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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119854428 | 11985442 | 8 | F | 20061209 | 20160922 | 20160201 | 20160929 | EXP | US-DSJP-DSU-2015-121201 | DAIICHI | 0.00 | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119854428 | 11985442 | 1 | PS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK | Y | Y | 21286 | TABLET | ||||||||
| 119854428 | 11985442 | 2 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 40 MG, QD | Y | Y | 21286 | 40 | MG | TABLET | QD | ||||
| 119854428 | 11985442 | 3 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 20 MG, QD | Y | Y | 21286 | 20 | MG | TABLET | QD | ||||
| 119854428 | 11985442 | 4 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | UNK | Y | Y | 21286 | TABLET | ||||||||
| 119854428 | 11985442 | 5 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 40/12.5MG, QD | 0 | 1 | DF | FILM-COATED TABLET | QD | ||||||
| 119854428 | 11985442 | 6 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 119854428 | 11985442 | 7 | C | DIOVAN | VALSARTAN | 1 | 160 MG, QD | 0 | 160 | MG | QD | ||||||||
| 119854428 | 11985442 | 8 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | 100 MG, QD | 0 | 100 | MG | QD | ||||||||
| 119854428 | 11985442 | 9 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 119854428 | 11985442 | 10 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0.5 MG, QD | 0 | .5 | MG | QD | ||||||||
| 119854428 | 11985442 | 11 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0 | ||||||||||||
| 119854428 | 11985442 | 12 | C | CALTRATE WITH VITAMIN D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | UNK, QD | 0 | QD | ||||||||||
| 119854428 | 11985442 | 13 | C | PROBIOTIC /06395501/ | BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS | 1 | UNK, QD | 0 | QD | ||||||||||
| 119854428 | 11985442 | 14 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | 5 MG, QD | 0 | 5 | MG | TABLET | QD | |||||||
| 119854428 | 11985442 | 15 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | 2.5 MG | 0 | 2.5 | MG | TABLET | ||||||||
| 119854428 | 11985442 | 16 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Oral | 81 MG, QD | 0 | 81 | MG | QD | |||||||
| 119854428 | 11985442 | 17 | C | COZAAR | LOSARTAN POTASSIUM | 1 | 100/12.5 MG, UNK | 0 | 1 | DF | |||||||||
| 119854428 | 11985442 | 18 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 119854428 | 11985442 | 19 | C | KRILL OIL | DIETARY SUPPLEMENT | 1 | UNK, QD | 0 | QD | ||||||||||
| 119854428 | 11985442 | 20 | C | MULTIVITAMIN /00097801/ | VITAMINS | 1 | Oral | UNK, QD | 0 | CAPSULE | QD | ||||||||
| 119854428 | 11985442 | 21 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 5 MG, AS NEEDED | 0 | 5 | MG | ||||||||
| 119854428 | 11985442 | 22 | C | ESTRING | ESTRADIOL | 1 | 2 MG, UNK | 0 | 2 | MG | |||||||||
| 119854428 | 11985442 | 23 | C | RESTASIS | CYCLOSPORINE | 1 | 1 DROPS, BID | 0 | BID | ||||||||||
| 119854428 | 11985442 | 24 | C | B COMPLEX /00322001/ | CALCIUM PANTOTHENATECYANOCOBALAMINNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVINTHIAMINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 119854428 | 11985442 | 25 | C | CALCIUM | CALCIUM | 1 | Oral | 600 MG, BID | 0 | 600 | MG | TABLET | BID | ||||||
| 119854428 | 11985442 | 26 | C | COENZYME Q10 | UBIDECARENONE | 1 | 100 MG, QD | 0 | 100 | MG | QD | ||||||||
| 119854428 | 11985442 | 27 | C | VITAMIN E-C | 2 | UNK | 0 | ||||||||||||
| 119854428 | 11985442 | 28 | C | ACEEL | 2 | UNK | 0 | ||||||||||||
| 119854428 | 11985442 | 29 | C | FLAXSEED | FLAX SEED | 1 | 1 DF, QD | 0 | 1 | DF | QD | ||||||||
| 119854428 | 11985442 | 30 | C | RED YEAST RICE | DIETARY SUPPLEMENT | 1 | 2 PILLS, QD | 0 | 2 | DF | CAPSULE | QD | |||||||
| 119854428 | 11985442 | 31 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 50 MG, TID | 0 | 50 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119854428 | 11985442 | 1 | Hypertension |
| 119854428 | 11985442 | 5 | Hypertension |
| 119854428 | 11985442 | 6 | Hypertension |
| 119854428 | 11985442 | 7 | Hypertension |
| 119854428 | 11985442 | 8 | Hypertension |
| 119854428 | 11985442 | 10 | Depression |
| 119854428 | 11985442 | 11 | Anxiety |
| 119854428 | 11985442 | 12 | Supplementation therapy |
| 119854428 | 11985442 | 13 | Supplementation therapy |
| 119854428 | 11985442 | 14 | Hypertension |
| 119854428 | 11985442 | 16 | Cardiac disorder |
| 119854428 | 11985442 | 17 | Hypertension |
| 119854428 | 11985442 | 18 | Depression |
| 119854428 | 11985442 | 19 | Supplementation therapy |
| 119854428 | 11985442 | 20 | Supplementation therapy |
| 119854428 | 11985442 | 21 | Insomnia |
| 119854428 | 11985442 | 22 | Product used for unknown indication |
| 119854428 | 11985442 | 23 | Dry eye |
| 119854428 | 11985442 | 24 | Product used for unknown indication |
| 119854428 | 11985442 | 25 | Calcium deficiency |
| 119854428 | 11985442 | 26 | Product used for unknown indication |
| 119854428 | 11985442 | 27 | Product used for unknown indication |
| 119854428 | 11985442 | 28 | Product used for unknown indication |
| 119854428 | 11985442 | 29 | Product used for unknown indication |
| 119854428 | 11985442 | 30 | Product used for unknown indication |
| 119854428 | 11985442 | 31 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119854428 | 11985442 | OT |
| 119854428 | 11985442 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119854428 | 11985442 | Colon adenoma | |
| 119854428 | 11985442 | Haemorrhoids | |
| 119854428 | 11985442 | Hepatic cyst | |
| 119854428 | 11985442 | Hepatitis | |
| 119854428 | 11985442 | Hypotension | |
| 119854428 | 11985442 | 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 |
|---|---|---|---|---|---|---|
| 119854428 | 11985442 | 1 | 2006 | 0 | ||
| 119854428 | 11985442 | 5 | 20090205 | 201211 | 0 |