85/100 · Critical
Manufactured by AAA Pharmaceutical, Inc.
High Serious Reaction Rate for Acetaminophen Extended Release Tablets
733,850 FDA adverse event reports analyzed
Last updated: 2026-05-12
ACETAMINOPHEN TABLET EXTENDED RELEASE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AAA Pharmaceutical, Inc.. Based on analysis of 733,850 FDA adverse event reports, ACETAMINOPHEN TABLET EXTENDED RELEASE 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 ACETAMINOPHEN TABLET EXTENDED RELEASE 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 ACETAMINOPHEN TABLET EXTENDED RELEASE.
Acetaminophen Tablet Extended Release 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 733,850 adverse event reports for this medication, which is primarily manufactured by Aaa Pharmaceutical, Inc..
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 reactions are non-serious, but the serious reaction rate is high at 87.4%.
Pain and fatigue are the most common reactions, with over 17,000 reports each. Overdose and death are significant safety concerns, with 7,490 and 8,925 reports respectively.
Patients taking Acetaminophen Tablet Extended Release should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Acetaminophen extended release tablets can cause liver toxicity and should be used with caution, especially in patients with pre-existing liver conditions or those at risk of overdose. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Acetaminophen Tablet Extended Release received a safety concern score of 85/100 (high concern). This is based on a 87.4% serious event ratio across 239,187 classified reports. The score accounts for 733,850 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: 130,723, Male: 78,870, Unknown: 510. The most frequently reported age groups are age 44 (3,732 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 239,187 classified reports for ACETAMINOPHEN TABLET EXTENDED RELEASE:
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.
Acetaminophen extended release tablets can cause liver toxicity and should be used with caution, especially in patients with pre-existing liver conditions or those at risk of overdose.
If you are taking Acetaminophen Tablet Extended Release, 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. Always follow the prescribed dosage and do not exceed the recommended limit to avoid liver damage and overdose. Be aware of potential interactions with other medications and inform your healthcare provider of all medications you are taking. 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 acetaminophen extended release tablets, and any unusual symptoms should be reported to healthcare providers immediately.
The FDA has received approximately 733,850 adverse event reports associated with Acetaminophen Tablet Extended Release. 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 Acetaminophen Tablet Extended Release include Off Label Use, Fatigue, Drug Ineffective, Pain, Nausea. By volume, the top reported reactions are: Off Label Use (21,662 reports), Fatigue (19,922 reports), Drug Ineffective (17,777 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Acetaminophen Tablet Extended Release.
Out of 239,187 classified reports, 208,978 (87.4%) were classified as serious and 30,209 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 Acetaminophen Tablet Extended Release break down by patient sex as follows: Female: 130,723, Male: 78,870, 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 Acetaminophen Tablet Extended Release adverse events are: age 44: 3,732 reports, age 65: 3,469 reports, age 43: 3,414 reports, age 66: 3,405 reports, age 72: 3,192 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 Acetaminophen Tablet Extended Release adverse event reports is Aaa Pharmaceutical, 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 Acetaminophen Tablet Extended Release 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 Acetaminophen Tablet Extended Release 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.
Acetaminophen Tablet Extended Release 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 reactions are non-serious, but the serious reaction rate is high at 87.4%.
Key safety signals identified in Acetaminophen Tablet Extended Release's adverse event data include: Over 8,000 reports of death, indicating a high risk of fatal outcomes.. Over 7,000 reports of overdose, highlighting the potential for misuse.. More than 14,000 reports of toxicity, suggesting a risk of adverse effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Acetaminophen extended release tablets can cause liver toxicity and should be used with caution, especially in patients with pre-existing liver conditions or those at risk of overdose. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Acetaminophen Tablet Extended Release.
Always follow the prescribed dosage and do not exceed the recommended limit to avoid liver damage and overdose. Be aware of potential interactions with other medications and inform your healthcare provider of all medications you are taking.
Acetaminophen Tablet Extended Release has 733,850 adverse event reports on file with the FDA. Pain and fatigue are the most common reactions, with over 17,000 reports each. The volume of reports for Acetaminophen Tablet Extended Release reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of acetaminophen extended release tablets, and any unusual symptoms should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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