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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126896472 | 12689647 | 2 | F | 20160830 | 20160826 | 20160904 | EXP | ES-AUROBINDO-AUR-APL-2016-10934 | AUROBINDO | 49.00 | YR | M | Y | 0.00000 | 20160904 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126896472 | 12689647 | 1 | PS | Paracetamol | ACETAMINOPHEN | 1 | Unknown | U | U | 2147483647 | |||||||||
| 126896472 | 12689647 | 2 | SS | VALSARTAN. | VALSARTAN | 1 | Unknown | U | U | 0 | |||||||||
| 126896472 | 12689647 | 3 | SS | VALSARTAN. | VALSARTAN | 1 | U | U | 0 | ||||||||||
| 126896472 | 12689647 | 4 | SS | GEMFIBROZIL. | GEMFIBROZIL | 1 | Unknown | U | U | 0 | |||||||||
| 126896472 | 12689647 | 5 | SS | GEMFIBROZIL. | GEMFIBROZIL | 1 | U | U | 0 | ||||||||||
| 126896472 | 12689647 | 6 | SS | DIPYRONE | DIPYRONE | 1 | Oral | 575 MG / 8 HRS | U | U | 0 | 575 | MG | ||||||
| 126896472 | 12689647 | 7 | SS | DIPYRONE | DIPYRONE | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126896472 | 12689647 | 1 | Product used for unknown indication |
| 126896472 | 12689647 | 2 | Hypertension |
| 126896472 | 12689647 | 3 | Hypertriglyceridaemia |
| 126896472 | 12689647 | 4 | Hypertension |
| 126896472 | 12689647 | 5 | Hypertriglyceridaemia |
| 126896472 | 12689647 | 6 | Influenza |
| 126896472 | 12689647 | 7 | Nasopharyngitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126896472 | 12689647 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126896472 | 12689647 | Abdominal pain | |
| 126896472 | 12689647 | Acute kidney injury | |
| 126896472 | 12689647 | Asthenia | |
| 126896472 | 12689647 | Condition aggravated | |
| 126896472 | 12689647 | Decreased appetite | |
| 126896472 | 12689647 | Glomerular filtration rate abnormal | |
| 126896472 | 12689647 | Hyperlactacidaemia | |
| 126896472 | 12689647 | Hypouricaemia | |
| 126896472 | 12689647 | Nausea | |
| 126896472 | 12689647 | Proteinuria | |
| 126896472 | 12689647 | Renal tubular disorder | |
| 126896472 | 12689647 | Renal tubular necrosis | |
| 126896472 | 12689647 | Tubulointerstitial nephritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |