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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127548581 | 12754858 | 1 | I | 20160811 | 20160907 | 20160916 | 20160916 | EXP | DE-MYLANLABS-2016M1039174 | MYLAN | 0.00 | Y | 0.00000 | 20160916 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127548581 | 12754858 | 1 | SS | DULOXETINE. | DULOXETINE | 1 | Transplacental | 30 MG, QD (30 [MG/D ]) | D | 0 | 30 | MG | QD | ||||||
| 127548581 | 12754858 | 2 | PS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | UNK (3 [MG/D (-2) ]) | D | 76288 | |||||||||
| 127548581 | 12754858 | 3 | SS | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Transplacental | UNK | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127548581 | 12754858 | 1 | Bipolar disorder |
| 127548581 | 12754858 | 2 | Bipolar disorder |
| 127548581 | 12754858 | 3 | Extrapyramidal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127548581 | 12754858 | OT |
| 127548581 | 12754858 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127548581 | 12754858 | Foetal exposure during pregnancy | |
| 127548581 | 12754858 | Gastroschisis | |
| 127548581 | 12754858 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |