HIGH-VOLUME · DEATH-HEAVY
methadone Side Effects
methadone (also sold as Dolophine) is HIGH-VOLUME in this FAERS book #158 of 524 by FAERS report count. Signature opener: DEATH-HEAVY - 32.2% of FAERS reports list death as an outcome (13,420 of 41,632).
Data updated 2026-05-15
- 41,632
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
methadone: 32.2% of FAERS reports list death as an outcome (13,420 of 41,632). Caseload stamp CASELOAD; volume band HIGH-VOLUME #158 of 524 by FAERS report count.
High-report extract for methadone (Dolophine): 41,632 FAERS rows (2003-2025). Top named reactions: DRUG DEPENDENCE, TOXICITY TO VARIOUS AGENTS, DRUG ABUSE. Outcome stamps DEATH-HEAVY · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
DRUG DEPENDENCE leads 5,614 of 41,632 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (11,902 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (13,420 reports, 32.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 4,075 |
| DEATH | 3,515 |
| DRUG ABUSE | 3,155 |
| OVERDOSE | 1,357 |
| COMPLETED SUICIDE | 1,077 |
| CARDIAC ARREST | 852 |
| RESPIRATORY ARREST | 712 |
| CARDIO-RESPIRATORY ARREST | 697 |
| DRUG DEPENDENCE | 664 |
| DRUG INTERACTION | 439 |
| POISONING | 409 |
| PULMONARY OEDEMA | 386 |
| RESPIRATORY DEPRESSION | 372 |
| ACCIDENTAL OVERDOSE | 341 |
| INTENTIONAL PRODUCT MISUSE | 283 |
| PNEUMONIA | 276 |
| ASPHYXIA | 259 |
| SOMNOLENCE | 240 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 236 |
| BRAIN OEDEMA | 223 |
Reactions in Hospitalization Reports
Hospitalization mid-share (11,019, 26.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 1,131 |
| DRUG ABUSE | 1,044 |
| OVERDOSE | 746 |
| DRUG DEPENDENCE | 693 |
| DRUG INTERACTION | 671 |
| PAIN | 633 |
| VOMITING | 587 |
| COMA | 570 |
| NAUSEA | 569 |
| PNEUMONIA | 548 |
| SOMNOLENCE | 489 |
| DRUG WITHDRAWAL SYNDROME | 479 |
| FATIGUE | 463 |
| DYSPNOEA | 457 |
| RESPIRATORY DEPRESSION | 446 |
| CONFUSIONAL STATE | 392 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 390 |
| FALL | 386 |
How to read methadone FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 41,632 voluntary reports linked to methadone (Dolophine), 2003-2025. Death is listed on 13,420 (32.2%). Hospitalization appears on 11,019 (26.5%). 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 methadone
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 41,778 FAERS cases (Δ 146 heavier vs methadone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 40,954 FAERS cases (Δ 678 lighter vs methadone); DEATH-MARKED · HOSP-MID · MALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 40,790 FAERS cases (Δ 842 lighter vs methadone); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 42,504 FAERS cases (Δ 872 heavier vs methadone); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 0.0% death-mentioned reports (Δ 32.2 pp vs methadone's DEATH-HEAVY): MEGA-CASE · HOSP-LIGHT.
methadone stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.