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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125445381 | 12544538 | 1 | I | 20160627 | 20160711 | 20160711 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41671BP | BOEHRINGER INGELHEIM | 0.00 | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125445381 | 12544538 | 1 | PS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 0.5 MG | 22421 | .5 | MG | TABLET | QD | ||||||
| 125445381 | 12544538 | 2 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 1 MG | 22421 | .5 | MG | TABLET | BID | ||||||
| 125445381 | 12544538 | 3 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 1.5 MG | 22421 | .5 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125445381 | 12544538 | 1 | Restless legs syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125445381 | 12544538 | Fatigue | |
| 125445381 | 12544538 | Gait disturbance | |
| 125445381 | 12544538 | Incorrect dose administered | |
| 125445381 | 12544538 | Myalgia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |