURN RELIEF.
Burn Relief has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 98,034 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 73.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events reported are serious, with over 73% of reactions classified as such.
Pain and fatigue are among the most frequently reported symptoms, indicating potential issues with the drug's efficacy. Death and severe allergic reactions are notable among the serious events, highlighting significant safety concerns.
Patients taking Burn Relief should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and off-label use warnings are present, indicating potential risks when used in combination with other medications or for unapproved conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Burn Relief received a safety concern score of 82/100 (high concern). This is based on a 73.1% serious event ratio across 46,209 classified reports. The score accounts for 98,034 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: 26,521, Male: 15,464, Unknown: 101. The most frequently reported age groups are age 62 (705 reports), age 66 (691 reports), age 67 (656 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 46,209 classified reports for BURN RELIEF:
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.
Drug interactions and off-label use warnings are present, indicating potential risks when used in combination with other medications or for unapproved conditions.
If you are taking Burn Relief, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consumers should strictly follow the prescribed dosage and use as directed by healthcare providers. Report any adverse reactions to the FDA's MedWatch program for further evaluation. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring proper use of the drug.
The FDA has received approximately 98,034 adverse event reports associated with Burn Relief. 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 Burn Relief include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (3,442 reports), Pain (3,063 reports), Fatigue (2,859 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Burn Relief.
Out of 46,209 classified reports, 33,767 (73.1%) were classified as serious and 12,442 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 Burn Relief break down by patient sex as follows: Female: 26,521, Male: 15,464, Unknown: 101. 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 Burn Relief adverse events are: age 62: 705 reports, age 66: 691 reports, age 67: 656 reports, age 64: 655 reports, age 74: 649 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 Burn Relief adverse event reports is Actavis Pharma, Inc.. 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 Burn Relief include: Off Label Use, Dyspnoea, Sinusitis, Pneumonia, Diarrhoea. 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 Burn Relief 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.
Burn Relief has a safety concern score of 82 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 adverse events reported are serious, with over 73% of reactions classified as such.
Key safety signals identified in Burn Relief's adverse event data include: High percentage of serious adverse events (73.1%). Multiple reports of fatal outcomes. Severe allergic reactions and anaphylactic shock are reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and off-label use warnings are present, indicating potential risks when used in combination with other medications or for unapproved conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Burn Relief.
Consumers should strictly follow the prescribed dosage and use as directed by healthcare providers. Report any adverse reactions to the FDA's MedWatch program for further evaluation.
Burn Relief has 98,034 adverse event reports on file with the FDA. Pain and fatigue are among the most frequently reported symptoms, indicating potential issues with the drug's efficacy. The volume of reports for Burn Relief reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring proper use of the drug. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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