HIGH-VOLUME · DEATH-HEAVY
buprenorphine Side Effects
buprenorphine (also sold as Subutex, Sublocade) is HIGH-VOLUME in this FAERS book #84 of 524 by FAERS report count. Signature opener: DEATH-HEAVY - 28.7% of FAERS reports list death as an outcome (25,836 of 90,121).
Data updated 2026-05-15
- 90,121
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
buprenorphine: 28.7% of FAERS reports list death as an outcome (25,836 of 90,121). Caseload stamp CASELOAD; volume band HIGH-VOLUME #84 of 524 by FAERS report count.
High-report extract for buprenorphine (Subutex): 90,121 FAERS rows (2004-2025). Top named reactions: DEATH, DRUG DEPENDENCE, OVERDOSE. Outcome stamps DEATH-HEAVY · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
DEATH leads 13,278 of 90,121 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (9,031 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (25,836 reports, 28.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 13,268 |
| TOXICITY TO VARIOUS AGENTS | 8,899 |
| OVERDOSE | 6,404 |
| DRUG ABUSE | 1,762 |
| DRUG DEPENDENCE | 1,610 |
| ACCIDENTAL OVERDOSE | 791 |
| ARTHRALGIA | 772 |
| ASTHENIA | 759 |
| DIZZINESS | 708 |
| PAIN | 694 |
| ABDOMINAL PAIN UPPER | 686 |
| FATIGUE | 682 |
| CONFUSIONAL STATE | 679 |
| VOMITING | 668 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 660 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 640 |
| PEMPHIGUS | 635 |
| PSORIATIC ARTHROPATHY | 631 |
| TYPE 2 DIABETES MELLITUS | 628 |
Reactions in Hospitalization Reports
Hospitalization mid-share (10,461, 11.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 1,763 |
| DRUG ABUSE | 1,069 |
| PAIN | 978 |
| CONFUSIONAL STATE | 907 |
| OVERDOSE | 861 |
| DRUG DEPENDENCE | 833 |
| NAUSEA | 825 |
| VOMITING | 824 |
| FATIGUE | 769 |
| CONDITION AGGRAVATED | 738 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 721 |
| DYSPNOEA | 700 |
| ASTHENIA | 689 |
| FALL | 674 |
| DIZZINESS | 671 |
| HEADACHE | 659 |
| ARTHRALGIA | 649 |
| MATERNAL EXPOSURE DURING PREGNANCY | 640 |
How to read buprenorphine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 90,121 voluntary reports linked to buprenorphine (Subutex, Sublocade), 2004-2025. Death is listed on 25,836 (28.7%). Hospitalization appears on 10,461 (11.6%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; DEATH-HEAVY is the page opener, not a per-patient risk.
Read with buprenorphine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 90,083 FAERS cases (Δ 38 lighter vs buprenorphine); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 90,652 FAERS cases (Δ 531 heavier vs buprenorphine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 89,398 FAERS cases (Δ 723 lighter vs buprenorphine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 91,655 FAERS cases (Δ 1,534 heavier vs buprenorphine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 33.4 pp vs buprenorphine's DEATH-HEAVY): CASELOAD · HOSP-MID.
buprenorphine stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.