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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127599331 | 12759933 | 1 | I | 20160908 | 20160919 | 20160919 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00559 | AMNEAL | 69.00 | YR | F | Y | 65.99000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127599331 | 12759933 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | UNK | 75927 | |||||||||||
| 127599331 | 12759933 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | 75927 | ||||||||||||
| 127599331 | 12759933 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | 0 | |||||||||||
| 127599331 | 12759933 | 4 | C | chondroitin | CHONDROITIN | 1 | UNK | 0 | |||||||||||
| 127599331 | 12759933 | 5 | C | calcium | CALCIUM | 1 | UNK | 0 | |||||||||||
| 127599331 | 12759933 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | 0 | |||||||||||
| 127599331 | 12759933 | 7 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | UNK | 0 | |||||||||||
| 127599331 | 12759933 | 8 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | 0 | |||||||||||
| 127599331 | 12759933 | 9 | C | amitriptyline | AMITRIPTYLINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127599331 | 12759933 | 1 | Osteoporosis |
| 127599331 | 12759933 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127599331 | 12759933 | OT |
| 127599331 | 12759933 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127599331 | 12759933 | Arthralgia |
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 |
|---|---|---|---|---|---|---|
| 127599331 | 12759933 | 1 | 20081016 | 20100426 | 0 | |
| 127599331 | 12759933 | 3 | 20081016 | 201005 | 0 | |
| 127599331 | 12759933 | 4 | 2005 | 201005 | 0 | |
| 127599331 | 12759933 | 5 | 1998 | 0 | ||
| 127599331 | 12759933 | 6 | 1988 | 0 | ||
| 127599331 | 12759933 | 7 | 1988 | 0 | ||
| 127599331 | 12759933 | 8 | 2000 | 0 | ||
| 127599331 | 12759933 | 9 | 1987 | 201010 | 0 |