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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126092731 | 12609273 | 1 | I | 20160721 | 20160801 | 20160801 | EXP | US-MYLANLABS-2016M1030829 | MYLAN | RUBIN JN, TE HS. REFRACTORY AUTOIMMUNE HEPATITIS: BEYOND STANDARD THERAPY. DIG-DIS-SCI 2016;61(6):1757-1762. | 0.00 | Y | 0.00000 | 20160801 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126092731 | 12609273 | 1 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 3 MG DAILY; LATER THE DOSE WAS INCREASED | Y | 0 | |||||||||
| 126092731 | 12609273 | 2 | PS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | U | U | 75568 | |||||||||
| 126092731 | 12609273 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | U | 0 | |||||||||
| 126092731 | 12609273 | 4 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126092731 | 12609273 | 1 | Autoimmune hepatitis |
| 126092731 | 12609273 | 2 | Autoimmune hepatitis |
| 126092731 | 12609273 | 3 | Autoimmune hepatitis |
| 126092731 | 12609273 | 4 | Autoimmune hepatitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126092731 | 12609273 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126092731 | 12609273 | Headache | |
| 126092731 | 12609273 | Renal failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |