methadone Side Effects
Also known as: Dolophine
Analysis of 41,632 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
41,632
Death-Related
13,420
32.2% of reports
Hospitalizations
11,019
26.5% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 13,420 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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
Top reactions in 11,019 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 1,131 |
| DRUG ABUSE | 1,044 |
| OVERDOSE | 746 |
| DRUG DEPENDENCE | 693 |
| DRUG INTERACTION | 671 |
| PAIN | 633 |
| DRUG INEFFECTIVE | 611 |
| VOMITING | 587 |
| COMA | 570 |
| NAUSEA | 569 |
| OFF LABEL USE | 551 |
| 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 |
Nearby — Related Medications
What the FAERS Data Reveals About methadone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 41,632 voluntary reports linked to methadone and its brand equivalents (Dolophine), spanning 2003 through 2025. Of those, 13,420 (32.2%) listed death as an outcome and 11,019 (26.5%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 44% were female and 55% male; age distribution skews toward 18-44, with 11,902 reports in that bracket. The single most reported reaction is drug dependence with 5,614 submissions, followed by toxicity to various agents and drug abuse.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.