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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127631321 | 12763132 | 1 | I | 20090512 | 20160908 | 20160920 | 20160920 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00546 | AMNEAL | 55.00 | YR | F | Y | 100.50000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127631321 | 12763132 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 3X/DAY | Y | 75927 | TID | ||||||||
| 127631321 | 12763132 | 2 | C | enalapril | ENALAPRIL | 1 | UNK | U | U | 0 | |||||||||
| 127631321 | 12763132 | 3 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | U | U | 0 | |||||||||
| 127631321 | 12763132 | 4 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 127631321 | 12763132 | 5 | C | METOPROLOL. | METOPROLOL | 1 | UNK | U | U | 0 | |||||||||
| 127631321 | 12763132 | 6 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | U | 0 | |||||||||
| 127631321 | 12763132 | 7 | C | esomeprazole | ESOMEPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 127631321 | 12763132 | 8 | C | paracetamol | ACETAMINOPHEN | 1 | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127631321 | 12763132 | 1 | Osteoarthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127631321 | 12763132 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127631321 | 12763132 | Angina unstable |
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 |
|---|---|---|---|---|---|---|
| 127631321 | 12763132 | 1 | 20071018 | 20090512 | 0 | |
| 127631321 | 12763132 | 2 | 20080918 | 0 | ||
| 127631321 | 12763132 | 3 | 20071129 | 0 | ||
| 127631321 | 12763132 | 4 | 20080318 | 0 | ||
| 127631321 | 12763132 | 5 | 20080902 | 0 | ||
| 127631321 | 12763132 | 6 | 20090415 | 0 | ||
| 127631321 | 12763132 | 7 | 20071018 | 0 | ||
| 127631321 | 12763132 | 8 | 20071218 | 0 |