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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127770531 | 12777053 | 1 | I | 20081108 | 20160909 | 20160923 | 20160923 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00597 | AMNEAL | 69.00 | YR | F | Y | 173.50000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127770531 | 12777053 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | UNK | Y | 75927 | ||||||||||
| 127770531 | 12777053 | 2 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Intra-articular | UNK | Y | U | 0 | INJECTION | |||||||
| 127770531 | 12777053 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 20 MG, 1X/DAY | 0 | 20 | MG | TABLET | QD | |||||||
| 127770531 | 12777053 | 4 | C | asaphen | ASPIRIN | 1 | 80 MG, 1X/DAY | 0 | 80 | MG | TABLET | QD | |||||||
| 127770531 | 12777053 | 5 | C | Nitro | NITROGLYCERIN | 1 | UNK | U | U | 0 | |||||||||
| 127770531 | 12777053 | 6 | C | SUMATRIPTAN SUCCINATE. | SUMATRIPTAN SUCCINATE | 1 | UNK | U | U | 0 | |||||||||
| 127770531 | 12777053 | 7 | C | carbocal D 400 | 2 | UNK | U | U | 0 | ||||||||||
| 127770531 | 12777053 | 8 | C | SENOKOT | SENNOSIDES | 1 | UNK | U | U | 0 | |||||||||
| 127770531 | 12777053 | 9 | C | DETROL LA | TOLTERODINE TARTRATE | 1 | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127770531 | 12777053 | 1 | Osteoarthritis |
| 127770531 | 12777053 | 2 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127770531 | 12777053 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127770531 | 12777053 | Colitis ischaemic | |
| 127770531 | 12777053 | Diarrhoea | |
| 127770531 | 12777053 | Drug interaction |
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 |
|---|---|---|---|---|---|---|
| 127770531 | 12777053 | 1 | 20081106 | 20081109 | 0 | |
| 127770531 | 12777053 | 2 | 20081108 | 20081108 | 0 | |
| 127770531 | 12777053 | 3 | 20081106 | 0 | ||
| 127770531 | 12777053 | 4 | 20140817 | 0 |