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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88040123 | 8804012 | 3 | F | 20160715 | 20120924 | 20160720 | EXP | US-GLAXOSMITHKLINE-A0994258A | GLAXOSMITHKLINE | 0.00 | F | Y | 0.00000 | 20160720 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88040123 | 8804012 | 1 | PS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 37.5 MG, U | 20936 | 37.5 | MG | MODIFIED-RELEASE TABLET | |||||||
| 88040123 | 8804012 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG, QD | U | 0 | 25 | MG | QD | ||||||
| 88040123 | 8804012 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 37.5 UNK, | U | 0 | 37.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88040123 | 8804012 | 1 | Depression |
| 88040123 | 8804012 | 2 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88040123 | 8804012 | OT |
| 88040123 | 8804012 | HO |
| 88040123 | 8804012 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88040123 | 8804012 | Cardiac failure congestive | |
| 88040123 | 8804012 | Cardiac murmur | |
| 88040123 | 8804012 | Developmental delay | |
| 88040123 | 8804012 | Foetal exposure during pregnancy | |
| 88040123 | 8804012 | Heart disease congenital | |
| 88040123 | 8804012 | Left ventricular hypertrophy | |
| 88040123 | 8804012 | Pectus excavatum | |
| 88040123 | 8804012 | 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 |
|---|---|---|---|---|---|---|
| 88040123 | 8804012 | 3 | 20020905 | 20031004 | 0 |