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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125266301 | 12526630 | 1 | I | 20160118 | 20160119 | 20160705 | 20160705 | PER | US-ENDO PHARMACEUTICALS INC.-2016-000529 | ENDO | 62.17 | YR | F | Y | 49.03000 | KG | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125266301 | 12526630 | 1 | PS | NYSTATIN SUSPENSION | NYSTATIN | 1 | Oral | Y | 65148 | 500000 | DF | SUSPENSION | TID | ||||||
| 125266301 | 12526630 | 2 | SS | GATORADE | CARBOHYDRATESELECTROLYTES NOSVITAMINS | 1 | Unknown | U | 0 | UNKNOWN | |||||||||
| 125266301 | 12526630 | 3 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125266301 | 12526630 | 1 | Vulvovaginal mycotic infection |
| 125266301 | 12526630 | 2 | Product used for unknown indication |
| 125266301 | 12526630 | 3 | Thyroid disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125266301 | 12526630 | Abdominal pain | |
| 125266301 | 12526630 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 125266301 | 12526630 | 1 | 20160118 | 0 | ||
| 125266301 | 12526630 | 2 | 20160118 | 0 |