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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126197391 | 12619739 | 1 | I | 20160726 | 20160803 | 20160803 | EXP | PHHY2016JP103115 | SANDOZ | MIURA M, NANAO K, FUKUSHIMA N, FUKUSHIMA H, NAMERA. A NEONATAL PROLONGED QT SYNDROME DUE TO MATERNAL USE OF ORAL TRICYCLIC ANTIDEPRESSANTS.. EUROPEAN JOURNAL OF PEDIATRICS. 2016;175:1129-32 | 1.00 | DY | M | Y | 3.44000 | KG | 20160803 | OT | JP | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126197391 | 12619739 | 1 | PS | CLOMIPRAMINE | CLOMIPRAMINE | 1 | Transplacental | MATERNAL DOSE: 20 MG TID | 74364 | ||||||||||
| 126197391 | 12619739 | 2 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | MATERNAL DOSE: 2 MG TID | 0 | ||||||||||
| 126197391 | 12619739 | 3 | SS | TANDOSPIRONE CITRATE | TANDOSPIRONE CITRATE | 1 | Transplacental | MATERNAL DOSE: 10 MG TID | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126197391 | 12619739 | 1 | Foetal exposure during pregnancy |
| 126197391 | 12619739 | 2 | Foetal exposure during pregnancy |
| 126197391 | 12619739 | 3 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126197391 | 12619739 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126197391 | 12619739 | Electrocardiogram QT prolonged | |
| 126197391 | 12619739 | Foetal exposure during pregnancy | |
| 126197391 | 12619739 | Torsade de pointes |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |