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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393291 | 12539329 | 1 | I | 2002 | 20160628 | 20160708 | 20160708 | EXP | GXBR2016US002167 | SANDOZ | 72.00 | YR | M | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393291 | 12539329 | 1 | PS | OMEPRAZOLE DELAYED RELEASE | OMEPRAZOLE | 1 | Oral | 20 MG, QD | Y | 75757 | 20 | MG | EXTENDED RELEASE CAPSULES | QD | |||||
| 125393291 | 12539329 | 2 | SS | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK DF, UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125393291 | 12539329 | 1 | Gastrooesophageal reflux disease |
| 125393291 | 12539329 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125393291 | 12539329 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125393291 | 12539329 | Abdominal distension | |
| 125393291 | 12539329 | Acute kidney injury | |
| 125393291 | 12539329 | Blister | |
| 125393291 | 12539329 | Chronic kidney disease | |
| 125393291 | 12539329 | Furuncle | |
| 125393291 | 12539329 | Hypertension | |
| 125393291 | 12539329 | Hypoaesthesia | |
| 125393291 | 12539329 | Infection | |
| 125393291 | 12539329 | Joint swelling | |
| 125393291 | 12539329 | Limb discomfort | |
| 125393291 | 12539329 | Malaise | |
| 125393291 | 12539329 | Pain | |
| 125393291 | 12539329 | Peripheral swelling | |
| 125393291 | 12539329 | Pruritus | |
| 125393291 | 12539329 | Rash | |
| 125393291 | 12539329 | Skin discolouration | |
| 125393291 | 12539329 | Urinary incontinence | |
| 125393291 | 12539329 | Urinary retention | |
| 125393291 | 12539329 | Yellow skin |
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 |
|---|---|---|---|---|---|---|
| 125393291 | 12539329 | 1 | 1995 | 201512 | 0 | |
| 125393291 | 12539329 | 2 | 1995 | 0 |