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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127504291 | 12750429 | 1 | I | 20101215 | 20160907 | 20160916 | 20160916 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00527 | AMNEAL | 76.00 | YR | F | Y | 89.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127504291 | 12750429 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 2X/DAY | Y | 75927 | BID | ||||||||
| 127504291 | 12750429 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | 75927 | |||||||||||
| 127504291 | 12750429 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 20 MG, 1X/DAY | 8940 | MG | Y | U | 0 | 20 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127504291 | 12750429 | 1 | Osteoarthritis |
| 127504291 | 12750429 | 2 | Rheumatoid arthritis |
| 127504291 | 12750429 | 3 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127504291 | 12750429 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127504291 | 12750429 | Anaemia | |
| 127504291 | 12750429 | Constipation | |
| 127504291 | 12750429 | Dehydration | |
| 127504291 | 12750429 | Diverticulum intestinal haemorrhagic | |
| 127504291 | 12750429 | Large intestinal ulcer | |
| 127504291 | 12750429 | Nausea | |
| 127504291 | 12750429 | Spinal compression fracture | |
| 127504291 | 12750429 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127504291 | 12750429 | 1 | 20090926 | 20101215 | 0 | |
| 127504291 | 12750429 | 3 | 20090925 | 20101215 | 0 |