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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125756591 | 12575659 | 1 | I | 20160708 | 20160720 | 20160720 | EXP | ES-PERRIGO-16ES018064 | PERRIGO | 47.00 | YR | F | Y | 0.00000 | 20160720 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125756591 | 12575659 | 1 | PS | NAPROXEN SODIUM. | NAPROXEN SODIUM | 1 | Oral | UNK | Y | Y | UNKNOWN | 74661 | TABLET | ||||||
| 125756591 | 12575659 | 2 | SS | NAPROXEN SODIUM. | NAPROXEN SODIUM | 1 | Oral | 55 MG CUMULATIVE | Y | Y | UNKNOWN | 74661 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125756591 | 12575659 | 1 | Product used for unknown indication |
| 125756591 | 12575659 | 2 | Drug provocation test |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125756591 | 12575659 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125756591 | 12575659 | Anaphylactic reaction | |
| 125756591 | 12575659 | Oedema | |
| 125756591 | 12575659 | Pruritus | |
| 125756591 | 12575659 | Urticaria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |