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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 99813602 | 9981360 | 2 | F | 20130728 | 20160915 | 20140307 | 20160927 | EXP | GB-TEVA-466525ISR | TEVA | 1.00 | HR | M | Y | 3.99000 | KG | 20160927 | CN | DE | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 99813602 | 9981360 | 1 | PS | QUETIAPINE. | QUETIAPINE | 1 | Transplacental | 200 MILLIGRAM DAILY; EACH EVENING | Y | U | 77745 | 200 | MG | QD | |||||
| 99813602 | 9981360 | 2 | SS | ZOPICLONE | ZOPICLONE | 1 | Transplacental | 7.5 MILLIGRAM DAILY; | U | U | 0 | 7.5 | MG | QD | |||||
| 99813602 | 9981360 | 3 | SS | DULOXETINE HYDROCHLORIDE. | DULOXETINE HYDROCHLORIDE | 1 | Transplacental | 60 MG, QD | Y | U | 0 | 60 | MG | QD | |||||
| 99813602 | 9981360 | 4 | SS | ZYPREXA | OLANZAPINE | 1 | Transplacental | 10 MG, EACH EVENING | U | U | 0 | 10 | MG | TABLET | QD | ||||
| 99813602 | 9981360 | 5 | SS | ZYPREXA | OLANZAPINE | 1 | Transplacental | 15 MG, EACH MORNING | U | U | 0 | 15 | MG | TABLET | QD | ||||
| 99813602 | 9981360 | 6 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Transplacental | Y | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 99813602 | 9981360 | 1 | Product used for unknown indication |
| 99813602 | 9981360 | 2 | Product used for unknown indication |
| 99813602 | 9981360 | 3 | Product used for unknown indication |
| 99813602 | 9981360 | 4 | Schizoaffective disorder |
| 99813602 | 9981360 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 99813602 | 9981360 | OT |
| 99813602 | 9981360 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 99813602 | 9981360 | Cleft palate | |
| 99813602 | 9981360 | Exposure during breast feeding | |
| 99813602 | 9981360 | Foetal exposure during pregnancy | |
| 99813602 | 9981360 | High arched palate | |
| 99813602 | 9981360 | Selective eating disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 99813602 | 9981360 | 4 | 20130425 | 0 | ||
| 99813602 | 9981360 | 5 | 20130531 | 0 | ||
| 99813602 | 9981360 | 6 | 20121120 | 20130103 | 0 |