Butransbuprenorphine
According to the FDA label: Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction.
83,431 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Butrans 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
Tap any term below for a plain-language definition.
Death 13,295 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 Dependence 12,022 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 →Overdose 10,851 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Toxicity to Various Agents 10,706 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Pain 8,068 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Drug Ineffective 6,076 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 →Drug Withdrawal Syndrome 5,697 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 →Emotional Distress 5,438 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 →Nausea 4,144 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 Abuse 3,444 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 →- Inadequate Analgesia 3,034 reports
Application Site Rash 3,014 reports
A rash on the skin where a medication was applied, such as under a patch or cream.
Full definition in the glossary →Product Adhesion Issue 2,837 reports
A report that a medication meant to stick to the skin, such as a patch, did not adhere properly. This is a product-performance category.
Full definition in the glossary →Dizziness 2,548 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Rash 2,467 reports
An area of irritated, red, or bumpy skin.
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 | 33,125 |
| Male | 24,387 |
| Unknown | 178 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 446 |
| 18-34 | 3,141 |
| 35-49 | 6,274 |
| 50-64 | 5,009 |
| 65-74 | 2,282 |
| 75+ | 2,799 |
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 Butrans. 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 |
|---|---|
| Non-Serious | 30,598 |
| Other Serious | 28,132 |
| Death | 25,957 |
| Hospitalization | 10,199 |
| Disability | 4,082 |
| Life-Threatening | 2,389 |
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 Butrans. 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 | 3 |
| 2005 | 34 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 37 |
| 2010 | 96 |
| 2011 | 427 |
| 2012 | 667 |
| 2013 | 13,502 |
| 2014 | 5,252 |
| 2015 | 4,558 |
| 2016 | 3,033 |
| 2017 | 4,503 |
| 2018 | 22,271 |
| 2019 | 2,613 |
| 2020 | 3,986 |
| 2021 | 8,147 |
| 2022 | 5,243 |
| 2023 | 2,350 |
| 2024 | 2,860 |
| 2025 | 3,219 |
| 2026 (partial) | 621 |
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 Butrans
In FDA adverse event reports that mention Butrans, these medications appeared most often in the same report.
- Oxycodone (32,533 reports)
- Hydromorphone (29,926 reports)
- Morphine (29,577 reports)
- Hydrocodone (25,212 reports)
- Oxycodone And Acetaminophen (22,549 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