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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678511 | 12767851 | 1 | I | 20091101 | 20160908 | 20160921 | 20160921 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00547 | AMNEAL | 59.00 | YR | M | Y | 87.50000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678511 | 12767851 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK | Y | U | 75927 | ||||||||
| 127678511 | 12767851 | 2 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 20MG, 1X/DAY OR 40 MG ONCE DAILY | 3299.2229 | MG | Y | U | 0 | 20 | MG | CAPSULE | QD | |||
| 127678511 | 12767851 | 3 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 127678511 | 12767851 | 4 | C | isosorbite mononitrate | 2 | Oral | 20 MG, 3X/DAY | Y | U | 0 | 20 | MG | CAPSULE | TID | |||||
| 127678511 | 12767851 | 5 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 50 MG, 2X/DAY | Y | U | 0 | 50 | MG | CAPSULE | BID | ||||
| 127678511 | 12767851 | 6 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0.5 MG UNK AS NEEDED | 0 | .5 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127678511 | 12767851 | 1 | Osteoarthritis |
| 127678511 | 12767851 | 2 | Prophylaxis against gastrointestinal ulcer |
| 127678511 | 12767851 | 3 | Insomnia |
| 127678511 | 12767851 | 4 | Angina pectoris |
| 127678511 | 12767851 | 5 | Hypertension |
| 127678511 | 12767851 | 6 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127678511 | 12767851 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127678511 | 12767851 | 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 |
|---|---|---|---|---|---|---|
| 127678511 | 12767851 | 1 | 20090520 | 20091114 | 0 | |
| 127678511 | 12767851 | 2 | 20090521 | 20091113 | 0 | |
| 127678511 | 12767851 | 3 | 200610 | 0 | ||
| 127678511 | 12767851 | 4 | 200610 | 20091120 | 0 | |
| 127678511 | 12767851 | 5 | 200610 | 20091120 | 0 | |
| 127678511 | 12767851 | 6 | 200904 | 0 |