Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125917711 | 12591771 | 1 | I | 20160712 | 20160726 | 20160726 | EXP | AU-LUPIN PHARMACEUTICALS INC.-2016-03260 | LUPIN | POLASEK T, PERERA V, LUCIRE Y. SERIOUS ADVERSE DRUG REACTIONS TO ZOLPIDEM: DOES IMPAIRED METABOLIC CLEARANCE AND CONCURRENT SSRI/SNRI USE INCREASE RISK?. JOURNAL OF PHARMACY PRACTICE AND RESEARCH. 2016;46:139-142. | 46.00 | YR | M | Y | 0.00000 | 20160726 | MD | AU | AU |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125917711 | 12591771 | 1 | PS | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | UNKNOWN | 78970 | ||||||||||
| 125917711 | 12591771 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNKNOWN | 77670 | ||||||||||
| 125917711 | 12591771 | 3 | SS | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | UNKNOWN | 204299 | ||||||||||
| 125917711 | 12591771 | 4 | C | Esomeprazole | ESOMEPRAZOLE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125917711 | 12591771 | 1 | Insomnia |
| 125917711 | 12591771 | 2 | Product used for unknown indication |
| 125917711 | 12591771 | 3 | Insomnia |
| 125917711 | 12591771 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125917711 | 12591771 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125917711 | 12591771 | Akathisia | |
| 125917711 | 12591771 | Amnesia | |
| 125917711 | 12591771 | Drug interaction | |
| 125917711 | 12591771 | Fear | |
| 125917711 | 12591771 | Homicidal ideation | |
| 125917711 | 12591771 | Insomnia | |
| 125917711 | 12591771 | Paranoia | |
| 125917711 | 12591771 | Suicidal ideation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |