Morphine Sulfate Extended Release
66,166 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Morphine Sulfate Extended Release in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Dependence 10,437 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Drug Hypersensitivity 10,093 reports
An allergic-type reaction to a medication.
Full definition in the glossary →Pain 9,099 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Overdose 7,699 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Emotional Distress 5,159 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Dependence 4,672 reports
A state in which the body or mind has come to rely on a substance, so that stopping it causes difficulty. Closely related to drug dependence.
Full definition in the glossary →Nausea 4,520 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 4,288 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Death 4,171 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Drug Withdrawal Syndrome 3,349 reports
The set of symptoms that can occur when a medication the body has gotten used to is stopped or reduced.
Full definition in the glossary →Fatigue 3,251 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Vomiting 3,209 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Headache 2,908 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 2,812 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Constipation 2,493 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 33,972 |
| Male | 26,066 |
| Unknown | 219 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,160 |
| 18-34 | 3,374 |
| 35-49 | 6,943 |
| 50-64 | 11,862 |
| 65-74 | 7,185 |
| 75+ | 5,366 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Morphine Sulfate Extended Release. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 36,117 |
| Hospitalization | 16,074 |
| Non-Serious | 15,214 |
| Death | 11,763 |
| Disability | 3,342 |
| Life-Threatening | 2,817 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Morphine Sulfate Extended Release. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 3 |
| 2004 | 1,244 |
| 2005 | 1,048 |
| 2006 | 952 |
| 2007 | 529 |
| 2008 | 649 |
| 2009 | 697 |
| 2010 | 892 |
| 2011 | 1,191 |
| 2012 | 1,837 |
| 2013 | 1,471 |
| 2014 | 1,867 |
| 2015 | 2,356 |
| 2016 | 2,908 |
| 2017 | 2,710 |
| 2018 | 5,587 |
| 2019 | 4,349 |
| 2020 | 3,818 |
| 2021 | 7,862 |
| 2022 | 8,450 |
| 2023 | 8,187 |
| 2024 | 3,554 |
| 2025 | 3,324 |
| 2026 (partial) | 681 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Morphine Sulfate Extended Release
In FDA adverse event reports that mention Morphine Sulfate Extended Release, these medications appeared most often in the same report.
- Oxycodone (12,621 reports)
- Hydromorphone (9,129 reports)
- Acetaminophen (8,954 reports)
- Gabapentin (6,484 reports)
- Oxycodone And Acetaminophen (5,618 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026