72/100 · Elevated
Manufactured by Amneal Pharmaceuticals of New York LLC
Moderate Safety Concerns with Tramadol Hydrochloride and Acetaminophen
2,295 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals of New York LLC. Based on analysis of 2,295 FDA adverse event reports, TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN has a safety score of 72 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 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN include NAUSEA, DRUG INEFFECTIVE, OFF LABEL USE, DIZZINESS, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN.
Tramadol Hydrochloride And Acetaminophen has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 2,295 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Of New York Llc.
The most commonly reported adverse events include Nausea, Drug Ineffective, Off Label Use. Of classified reports, 83.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and dizziness are the most common side effects.
Serious adverse events, such as pneumonia and hospitalization, are reported. Drug interactions and ineffective drug performance are significant concerns. Pain and gastrointestinal issues are frequently reported.
Patients taking Tramadol Hydrochloride And Acetaminophen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Caution is advised when used with other central nervous system depressants. Monitor for drug interactions and potential for adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tramadol Hydrochloride And Acetaminophen received a safety concern score of 72/100 (elevated concern). This is based on a 83.8% serious event ratio across 896 classified reports. The score accounts for 2,295 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 525, Male: 294, Unknown: 1. The most frequently reported age groups are age 69 (21 reports), age 74 (21 reports), age 63 (18 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 896 classified reports for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN:
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.
Caution is advised when used with other central nervous system depressants. Monitor for drug interactions and potential for adverse effects.
If you are taking Tramadol Hydrochloride And Acetaminophen, here are important things to know. The most commonly reported side effects include nausea, drug ineffective, off label use, dizziness, malaise. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and do not exceed recommended limits. Inform your healthcare provider about any other medications you are taking to avoid potential interactions. 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 received reports of serious adverse events, indicating a need for close monitoring and adherence to prescribed dosages. Regulatory oversight is ongoing to ensure patient safety.
The FDA has received approximately 2,295 adverse event reports associated with Tramadol Hydrochloride And Acetaminophen. 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 Tramadol Hydrochloride And Acetaminophen include Nausea, Drug Ineffective, Off Label Use, Dizziness, Malaise. By volume, the top reported reactions are: Nausea (78 reports), Drug Ineffective (67 reports), Off Label Use (67 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tramadol Hydrochloride And Acetaminophen.
Out of 896 classified reports, 751 (83.8%) were classified as serious and 145 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 Tramadol Hydrochloride And Acetaminophen break down by patient sex as follows: Female: 525, Male: 294, Unknown: 1. 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 Tramadol Hydrochloride And Acetaminophen adverse events are: age 69: 21 reports, age 74: 21 reports, age 63: 18 reports, age 77: 18 reports, age 43: 17 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 Tramadol Hydrochloride And Acetaminophen adverse event reports is Amneal Pharmaceuticals Of New York 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 Tramadol Hydrochloride And Acetaminophen include: Pain, Vomiting, Headache, Dyspnoea, Fatigue. 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 Tramadol Hydrochloride And Acetaminophen 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.
Tramadol Hydrochloride And Acetaminophen has a safety concern score of 72 out of 100 (elevated 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. Nausea and dizziness are the most common side effects.
Key safety signals identified in Tramadol Hydrochloride And Acetaminophen's adverse event data include: High frequency of nausea and dizziness.. Serious events like pneumonia and hospitalization.. Multiple reports of drug ineffectiveness and intolerance.. Significant number of falls and confusion reports.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Caution is advised when used with other central nervous system depressants. Monitor for drug interactions and potential for adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tramadol Hydrochloride And Acetaminophen.
Follow prescribed dosages and do not exceed recommended limits. Inform your healthcare provider about any other medications you are taking to avoid potential interactions.
Tramadol Hydrochloride And Acetaminophen has 2,295 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and hospitalization, are reported. The volume of reports for Tramadol Hydrochloride And Acetaminophen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has received reports of serious adverse events, indicating a need for close monitoring and adherence to prescribed dosages. Regulatory oversight is ongoing to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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