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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122654463 | 12265446 | 3 | F | 20160705 | 20160413 | 20160714 | EXP | JP-PFIZER INC-2016199652 | PFIZER | WAKATABE, M.. SEVERE STEATOHEPATITIS WITH SUSPICIOUS RELATION TO IMMUNOSUPPRESSANT: A CASE REPORT. TRANSPLANTATION NOW. 2015;28 (6):710-712 | 36.00 | YR | F | Y | 49.00000 | KG | 20160714 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122654463 | 12265446 | 1 | PS | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | Unknown | 5 MG, 1X/DAY | 20702 | 5 | MG | QD | |||||||
| 122654463 | 12265446 | 2 | SS | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | Unknown | 10 MG, 1X/DAY | 20702 | 10 | MG | QD | |||||||
| 122654463 | 12265446 | 3 | SS | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | Unknown | 20 MG, 1X/DAY | 20702 | 20 | MG | QD | |||||||
| 122654463 | 12265446 | 4 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNK | U | 0 | |||||||||
| 122654463 | 12265446 | 5 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNK | U | 0 | |||||||||
| 122654463 | 12265446 | 6 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNK | U | 0 | |||||||||
| 122654463 | 12265446 | 7 | SS | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | UNK | 0 | ||||||||||
| 122654463 | 12265446 | 8 | SS | MIZORIBINE | MIZORIBINE | 1 | UNK | U | 0 | ||||||||||
| 122654463 | 12265446 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 122654463 | 12265446 | 10 | C | VALPROATE | VALPROIC ACID | 1 | UNK | 0 | |||||||||||
| 122654463 | 12265446 | 11 | C | BASILIXIMAB | BASILIXIMAB | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122654463 | 12265446 | 4 | Immunosuppressant drug therapy |
| 122654463 | 12265446 | 7 | Immunosuppressant drug therapy |
| 122654463 | 12265446 | 8 | Immunosuppressant drug therapy |
| 122654463 | 12265446 | 9 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122654463 | 12265446 | DS |
| 122654463 | 12265446 | HO |
| 122654463 | 12265446 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122654463 | 12265446 | Depression | |
| 122654463 | 12265446 | Hepatic steatosis | |
| 122654463 | 12265446 | Nephropathy toxic | |
| 122654463 | 12265446 | Neurosis | |
| 122654463 | 12265446 | Osteonecrosis | |
| 122654463 | 12265446 | Type 2 diabetes mellitus |
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 |
|---|---|---|---|---|---|---|
| 122654463 | 12265446 | 1 | 2011 | 0 | ||
| 122654463 | 12265446 | 2 | 2011 | 2014 | 0 | |
| 122654463 | 12265446 | 3 | 2014 | 20150115 | 0 | |
| 122654463 | 12265446 | 6 | 2015 | 0 | ||
| 122654463 | 12265446 | 7 | 20140303 | 20150115 | 0 | |
| 122654463 | 12265446 | 11 | 20130415 | 20140303 | 0 |