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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124535102 | 12453510 | 2 | F | 2010 | 20151104 | 20160609 | 20160720 | PER | US-DSJP-DSU-2015-125962 | DAIICHI | 67.73 | YR | F | Y | 95.24000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124535102 | 12453510 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 20/12.5 MG, QD | Y | 21532 | FILM-COATED TABLET | QD | |||||||
| 124535102 | 12453510 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 40/12.5 MG, QD | Y | 21532 | FILM-COATED TABLET | QD | |||||||
| 124535102 | 12453510 | 3 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | 40 MG, UNK | Y | 0 | 40 | MG | TABLET | QD | ||||||
| 124535102 | 12453510 | 4 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | 40 MG, QD | Y | 0 | 40 | MG | TABLET | QD | ||||||
| 124535102 | 12453510 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | BID | |||||||
| 124535102 | 12453510 | 6 | C | AMARYL | GLIMEPIRIDE | 1 | Oral | 4 MG, UNK | 0 | 4 | MG | ||||||||
| 124535102 | 12453510 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 50 ?G, QD | 0 | 50 | UG | QD | |||||||
| 124535102 | 12453510 | 8 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Oral | 160 MG, QHS | 0 | 160 | MG | QD | |||||||
| 124535102 | 12453510 | 9 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Oral | 81 MG, UNK | 0 | 81 | MG | QD | |||||||
| 124535102 | 12453510 | 10 | C | CALCIUM + VIT D | CALCIUMVITAMIN D | 1 | 600MG (1,500MG) - 400 UNITS ORAL CAPSULE ONE QD | 0 | 600 | MG | QD | ||||||||
| 124535102 | 12453510 | 11 | C | BIOTIN | BIOTIN | 1 | Oral | 2500 ?G, QD | 0 | 2500 | UG | QD | |||||||
| 124535102 | 12453510 | 12 | C | OMEGA-3 FISH OIL +VITAMIN D | 2 | Oral | 910-1,400 MG, QD | 0 | QD | ||||||||||
| 124535102 | 12453510 | 13 | C | LASIX | FUROSEMIDE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | QD | |||||||
| 124535102 | 12453510 | 14 | C | KLOR-CON M20 | POTASSIUM CHLORIDE | 1 | Oral | 20 MEQ, UNK | 0 | 20 | MEQ | QD | |||||||
| 124535102 | 12453510 | 15 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 75MG TABLET, 0.5 TABLET ORAL QHS | 0 | 75 | MG | |||||||||
| 124535102 | 12453510 | 16 | C | VILAZODONE | VILAZODONE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 124535102 | 12453510 | 17 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | 500 MG, UNK | 0 | 500 | MG | BID | |||||||
| 124535102 | 12453510 | 18 | C | OXYBUTYNIN CHLORIDE. | OXYBUTYNIN CHLORIDE | 1 | 5 MG, 5MG ORAL TABLET, THREE TABLETS PO QHS | 0 | 5 | MG | |||||||||
| 124535102 | 12453510 | 19 | C | ZYPREXA | OLANZAPINE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 124535102 | 12453510 | 20 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 124535102 | 12453510 | 21 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 124535102 | 12453510 | 22 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 40 MG, UNK | 0 | 40 | MG | QD | ||||||||
| 124535102 | 12453510 | 23 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 20 MG, QHS | 0 | 20 | MG | ||||||||
| 124535102 | 12453510 | 24 | C | LISINOPRIL + HIDROCLOROTIAZIDA | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | 12.5 MG, UNK | 0 | 12.5 | MG | |||||||||
| 124535102 | 12453510 | 25 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 124535102 | 12453510 | 26 | C | VALSARTAN. | VALSARTAN | 1 | 160 MG, UNK | 0 | 160 | MG | |||||||||
| 124535102 | 12453510 | 27 | C | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | 20 MG, UNK | 0 | 20 | MG | BID | ||||||||
| 124535102 | 12453510 | 28 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124535102 | 12453510 | 1 | Hypertension |
| 124535102 | 12453510 | 3 | Hypertension |
| 124535102 | 12453510 | 5 | Product used for unknown indication |
| 124535102 | 12453510 | 6 | Product used for unknown indication |
| 124535102 | 12453510 | 7 | Product used for unknown indication |
| 124535102 | 12453510 | 8 | Product used for unknown indication |
| 124535102 | 12453510 | 9 | Product used for unknown indication |
| 124535102 | 12453510 | 10 | Product used for unknown indication |
| 124535102 | 12453510 | 11 | Product used for unknown indication |
| 124535102 | 12453510 | 12 | Product used for unknown indication |
| 124535102 | 12453510 | 13 | Product used for unknown indication |
| 124535102 | 12453510 | 14 | Product used for unknown indication |
| 124535102 | 12453510 | 15 | Product used for unknown indication |
| 124535102 | 12453510 | 16 | Product used for unknown indication |
| 124535102 | 12453510 | 17 | Product used for unknown indication |
| 124535102 | 12453510 | 18 | Product used for unknown indication |
| 124535102 | 12453510 | 19 | Product used for unknown indication |
| 124535102 | 12453510 | 20 | Product used for unknown indication |
| 124535102 | 12453510 | 21 | Product used for unknown indication |
| 124535102 | 12453510 | 22 | Product used for unknown indication |
| 124535102 | 12453510 | 23 | Product used for unknown indication |
| 124535102 | 12453510 | 24 | Product used for unknown indication |
| 124535102 | 12453510 | 25 | Product used for unknown indication |
| 124535102 | 12453510 | 26 | Product used for unknown indication |
| 124535102 | 12453510 | 27 | Product used for unknown indication |
| 124535102 | 12453510 | 28 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124535102 | 12453510 | Constipation | |
| 124535102 | 12453510 | Dysphagia | |
| 124535102 | 12453510 | Gastrointestinal melanosis | |
| 124535102 | 12453510 | Gastrooesophageal reflux disease | |
| 124535102 | 12453510 | Hiatus hernia | |
| 124535102 | 12453510 | Irritable bowel syndrome | |
| 124535102 | 12453510 | Large intestine polyp | |
| 124535102 | 12453510 | Malabsorption | |
| 124535102 | 12453510 | Oesophageal stenosis |
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 |
|---|---|---|---|---|---|---|
| 124535102 | 12453510 | 1 | 20130514 | 201310 | 0 | |
| 124535102 | 12453510 | 2 | 201312 | 201505 | 0 | |
| 124535102 | 12453510 | 3 | 20131112 | 20150330 | 0 | |
| 124535102 | 12453510 | 4 | 20121229 | 201311 | 0 | |
| 124535102 | 12453510 | 22 | 20131112 | 20150425 | 0 | |
| 124535102 | 12453510 | 23 | 20130514 | 0 | ||
| 124535102 | 12453510 | 24 | 2013 | 0 | ||
| 124535102 | 12453510 | 25 | 20130514 | 20150411 | 0 | |
| 124535102 | 12453510 | 26 | 20150429 | 0 | ||
| 124535102 | 12453510 | 27 | 20150721 | 0 |