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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125803412 | 12580341 | 2 | F | 2014 | 20160715 | 20160721 | 20160722 | EXP | US-TEVA-677947USA | TEVA | 78.14 | YR | M | Y | 93.07000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125803412 | 12580341 | 1 | PS | NUVIGIL | ARMODAFINIL | 1 | Unknown | 450 MILLIGRAM DAILY; 2 X 225MG TABLETS | Y | 21875 | TABLET | ||||||||
| 125803412 | 12580341 | 2 | SS | NUVIGIL | ARMODAFINIL | 1 | Y | 21875 | |||||||||||
| 125803412 | 12580341 | 3 | SS | NUVIGIL | ARMODAFINIL | 1 | Y | 21875 | |||||||||||
| 125803412 | 12580341 | 4 | C | pantoprazole | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 125803412 | 12580341 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 125803412 | 12580341 | 6 | C | LOSARTAN. | LOSARTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125803412 | 12580341 | 1 | Attention deficit/hyperactivity disorder |
| 125803412 | 12580341 | 2 | Depression |
| 125803412 | 12580341 | 3 | Mood altered |
| 125803412 | 12580341 | 4 | Gastrooesophageal reflux disease |
| 125803412 | 12580341 | 5 | Blood cholesterol increased |
| 125803412 | 12580341 | 6 | Blood pressure increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125803412 | 12580341 | OT |
| 125803412 | 12580341 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125803412 | 12580341 | Aortic valve replacement | |
| 125803412 | 12580341 | Drug dose omission | |
| 125803412 | 12580341 | Pollakiuria | |
| 125803412 | 12580341 | Polyuria | |
| 125803412 | 12580341 | Product use issue | |
| 125803412 | 12580341 | Prostatic specific antigen increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |