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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127786971 | 12778697 | 1 | I | 20130728 | 20160915 | 20160926 | 20160926 | EXP | GB-CIPLA LTD.-2016GB18656 | CIPLA | 0.00 | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127786971 | 12778697 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Transplacental | 10 MG, QD EACH EVENING | U | U | 203333 | 10 | MG | QD | |||||
| 127786971 | 12778697 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Transplacental | 15 MG, QD EACH MORNING | U | U | 203333 | 15 | MG | QD | |||||
| 127786971 | 12778697 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Transplacental | 10 MG, UNK | Y | U | 0 | 10 | MG | ||||||
| 127786971 | 12778697 | 4 | SS | QUETIAPINE. | QUETIAPINE | 1 | Transplacental | 200 MG, QD EACH EVENING | Y | U | 0 | 200 | MG | QD | |||||
| 127786971 | 12778697 | 5 | SS | Zopiclone | ZOPICLONE | 1 | Transplacental | 7.5 MG, QD, EACH EVENING | U | U | 0 | 7.5 | MG | QD | |||||
| 127786971 | 12778697 | 6 | SS | DULOXETINE HYDROCHLORIDE. | DULOXETINE HYDROCHLORIDE | 1 | Transplacental | 60 MG, QD | Y | U | 0 | 60 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127786971 | 12778697 | 1 | Schizoaffective disorder |
| 127786971 | 12778697 | 3 | Product used for unknown indication |
| 127786971 | 12778697 | 4 | Product used for unknown indication |
| 127786971 | 12778697 | 5 | Product used for unknown indication |
| 127786971 | 12778697 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127786971 | 12778697 | CA |
| 127786971 | 12778697 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127786971 | 12778697 | Cleft palate | |
| 127786971 | 12778697 | Exposure during breast feeding | |
| 127786971 | 12778697 | Foetal exposure during pregnancy | |
| 127786971 | 12778697 | High arched palate | |
| 127786971 | 12778697 | Selective eating disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |