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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321081 | 12532108 | 1 | I | 20150619 | 20160624 | 20160706 | 20160706 | EXP | DE-BFARM-16213633 | DE-WATSON-2016-14356 | WATSON | 1.00 | DY | M | Y | 0.00000 | 20160706 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125321081 | 12532108 | 1 | SS | Ziprasidone (Unknown) | ZIPRASIDONE | 1 | Transplacental | 80 MG, BID | Y | UNCONFIRMED | 0 | 80 | MG | UNK | BID | ||||
| 125321081 | 12532108 | 2 | PS | Simvastatin (Unknown) | SIMVASTATIN | 1 | Transplacental | 20 MG, DAILY | Y | UNCONFIRMED | 76685 | 20 | MG | UNK | QD | ||||
| 125321081 | 12532108 | 3 | SS | LEPONEX | CLOZAPINE | 1 | Transplacental | 300 MG, DAILY | 66000 | MG | 0 | 300 | MG | QD | |||||
| 125321081 | 12532108 | 4 | SS | INSIDON | OPIPRAMOL HYDROCHLORIDE | 1 | Transplacental | 100 MG, TID | 66000 | MG | 0 | 100 | MG | TID | |||||
| 125321081 | 12532108 | 5 | SS | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Transplacental | 20 MG, DAILY | 4400 | MG | 0 | 20 | MG | QD | |||||
| 125321081 | 12532108 | 6 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Transplacental | UNK; STARTED FROM GW 17 | U | 0 | |||||||||
| 125321081 | 12532108 | 7 | C | FOLSAEURE | FOLIC ACID | 1 | Transplacental | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125321081 | 12532108 | 1 | Schizophrenia |
| 125321081 | 12532108 | 2 | Product used for unknown indication |
| 125321081 | 12532108 | 3 | Schizophrenia |
| 125321081 | 12532108 | 4 | Anxiety disorder |
| 125321081 | 12532108 | 5 | Product used for unknown indication |
| 125321081 | 12532108 | 6 | Schizophrenia |
| 125321081 | 12532108 | 7 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125321081 | 12532108 | OT |
| 125321081 | 12532108 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125321081 | 12532108 | Abnormal palmar/plantar creases | |
| 125321081 | 12532108 | Developmental delay | |
| 125321081 | 12532108 | Dysmorphism | |
| 125321081 | 12532108 | Feeding disorder | |
| 125321081 | 12532108 | Foetal exposure during pregnancy | |
| 125321081 | 12532108 | Hyperbilirubinaemia neonatal | |
| 125321081 | 12532108 | Hypotonia neonatal | |
| 125321081 | 12532108 | Neonatal respiratory distress syndrome | |
| 125321081 | 12532108 | Premature baby |
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 |
|---|---|---|---|---|---|---|
| 125321081 | 12532108 | 3 | 20141112 | 20150619 | 0 | |
| 125321081 | 12532108 | 4 | 20141112 | 20150619 | 0 | |
| 125321081 | 12532108 | 5 | 20141112 | 20150619 | 0 |