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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107212659 | 10721265 | 9 | F | 2004 | 20160909 | 20150119 | 20160921 | EXP | US-APOTEX-2015AP005219 | APOTEX | 0.00 | YR | F | Y | 3.04000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107212659 | 10721265 | 1 | PS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 37.5 MG, QD | 27687 | MG | D | 20031 | 37.5 | MG | TABLET | ||||
| 107212659 | 10721265 | 2 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG, QD | 27687 | MG | D | 20031 | 25 | MG | TABLET | ||||
| 107212659 | 10721265 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 37.5 MG, DAILY | D | 20031 | 37.5 | MG | TABLET | ||||||
| 107212659 | 10721265 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG, DAILY | D | 20031 | 25 | MG | TABLET | ||||||
| 107212659 | 10721265 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | D | 20031 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107212659 | 10721265 | 1 | Depression |
| 107212659 | 10721265 | 3 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107212659 | 10721265 | OT |
| 107212659 | 10721265 | HO |
| 107212659 | 10721265 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107212659 | 10721265 | Cardiac failure congestive | |
| 107212659 | 10721265 | Cardiac murmur | |
| 107212659 | 10721265 | Cardiomegaly | |
| 107212659 | 10721265 | Developmental delay | |
| 107212659 | 10721265 | Foetal exposure during pregnancy | |
| 107212659 | 10721265 | Headache | |
| 107212659 | 10721265 | Heart disease congenital | |
| 107212659 | 10721265 | Mitral valve incompetence | |
| 107212659 | 10721265 | Pectus excavatum | |
| 107212659 | 10721265 | Ventricular hypertrophy | |
| 107212659 | 10721265 | Ventricular septal defect |
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 |
|---|---|---|---|---|---|---|
| 107212659 | 10721265 | 1 | 20030311 | 20030904 | 0 | |
| 107212659 | 10721265 | 2 | 20020618 | 20020804 | 0 | |
| 107212659 | 10721265 | 3 | 2003 | 20031004 | 0 |