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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978423 | 12497842 | 3 | F | 20160706 | 20160625 | 20160714 | EXP | GB-APOTEX-2016AP009324 | APOTEX | 45.00 | YR | M | Y | 0.00000 | 20160714 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978423 | 12497842 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | |||||
| 124978423 | 12497842 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | |||||
| 124978423 | 12497842 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124978423 | 12497842 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, UNKNOWN | U | U | 0 | 30 | MG | TABLET | |||||
| 124978423 | 12497842 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, QD | U | U | 0 | 30 | MG | TABLET | QD | ||||
| 124978423 | 12497842 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, UNKNOWN | U | U | 0 | 30 | MG | TABLET | |||||
| 124978423 | 12497842 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, QD | U | U | 0 | 30 | MG | TABLET | |||||
| 124978423 | 12497842 | 8 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978423 | 12497842 | 9 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | ||||||
| 124978423 | 12497842 | 10 | C | LOFEPRAMINE | LOFEPRAMINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978423 | 12497842 | 11 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | 10 MG, Q.H.S. | U | U | 0 | 10 | MG | QD | |||||
| 124978423 | 12497842 | 12 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 2 MG, BID | U | U | 0 | 2 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978423 | 12497842 | 1 | Product used for unknown indication |
| 124978423 | 12497842 | 3 | Product used for unknown indication |
| 124978423 | 12497842 | 8 | Depression |
| 124978423 | 12497842 | 10 | Depression |
| 124978423 | 12497842 | 11 | Product used for unknown indication |
| 124978423 | 12497842 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978423 | 12497842 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978423 | 12497842 | Aggression | |
| 124978423 | 12497842 | Disturbance in attention | |
| 124978423 | 12497842 | Drug withdrawal syndrome | |
| 124978423 | 12497842 | Fatigue | |
| 124978423 | 12497842 | Insomnia | |
| 124978423 | 12497842 | Mood swings | |
| 124978423 | 12497842 | Pain | |
| 124978423 | 12497842 | Paraesthesia | |
| 124978423 | 12497842 | Sleep disorder | |
| 124978423 | 12497842 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 124978423 | 12497842 | 1 | 20010712 | 0 | ||
| 124978423 | 12497842 | 2 | 20010820 | 20081013 | 0 | |
| 124978423 | 12497842 | 3 | 20010712 | 0 | ||
| 124978423 | 12497842 | 4 | 20061024 | 0 | ||
| 124978423 | 12497842 | 5 | 20070723 | 20110114 | 0 | |
| 124978423 | 12497842 | 6 | 20160404 | 0 | ||
| 124978423 | 12497842 | 8 | 19911111 | 0 | ||
| 124978423 | 12497842 | 9 | 199802 | 0 | ||
| 124978423 | 12497842 | 10 | 1991 | 0 | ||
| 124978423 | 12497842 | 12 | 200108 | 0 |