87/100 · Critical
Manufactured by Rhodes Pharmaceuticals L.P.
High Safety Concerns with Morphine Sulfate, Particularly Overdose and Death
294,935 FDA adverse event reports analyzed
Last updated: 2026-05-12
MORPHINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rhodes Pharmaceuticals L.P.. Based on analysis of 294,935 FDA adverse event reports, MORPHINE SULFATE has a safety score of 87 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 MORPHINE SULFATE include DRUG DEPENDENCE, OVERDOSE, PAIN, DEATH, EMOTIONAL DISTRESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MORPHINE SULFATE.
Morphine Sulfate has a safety concern score of 87 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 294,935 adverse event reports for this medication, which is primarily manufactured by Rhodes Pharmaceuticals L.P..
The most commonly reported adverse events include Drug Dependence, Overdose, Pain. Of classified reports, 85.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Overdose and death are the most serious reactions, with high report volumes.
Dependence and withdrawal syndromes are common, indicating potential for addiction. Pain and emotional distress are frequent, reflecting the drug's intended use and side effects.
Patients taking Morphine Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Morphine Sulfate can interact with other drugs, leading to increased risk of adverse effects. Warnings include monitoring for drug interactions and managing potential withdrawal symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Morphine Sulfate received a safety concern score of 87/100 (high concern). This is based on a 85.6% serious event ratio across 118,964 classified reports. The score accounts for 294,935 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: 47,147, Male: 42,715, Unknown: 255. The most frequently reported age groups are age 59 (1,217 reports), age 58 (1,121 reports), age 65 (1,096 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 118,964 classified reports for MORPHINE SULFATE:
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.
Morphine Sulfate can interact with other drugs, leading to increased risk of adverse effects. Warnings include monitoring for drug interactions and managing potential withdrawal symptoms.
If you are taking Morphine Sulfate, here are important things to know. The most commonly reported side effects include drug dependence, overdose, pain, death, emotional distress. 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 prescribed dosages and avoid self-medication. Healthcare providers should monitor patients for signs of dependence and withdrawal. 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 Morphine Sulfate due to its high safety concerns. Healthcare providers should be vigilant in managing patient care and reporting adverse events.
The FDA has received approximately 294,935 adverse event reports associated with Morphine Sulfate. 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 Morphine Sulfate include Drug Dependence, Overdose, Pain, Death, Emotional Distress. By volume, the top reported reactions are: Drug Dependence (32,800 reports), Overdose (23,424 reports), Pain (21,520 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Morphine Sulfate.
Out of 118,964 classified reports, 101,864 (85.6%) were classified as serious and 17,100 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 Morphine Sulfate break down by patient sex as follows: Female: 47,147, Male: 42,715, Unknown: 255. 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 Morphine Sulfate adverse events are: age 59: 1,217 reports, age 58: 1,121 reports, age 65: 1,096 reports, age 61: 1,044 reports, age 56: 1,001 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 Morphine Sulfate adverse event reports is Rhodes Pharmaceuticals L.P.. 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 Morphine Sulfate include: Drug Withdrawal Syndrome, Toxicity To Various Agents, Drug Hypersensitivity, Nausea, Dependence. 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 Morphine Sulfate 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.
Morphine Sulfate has a safety concern score of 87 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 death are the most serious reactions, with high report volumes.
Key safety signals identified in Morphine Sulfate's adverse event data include: Overdose and death are the most serious and frequent reactions.. Dependence and withdrawal syndromes are significant safety signals.. Pain and emotional distress are common, indicating the drug's impact on patients.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Morphine Sulfate can interact with other drugs, leading to increased risk of adverse effects. Warnings include monitoring for drug interactions and managing potential withdrawal symptoms. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Morphine Sulfate.
Patients should strictly follow prescribed dosages and avoid self-medication. Healthcare providers should monitor patients for signs of dependence and withdrawal.
Morphine Sulfate has 294,935 adverse event reports on file with the FDA. Dependence and withdrawal syndromes are common, indicating potential for addiction. The volume of reports for Morphine Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Morphine Sulfate due to its high safety concerns. Healthcare providers should be vigilant in managing patient care and reporting adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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