85/100 · Critical
Manufactured by Better Living Brands, LLC
High Seriousness and Diverse Reactions in Pain Reliever Adverse Events
734,012 FDA adverse event reports analyzed
Last updated: 2026-05-12
PAIN RELIEVER is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Better Living Brands, LLC. Based on analysis of 734,012 FDA adverse event reports, PAIN RELIEVER 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 PAIN RELIEVER include OFF LABEL USE, FATIGUE, DRUG INEFFECTIVE, PAIN, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PAIN RELIEVER.
Pain Reliever 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 734,012 adverse event reports for this medication, which is primarily manufactured by Better Living Brands, Llc.
The most commonly reported adverse events include Off Label Use, Fatigue, Drug Ineffective. Of classified reports, 87.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving death and severe conditions.
A wide variety of reactions are reported, indicating potential for diverse side effects. Reports indicate significant issues with drug ineffectiveness and toxicity, suggesting potential safety concerns.
Patients taking Pain Reliever should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs are reported, and patients should be cautious when using this pain reliever with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pain Reliever received a safety concern score of 85/100 (high concern). This is based on a 87.4% serious event ratio across 239,286 classified reports. The score accounts for 734,012 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: 130,787, Male: 78,897, Unknown: 510. The most frequently reported age groups are age 44 (3,733 reports), age 65 (3,469 reports), age 43 (3,414 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 239,286 classified reports for PAIN RELIEVER:
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.
Interactions with other drugs are reported, and patients should be cautious when using this pain reliever with other medications.
If you are taking Pain Reliever, here are important things to know. The most commonly reported side effects include off label use, fatigue, drug ineffective, pain, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting or stopping this medication, especially if you have pre-existing conditions. Report any unusual symptoms or side effects to your healthcare provider immediately. 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 the FDA monitoring these adverse events closely.
The FDA has received approximately 734,012 adverse event reports associated with Pain Reliever. 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 Pain Reliever include Off Label Use, Fatigue, Drug Ineffective, Pain, Nausea. By volume, the top reported reactions are: Off Label Use (21,668 reports), Fatigue (19,929 reports), Drug Ineffective (17,788 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pain Reliever.
Out of 239,286 classified reports, 209,028 (87.4%) were classified as serious and 30,258 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 Pain Reliever break down by patient sex as follows: Female: 130,787, Male: 78,897, Unknown: 510. 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 Pain Reliever adverse events are: age 44: 3,733 reports, age 65: 3,469 reports, age 43: 3,414 reports, age 66: 3,406 reports, age 72: 3,194 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 Pain Reliever adverse event reports is Better Living Brands, 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 Pain Reliever include: Headache, Toxicity To Various Agents, Dyspnoea, Arthralgia, Pyrexia. 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 Pain Reliever 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.
Pain Reliever 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 adverse events are serious, with a high percentage of reports involving death and severe conditions.
Key safety signals identified in Pain Reliever's adverse event data include: High number of serious reactions, including death and severe conditions.. Diverse range of reactions, including respiratory, gastrointestinal, and neurological issues.. Significant reports of drug ineffectiveness and toxicity.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs are reported, and patients should be cautious when using this pain reliever with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pain Reliever.
Consult a healthcare provider before starting or stopping this medication, especially if you have pre-existing conditions. Report any unusual symptoms or side effects to your healthcare provider immediately.
Pain Reliever has 734,012 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating potential for diverse side effects. The volume of reports for Pain Reliever reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA monitoring these adverse events closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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