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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127504341 | 12750434 | 1 | I | 20100706 | 20160907 | 20160916 | 20160916 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00536 | AMNEAL | 66.00 | YR | M | Y | 99.50000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127504341 | 12750434 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | 75927 | ||||||||||||
| 127504341 | 12750434 | 2 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Y | 0 | |||||||||||
| 127504341 | 12750434 | 3 | C | NORFLEX | ORPHENADRINE CITRATE | 1 | UNK | U | 0 | ||||||||||
| 127504341 | 12750434 | 4 | C | ASPIRIN. | ASPIRIN | 1 | UNK | 0 | |||||||||||
| 127504341 | 12750434 | 5 | C | IMDUR | ISOSORBIDE MONONITRATE | 1 | UNK | Y | 0 | ||||||||||
| 127504341 | 12750434 | 6 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK | 0 | |||||||||||
| 127504341 | 12750434 | 7 | C | gen nitro | 2 | UNK | 0 | ||||||||||||
| 127504341 | 12750434 | 8 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 127504341 | 12750434 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | Y | 0 | ||||||||||
| 127504341 | 12750434 | 10 | C | DIOVAN | VALSARTAN | 1 | UNK | 0 | |||||||||||
| 127504341 | 12750434 | 11 | C | NORVASC | AMLODIPINE BESYLATE | 1 | UNK | 0 | |||||||||||
| 127504341 | 12750434 | 12 | C | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 127504341 | 12750434 | 13 | C | pantoloc | PANTOPRAZOLE SODIUM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127504341 | 12750434 | 3 | Muscle relaxant therapy |
| 127504341 | 12750434 | 6 | Osteoarthritis |
| 127504341 | 12750434 | 8 | Benign prostatic hyperplasia |
| 127504341 | 12750434 | 10 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127504341 | 12750434 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127504341 | 12750434 | 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 |
|---|---|---|---|---|---|---|
| 127504341 | 12750434 | 3 | 20100130 | 0 | ||
| 127504341 | 12750434 | 4 | 1999 | 0 | ||
| 127504341 | 12750434 | 5 | 20100510 | 20100824 | 0 | |
| 127504341 | 12750434 | 6 | 20090615 | 0 | ||
| 127504341 | 12750434 | 7 | 20100510 | 0 | ||
| 127504341 | 12750434 | 8 | 2005 | 0 | ||
| 127504341 | 12750434 | 9 | 2004 | 20100830 | 0 | |
| 127504341 | 12750434 | 10 | 2004 | 20100831 | 0 | |
| 127504341 | 12750434 | 11 | 2006 | 0 | ||
| 127504341 | 12750434 | 12 | 1999 | 0 | ||
| 127504341 | 12750434 | 13 | 20090131 | 0 |