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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126102241 | 12610224 | 1 | I | 20150929 | 20160720 | 20160801 | 20160801 | EXP | DE-MYLANLABS-2016M1030273 | MYLAN | 0.00 | Y | 0.00000 | 20160801 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126102241 | 12610224 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 75 MG, QD (75 [MG/D ]) | U | 78626 | 75 | MG | QD | ||||||
| 126102241 | 12610224 | 2 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Transplacental | UNK (FOR PROPHYLAXIS OR FOR GASTRITIS. CONTRADICTORY STATEMENTS IF PANTOPRAZOL OR OMEPRAZOL) | U | 0 | |||||||||
| 126102241 | 12610224 | 3 | C | MCP /00041902/ | 2 | Transplacental | UNK | U | 0 | ||||||||||
| 126102241 | 12610224 | 4 | C | OMEPRAZOL /00661201/ | OMEPRAZOLE | 1 | Transplacental | UNK (20 [MG/D ]/ FOR PROPHYLAXIS OR FOR GASTRITIS. CONTRADICTORY STATEMENTS IF PANTOPRAZOL OR OMEPR) | U | 0 | |||||||||
| 126102241 | 12610224 | 5 | C | GLUCOSE | DEXTROSE | 1 | Transplacental | UNK | U | 0 | |||||||||
| 126102241 | 12610224 | 6 | C | MIRTAZAPIN | MIRTAZAPINE | 1 | Transplacental | UNK (IF REQUIRED. IN TOTAL ONLY FOR 3 DAYS.) | U | 0 | |||||||||
| 126102241 | 12610224 | 7 | C | TAVOR (LORAZEPAM) | LORAZEPAM | 1 | Transplacental | 1 MG, QD (1 [MG/D ]/ ONCE) | U | 0 | 1 | MG | QD | ||||||
| 126102241 | 12610224 | 8 | C | GYNVITAL GRAVIDA | HERBALS | 1 | Transplacental | 0.4 MG, QD (0.4 [MG/D ]) | U | 0 | .4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126102241 | 12610224 | 1 | Anxiety disorder |
| 126102241 | 12610224 | 2 | Gastritis |
| 126102241 | 12610224 | 3 | Nausea |
| 126102241 | 12610224 | 4 | Prophylaxis against gastrointestinal ulcer |
| 126102241 | 12610224 | 5 | Nausea |
| 126102241 | 12610224 | 6 | Nausea |
| 126102241 | 12610224 | 7 | Product used for unknown indication |
| 126102241 | 12610224 | 8 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126102241 | 12610224 | OT |
| 126102241 | 12610224 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126102241 | 12610224 | Congenital skin dimples | |
| 126102241 | 12610224 | Foetal exposure during pregnancy | |
| 126102241 | 12610224 | Granulocytopenia neonatal | |
| 126102241 | 12610224 | Neonatal respiratory distress syndrome | |
| 126102241 | 12610224 | Premature baby | |
| 126102241 | 12610224 | Tethered cord syndrome |
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 |
|---|---|---|---|---|---|---|
| 126102241 | 12610224 | 1 | 20150223 | 20150929 | 0 | |
| 126102241 | 12610224 | 3 | 20150529 | 20150529 | 0 | |
| 126102241 | 12610224 | 5 | 20150529 | 20150529 | 0 |