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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126532091 | 12653209 | 1 | I | 2013 | 20160602 | 20160815 | 20160815 | PER | US-ENDO PHARMACEUTICALS INC.-2016-003710 | ENDO | 0.00 | M | Y | 108.05000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126532091 | 12653209 | 1 | PS | LACTULOSE ORAL SOLUTION | LACTULOSE | 1 | Oral | Y | 75993 | 15 | ML | SOLUTION | |||||||
| 126532091 | 12653209 | 2 | SS | LACTULOSE ORAL SOLUTION | LACTULOSE | 1 | Oral | Y | 75993 | 15 | ML | SOLUTION | |||||||
| 126532091 | 12653209 | 3 | C | AMILORIDE | AMILORIDE | 1 | Oral | 0 | 5 | MG | TABLETS | QD | |||||||
| 126532091 | 12653209 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | CAPSULE | QD | |||||||
| 126532091 | 12653209 | 5 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | TABLETS | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126532091 | 12653209 | 1 | Encephalopathy |
| 126532091 | 12653209 | 2 | Ammonia |
| 126532091 | 12653209 | 3 | Swelling |
| 126532091 | 12653209 | 4 | Gastrointestinal disorder |
| 126532091 | 12653209 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126532091 | 12653209 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126532091 | 12653209 | Diarrhoea | |
| 126532091 | 12653209 | Off label use | |
| 126532091 | 12653209 | Swollen tongue | |
| 126532091 | 12653209 | Vomiting | |
| 126532091 | 12653209 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 126532091 | 12653209 | 1 | 2013 | 201507 | 0 | |
| 126532091 | 12653209 | 2 | 201507 | 0 | ||
| 126532091 | 12653209 | 3 | 2015 | 0 |