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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126062811 | 12606281 | 1 | I | 20160726 | 20160729 | 20160729 | EXP | DE-BFARM-16252160 | DE-WATSON-2016-16514 | WATSON | 0.00 | N | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126062811 | 12606281 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | 20 MG, DAILY | N | UNCONFIRMED | 77034 | 20 | MG | UNK | QD | ||||
| 126062811 | 12606281 | 2 | C | DIMENHYDRINATE. | DIMENHYDRINATE | 1 | Transplacental | 50 MG, QID (DURING 21 - 22 GESTATIONAL WEEK) | U | 0 | 50 | MG | |||||||
| 126062811 | 12606281 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Transplacental | 20 MG, PRN (BETWEEN 25 AND 29 GW) | U | 0 | 20 | MG | |||||||
| 126062811 | 12606281 | 4 | C | RENNIE /06879101/ | CALCIUM CARBONATEMAGNESIUM CARBONATE | 1 | Transplacental | 6 TIMES A DAY (DURING SECOND TRIMESTER) | U | 0 | |||||||||
| 126062811 | 12606281 | 5 | C | FOLIO | FOLIC ACID | 1 | Transplacental | 0.4 MG, DAILY | U | 0 | .4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126062811 | 12606281 | 1 | Depression |
| 126062811 | 12606281 | 2 | Vomiting in pregnancy |
| 126062811 | 12606281 | 3 | Dyspepsia |
| 126062811 | 12606281 | 4 | Dyspepsia |
| 126062811 | 12606281 | 5 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126062811 | 12606281 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126062811 | 12606281 | Aortic valve incompetence | |
| 126062811 | 12606281 | Dysmorphism | |
| 126062811 | 12606281 | Foetal exposure during pregnancy | |
| 126062811 | 12606281 | Presbyacusis | |
| 126062811 | 12606281 | Ventricular septal defect |
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 |
|---|---|---|---|---|---|---|
| 126062811 | 12606281 | 5 | 20141217 | 20150821 | 0 |