Table 2.
Analysis of fatal promethazine abuse/misuse/dependence/withdrawal cases recorded by EudraVigilance (EV), 2003–2019.
| Fatal cases on abuse/misuse/dependence/withdrawal reactions | 310 (310/557 = 55.6%) |
|---|---|
| Age-range | |
| Adult | 303 (97.7%) |
| Adolescent | 7 (2.3%) |
| Elderly (>65 years) | – |
| Neonatal | – |
| Infant | – |
| Child | – |
| Gender | M 103 (33.2%) |
| F 177 (57.1%) | |
| Unknown 30 (9.7%) | |
| Most recorded PTs | |
| Drug abuse/drug abuser/substance abuse | 228/3/6 |
| Intentional product misuse/Intentional product use issue | 77/3 |
| Drug dependence | 1 |
| Reported death code | |
| Intentional overdose | 1 |
| Overdose | 4 |
| Completed suicide/suicide | 7 |
| Drug toxicity/drug abuse | 197 |
| Toxicity to various agents | 48 |
| Intentional product misuse | 41 |
| Respiratory depression | 5 |
| Pneumonia | 1 |
| Cardiac arrest | 10 |
| Drug dependence | 1 |
| Most reported concomitant drugs | |
| Opioids | 356 |
| Methadone | 103 |
| Dihydrocodeine | 1 |
| Codeine | 32 |
| Fentanyl | 44 |
| Oxycodone | 63 |
| Morphine | 55 |
| Hydrocodone | 33 |
| Hydromorphone | 3 |
| Tramadol | 22 |
| Antidepressants | 221 |
| Duloxetine | 1 |
| Escitalopram | 1 |
| Sertraline | 16 |
| Paroxetine | 34 |
| Trazodone | 15 |
| Mirtazapine | 33 |
| Fluoxetine | 24 |
| Venlafaxine | 9 |
| Bupropion | 1 |
| Amitriptyline | 35 |
| Nortriptyline | 6 |
| Clomipramine | 5 |
| Citalopram | 41 |
| Benzodiazepines | 141 |
| Lorazepam | 3 |
| Temazepam | 6 |
| Clonazepam | 21 |
| Diazepam | 60 |
| Flunitrazepam | 1 |
| Brotizolam | 1 |
| Alprazolam | 42 |
| Midazolam | 4 |
| Oxazepam | 3 |
| Mood stabilisers | 11 |
| Gabapentin | 3 |
| Topiramate | 8 |
| Antipsychotics | 24 |
| Olanzapine | 1 |
| Quetiapine | 20 |
| Haloperidol | 1 |
| Amisulpride | 1 |
| Levomepromazine | 1 |
| Z-drugs | 39 |
| Zolpidem | 37 |
| Zopiclone | 2 |
| Illicit drugs | |
| Amphetamine | 15 |
| Cocaine | 40 |
| Heroin | 52 |
| Alcohol | 26 |
PTs: preferred terms.