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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125016192 | 12501619 | 2 | F | 20030401 | 20160628 | 20160627 | 20160711 | EXP | GB-APOTEX-2016AP009459 | APOTEX | 30.00 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125016192 | 12501619 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 125016192 | 12501619 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, QD | U | U | 20031 | 30 | MG | TABLET | |||||
| 125016192 | 12501619 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 125016192 | 12501619 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 10 MG, UNK | U | U | 20031 | 10 | MG | TABLET | |||||
| 125016192 | 12501619 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 15 MG, QD | U | U | 20031 | 15 | MG | TABLET | |||||
| 125016192 | 12501619 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 125016192 | 12501619 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | U | 0 | TABLET | |||||||||
| 125016192 | 12501619 | 8 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | U | 0 | 20 | MG | ||||||
| 125016192 | 12501619 | 9 | C | MIANSERIN | MIANSERIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125016192 | 12501619 | 10 | C | DOTHIEPIN | DOTHIEPINDOTHIEPIN HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125016192 | 12501619 | 11 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125016192 | 12501619 | 12 | C | CIPRAMIL /00582602/ | CITALOPRAM HYDROBROMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125016192 | 12501619 | 13 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 37.5 MG, UNK | U | U | 0 | 37.5 | MG | ||||||
| 125016192 | 12501619 | 14 | C | PYRIDOXINE | PYRIDOXINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125016192 | 12501619 | 15 | C | NICOTINE. | NICOTINE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125016192 | 12501619 | 1 | Panic attack |
| 125016192 | 12501619 | 6 | Anxiety |
| 125016192 | 12501619 | 7 | Depression |
| 125016192 | 12501619 | 8 | Product used for unknown indication |
| 125016192 | 12501619 | 9 | Product used for unknown indication |
| 125016192 | 12501619 | 10 | Product used for unknown indication |
| 125016192 | 12501619 | 11 | Product used for unknown indication |
| 125016192 | 12501619 | 12 | Product used for unknown indication |
| 125016192 | 12501619 | 13 | Poor quality sleep |
| 125016192 | 12501619 | 14 | Premenstrual syndrome |
| 125016192 | 12501619 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125016192 | 12501619 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125016192 | 12501619 | Adverse drug reaction | |
| 125016192 | 12501619 | Anger | |
| 125016192 | 12501619 | Depression | |
| 125016192 | 12501619 | Drug withdrawal syndrome | |
| 125016192 | 12501619 | Hyperhidrosis | |
| 125016192 | 12501619 | Intentional self-injury | |
| 125016192 | 12501619 | Malaise | |
| 125016192 | 12501619 | Mood swings | |
| 125016192 | 12501619 | Panic attack | |
| 125016192 | 12501619 | Paraesthesia | |
| 125016192 | 12501619 | Poor quality sleep | |
| 125016192 | 12501619 | Suicidal ideation | |
| 125016192 | 12501619 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125016192 | 12501619 | 1 | 1998 | 20150405 | 0 | |
| 125016192 | 12501619 | 2 | 20040112 | 20050602 | 0 | |
| 125016192 | 12501619 | 3 | 20140827 | 20150505 | 0 | |
| 125016192 | 12501619 | 4 | 20150203 | 20150420 | 0 | |
| 125016192 | 12501619 | 5 | 20150421 | 0 | ||
| 125016192 | 12501619 | 6 | 20100915 | 20150420 | 0 | |
| 125016192 | 12501619 | 8 | 19920206 | 20060421 | 0 | |
| 125016192 | 12501619 | 12 | 20060120 | 2007 | 0 | |
| 125016192 | 12501619 | 13 | 20050826 | 0 | ||
| 125016192 | 12501619 | 14 | 20060120 | 0 | ||
| 125016192 | 12501619 | 15 | 200802 | 0 |