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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116081253 | 11608125 | 3 | F | 20121207 | 20160624 | 20151007 | 20160706 | EXP | US-APOTEX-2015AP013209 | APOTEX | 69.00 | YR | F | Y | 0.00000 | 20160706 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116081253 | 11608125 | 1 | PS | TOBRAMYCIN OPHTHALMIC SOLUTION USP 0.3% | TOBRAMYCIN | 1 | Other | 10.8 G, UNK | 65087 | 10.8 | G | EYE DROPS, SOLUTION | |||||||
| 116081253 | 11608125 | 2 | SS | TOBRAMYCIN OPHTHALMIC SOLUTION USP 0.3% | TOBRAMYCIN | 1 | Other | 3.6 G, UNK | 65087 | 3.6 | G | EYE DROPS, SOLUTION | |||||||
| 116081253 | 11608125 | 3 | SS | LISINOPRIL. | LISINOPRIL | 1 | Oral | 20 MG, UNK | Y | 0 | 20 | MG | TABLET | ||||||
| 116081253 | 11608125 | 4 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 3.375 MG, EVERY 6 HOURS | Y | 0 | 3.375 | MG | INJECTION | Q6H | |||||
| 116081253 | 11608125 | 5 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | Y | 0 | ||||||||||
| 116081253 | 11608125 | 6 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Other | 12 G+4G | Y | 0 | |||||||||
| 116081253 | 11608125 | 7 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 1 G, BID | Y | 0 | 1 | G | BID | ||||||
| 116081253 | 11608125 | 8 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 750 MG, BID | Y | 0 | 750 | MG | BID | ||||||
| 116081253 | 11608125 | 9 | C | DULOXETINE. | DULOXETINE | 1 | Unknown | U | U | 0 | |||||||||
| 116081253 | 11608125 | 10 | C | SOLIFENACIN | SOLIFENACIN | 1 | Unknown | U | U | 0 | |||||||||
| 116081253 | 11608125 | 11 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | U | 0 | |||||||||
| 116081253 | 11608125 | 12 | C | HYDROCODONE/PARACETAMOL | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | U | U | 0 | |||||||||
| 116081253 | 11608125 | 13 | C | MORPHINE | MORPHINE | 1 | Unknown | U | U | 0 | |||||||||
| 116081253 | 11608125 | 14 | C | PAROXETINE. | PAROXETINE | 1 | Unknown | U | U | 0 | |||||||||
| 116081253 | 11608125 | 15 | C | RIFAMPIN. | RIFAMPIN | 1 | Oral | U | U | 0 | |||||||||
| 116081253 | 11608125 | 16 | C | CEPHALEXIN /00145501/ | CEPHALEXIN | 1 | Oral | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116081253 | 11608125 | 1 | Infection prophylaxis |
| 116081253 | 11608125 | 3 | Product used for unknown indication |
| 116081253 | 11608125 | 4 | Product used for unknown indication |
| 116081253 | 11608125 | 5 | Product used for unknown indication |
| 116081253 | 11608125 | 9 | Product used for unknown indication |
| 116081253 | 11608125 | 10 | Product used for unknown indication |
| 116081253 | 11608125 | 11 | Product used for unknown indication |
| 116081253 | 11608125 | 12 | Product used for unknown indication |
| 116081253 | 11608125 | 13 | Product used for unknown indication |
| 116081253 | 11608125 | 14 | Product used for unknown indication |
| 116081253 | 11608125 | 15 | Product used for unknown indication |
| 116081253 | 11608125 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116081253 | 11608125 | OT |
| 116081253 | 11608125 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116081253 | 11608125 | Acute kidney injury | |
| 116081253 | 11608125 | Arthritis bacterial | |
| 116081253 | 11608125 | Drug level increased | |
| 116081253 | 11608125 | Haemoglobin decreased | |
| 116081253 | 11608125 | Hypotension | |
| 116081253 | 11608125 | Leg amputation | |
| 116081253 | 11608125 | Renal tubular necrosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |