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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125076882 | 12507688 | 2 | F | 20160725 | 20160629 | 20160806 | EXP | ES-AUROBINDO-AUR-APL-2016-08397 | AUROBINDO | 48.00 | YR | M | Y | 0.00000 | 20160806 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125076882 | 12507688 | 1 | PS | Carvedilol 6.25 mg | CARVEDILOL | 1 | Oral | 6.25 MG, TWO TIMES A DAY | Y | U | 78332 | 6.25 | MG | BID | |||||
| 125076882 | 12507688 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 40 MG, ONCE A DAY | U | U | 0 | 40 | MG | QD | |||||
| 125076882 | 12507688 | 3 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 500 MG, 3 TIMES A DAY | U | 0 | 500 | MG | TID | ||||||
| 125076882 | 12507688 | 4 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 500 MG, 3 TIMES A DAY | U | 0 | 500 | MG | TID | ||||||
| 125076882 | 12507688 | 5 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | Intravenous (not otherwise specified) | 2 G, ONCE A DAY | U | 0 | 2 | G | QD | ||||||
| 125076882 | 12507688 | 6 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Intravenous (not otherwise specified) | 500 MG, ONCE A DAY | Y | U | 0 | 500 | MG | QD | |||||
| 125076882 | 12507688 | 7 | C | PENTOXIFYLLINE. | PENTOXIFYLLINE | 1 | Oral | 400 MG, 3 TIMES A DAY | U | 0 | 400 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125076882 | 12507688 | 1 | Portal hypertensive gastropathy |
| 125076882 | 12507688 | 2 | Hepatitis |
| 125076882 | 12507688 | 3 | Cough |
| 125076882 | 12507688 | 4 | Pyrexia |
| 125076882 | 12507688 | 5 | Pneumonia |
| 125076882 | 12507688 | 6 | Pneumonia |
| 125076882 | 12507688 | 7 | Pneumonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125076882 | 12507688 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125076882 | 12507688 | Acute kidney injury | |
| 125076882 | 12507688 | Cellulitis | |
| 125076882 | 12507688 | Condition aggravated | |
| 125076882 | 12507688 | Hypotension |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |