85/100 · Critical
Manufactured by Fresenius Kabi USA, LLC
Hydromorphone Hydrochloride Adverse Events: High Concern for Overdose and Drug Dependence
268,941 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROMORPHONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 268,941 FDA adverse event reports, HYDROMORPHONE 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 HYDROMORPHONE HYDROCHLORIDE include DRUG DEPENDENCE, OVERDOSE, PAIN, EMOTIONAL DISTRESS, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROMORPHONE HYDROCHLORIDE.
Hydromorphone 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 268,941 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Drug Dependence, Overdose, Pain. Of classified reports, 92.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Overdose and drug dependence are the most frequent and serious adverse events.
Death reports are significant, indicating a high risk of fatal outcomes. Neonatal drug withdrawal syndrome is a key concern for pregnant patients.
Patients taking Hydromorphone Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydromorphone Hydrochloride can cause drug dependence and overdose, and should be used with caution, especially in pregnant women and patients with a history of substance abuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydromorphone Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 92.7% serious event ratio across 90,648 classified reports. The score accounts for 268,941 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: 34,019, Male: 31,058, Unknown: 52. The most frequently reported age groups are age 65 (876 reports), age 59 (747 reports), age 58 (636 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 90,648 classified reports for HYDROMORPHONE 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.
Hydromorphone Hydrochloride can cause drug dependence and overdose, and should be used with caution, especially in pregnant women and patients with a history of substance abuse.
If you are taking Hydromorphone Hydrochloride, here are important things to know. The most commonly reported side effects include drug dependence, overdose, pain, emotional distress, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow the prescribed dosage and not exceed it. Pregnant women should avoid using this drug unless absolutely necessary, due to the risk of neonatal withdrawal syndrome. 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 the safety of Hydromorphone Hydrochloride, and any adverse events should be reported to the agency for further investigation.
The FDA has received approximately 268,941 adverse event reports associated with Hydromorphone 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 Hydromorphone Hydrochloride include Drug Dependence, Overdose, Pain, Emotional Distress, Death. By volume, the top reported reactions are: Drug Dependence (35,077 reports), Overdose (22,994 reports), Pain (22,128 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydromorphone Hydrochloride.
Out of 90,648 classified reports, 84,043 (92.7%) were classified as serious and 6,605 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 Hydromorphone Hydrochloride break down by patient sex as follows: Female: 34,019, Male: 31,058, Unknown: 52. 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 Hydromorphone Hydrochloride adverse events are: age 65: 876 reports, age 59: 747 reports, age 58: 636 reports, age 60: 553 reports, age 62: 548 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 Hydromorphone Hydrochloride adverse event reports is Fresenius Kabi Usa, 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 Hydromorphone Hydrochloride include: Drug Withdrawal Syndrome, Toxicity To Various Agents, Nausea, Drug Ineffective, 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 Hydromorphone 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.
Hydromorphone 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. Overdose and drug dependence are the most frequent and serious adverse events.
Key safety signals identified in Hydromorphone Hydrochloride's adverse event data include: Over 22,000 reports of overdose, making it the most common serious adverse event.. More than 14,000 reports of drug dependence, highlighting the risk of addiction.. Over 14,000 reports of death, indicating a high fatality rate.. Over 2,000 reports of neonatal drug withdrawal syndrome, a critical safety signal for pregnant patients.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydromorphone Hydrochloride can cause drug dependence and overdose, and should be used with caution, especially in pregnant women and patients with a history of substance abuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydromorphone Hydrochloride.
Patients should strictly follow the prescribed dosage and not exceed it. Pregnant women should avoid using this drug unless absolutely necessary, due to the risk of neonatal withdrawal syndrome.
Hydromorphone Hydrochloride has 268,941 adverse event reports on file with the FDA. Death reports are significant, indicating a high risk of fatal outcomes. The volume of reports for Hydromorphone Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors the safety of Hydromorphone Hydrochloride, and any adverse events should be reported to the agency for further investigation. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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