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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127129281 | 12712928 | 1 | I | 20160824 | 20160902 | 20160902 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-55427BP | BOEHRINGER INGELHEIM | 0.00 | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127129281 | 12712928 | 1 | PS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 1 MG | Y | 22421 | 1 | MG | TABLET | QD | |||||
| 127129281 | 12712928 | 2 | SS | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 3 MG | Y | 22421 | 3 | MG | TABLET | QD | |||||
| 127129281 | 12712928 | 3 | C | LOPRESSOR | METOPROLOL TARTRATE | 1 | Oral | 0 | TABLET | ||||||||||
| 127129281 | 12712928 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 0 | TABLET | ||||||||||
| 127129281 | 12712928 | 5 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127129281 | 12712928 | 1 | Restless legs syndrome |
| 127129281 | 12712928 | 3 | Hypertension |
| 127129281 | 12712928 | 4 | Hypertension |
| 127129281 | 12712928 | 5 | Depression |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127129281 | 12712928 | Abnormal behaviour | |
| 127129281 | 12712928 | Amnesia | |
| 127129281 | 12712928 | Asthenia | |
| 127129281 | 12712928 | Confusional state | |
| 127129281 | 12712928 | Delusion | |
| 127129281 | 12712928 | Dyspnoea | |
| 127129281 | 12712928 | Euphoric mood | |
| 127129281 | 12712928 | Fatigue | |
| 127129281 | 12712928 | Feeling abnormal | |
| 127129281 | 12712928 | Hallucination | |
| 127129281 | 12712928 | Homeless | |
| 127129281 | 12712928 | Loss of employment | |
| 127129281 | 12712928 | Narcolepsy | |
| 127129281 | 12712928 | Oedema peripheral | |
| 127129281 | 12712928 | Pica | |
| 127129281 | 12712928 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 127129281 | 12712928 | 1 | 201511 | 0 | ||
| 127129281 | 12712928 | 2 | 201511 | 0 |