Suboxonebuprenorphine + naloxone
23,840 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Suboxone 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 4,290 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 Withdrawal Syndrome 3,338 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 →Pain 2,558 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Off Label Use 2,071 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 →Overdose 1,858 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Nausea 1,638 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Emotional Distress 1,478 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 →Anxiety 1,354 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,341 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Headache 1,114 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Drug Abuse 1,104 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →Insomnia 1,076 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Foetal Exposure During Pregnancy 1,049 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Depression 1,031 reports
A persistent low mood, loss of interest, or feelings of sadness. 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 → See all drugs reporting this event →- Intentional Underdose 1,026 reports
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 | 10,040 |
| Male | 10,020 |
| Unknown | 100 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 366 |
| 18-34 | 3,898 |
| 35-49 | 3,603 |
| 50-64 | 2,199 |
| 65-74 | 410 |
| 75+ | 79 |
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 Suboxone. 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 | 11,751 |
| Non-Serious | 8,704 |
| Hospitalization | 4,827 |
| Disability | 1,284 |
| Death | 1,254 |
| Life-Threatening | 584 |
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 Suboxone. 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 |
|---|---|
| 2004 | 19 |
| 2005 | 33 |
| 2006 | 103 |
| 2007 | 163 |
| 2008 | 239 |
| 2009 | 442 |
| 2010 | 1,163 |
| 2011 | 1,071 |
| 2012 | 835 |
| 2013 | 504 |
| 2014 | 2,267 |
| 2015 | 2,187 |
| 2016 | 1,723 |
| 2017 | 1,850 |
| 2018 | 1,690 |
| 2019 | 1,264 |
| 2020 | 1,800 |
| 2021 | 2,627 |
| 2022 | 1,482 |
| 2023 | 838 |
| 2024 | 636 |
| 2025 | 784 |
| 2026 (partial) | 120 |
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 Suboxone
In FDA adverse event reports that mention Suboxone, these medications appeared most often in the same report.
- Oxycodone (3,001 reports)
- Hydrocodone And Acetaminophen (1,528 reports)
- Gabapentin (1,257 reports)
- Hydromorphone (1,133 reports)
- Methadone (998 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