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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125956651 | 12595665 | 1 | I | 20160115 | 20160718 | 20160726 | 20160726 | EXP | PHHY2016FR099700 | SANDOZ | 24.00 | YR | M | Y | 0.00000 | 20160726 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125956651 | 12595665 | 1 | PS | IBUPROFEN SANDOZ | IBUPROFEN | 1 | Oral | 400 MG, TID | Y | U | 70733 | 400 | MG | FILM-COATED TABLET | TID | ||||
| 125956651 | 12595665 | 2 | SS | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | 2 G, BID | Y | U | 0 | 2 | G | ORAL SUSPENSION | BID | ||||
| 125956651 | 12595665 | 3 | SS | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 1 G, TID | Y | U | 0 | 1 | G | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125956651 | 12595665 | 1 | Pyrexia |
| 125956651 | 12595665 | 2 | Infection |
| 125956651 | 12595665 | 3 | Pyrexia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125956651 | 12595665 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125956651 | 12595665 | Hepatitis | |
| 125956651 | 12595665 | Mononucleosis syndrome |
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 |
|---|---|---|---|---|---|---|
| 125956651 | 12595665 | 1 | 20160111 | 20160120 | 0 | |
| 125956651 | 12595665 | 2 | 20160111 | 20160515 | 0 | |
| 125956651 | 12595665 | 3 | 20160111 | 20160120 | 0 |