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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124178824 | 12417882 | 4 | F | 20160915 | 20160531 | 20160930 | EXP | DE-AUROBINDO-AUR-APL-2016-06712 | AUROBINDO | 73.00 | YR | M | Y | 0.00000 | 20160929 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124178824 | 12417882 | 1 | PS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | U | 78021 | |||||||||
| 124178824 | 12417882 | 2 | I | Simvastatin 40mg | SIMVASTATIN | 1 | Unknown | U | U | 0 | |||||||||
| 124178824 | 12417882 | 3 | I | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | U | U | 0 | |||||||||
| 124178824 | 12417882 | 4 | I | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | 50 MG, UNK | U | U | 0 | 50 | MG | ||||||
| 124178824 | 12417882 | 5 | I | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, UNK | U | U | 0 | 1000 | MG | ||||||
| 124178824 | 12417882 | 6 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124178824 | 12417882 | 1 | Hypertension |
| 124178824 | 12417882 | 2 | Hypercholesterolaemia |
| 124178824 | 12417882 | 3 | Diarrhoea |
| 124178824 | 12417882 | 4 | Immunosuppressant drug therapy |
| 124178824 | 12417882 | 5 | Immunosuppressant drug therapy |
| 124178824 | 12417882 | 6 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124178824 | 12417882 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124178824 | 12417882 | Asthenia | |
| 124178824 | 12417882 | Chromaturia | |
| 124178824 | 12417882 | Drug interaction | |
| 124178824 | 12417882 | Muscular weakness | |
| 124178824 | 12417882 | Rhabdomyolysis | |
| 124178824 | 12417882 | Urine output decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |