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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127912472 | 12791247 | 2 | F | 20040316 | 20160922 | 20160929 | 20160929 | EXP | US-APOTEX-2016AP012546 | APOTEX | 0.00 | DY | F | Y | 3.00000 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127912472 | 12791247 | 1 | PS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | UNK, 1D | D | 20031 | TABLET | ||||||||
127912472 | 12791247 | 2 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 37.5 MG, QD | D | 20031 | 37.5 | MG | TABLET | ||||||
127912472 | 12791247 | 3 | SS | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 25 MG, QD | D | 20031 | 25 | MG | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127912472 | 12791247 | 1 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127912472 | 12791247 | OT |
127912472 | 12791247 | CA |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127912472 | 12791247 | Congenital anomaly | |
127912472 | 12791247 | Foetal exposure during pregnancy | |
127912472 | 12791247 | Respiratory distress | |
127912472 | 12791247 | Tachypnoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |