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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126496411 | 12649641 | 1 | I | 2001 | 20160727 | 20160812 | 20160812 | EXP | PHHY2016FR106298 | SANDOZ | 70.00 | YR | M | Y | 0.00000 | 20160812 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126496411 | 12649641 | 1 | PS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | 0.25 MG, BID | 74112 | .25 | MG | BID | |||||||
| 126496411 | 12649641 | 2 | SS | OXAZEPAM. | OXAZEPAM | 1 | Unknown | 50 MG, UNK | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126496411 | 12649641 | 1 | Product used for unknown indication |
| 126496411 | 12649641 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126496411 | 12649641 | HO |
| 126496411 | 12649641 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126496411 | 12649641 | Agitation | |
| 126496411 | 12649641 | Confusional state | |
| 126496411 | 12649641 | Insomnia | |
| 126496411 | 12649641 | Respiratory distress | |
| 126496411 | 12649641 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |