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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112354067 | 11235406 | 7 | F | 20111031 | 20160920 | 20150702 | 20160927 | EXP | US-DSJP-DSU-2015-120467 | DAIICHI | 38.15 | YR | M | Y | 69.00000 | KG | 20160927 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112354067 | 11235406 | 1 | PS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 20 MG, QD | 220 | MG | Y | 21286 | 20 | MG | TABLET | QD | |||
| 112354067 | 11235406 | 2 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 40 MG, QD | 220 | MG | Y | 21286 | 40 | MG | TABLET | QD | |||
| 112354067 | 11235406 | 3 | SS | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | Oral | 625 MG, QID | Y | 0 | 625 | MG | TABLET | QID | |||||
| 112354067 | 11235406 | 4 | SS | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | Oral | 1875 MG, BID | Y | 0 | 1875 | MG | TABLET | BID | |||||
| 112354067 | 11235406 | 5 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | 10 MG, QD | 0 | 10 | MG | QD | ||||||||
| 112354067 | 11235406 | 6 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 | |||||||||||
| 112354067 | 11235406 | 7 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 6.25 MG, BID | 0 | 6.25 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112354067 | 11235406 | 1 | Hypertension |
| 112354067 | 11235406 | 3 | Product used for unknown indication |
| 112354067 | 11235406 | 5 | Product used for unknown indication |
| 112354067 | 11235406 | 6 | Product used for unknown indication |
| 112354067 | 11235406 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112354067 | 11235406 | HO |
| 112354067 | 11235406 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112354067 | 11235406 | Acute kidney injury | |
| 112354067 | 11235406 | Anxiety | |
| 112354067 | 11235406 | Chest pain | |
| 112354067 | 11235406 | Clostridium difficile infection | |
| 112354067 | 11235406 | Depression | |
| 112354067 | 11235406 | Diverticulum intestinal | |
| 112354067 | 11235406 | Dysphagia | |
| 112354067 | 11235406 | Haematuria | |
| 112354067 | 11235406 | Haemorrhoids | |
| 112354067 | 11235406 | Hiatus hernia | |
| 112354067 | 11235406 | Insomnia | |
| 112354067 | 11235406 | Irritable bowel syndrome | |
| 112354067 | 11235406 | Malabsorption |
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 |
|---|---|---|---|---|---|---|
| 112354067 | 11235406 | 1 | 20120130 | 20120209 | 0 | |
| 112354067 | 11235406 | 2 | 20120209 | 0 | ||
| 112354067 | 11235406 | 3 | 20141014 | 0 | ||
| 112354067 | 11235406 | 5 | 20120403 | 20140121 | 0 | |
| 112354067 | 11235406 | 6 | 20130613 | 20131023 | 0 | |
| 112354067 | 11235406 | 7 | 20150325 | 0 |