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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393842 | 12539384 | 2 | F | 201604 | 20160714 | 20160708 | 20160720 | EXP | US-BAUSCH-BL-2016-016287 | BAUSCH AND LOMB | 61.00 | YR | F | Y | 93.52000 | KG | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393842 | 12539384 | 1 | PS | XIFAXAN | RIFAXIMIN | 1 | Oral | PYMF | 21361 | 550 | MG | TABLET | BID | ||||||
| 125393842 | 12539384 | 2 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 0 | 100 | MG | |||||||||
| 125393842 | 12539384 | 3 | SS | METOPROLOL. | METOPROLOL | 1 | Oral | Y | 0 | 25 | MG | ||||||||
| 125393842 | 12539384 | 4 | C | LACTULOSE. | LACTULOSE | 1 | Oral | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125393842 | 12539384 | 1 | Hepatic cirrhosis |
| 125393842 | 12539384 | 2 | Hypertension |
| 125393842 | 12539384 | 3 | Hypertension |
| 125393842 | 12539384 | 4 | Hepatic cirrhosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125393842 | 12539384 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125393842 | 12539384 | Altered state of consciousness | |
| 125393842 | 12539384 | Angiopathy | |
| 125393842 | 12539384 | Blood magnesium decreased | |
| 125393842 | 12539384 | Dyspnoea | |
| 125393842 | 12539384 | Fatigue | |
| 125393842 | 12539384 | Palpitations | |
| 125393842 | 12539384 | Peripheral swelling | |
| 125393842 | 12539384 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 125393842 | 12539384 | 1 | 201601 | 0 | ||
| 125393842 | 12539384 | 2 | 201604 | 0 | ||
| 125393842 | 12539384 | 3 | 201606 | 201606 | 0 | |
| 125393842 | 12539384 | 4 | 201501 | 0 |