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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269281 | 12626928 | 1 | I | 20160727 | 20160805 | 20160805 | EXP | PT-MYLANLABS-2016M1032651 | MYLAN | BRAGA AC, VASCONCELOS C, BRAGA J. PREGNANCY WITH AUTOIMMUNE HEPATITIS. GAST-HEP-BED-BENCH 2016;9(3):220-224. | 0.00 | Y | 0.00000 | 20160805 | MD | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269281 | 12626928 | 1 | PS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Transplacental | 75568 | |||||||||||
| 126269281 | 12626928 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Transplacental | 0 | |||||||||||
| 126269281 | 12626928 | 3 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126269281 | 12626928 | 1 | Autoimmune hepatitis |
| 126269281 | 12626928 | 2 | Autoimmune hepatitis |
| 126269281 | 12626928 | 3 | Portal hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126269281 | 12626928 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126269281 | 12626928 | Foetal distress syndrome | |
| 126269281 | 12626928 | Foetal exposure during pregnancy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |