Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5154068 | 6170768 | I | 5154068-8 | 20060615 | 20061109 | 20061120 | EXP | FR-RB-004331-06 | RECKITTBENCKISER | M | Y | 3.93 | KG | 20061120 | OT | FRANCE |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5154068 | 1007866520 | PS | SUBUTEX | 1 | TRANSPLACENTAL | 020732 | |||||
| 5154068 | 1007866521 | C | EFFERALGAN CODEINE | 2 | DOSAGE UNKNOWN. MOTHER TOOK FOR TWO DAYS BEFORE BIRTH. | ||||||
| 5154068 | 1007866522 | C | IMOVANE | 2 | TRANSPLACENTAL | DOSAGE UNKNOWN | |||||
| 5154068 | 1007866523 | SS | XANAX | 1 | TRANSPLACENTAL | INTERMITTENTLY 4-5 MG QD |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5154068 | 1007866520 | ELECTROLYTE SUBSTITUTION THERAPY |
| 5154068 | 1007866522 | DRUG USE FOR UNKNOWN INDICATION |
| 5154068 | 1007866523 | DRUG USE FOR UNKNOWN INDICATION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5154068 | CA |
| 5154068 | DS |
| 5154068 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5154068 | CLEFT PALATE |
| 5154068 | CONGENITAL HEARING DISORDER |
| 5154068 | CONGENITAL JAW MALFORMATION |
| 5154068 | DRUG WITHDRAWAL SYNDROME NEONATAL |
| 5154068 | MICROGNATHIA |
| 5154068 | NEONATAL RESPIRATORY DISTRESS SYNDROME |
| 5154068 | PARESIS |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5154068 | 1007866520 | 20050921 | 20060615 | ||
| 5154068 | 1007866523 | 20050921 | 20060615 |