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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124558303 | 12455830 | 3 | F | 20160715 | 20160610 | 20160725 | EXP | US-009507513-1606USA004754 | MERCK | 45.00 | YR | F | Y | 0.00000 | 20160725 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124558303 | 12455830 | 1 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Oral | UNK | Y | 20829 | TABLET | ||||||||
| 124558303 | 12455830 | 2 | SS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Y | 20829 | TABLET | ||||||||||
| 124558303 | 12455830 | 3 | C | NIFEDIPINE. | NIFEDIPINE | 1 | Oral | UNK | U | 0 | CAPSULE | ||||||||
| 124558303 | 12455830 | 4 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124558303 | 12455830 | 1 | Urticaria chronic |
| 124558303 | 12455830 | 2 | Pruritus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124558303 | 12455830 | HO |
| 124558303 | 12455830 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124558303 | 12455830 | Drug-induced liver injury | |
| 124558303 | 12455830 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |