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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125379571 | 12537957 | 1 | I | 20151119 | 20160627 | 20160707 | 20160707 | EXP | DE-MYLANLABS-2016M1027346 | MYLAN | 0.00 | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125379571 | 12537957 | 1 | PS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Transplacental | 10 [MG/D ]/ INTERMITTENTLY 7.5 MG/D FOR A SHORT TIME PERIOD. | 77660 | 10 | MG | QD | |||||||
| 125379571 | 12537957 | 2 | SS | DECORTIN-H /00016201/ | PREDNISOLONE HEMISUCCINATE | 1 | Transplacental | 5.5 [MG/D ]/ MINIMUM DOSAGE 5 MG/D | 0 | 5.5 | MG | QD | |||||||
| 125379571 | 12537957 | 3 | C | L-THYROXIN | LEVOTHYROXINE SODIUM | 1 | Transplacental | 75 [?G/D ] | U | 0 | 75 | UG | QD | ||||||
| 125379571 | 12537957 | 4 | C | DEKRISTOL | CHOLECALCIFEROL | 1 | Transplacental | 1000 [IE/D ]/ PROBABLY TAKEN LONGER. REDUCTION TO 500 IE/D, STOPPED DURING THE 1ST TRIMESTER | U | 0 | 1000 | IU | QD | ||||||
| 125379571 | 12537957 | 5 | C | CYTOTEC | MISOPROSTOL | 1 | Transplacental | U | 0 | ||||||||||
| 125379571 | 12537957 | 6 | C | FEMIBION 1 | 2 | Transplacental | 0.8 [MG/D ] | U | 0 | .8 | MG | QD | |||||||
| 125379571 | 12537957 | 7 | C | AMPICILLIN | AMPICILLIN | 1 | Transplacental | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125379571 | 12537957 | 1 | Depression |
| 125379571 | 12537957 | 2 | Sarcoidosis |
| 125379571 | 12537957 | 3 | Hypothyroidism |
| 125379571 | 12537957 | 4 | Osteoporosis prophylaxis |
| 125379571 | 12537957 | 5 | Labour induction |
| 125379571 | 12537957 | 6 | Prophylaxis of neural tube defect |
| 125379571 | 12537957 | 7 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125379571 | 12537957 | OT |
| 125379571 | 12537957 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125379571 | 12537957 | Bradycardia neonatal | |
| 125379571 | 12537957 | Congenital hydronephrosis | |
| 125379571 | 12537957 | Foetal exposure during pregnancy | |
| 125379571 | 12537957 | Kidney duplex | |
| 125379571 | 12537957 | Respiratory disorder neonatal |
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 |
|---|---|---|---|---|---|---|
| 125379571 | 12537957 | 1 | 20150310 | 20151119 | 0 | |
| 125379571 | 12537957 | 2 | 20150310 | 20151119 | 0 | |
| 125379571 | 12537957 | 3 | 20150310 | 20151119 | 0 | |
| 125379571 | 12537957 | 4 | 20150310 | 20150413 | 0 | |
| 125379571 | 12537957 | 5 | 20151119 | 20151119 | 0 | |
| 125379571 | 12537957 | 7 | 20151119 | 20151119 | 0 |