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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124029202 | 12402920 | 2 | F | 20160920 | 20160525 | 20160927 | EXP | PHHY2016TR069538 | SANDOZ | SATAR M, ORTAKOYLU K, BATUN I, YILDIZDAS HY, OZLU F, DEMIR H ET AL.. WITHDRAWAL SYNDROME AND HYPOMAGNESAEMIA AND IN A NEWBORN EXPOSED TO VALPROIC ACID AND CARBAMAZEPINE DURING PREGNANCY. TURKISH ARCHIVES OF PEDIATRICS. 2016;51:114-6 | 39.00 | WK | M | Y | 4.00000 | KG | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124029202 | 12402920 | 1 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Transplacental | 2 X 400MG (MATERNAL DOSE) | D | 0 | TABLET | ||||||||
| 124029202 | 12402920 | 2 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Transplacental | UNK | D | 0 | |||||||||
| 124029202 | 12402920 | 3 | PS | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | Transplacental | UNK | D | 78290 | |||||||||
| 124029202 | 12402920 | 4 | SS | CONVULEX//VALPROIC ACID | VALPROIC ACID | 1 | Transplacental | 500 MG IN THE MORNINGS AND 750 MG IN THE EVENINGS THROUGHOUT HER GESTATION (MATERNAL DOSE) | D | 0 | |||||||||
| 124029202 | 12402920 | 5 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | 50 MG/KG, UNK | U | 0 | 50 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124029202 | 12402920 | 1 | Foetal exposure during pregnancy |
| 124029202 | 12402920 | 2 | Foetal exposure during pregnancy |
| 124029202 | 12402920 | 3 | Foetal exposure during pregnancy |
| 124029202 | 12402920 | 4 | Foetal exposure during pregnancy |
| 124029202 | 12402920 | 5 | Blood magnesium decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124029202 | 12402920 | OT |
| 124029202 | 12402920 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124029202 | 12402920 | Atrial septal defect | |
| 124029202 | 12402920 | Feeding disorder | |
| 124029202 | 12402920 | Foetal exposure during pregnancy | |
| 124029202 | 12402920 | Hypomagnesaemia | |
| 124029202 | 12402920 | Hyponatraemia | |
| 124029202 | 12402920 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |