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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114579163 | 11457916 | 3 | F | 20110106 | 20160512 | 20150904 | 20160705 | EXP | PHHO2011PT01052 | SANDOZ | 80.01 | YR | M | Y | 72.20000 | KG | 20160705 | MD | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114579163 | 11457916 | 1 | SS | ALISKIREN | ALISKIREN | 1 | Oral | 300 MG, UNK | Y | 0 | 300 | MG | TABLET | ||||||
| 114579163 | 11457916 | 2 | SS | ALISKIREN | ALISKIREN | 1 | Oral | 300 MG, UNK | Y | 0 | 300 | MG | TABLET | ||||||
| 114579163 | 11457916 | 3 | SS | ENALAPRIL | ENALAPRIL | 1 | Oral | 10 MG, BID | 860 | MG | Y | 0 | 10 | MG | BID | ||||
| 114579163 | 11457916 | 4 | SS | ENALAPRIL | ENALAPRIL | 1 | Oral | 10 MG, BID | 860 | MG | Y | 0 | 10 | MG | BID | ||||
| 114579163 | 11457916 | 5 | PS | DIGOXIN. | DIGOXIN | 1 | Oral | 0.125 MG, 5 TIMES A WEEK | U | 40481 | .125 | MG | |||||||
| 114579163 | 11457916 | 6 | SS | DIGOXIN. | DIGOXIN | 1 | Oral | 0.125 MG, QOD | U | 40481 | .125 | MG | |||||||
| 114579163 | 11457916 | 7 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 114579163 | 11457916 | 8 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114579163 | 11457916 | 9 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 60 MG, UNK | U | 0 | 60 | MG | |||||||
| 114579163 | 11457916 | 10 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 114579163 | 11457916 | 11 | SS | AMIODARONE | AMIODARONE | 1 | Unknown | U | U | 0 | |||||||||
| 114579163 | 11457916 | 12 | SS | BISOPROLOL | BISOPROLOL | 1 | Oral | 10 MG, QD | Y | U | 0 | 10 | MG | QD | |||||
| 114579163 | 11457916 | 13 | SS | BISOPROLOL | BISOPROLOL | 1 | Oral | 10 MG, UNK | Y | U | 0 | 10 | MG | ||||||
| 114579163 | 11457916 | 14 | SS | BISOPROLOL | BISOPROLOL | 1 | Oral | 5 MG, QD | Y | U | 0 | 5 | MG | QD | |||||
| 114579163 | 11457916 | 15 | SS | COLCHICINE. | COLCHICINE | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 16 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 17 | SS | MEROPENEM HIKMA | MEROPENEM | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 18 | SS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 19 | SS | CLINDAMICINA LABESFAL | CLINDAMYCIN HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 20 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 21 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | QD | ||||||
| 114579163 | 11457916 | 22 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 12.5 MG, QD | U | 0 | 12.5 | MG | QD | ||||||
| 114579163 | 11457916 | 23 | C | PERINDOPRIL | PERINDOPRIL | 1 | Oral | 10 MG, ID | 0 | 10 | MG | ||||||||
| 114579163 | 11457916 | 24 | C | FORMOTEROL | FORMOTEROL | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 25 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 114579163 | 11457916 | 26 | C | WARFARIN | WARFARIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114579163 | 11457916 | 1 | Cardiac failure |
| 114579163 | 11457916 | 3 | Cardiac failure |
| 114579163 | 11457916 | 5 | Cardiac failure |
| 114579163 | 11457916 | 6 | Atrial fibrillation |
| 114579163 | 11457916 | 7 | Cardiac failure chronic |
| 114579163 | 11457916 | 11 | Product used for unknown indication |
| 114579163 | 11457916 | 12 | Cardiac failure chronic |
| 114579163 | 11457916 | 15 | Product used for unknown indication |
| 114579163 | 11457916 | 16 | Product used for unknown indication |
| 114579163 | 11457916 | 17 | Product used for unknown indication |
| 114579163 | 11457916 | 18 | Product used for unknown indication |
| 114579163 | 11457916 | 19 | Product used for unknown indication |
| 114579163 | 11457916 | 20 | Cardiac failure |
| 114579163 | 11457916 | 21 | Cardiac failure |
| 114579163 | 11457916 | 23 | Cardiac failure |
| 114579163 | 11457916 | 24 | Chronic obstructive pulmonary disease |
| 114579163 | 11457916 | 25 | Chronic obstructive pulmonary disease |
| 114579163 | 11457916 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114579163 | 11457916 | OT |
| 114579163 | 11457916 | DS |
| 114579163 | 11457916 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114579163 | 11457916 | Atrial fibrillation | |
| 114579163 | 11457916 | Cardiac failure | |
| 114579163 | 11457916 | Chronic kidney disease | |
| 114579163 | 11457916 | Clostridium difficile infection | |
| 114579163 | 11457916 | Condition aggravated | |
| 114579163 | 11457916 | Cough | |
| 114579163 | 11457916 | Erysipelas | |
| 114579163 | 11457916 | Fungal oesophagitis | |
| 114579163 | 11457916 | Gout | |
| 114579163 | 11457916 | Pancytopenia | |
| 114579163 | 11457916 | Productive cough | |
| 114579163 | 11457916 | Pyrexia | |
| 114579163 | 11457916 | Respiratory tract infection | |
| 114579163 | 11457916 | Sinus node dysfunction | |
| 114579163 | 11457916 | Tracheobronchitis |
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 |
|---|---|---|---|---|---|---|
| 114579163 | 11457916 | 1 | 20101125 | 20111229 | 0 | |
| 114579163 | 11457916 | 2 | 20120111 | 20130306 | 0 | |
| 114579163 | 11457916 | 3 | 20101125 | 20111229 | 0 | |
| 114579163 | 11457916 | 4 | 20120111 | 20130306 | 0 | |
| 114579163 | 11457916 | 5 | 200912 | 20140206 | 0 | |
| 114579163 | 11457916 | 6 | 20140725 | 0 | ||
| 114579163 | 11457916 | 7 | 20120116 | 0 | ||
| 114579163 | 11457916 | 8 | 20120116 | 0 | ||
| 114579163 | 11457916 | 9 | 2013 | 20140206 | 0 | |
| 114579163 | 11457916 | 10 | 20140725 | 0 | ||
| 114579163 | 11457916 | 12 | 2011 | 20140206 | 0 | |
| 114579163 | 11457916 | 14 | 20140725 | 0 | ||
| 114579163 | 11457916 | 21 | 200912 | 20140206 | 0 | |
| 114579163 | 11457916 | 22 | 20140725 | 0 | ||
| 114579163 | 11457916 | 23 | 20130306 | 0 |