Tramadol Hydrochloride Extended-release
36,700 adverse event reports submitted to the FDA (1997–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tramadol Hydrochloride 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.
Show these terms with plain-language definitions
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Dependence 7,823 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 →Overdose 3,882 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Vomiting 3,283 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Pain 2,978 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Nausea 2,790 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 2,577 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 →Headache 2,341 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 2,335 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 2,317 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 2,290 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 →Drug Hypersensitivity 2,173 reports
An allergic-type reaction to a medication.
Full definition in the glossary →Drug Dependence 2,172 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 →Dizziness 2,002 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 1,979 reports
Pneumonia 1,954 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →
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 | 19,359 |
| Male | 12,639 |
| Unknown | 89 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 666 |
| 18-34 | 2,320 |
| 35-49 | 5,023 |
| 50-64 | 4,814 |
| 65-74 | 3,495 |
| 75+ | 3,036 |
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 Tramadol Hydrochloride 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 | 25,419 |
| Hospitalization | 11,452 |
| Death | 7,071 |
| Life-Threatening | 3,679 |
| Non-Serious | 3,593 |
| Disability | 2,992 |
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 Tramadol Hydrochloride 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 |
|---|---|
| 1997 | 1 |
| 1999 | 1 |
| 2004 | 115 |
| 2005 | 129 |
| 2006 | 93 |
| 2007 | 50 |
| 2008 | 124 |
| 2009 | 229 |
| 2010 | 566 |
| 2011 | 492 |
| 2012 | 930 |
| 2013 | 669 |
| 2014 | 630 |
| 2015 | 991 |
| 2016 | 1,030 |
| 2017 | 1,555 |
| 2018 | 1,818 |
| 2019 | 2,295 |
| 2020 | 2,129 |
| 2021 | 2,971 |
| 2022 | 2,923 |
| 2023 | 9,949 |
| 2024 | 3,695 |
| 2025 | 2,801 |
| 2026 (partial) | 514 |
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 Tramadol Hydrochloride Extended-release
In FDA adverse event reports that mention Tramadol Hydrochloride Extended-release, these medications appeared most often in the same report.
- Acetaminophen (6,843 reports)
- Oxycodone And Acetaminophen (4,955 reports)
- Prednisone (4,843 reports)
- Oxycodone (4,184 reports)
- Morphine (4,096 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