85/100 · Critical
Manufactured by Purdue Pharma LP
Hydrocodone Bitartrate Adverse Events: High Seriousness and Diverse Reactions
89,079 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCODONE BITARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Purdue Pharma LP. Based on analysis of 89,079 FDA adverse event reports, HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE include DEATH, DRUG DEPENDENCE, OVERDOSE, TOXICITY TO VARIOUS AGENTS, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCODONE BITARTRATE.
Hydrocodone Bitartrate 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 89,079 adverse event reports for this medication, which is primarily manufactured by Purdue Pharma Lp.
The most commonly reported adverse events include Death, Drug Dependence, Overdose. Of classified reports, 87.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Over 11,000 reports of death, indicating a high risk of fatal overdose.
Drug dependence and withdrawal syndrome are frequent, highlighting addiction concerns. Over 9,000 reports of overdose, underscoring the drug's potential for misuse and abuse. A significant number of serious reactions, including death, myocardial infarction, and respiratory arrest, are reported. The drug is associated with a wide range of adverse reactions, including mental disorders, falls, and injuries.
Patients taking Hydrocodone Bitartrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocodone Bitartrate can interact with other drugs, potentially increasing the risk of adverse effects. It is important to inform healthcare providers of all medications being taken. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrocodone Bitartrate received a safety concern score of 85/100 (high concern). This is based on a 87.2% serious event ratio across 42,957 classified reports. The score accounts for 89,079 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: 10,386, Male: 9,545, Unknown: 15. The most frequently reported age groups are age 55 (150 reports), age 59 (139 reports), age 63 (132 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 42,957 classified reports for HYDROCODONE BITARTRATE:
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.
Hydrocodone Bitartrate can interact with other drugs, potentially increasing the risk of adverse effects. It is important to inform healthcare providers of all medications being taken.
If you are taking Hydrocodone Bitartrate, here are important things to know. The most commonly reported side effects include death, drug dependence, overdose, toxicity to various agents, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosages and never exceed the recommended amount. Inform your healthcare provider about any history of substance abuse or addiction before starting Hydrocodone Bitartrate. Be aware of the signs of overdose and seek immediate medical attention if you or someone else experiences symptoms such as difficulty breathing, extreme drowsiness, or loss of consciousness. 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 Hydrocodone Bitartrate and has taken steps to limit its availability, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use.
The FDA has received approximately 89,079 adverse event reports associated with Hydrocodone Bitartrate. 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 Hydrocodone Bitartrate include Death, Drug Dependence, Overdose, Toxicity To Various Agents, Pain. By volume, the top reported reactions are: Death (11,931 reports), Drug Dependence (10,327 reports), Overdose (9,646 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydrocodone Bitartrate.
Out of 42,957 classified reports, 37,460 (87.2%) were classified as serious and 5,497 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 Hydrocodone Bitartrate break down by patient sex as follows: Female: 10,386, Male: 9,545, Unknown: 15. 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 Hydrocodone Bitartrate adverse events are: age 55: 150 reports, age 59: 139 reports, age 63: 132 reports, age 52: 131 reports, age 50: 129 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 Hydrocodone Bitartrate adverse event reports is Purdue Pharma Lp. 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 Hydrocodone Bitartrate include: Emotional Distress, Drug Withdrawal Syndrome, Drug Abuse, Drug Withdrawal Syndrome Neonatal, Nausea. 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 Hydrocodone Bitartrate 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.
Hydrocodone Bitartrate 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, indicating a high risk of fatal overdose.
Key safety signals identified in Hydrocodone Bitartrate's adverse event data include: Over 11,000 reports of death, indicating a high risk of fatal overdose.. More than 9,000 reports of overdose, highlighting the potential for misuse and abuse.. Over 10,000 reports of drug dependence and withdrawal syndrome, indicating significant addiction concerns.. Multiple serious reactions, including myocardial infarction, respiratory arrest, and falls, are reported.. A diverse range of adverse reactions, including mental disorders, falls, and injuries, are documented.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocodone Bitartrate can interact with other drugs, potentially increasing the risk of adverse effects. It is important to inform healthcare providers of all medications being taken. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrocodone Bitartrate.
Always follow prescribed dosages and never exceed the recommended amount. Inform your healthcare provider about any history of substance abuse or addiction before starting Hydrocodone Bitartrate. Be aware of the signs of overdose and seek immediate medical attention if you or someone else experiences symptoms such as difficulty breathing, extreme drowsiness, or loss of consciousness.
Hydrocodone Bitartrate has 89,079 adverse event reports on file with the FDA. Drug dependence and withdrawal syndrome are frequent, highlighting addiction concerns. The volume of reports for Hydrocodone Bitartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Hydrocodone Bitartrate and has taken steps to limit its availability, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Purdue Pharma LP and compare their safety profiles:
The following drugs share commonly reported adverse reactions with HYDROCODONE BITARTRATE:
Drugs related to HYDROCODONE BITARTRATE based on therapeutic use, drug class, or shared indications: