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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125573601 | 12557360 | 1 | I | 20150208 | 20160706 | 20160714 | 20160714 | EXP | IT-MINISAL02-366102 | IT-MYLANLABS-2016M1028502 | MYLAN | 0.00 | Y | 0.00000 | 20160714 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125573601 | 12557360 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 10 MG, QD | Y | 90868 | 10 | MG | QD | ||||||
| 125573601 | 12557360 | 2 | I | AMOXICILLIN/CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Oral | 2 G, QD | 0 | 2 | G | QD | |||||||
| 125573601 | 12557360 | 3 | C | METFORMINA TEVA | METFORMIN HYDROCHLORIDE | 1 | Oral | 1 DF, UNK | 0 | 1 | DF | ||||||||
| 125573601 | 12557360 | 4 | C | OMEPRAZEN /00661201/ | OMEPRAZOLE | 1 | Oral | 1 DF, UNK | 0 | 1 | DF | CAPSULE, HARD | |||||||
| 125573601 | 12557360 | 5 | C | DEBRIDAT /00465202/ | TRIMEBUTINE | 1 | Oral | 2 DF, UNK | 0 | 2 | DF | CAPSULE | |||||||
| 125573601 | 12557360 | 6 | C | BIOCHETASI /07501001/ | 2 | 1 DF, UNK | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125573601 | 12557360 | 1 | Product used for unknown indication |
| 125573601 | 12557360 | 2 | Antibiotic prophylaxis |
| 125573601 | 12557360 | 3 | Product used for unknown indication |
| 125573601 | 12557360 | 4 | Abdominal pain upper |
| 125573601 | 12557360 | 5 | Product used for unknown indication |
| 125573601 | 12557360 | 6 | Vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125573601 | 12557360 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125573601 | 12557360 | Drug interaction | |
| 125573601 | 12557360 | Jaundice | |
| 125573601 | 12557360 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 125573601 | 12557360 | 2 | 20150121 | 20150126 | 0 | |
| 125573601 | 12557360 | 4 | 20150131 | 20150209 | 0 | |
| 125573601 | 12557360 | 5 | 20150131 | 20150209 | 0 | |
| 125573601 | 12557360 | 6 | 20150131 | 20150203 | 0 |