85/100 · Critical
Manufactured by Vertical Pharmaceuticals, LLC
Tramadol Hydrochloride Adverse Events: High Seriousness and Diverse Reactions
142,038 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRAMADOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Vertical Pharmaceuticals, LLC. Based on analysis of 142,038 FDA adverse event reports, TRAMADOL HYDROCHLORIDE 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 TRAMADOL HYDROCHLORIDE include DEPENDENCE, OVERDOSE, VOMITING, PAIN, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRAMADOL HYDROCHLORIDE.
Tramadol Hydrochloride 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 142,038 adverse event reports for this medication, which is primarily manufactured by Vertical Pharmaceuticals, Llc.
The most commonly reported adverse events include Dependence, Overdose, Vomiting. Of classified reports, 90.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Over 17,000 reports of dependence and overdose highlight significant misuse concerns.
Vomiting, nausea, and pain are common, with over 5,000 reports each. Serious reactions such as death, pneumonia, and liver injury are reported.
Patients taking Tramadol Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tramadol can interact with other drugs, including monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitors (SSRIs), leading to serious adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tramadol Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 90.1% serious event ratio across 36,174 classified reports. The score accounts for 142,038 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: 19,067, Male: 12,477, Unknown: 90. The most frequently reported age groups are age 40 (867 reports), age 65 (825 reports), age 43 (770 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,174 classified reports for TRAMADOL HYDROCHLORIDE:
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.
Tramadol can interact with other drugs, including monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitors (SSRIs), leading to serious adverse effects.
If you are taking Tramadol Hydrochloride, here are important things to know. The most commonly reported side effects include dependence, overdose, vomiting, pain, nausea. 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 strictly to avoid dependence and overdose. 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.
The FDA closely monitors Tramadol due to its high risk of misuse, dependence, and serious adverse events. Healthcare providers should be vigilant and consider alternative treatments when appropriate.
The FDA has received approximately 142,038 adverse event reports associated with Tramadol Hydrochloride. 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 include Dependence, Overdose, Vomiting, Pain, Nausea. By volume, the top reported reactions are: Dependence (7,820 reports), Overdose (3,855 reports), Vomiting (3,155 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.
Out of 36,174 classified reports, 32,581 (90.1%) were classified as serious and 3,593 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 break down by patient sex as follows: Female: 19,067, Male: 12,477, Unknown: 90. 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 adverse events are: age 40: 867 reports, age 65: 825 reports, age 43: 770 reports, age 44: 712 reports, age 54: 450 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 adverse event reports is Vertical Pharmaceuticals, 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 include: Drug Ineffective, Headache, Fatigue, Dyspnoea, Off Label Use. 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 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 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. Over 17,000 reports of dependence and overdose highlight significant misuse concerns.
Key safety signals identified in Tramadol Hydrochloride's adverse event data include: Over 7,000 reports of drug dependence and overdose indicate misuse and abuse potential.. More than 1,700 reports of serious reactions, including death and pneumonia, are concerning.. Liver injury and increased hepatic enzymes are reported, suggesting potential hepatotoxicity.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tramadol can interact with other drugs, including monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitors (SSRIs), leading to serious adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tramadol Hydrochloride.
Follow prescribed dosages strictly to avoid dependence and overdose. Report any unusual symptoms or side effects to your healthcare provider immediately.
Tramadol Hydrochloride has 142,038 adverse event reports on file with the FDA. Vomiting, nausea, and pain are common, with over 5,000 reports each. The volume of reports for Tramadol Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Tramadol due to its high risk of misuse, dependence, and serious adverse events. Healthcare providers should be vigilant and consider alternative treatments when appropriate. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with TRAMADOL HYDROCHLORIDE:
Drugs related to TRAMADOL HYDROCHLORIDE based on therapeutic use, drug class, or shared indications: