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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124502242 | 12450224 | 2 | F | 20160628 | 20160609 | 20160712 | EXP | US-AUROBINDO-AUR-APL-2016-07674 | AUROBINDO | 39.00 | YR | F | Y | 0.00000 | 20160712 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124502242 | 12450224 | 1 | PS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | UNK | U | 90871 | |||||||||
| 124502242 | 12450224 | 2 | I | Sertraline 50mg | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 124502242 | 12450224 | 3 | I | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 150 MG, UNK | U | 0 | 150 | MG | |||||||
| 124502242 | 12450224 | 4 | I | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | 10 MG, AT NIGHT | U | 0 | 10 | MG | |||||||
| 124502242 | 12450224 | 5 | SS | ALCOHOL. | ALCOHOL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124502242 | 12450224 | 1 | Phobia of flying |
| 124502242 | 12450224 | 2 | Product used for unknown indication |
| 124502242 | 12450224 | 3 | Product used for unknown indication |
| 124502242 | 12450224 | 4 | Insomnia |
| 124502242 | 12450224 | 5 | Phobia of flying |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124502242 | 12450224 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124502242 | 12450224 | Aggression | |
| 124502242 | 12450224 | Agitation | |
| 124502242 | 12450224 | Akathisia | |
| 124502242 | 12450224 | Delirium | |
| 124502242 | 12450224 | Depressed mood | |
| 124502242 | 12450224 | Drug interaction | |
| 124502242 | 12450224 | Euphoric mood | |
| 124502242 | 12450224 | Feeling abnormal | |
| 124502242 | 12450224 | Homicide | |
| 124502242 | 12450224 | Intentional overdose | |
| 124502242 | 12450224 | Restlessness | |
| 124502242 | 12450224 | Suicidal ideation | |
| 124502242 | 12450224 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |