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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199831 | 12619983 | 1 | I | 20160725 | 20160729 | 20160803 | 20160803 | PER | US-SHIRE-US201609686 | SHIRE | 79.71 | YR | F | Y | 50.79000 | KG | 20160803 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199831 | 12619983 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 2000 MG(FOUR 500MG TABLETS IN AM AND FOUR 500MG TABLETS IN PM), 2X/DAY:BID | 20049 | 2000 | MG | CAPSULE | BID | ||||||
| 126199831 | 12619983 | 2 | C | LOSARTAN + HIDROCLOROTIAZIDA /01284801/ | HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM | 1 | Oral | (ONE HALF 125MG TABLET)1X/DAY:QD | 0 | TABLET | QD | ||||||||
| 126199831 | 12619983 | 3 | C | JANUMET | METFORMIN HYDROCHLORIDESITAGLIPTIN PHOSPHATE | 1 | Oral | 500 MG, 2X/DAY:BID | 0 | 500 | MG | BID | |||||||
| 126199831 | 12619983 | 4 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 40 MG, 1X/DAY:QD | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126199831 | 12619983 | 1 | Crohn's disease |
| 126199831 | 12619983 | 2 | Product used for unknown indication |
| 126199831 | 12619983 | 3 | Diabetes mellitus |
| 126199831 | 12619983 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126199831 | 12619983 | Nasopharyngitis | |
| 126199831 | 12619983 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 126199831 | 12619983 | 1 | 2014 | 0 |