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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127460571 | 12746057 | 1 | I | 20090723 | 20160907 | 20160915 | 20160915 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00523 | AMNEAL | 49.00 | YR | M | Y | 69.00000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127460571 | 12746057 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK | Y | N | 75927 | ||||||||
| 127460571 | 12746057 | 2 | C | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | UNK | U | U | 0 | ||||||||
| 127460571 | 12746057 | 3 | C | tears naturale II | TEARS NATURALE II | 1 | Ophthalmic | UNK EYE DROPS | 0 | EYE DROPS | |||||||||
| 127460571 | 12746057 | 4 | C | TOBRADEX | DEXAMETHASONETOBRAMYCIN | 1 | Ophthalmic | UNK | 0 | EYE DROPS | |||||||||
| 127460571 | 12746057 | 5 | C | carbomer gel | 2 | Ophthalmic | UNK EYE GEL | 0 | GEL | ||||||||||
| 127460571 | 12746057 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | UNK | Y | U | 0 | TABLET | |||||||
| 127460571 | 12746057 | 7 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | UNK | U | 0 | CAPSULE | ||||||||
| 127460571 | 12746057 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | U | 0 | CAPSULE | ||||||||||
| 127460571 | 12746057 | 9 | C | ENALAPRIL MALEATE. | ENALAPRIL MALEATE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 127460571 | 12746057 | 10 | C | CLONIDINE. | CLONIDINE | 1 | Oral | UNK | U | U | 0 | ||||||||
| 127460571 | 12746057 | 11 | C | co-renitec | ENALAPRILHYDROCHLOROTHIAZIDE | 1 | Oral | UNK | U | U | 0 | TABLET | |||||||
| 127460571 | 12746057 | 12 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 127460571 | 12746057 | 13 | C | ISORDIL | ISOSORBIDE DINITRATE | 1 | UNK | Y | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127460571 | 12746057 | 2 | Rheumatoid arthritis |
| 127460571 | 12746057 | 3 | Dry eye |
| 127460571 | 12746057 | 4 | Dry eye |
| 127460571 | 12746057 | 5 | Dry eye |
| 127460571 | 12746057 | 7 | Gastritis erosive |
| 127460571 | 12746057 | 8 | Gastrooesophageal reflux disease |
| 127460571 | 12746057 | 9 | Hypertension |
| 127460571 | 12746057 | 10 | Hypertension |
| 127460571 | 12746057 | 11 | Hypertension |
| 127460571 | 12746057 | 12 | Hypertension |
| 127460571 | 12746057 | 13 | Angina unstable |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127460571 | 12746057 | 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 |
|---|---|---|---|---|---|---|
| 127460571 | 12746057 | 1 | 20080423 | 20091222 | 0 | |
| 127460571 | 12746057 | 2 | 20080219 | 0 | ||
| 127460571 | 12746057 | 3 | 20080826 | 0 | ||
| 127460571 | 12746057 | 4 | 20090826 | 0 | ||
| 127460571 | 12746057 | 5 | 20090115 | 0 | ||
| 127460571 | 12746057 | 6 | 20090421 | 20090724 | 0 | |
| 127460571 | 12746057 | 7 | 20080423 | 0 | ||
| 127460571 | 12746057 | 9 | 20090211 | 0 | ||
| 127460571 | 12746057 | 10 | 20090421 | 0 | ||
| 127460571 | 12746057 | 12 | 20090724 | 0 |