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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127574941 | 12757494 | 1 | I | 201507 | 20160823 | 20160919 | 20160919 | PER | US-TEVA-2015-24641 | TEVA | 29.88 | YR | F | Y | 90.80000 | KG | 20160919 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127574941 | 12757494 | 1 | PS | ACETAMINOPHEN W/OXYCODONE | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | 1 DF, EVERY 4-6 HOURS AS NEEDED-10/325 | Y | U | UNKNOWN | 40535 | 1 | DF | TABLET | ||||
| 127574941 | 12757494 | 2 | SS | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 1 DF, EVERY 4-6 HOURS AS NEEDED | UNKNOWN | 0 | 1 | DF | |||||||
| 127574941 | 12757494 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 40 MG, UNKNOWN | UNKNOWN | 0 | 40 | MG | |||||||
| 127574941 | 12757494 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 5000 IU, UNKNOWN | UNKNOWN | 0 | 5000 | IU | |||||||
| 127574941 | 12757494 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0.5 MG, UNKNOWN | UNKNOWN | 0 | .5 | MG | |||||||
| 127574941 | 12757494 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, UNKNOWN | UNKNOWN | 0 | 300 | MG | |||||||
| 127574941 | 12757494 | 7 | C | ORPHENADRINE | ORPHENADRINE | 1 | Unknown | 100 MG, UNKNOWN | UNKNOWN | 0 | 100 | MG | |||||||
| 127574941 | 12757494 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | UNKNOWN | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127574941 | 12757494 | 1 | Back pain |
| 127574941 | 12757494 | 2 | Pain |
| 127574941 | 12757494 | 3 | Product used for unknown indication |
| 127574941 | 12757494 | 4 | Product used for unknown indication |
| 127574941 | 12757494 | 5 | Product used for unknown indication |
| 127574941 | 12757494 | 6 | Product used for unknown indication |
| 127574941 | 12757494 | 7 | Product used for unknown indication |
| 127574941 | 12757494 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127574941 | 12757494 | Dizziness | |
| 127574941 | 12757494 | Hypoaesthesia oral | |
| 127574941 | 12757494 | Influenza like illness | |
| 127574941 | 12757494 | Malaise | |
| 127574941 | 12757494 | Nausea | |
| 127574941 | 12757494 | Paraesthesia oral |
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 |
|---|---|---|---|---|---|---|
| 127574941 | 12757494 | 1 | 20150512 | 20150519 | 0 | |
| 127574941 | 12757494 | 2 | 20150811 | 0 |