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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127916961 | 12791696 | 1 | I | 20041231 | 20160919 | 20160929 | 20160929 | EXP | US-APOTEX-2016AP012542 | APOTEX | 0.00 | DY | M | Y | 4.00000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127916961 | 12791696 | 1 | PS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 37.5 MG, UNK | D | 20031 | 37.5 | MG | TABLET | ||||||
| 127916961 | 12791696 | 2 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG, UNK | D | 20031 | 25 | MG | TABLET | ||||||
| 127916961 | 12791696 | 3 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 12.5MG, UNK | D | 20031 | 12.5 | MG | TABLET | ||||||
| 127916961 | 12791696 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 40 MG, UNK | D | 20031 | 40 | MG | TABLET | ||||||
| 127916961 | 12791696 | 5 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 40 MG, UNK | D | 0 | 40 | MG | TABLET | ||||||
| 127916961 | 12791696 | 6 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 10MG, UNK | D | 0 | 10 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127916961 | 12791696 | 1 | Product used for unknown indication |
| 127916961 | 12791696 | 4 | Product used for unknown indication |
| 127916961 | 12791696 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127916961 | 12791696 | OT |
| 127916961 | 12791696 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127916961 | 12791696 | Cardiac murmur | |
| 127916961 | 12791696 | Congenital anomaly | |
| 127916961 | 12791696 | Foetal exposure during pregnancy | |
| 127916961 | 12791696 | Respiratory distress | |
| 127916961 | 12791696 | Tachypnoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |