82/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Hydrocodone and Acetaminophen Adverse Events: High Concern for Overdose and Dependence
153,212 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCODONE BITARTRATE AND ACETAMINOPHEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 153,212 FDA adverse event reports, HYDROCODONE BITARTRATE AND ACETAMINOPHEN has a safety score of 82 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 AND ACETAMINOPHEN include DRUG DEPENDENCE, OVERDOSE, PAIN, EMOTIONAL DISTRESS, DRUG WITHDRAWAL SYNDROME. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCODONE BITARTRATE AND ACETAMINOPHEN.
Hydrocodone Bitartrate And Acetaminophen has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 153,212 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Drug Dependence, Overdose, Pain. Of classified reports, 86.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Overdose and drug dependence are the most common serious adverse events.
Death and severe mental health issues are also significant concerns. Fetal exposure during pregnancy and neonatal withdrawal syndrome are critical risks for pregnant women.
Patients taking Hydrocodone Bitartrate And Acetaminophen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocodone and Acetaminophen can interact with other drugs, potentially increasing the risk of overdose and adverse effects. 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.
Hydrocodone Bitartrate And Acetaminophen received a safety concern score of 82/100 (high concern). This is based on a 86.4% serious event ratio across 55,706 classified reports. The score accounts for 153,212 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: Male: 27,184, Female: 26,193, Unknown: 4. The most frequently reported age groups are age 59 (366 reports), age 61 (364 reports), age 55 (344 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,706 classified reports for HYDROCODONE BITARTRATE 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.
Hydrocodone and Acetaminophen can interact with other drugs, potentially increasing the risk of overdose and adverse effects. Patients should avoid alcohol and other CNS depressants.
If you are taking Hydrocodone Bitartrate And Acetaminophen, here are important things to know. The most commonly reported side effects include drug dependence, overdose, pain, emotional distress, drug withdrawal syndrome. 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 overdose. Do not combine with alcohol or other CNS depressants without consulting a healthcare provider. 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 these drugs due to their high risk of misuse and serious adverse events. Healthcare providers should carefully weigh the benefits against the risks, especially for patients with a history of substance abuse.
The FDA has received approximately 153,212 adverse event reports associated with Hydrocodone Bitartrate 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 Hydrocodone Bitartrate And Acetaminophen include Drug Dependence, Overdose, Pain, Emotional Distress, Drug Withdrawal Syndrome. By volume, the top reported reactions are: Drug Dependence (33,265 reports), Overdose (14,484 reports), Pain (12,015 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 And Acetaminophen.
Out of 55,706 classified reports, 48,149 (86.4%) were classified as serious and 7,557 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 And Acetaminophen break down by patient sex as follows: Male: 27,184, Female: 26,193, Unknown: 4. 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 And Acetaminophen adverse events are: age 59: 366 reports, age 61: 364 reports, age 55: 344 reports, age 60: 341 reports, age 56: 338 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 And Acetaminophen adverse event reports is Amneal 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 Hydrocodone Bitartrate And Acetaminophen include: Anxiety, Death, Depression, Learning Disability, Foetal Exposure During Pregnancy. 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 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.
Hydrocodone Bitartrate And Acetaminophen has a safety concern score of 82 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. Overdose and drug dependence are the most common serious adverse events.
Key safety signals identified in Hydrocodone Bitartrate And Acetaminophen's adverse event data include: Overdose. Drug dependence and withdrawal syndrome. Death. Severe mental health issues (e.g., depression, anxiety). Fetal exposure and neonatal withdrawal syndrome. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocodone and Acetaminophen can interact with other drugs, potentially increasing the risk of overdose and adverse effects. 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 Hydrocodone Bitartrate And Acetaminophen.
Follow prescribed dosages strictly to avoid overdose. Do not combine with alcohol or other CNS depressants without consulting a healthcare provider.
Hydrocodone Bitartrate And Acetaminophen has 153,212 adverse event reports on file with the FDA. Death and severe mental health issues are also significant concerns. The volume of reports for Hydrocodone Bitartrate And Acetaminophen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these drugs due to their high risk of misuse and serious adverse events. Healthcare providers should carefully weigh the benefits against the risks, especially for patients with a history of substance abuse. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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