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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127204431 | 12720443 | 1 | I | 20160717 | 20160824 | 20160907 | 20160907 | EXP | FR-AUROBINDO-AUR-APL-2016-11037 | AUROBINDO | 26.00 | YR | M | Y | 0.00000 | 20160907 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127204431 | 12720443 | 1 | SS | TRAMADOL / PARACETAMOL 37.5 MG/325 MG EFFERVESCENT TABLE | ACETAMINOPHENTRAMADOL | 1 | Oral | 1 DF, ONCE A DAY | 4 | DF | Y | U | 0 | 1 | DF | EFFERVESCENT TABLET | QD | ||
| 127204431 | 12720443 | 2 | PS | Hydroxyzine Arrow film-coated tablet | HYDROXYZINE HYDROCHLORIDE | 1 | Oral | 1 DF, DAILY | Y | U | 87869 | 1 | DF | FILM-COATED TABLET | |||||
| 127204431 | 12720443 | 3 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 3.5 MG, ONCE A DAY | 129.5 | MG | Y | U | 0 | 3.5 | MG | QD | |||
| 127204431 | 12720443 | 4 | SS | PIPERACILLIN | PIPERACILLIN | 1 | Intravenous (not otherwise specified) | UNK | Y | U | 0 | ||||||||
| 127204431 | 12720443 | 5 | SS | TAZOBACTAM | TAZOBACTAM | 1 | UNK | Y | U | 0 | |||||||||
| 127204431 | 12720443 | 6 | SS | ALPRAZOLAM MYLAN | ALPRAZOLAM | 1 | 1 DF, ONCE A DAY | 5 | DF | Y | U | 0 | 1 | DF | TABLET | QD | |||
| 127204431 | 12720443 | 7 | SS | NEFOPAM MYLAN | NEFOPAM | 1 | Intravenous (not otherwise specified) | UNK | U | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127204431 | 12720443 | 1 | Pain |
| 127204431 | 12720443 | 2 | Product used for unknown indication |
| 127204431 | 12720443 | 3 | Antibiotic prophylaxis |
| 127204431 | 12720443 | 4 | Antibiotic prophylaxis |
| 127204431 | 12720443 | 5 | Antibiotic prophylaxis |
| 127204431 | 12720443 | 6 | Product used for unknown indication |
| 127204431 | 12720443 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127204431 | 12720443 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127204431 | 12720443 | Blood creatinine increased | |
| 127204431 | 12720443 | Eosinophilia | |
| 127204431 | 12720443 | Pruritus generalised | |
| 127204431 | 12720443 | Rash maculo-papular | |
| 127204431 | 12720443 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 127204431 | 12720443 | 1 | 20160713 | 20160721 | 0 | |
| 127204431 | 12720443 | 2 | 20160712 | 20160724 | 0 | |
| 127204431 | 12720443 | 3 | 20160610 | 20160726 | 0 | |
| 127204431 | 12720443 | 4 | 20160610 | 20160726 | 0 | |
| 127204431 | 12720443 | 5 | 20160610 | 20160726 | 0 | |
| 127204431 | 12720443 | 6 | 20160712 | 20160728 | 0 | |
| 127204431 | 12720443 | 7 | 20160722 | 0 |