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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126193471 | 12619347 | 1 | I | 20160726 | 20160803 | 20160803 | EXP | DE-MYLANLABS-2016M1031155 | MYLAN | 0.00 | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126193471 | 12619347 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | 20 MG, QD | 77042 | 20 | MG | QD | |||||||
| 126193471 | 12619347 | 2 | C | DIMENHYDRINATE. | DIMENHYDRINATE | 1 | Transplacental | 200 [MG/D ] | 0 | 50 | MG | QID | |||||||
| 126193471 | 12619347 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Transplacental | 20 [MG/D ]/ IF REQUIRED | 0 | ||||||||||
| 126193471 | 12619347 | 4 | C | RENNIE /01739201/ | 2 | Transplacental | 6 X PER DIE | 0 | |||||||||||
| 126193471 | 12619347 | 5 | C | FOLIO /00349401/ | 2 | Transplacental | 0.4 [MG/D ] | U | 0 | .4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126193471 | 12619347 | 1 | Depression |
| 126193471 | 12619347 | 2 | Vomiting in pregnancy |
| 126193471 | 12619347 | 3 | Dyspepsia |
| 126193471 | 12619347 | 4 | Dyspepsia |
| 126193471 | 12619347 | 5 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126193471 | 12619347 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126193471 | 12619347 | Aortic valve incompetence | |
| 126193471 | 12619347 | Dysmorphism | |
| 126193471 | 12619347 | Foetal exposure during pregnancy | |
| 126193471 | 12619347 | Presbyacusis | |
| 126193471 | 12619347 | 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 |
|---|---|---|---|---|---|---|
| 126193471 | 12619347 | 5 | 20141217 | 20150821 | 0 |