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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125323601 | 12532360 | 1 | I | 20150911 | 20160624 | 20160706 | 20160706 | EXP | DE-MYLANLABS-2016M1027378 | MYLAN | 0.00 | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125323601 | 12532360 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | UNK (DOSAGE UNKNOWN) | 77042 | ||||||||||
| 125323601 | 12532360 | 2 | SS | TWYNSTA | AMLODIPINE BESYLATETELMISARTAN | 1 | Transplacental | 40 MG, QD (5 [MG/D ] / 40 [MG/D ]) | 2600 | MG | U | 0 | 40 | MG | QD | ||||
| 125323601 | 12532360 | 3 | SS | METHYLDOPA. | METHYLDOPA | 1 | Transplacental | 250 MG, TID (750 [MG/D ]) | 158250 | MG | U | 0 | 250 | MG | TID | ||||
| 125323601 | 12532360 | 4 | C | FOLIO /00349401/ | 2 | Transplacental | 0.4 MG, QD (0.4 [MG/D ]) | 110.400002 | MG | U | 0 | .4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125323601 | 12532360 | 1 | Depression |
| 125323601 | 12532360 | 2 | Hypertension |
| 125323601 | 12532360 | 3 | Hypertension |
| 125323601 | 12532360 | 4 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125323601 | 12532360 | OT |
| 125323601 | 12532360 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125323601 | 12532360 | Foetal exposure during pregnancy | |
| 125323601 | 12532360 | Foot deformity | |
| 125323601 | 12532360 | Hypospadias | |
| 125323601 | 12532360 | Kinematic imbalances due to suboccipital strain |
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 |
|---|---|---|---|---|---|---|
| 125323601 | 12532360 | 1 | 20141210 | 20150911 | 0 | |
| 125323601 | 12532360 | 2 | 20141210 | 20150212 | 0 | |
| 125323601 | 12532360 | 3 | 20150213 | 20150911 | 0 | |
| 125323601 | 12532360 | 4 | 20141210 | 20150911 | 0 |