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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126287691 | 12628769 | 1 | I | 20160725 | 20160808 | 20160808 | EXP | DE-LUPIN PHARMACEUTICALS INC.-2016-03467 | LUPIN | 31.00 | YR | F | Y | 48.00000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126287691 | 12628769 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNKNOWN | 77670 | 75 | MG | QD | |||||||
| 126287691 | 12628769 | 2 | C | Tavor 1,0 expidet | 2 | Transplacental | 0 | 1 | MG | QD | |||||||||
| 126287691 | 12628769 | 3 | C | Gynvital Gravida | HERBALS | 1 | Transplacental | 0.4 [MG/D ] | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126287691 | 12628769 | 1 | Anxiety disorder |
| 126287691 | 12628769 | 2 | Product used for unknown indication |
| 126287691 | 12628769 | 3 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126287691 | 12628769 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126287691 | 12628769 | Cholestasis | |
| 126287691 | 12628769 | Exposure during pregnancy | |
| 126287691 | 12628769 | Gastritis | |
| 126287691 | 12628769 | HELLP syndrome | |
| 126287691 | 12628769 | Hypertension | |
| 126287691 | 12628769 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 126287691 | 12628769 | 1 | 20150223 | 20150929 | 0 |