85/100 · Critical
Manufactured by Collegium Pharmaceutical, Inc.
High Safety Concerns with Tapentadol Hydrochloride, Particularly Overdose and Toxicity
50,606 FDA adverse event reports analyzed
Last updated: 2026-05-12
TAPENTADOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Collegium Pharmaceutical, Inc.. Based on analysis of 50,606 FDA adverse event reports, TAPENTADOL 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 TAPENTADOL HYDROCHLORIDE include DEATH, TOXICITY TO VARIOUS AGENTS, OVERDOSE, DRUG ABUSE, DRUG DEPENDENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TAPENTADOL HYDROCHLORIDE.
Tapentadol 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 50,606 adverse event reports for this medication, which is primarily manufactured by Collegium Pharmaceutical, Inc..
The most commonly reported adverse events include Death, Toxicity To Various Agents, Overdose. Of classified reports, 89.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Over 11,000 reports of death and toxicity are concerning.
Overdose and drug abuse are frequent, indicating a high risk of misuse. Neonatal drug withdrawal syndrome and accidental overdose are significant risks.
Patients taking Tapentadol Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tapentadol Hydrochloride can interact with other drugs, leading to toxicity and increased risk of overdose. Patients should avoid alcohol and other CNS depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tapentadol Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 89.6% serious event ratio across 33,053 classified reports. The score accounts for 50,606 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: 5,453, Male: 3,146, Unknown: 29. The most frequently reported age groups are age 61 (180 reports), age 54 (158 reports), age 50 (151 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,053 classified reports for TAPENTADOL 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.
Tapentadol Hydrochloride can interact with other drugs, leading to toxicity and increased risk of overdose. Patients should avoid alcohol and other CNS depressants.
If you are taking Tapentadol Hydrochloride, here are important things to know. The most commonly reported side effects include death, toxicity to various agents, overdose, drug abuse, drug dependence. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Do not exceed the prescribed dose and do not use with alcohol or other CNS depressants. Seek immediate medical attention if you experience symptoms of overdose or toxicity. 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 issued warnings about the serious risks associated with Tapentadol Hydrochloride, including death and toxicity. Close monitoring and strict adherence to dosing instructions are crucial.
The FDA has received approximately 50,606 adverse event reports associated with Tapentadol 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 Tapentadol Hydrochloride include Death, Toxicity To Various Agents, Overdose, Drug Abuse, Drug Dependence. By volume, the top reported reactions are: Death (11,641 reports), Toxicity To Various Agents (9,719 reports), Overdose (5,886 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tapentadol Hydrochloride.
Out of 33,053 classified reports, 29,628 (89.6%) were classified as serious and 3,425 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 Tapentadol Hydrochloride break down by patient sex as follows: Female: 5,453, Male: 3,146, Unknown: 29. 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 Tapentadol Hydrochloride adverse events are: age 61: 180 reports, age 54: 158 reports, age 50: 151 reports, age 57: 137 reports, age 53: 134 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 Tapentadol Hydrochloride adverse event reports is Collegium 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 Tapentadol Hydrochloride include: Drug Ineffective, Drug Withdrawal Syndrome Neonatal, Pain, Nausea, Accidental Overdose. 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 Tapentadol 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.
Tapentadol 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 11,000 reports of death and toxicity are concerning.
Key safety signals identified in Tapentadol Hydrochloride's adverse event data include: Over 11,000 reports of death and toxicity.. Frequent reports of overdose and drug abuse.. High incidence of neonatal drug withdrawal syndrome and accidental overdose.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tapentadol Hydrochloride can interact with other drugs, leading to toxicity and increased risk of overdose. Patients should avoid alcohol and other CNS depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tapentadol Hydrochloride.
Do not exceed the prescribed dose and do not use with alcohol or other CNS depressants. Seek immediate medical attention if you experience symptoms of overdose or toxicity.
Tapentadol Hydrochloride has 50,606 adverse event reports on file with the FDA. Overdose and drug abuse are frequent, indicating a high risk of misuse. The volume of reports for Tapentadol Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings about the serious risks associated with Tapentadol Hydrochloride, including death and toxicity. Close monitoring and strict adherence to dosing instructions are crucial. 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 TAPENTADOL HYDROCHLORIDE:
Drugs related to TAPENTADOL HYDROCHLORIDE based on therapeutic use, drug class, or shared indications: