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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044821 | 12604482 | 1 | I | 20160407 | 20160718 | 20160728 | 20160728 | EXP | DE-MYLANLABS-2016M1030031 | MYLAN | 0.00 | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044821 | 12604482 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 50 MG, QD (50 [MG/D ]) | U | 78626 | 50 | MG | QD | ||||||
| 126044821 | 12604482 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Transplacental | UNK | U | 0 | |||||||||
| 126044821 | 12604482 | 3 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Transplacental | UNK (10 [MG/D ]/ IF REQUIRED) | U | 0 | |||||||||
| 126044821 | 12604482 | 4 | C | SALBUTAMOL | ALBUTEROL | 1 | Transplacental | UNK (0.1 [MG/D BEI BEDARF ]/ IF REQUIRED) | U | 0 | |||||||||
| 126044821 | 12604482 | 5 | C | PROTOPIC | TACROLIMUS | 1 | Transplacental | UNK (IF REQUIRED) | U | 0 | |||||||||
| 126044821 | 12604482 | 6 | C | FOLSAEURE | FOLIC ACID | 1 | Transplacental | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126044821 | 12604482 | 1 | Depression |
| 126044821 | 12604482 | 2 | Asthma |
| 126044821 | 12604482 | 3 | Food allergy |
| 126044821 | 12604482 | 4 | Asthma |
| 126044821 | 12604482 | 5 | Neurodermatitis |
| 126044821 | 12604482 | 6 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126044821 | 12604482 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126044821 | 12604482 | Foetal exposure during pregnancy | |
| 126044821 | 12604482 | Small for dates baby |
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 |
|---|---|---|---|---|---|---|
| 126044821 | 12604482 | 1 | 20150709 | 20160407 | 0 | |
| 126044821 | 12604482 | 2 | 20150709 | 20160407 | 0 | |
| 126044821 | 12604482 | 3 | 20150709 | 20160407 | 0 | |
| 126044821 | 12604482 | 4 | 20150709 | 20160407 | 0 | |
| 126044821 | 12604482 | 5 | 20150709 | 20160407 | 0 | |
| 126044821 | 12604482 | 6 | 20150822 | 20160407 | 0 |