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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125502782 | 12550278 | 2 | F | 2016 | 20160809 | 20160712 | 20160815 | EXP | US-BAUSCH-BL-2016-016302 | BAUSCH AND LOMB | 56.00 | YR | M | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125502782 | 12550278 | 1 | PS | XIFAXAN | RIFAXIMIN | 1 | Oral | 21361 | 550 | MG | TABLET | BID | |||||||
| 125502782 | 12550278 | 2 | SS | XIFAXAN | RIFAXIMIN | 1 | Oral | 21361 | 550 | MG | TABLET | BID | |||||||
| 125502782 | 12550278 | 3 | SS | LACTULOSE. | LACTULOSE | 1 | Oral | 0 | 45 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125502782 | 12550278 | 1 | Hepatic encephalopathy |
| 125502782 | 12550278 | 2 | Ammonia increased |
| 125502782 | 12550278 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125502782 | 12550278 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125502782 | 12550278 | Ammonia increased | |
| 125502782 | 12550278 | Blood test abnormal | |
| 125502782 | 12550278 | Condition aggravated | |
| 125502782 | 12550278 | Dementia | |
| 125502782 | 12550278 | Drug dose omission | |
| 125502782 | 12550278 | Dysphagia | |
| 125502782 | 12550278 | Feeling abnormal | |
| 125502782 | 12550278 | Hospice care | |
| 125502782 | 12550278 | Liver disorder | |
| 125502782 | 12550278 | Pneumonia | |
| 125502782 | 12550278 | Renal disorder |
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 |
|---|---|---|---|---|---|---|
| 125502782 | 12550278 | 1 | 2015 | 201606 | 0 | |
| 125502782 | 12550278 | 2 | 2016 | 0 | ||
| 125502782 | 12550278 | 3 | 2015 | 0 |