85/100 · Critical
Manufactured by Edenbridge Pharmaceuticals, LLC
High Safety Concerns with Morphine Use
172,090 FDA adverse event reports analyzed
Last updated: 2026-05-12
MORPHINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Edenbridge Pharmaceuticals, LLC. Based on analysis of 172,090 FDA adverse event reports, MORPHINE 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 MORPHINE include PAIN, NAUSEA, DRUG INEFFECTIVE, VOMITING, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MORPHINE.
Morphine 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 172,090 adverse event reports for this medication, which is primarily manufactured by Edenbridge Pharmaceuticals, Llc.
The most commonly reported adverse events include Pain, Nausea, Drug Ineffective. Of classified reports, 87.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Morphine reports a high percentage of serious adverse events, including death and respiratory depression.
The drug is frequently reported to be ineffective, leading to overuse and potential misuse. Significant drug interactions and warnings are associated with Morphine use.
Patients taking Morphine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Morphine can interact with a variety of drugs, including other analgesics, sedatives, and antipsychotics, potentially leading to severe adverse effects such as respiratory depression and hypotension. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Morphine received a safety concern score of 85/100 (high concern). This is based on a 87.1% serious event ratio across 72,136 classified reports. The score accounts for 172,090 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: 36,042, Male: 30,357, Unknown: 295. The most frequently reported age groups are age 59 (1,279 reports), age 58 (1,228 reports), age 61 (1,193 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 72,136 classified reports for MORPHINE:
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 can interact with a variety of drugs, including other analgesics, sedatives, and antipsychotics, potentially leading to severe adverse effects such as respiratory depression and hypotension.
If you are taking Morphine, here are important things to know. The most commonly reported side effects include pain, nausea, drug ineffective, vomiting, 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 prescribed dosages and avoid driving or operating heavy machinery due to potential drowsiness and impaired cognitive function. Inform healthcare providers about all medications and supplements being taken to avoid drug interactions. 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 use due to its high risk of serious adverse events, particularly respiratory depression and overdose. Healthcare providers should be vigilant in managing patient care and monitoring for signs of adverse reactions.
The FDA has received approximately 172,090 adverse event reports associated with Morphine. 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 include Pain, Nausea, Drug Ineffective, Vomiting, Death. By volume, the top reported reactions are: Pain (5,855 reports), Nausea (5,531 reports), Drug Ineffective (5,004 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.
Out of 72,136 classified reports, 62,823 (87.1%) were classified as serious and 9,313 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 break down by patient sex as follows: Female: 36,042, Male: 30,357, Unknown: 295. 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 adverse events are: age 59: 1,279 reports, age 58: 1,228 reports, age 61: 1,193 reports, age 60: 1,188 reports, age 57: 1,146 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 adverse event reports is Edenbridge 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 Morphine include: Fatigue, Toxicity To Various Agents, Off Label Use, Diarrhoea, Dyspnoea. 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 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 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. Morphine reports a high percentage of serious adverse events, including death and respiratory depression.
Key safety signals identified in Morphine's adverse event data include: Over 4,300 reports of death, indicating a high lethality risk.. More than 2,200 reports of respiratory depression, a critical safety signal.. Over 1,700 reports of drug interactions, highlighting potential risks when combined with other medications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Morphine can interact with a variety of drugs, including other analgesics, sedatives, and antipsychotics, potentially leading to severe adverse effects such as respiratory depression and hypotension. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Morphine.
Patients should strictly follow prescribed dosages and avoid driving or operating heavy machinery due to potential drowsiness and impaired cognitive function. Inform healthcare providers about all medications and supplements being taken to avoid drug interactions.
Morphine has 172,090 adverse event reports on file with the FDA. The drug is frequently reported to be ineffective, leading to overuse and potential misuse. The volume of reports for Morphine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Morphine use due to its high risk of serious adverse events, particularly respiratory depression and overdose. Healthcare providers should be vigilant in managing patient care and monitoring for signs of adverse reactions. 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 MORPHINE:
Drugs related to MORPHINE based on therapeutic use, drug class, or shared indications: