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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125008912 | 12500891 | 2 | F | 20160706 | 20160627 | 20160719 | EXP | TR-JUBILANT CADISTA PHARMACEUTICALS-2016JUB00225 | JUBILANT | SATAR M, ORTAKOYLU K, BATUN I, ET AL. WITHDRAWAL SYNDROME AND HYPOMAGNESAEMIA AND IN A NEWBORN EXPOSED TO VALPROIC ACID AND CARBAMAZEPINE DURING PREGNANCY.. TURK PEDIATR ARS.. 2016;51(2):114-6 | 0.00 | C | Y | 0.00000 | 20160719 | OT | TR | TR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125008912 | 12500891 | 1 | PS | TEGRETOL | CARBAMAZEPINE | 1 | Transplacental | 0 | |||||||||||
| 125008912 | 12500891 | 2 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125008912 | 12500891 | 1 | Epilepsy |
| 125008912 | 12500891 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125008912 | 12500891 | OT |
| 125008912 | 12500891 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125008912 | 12500891 | Atrial septal defect | |
| 125008912 | 12500891 | Foetal exposure during pregnancy | |
| 125008912 | 12500891 | Hypomagnesaemia | |
| 125008912 | 12500891 | Hyponatraemia | |
| 125008912 | 12500891 | Poor feeding infant | |
| 125008912 | 12500891 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |