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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106937007 | 10693700 | 7 | F | 20040107 | 20160810 | 20150106 | 20160819 | EXP | US-APOTEX-2014AP006480 | APOTEX | 0.00 | DY | M | Y | 0.00000 | 20160819 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106937007 | 10693700 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 30 MG, QD | 20936 | 30 | MG | TABLET | |||||||
| 106937007 | 10693700 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG, QD | 20936 | 25 | MG | TABLET | |||||||
| 106937007 | 10693700 | 3 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 12.5 MG, QD | 46ZP06 | 20936 | 12.5 | MG | TABLET | ||||||
| 106937007 | 10693700 | 4 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG AND 37.5 MG INTERMITTENTLY | 1462P07 | 20936 | TABLET | ||||||||
| 106937007 | 10693700 | 5 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | 20936 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106937007 | 10693700 | 1 | Anxiety |
| 106937007 | 10693700 | 3 | Anxiety |
| 106937007 | 10693700 | 4 | Panic attack |
| 106937007 | 10693700 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106937007 | 10693700 | OT |
| 106937007 | 10693700 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106937007 | 10693700 | Developmental delay | |
| 106937007 | 10693700 | Foetal exposure during pregnancy | |
| 106937007 | 10693700 | Knee deformity | |
| 106937007 | 10693700 | Strabismus | |
| 106937007 | 10693700 | Talipes |
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 |
|---|---|---|---|---|---|---|
| 106937007 | 10693700 | 1 | 2004 | 0 | ||
| 106937007 | 10693700 | 3 | 2003 | 2004 | 0 | |
| 106937007 | 10693700 | 4 | 2003 | 2004 | 0 |