82/100 · Critical
Manufactured by Purdue Pharma LP
Buprenorphine Adverse Events: High Seriousness and Overdose Concerns
185,849 FDA adverse event reports analyzed
Last updated: 2026-05-12
BUPRENORPHINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Purdue Pharma LP. Based on analysis of 185,849 FDA adverse event reports, BUPRENORPHINE has a safety score of 82 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 BUPRENORPHINE include DEATH, DRUG DEPENDENCE, OVERDOSE, TOXICITY TO VARIOUS AGENTS, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPRENORPHINE.
Buprenorphine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 185,849 adverse event reports for this medication, which is primarily manufactured by Purdue Pharma Lp.
The most commonly reported adverse events include Death, Drug Dependence, Overdose. Of classified reports, 59.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Over 13,000 reports of death and over 10,000 reports of overdose highlight severe safety concerns.
Drug dependence and withdrawal syndrome are frequent, indicating potential for addiction and withdrawal issues. Over 8,000 reports of nausea and vomiting suggest gastrointestinal side effects are common.
Patients taking Buprenorphine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Buprenorphine can cause significant drug interactions, including with other opioids and sedatives, and should be used with caution. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Buprenorphine received a safety concern score of 82/100 (high concern). This is based on a 59.3% serious event ratio across 90,114 classified reports. The score accounts for 185,849 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: 35,466, Male: 27,244, Unknown: 191. The most frequently reported age groups are age 40 (1,261 reports), age 43 (813 reports), age 35 (569 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 90,114 classified reports for BUPRENORPHINE:
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.
Buprenorphine can cause significant drug interactions, including with other opioids and sedatives, and should be used with caution.
If you are taking Buprenorphine, here are important things to know. The most commonly reported side effects include death, drug dependence, overdose, toxicity to various agents, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages strictly to avoid overdose and dependency. Monitor for signs of withdrawal and seek medical assistance if symptoms persist or worsen. 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 continues to monitor buprenorphine safety, with ongoing restrictions and warnings to mitigate risks.
The FDA has received approximately 185,849 adverse event reports associated with Buprenorphine. 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 Buprenorphine include Death, Drug Dependence, Overdose, Toxicity To Various Agents, Pain. By volume, the top reported reactions are: Death (13,278 reports), Drug Dependence (12,452 reports), Overdose (10,911 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Buprenorphine.
Out of 90,114 classified reports, 53,443 (59.3%) were classified as serious and 36,671 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 Buprenorphine break down by patient sex as follows: Female: 35,466, Male: 27,244, Unknown: 191. 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 Buprenorphine adverse events are: age 40: 1,261 reports, age 43: 813 reports, age 35: 569 reports, age 30: 479 reports, age 50: 428 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 Buprenorphine adverse event reports is Purdue Pharma Lp. 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 Buprenorphine include: Drug Withdrawal Syndrome, Drug Ineffective, Emotional Distress, Nausea, Drug Abuse. 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 Buprenorphine 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.
Buprenorphine has a safety concern score of 82 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. Over 13,000 reports of death and over 10,000 reports of overdose highlight severe safety concerns.
Key safety signals identified in Buprenorphine's adverse event data include: Over 13,000 reports of death indicate a high risk of fatal outcomes.. More than 10,000 reports of overdose highlight the potential for misuse and accidental overdose.. Drug dependence and withdrawal syndrome are reported in over 6,000 cases, signaling addiction risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Buprenorphine can cause significant drug interactions, including with other opioids and sedatives, and should be used with caution. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Buprenorphine.
Follow prescribed dosages strictly to avoid overdose and dependency. Monitor for signs of withdrawal and seek medical assistance if symptoms persist or worsen.
Buprenorphine has 185,849 adverse event reports on file with the FDA. Drug dependence and withdrawal syndrome are frequent, indicating potential for addiction and withdrawal issues. The volume of reports for Buprenorphine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor buprenorphine safety, with ongoing restrictions and warnings to mitigate risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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