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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126466971 | 12646697 | 1 | I | 20160803 | 20160812 | 20160812 | EXP | US-ZYDUS-011869 | ZYDUS PHARM | HU S, CHOW A, AMOROSA LF. ACUTE RENAL FAILURE CAUSED BY SIMVASTATIN-INDUCED RHABDOMYOLYSIS ASSOCIATED WITH SECONDARY HYPERCALCEMIA NOT RELATED TO HYPERPARATHYROIDISM. ENDOCR-REV 2014;35 ABSTR. SAT-0196. | 60.00 | YR | M | Y | 0.00000 | 20160812 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126466971 | 12646697 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | Y | UNKNOWN | 77837 | 80 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126466971 | 12646697 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126466971 | 12646697 | OT |
| 126466971 | 12646697 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126466971 | 12646697 | Acute kidney injury | |
| 126466971 | 12646697 | Asthenia | |
| 126466971 | 12646697 | Condition aggravated | |
| 126466971 | 12646697 | Dysphagia | |
| 126466971 | 12646697 | Hypercalcaemia | |
| 126466971 | 12646697 | Hypokinesia | |
| 126466971 | 12646697 | Muscle atrophy | |
| 126466971 | 12646697 | Muscle necrosis | |
| 126466971 | 12646697 | Myositis | |
| 126466971 | 12646697 | Oliguria | |
| 126466971 | 12646697 | Rhabdomyolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |