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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125213611 | 12521361 | 1 | I | 20160523 | 20160701 | 20160701 | EXP | JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-118827 | RANBAXY | 0.00 | C | Y | 0.00000 | 20160701 | OT | GB | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125213611 | 12521361 | 1 | SS | PHENOBARBITAL. | PHENOBARBITAL | 1 | Transplacental | 0 | 80 | MG | |||||||||
| 125213611 | 12521361 | 2 | PS | VALPROIC ACID. | VALPROIC ACID | 1 | Transplacental | 800 MG, DAILY | 91037 | 800 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125213611 | 12521361 | 1 | Product used for unknown indication |
| 125213611 | 12521361 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125213611 | 12521361 | OT |
| 125213611 | 12521361 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125213611 | 12521361 | Foetal exposure during pregnancy | |
| 125213611 | 12521361 | Heart disease congenital |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |