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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125488334 | 12548833 | 4 | F | 20160518 | 20160815 | 20160712 | 20160829 | EXP | JP-APOTEX-2016AP009755 | APOTEX | 40.00 | YR | F | Y | 0.00000 | 20160829 | CN | GB | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125488334 | 12548833 | 1 | PS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Oral | 12.5 MG, UNK | 20031 | 12.5 | MG | TABLET | |||||||
| 125488334 | 12548833 | 2 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK | 20031 | 50 | MG | TABLET | |||||||
| 125488334 | 12548833 | 3 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Oral | 12.5 MG, UNK | 20031 | 12.5 | MG | TABLET | |||||||
| 125488334 | 12548833 | 4 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK | 20031 | 50 | MG | TABLET | |||||||
| 125488334 | 12548833 | 5 | C | XEPLION | PALIPERIDONE PALMITATE | 1 | Unknown | 150 MG, UNK | U | U | 0 | 150 | MG | ||||||
| 125488334 | 12548833 | 6 | C | XEPLION | PALIPERIDONE PALMITATE | 1 | Unknown | 50 MG, UNK | U | U | 0 | 50 | MG | ||||||
| 125488334 | 12548833 | 7 | C | XEPLION | PALIPERIDONE PALMITATE | 1 | Unknown | 75 MG, UNK | U | U | 0 | 75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125488334 | 12548833 | 1 | Anxiety |
| 125488334 | 12548833 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125488334 | 12548833 | OT |
| 125488334 | 12548833 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125488334 | 12548833 | Anxiety | |
| 125488334 | 12548833 | Completed suicide | |
| 125488334 | 12548833 | Off label use | |
| 125488334 | 12548833 | Suicidal ideation | |
| 125488334 | 12548833 | Suicide attempt |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125488334 | 12548833 | 2 | 20151017 | 0 | ||
| 125488334 | 12548833 | 5 | 20131228 | 0 |