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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124369093 | 12436909 | 3 | F | 20160705 | 20160606 | 20160714 | PER | PHEH2016US012826 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160714 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124369093 | 12436909 | 1 | PS | ENTRESTO | SACUBITRILVALSARTAN | 1 | Oral | 50 MG, BID | U | F0003 | 207620 | 50 | MG | TABLET | BID | ||||
| 124369093 | 12436909 | 2 | SS | ENTRESTO | SACUBITRILVALSARTAN | 1 | U | 207620 | TABLET | ||||||||||
| 124369093 | 12436909 | 3 | SS | EPINEPHRINE. | EPINEPHRINE | 1 | Unknown | U | 0 | ||||||||||
| 124369093 | 12436909 | 4 | C | IMDUR | ISOSORBIDE MONONITRATE | 1 | Oral | 1 DF, QD (AM-MORNING) | U | 0 | 1 | DF | TABLET | QD | |||||
| 124369093 | 12436909 | 5 | C | RANEXA | RANOLAZINE | 1 | Oral | 1 UNK, (7 AM AND 5 PM) | U | 0 | 1 | DF | BID | ||||||
| 124369093 | 12436909 | 6 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 0.5 UNK, (7 AM- MON, WED, FRI) | U | 0 | .5 | DF | |||||||
| 124369093 | 12436909 | 7 | C | ALDACTONE | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 124369093 | 12436909 | 8 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Oral | 1 DF, (AM AND PM- MORNING AND EVENING ) | U | 0 | 1 | DF | TABLET | BID | |||||
| 124369093 | 12436909 | 9 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | U | 0 | TABLET | ||||||||||
| 124369093 | 12436909 | 10 | C | LASIX | FUROSEMIDE | 1 | 40 MG, (5 PM-MON, WED, FRI) | U | 0 | 40 | MG | ||||||||
| 124369093 | 12436909 | 11 | C | LASIX | FUROSEMIDE | 1 | 20 MG, (5 PM -TUE, THUR, SAT AND SUN) | U | 0 | 20 | MG | ||||||||
| 124369093 | 12436909 | 12 | C | ELIQUIS | APIXABAN | 1 | Oral | 1 DF, Q12H (7 AM AND 7 PM) | U | 0 | 1 | DF | TABLET | Q12H | |||||
| 124369093 | 12436909 | 13 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 1 DF, QD (7 PM- M,T,W,TH, F ONE HOUR BEFORE BREAKFAST) | U | 0 | 1 | DF | QD | |||||||
| 124369093 | 12436909 | 14 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0.5 DF, (SAT AND SUN) | U | 0 | .5 | DF | ||||||||
| 124369093 | 12436909 | 15 | C | VYTORIN | EZETIMIBESIMVASTATIN | 1 | Oral | 10/40 TABLET 0.5 DF, (BEDTIME) | U | 0 | .5 | DF | TABLET | QD | |||||
| 124369093 | 12436909 | 16 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 1 DF, (BEDTIME) | U | 0 | 1 | DF | |||||||
| 124369093 | 12436909 | 17 | C | RESTORIL | TEMAZEPAM | 1 | Oral | 1 -2 AT BED TIME, PRN | U | 0 | CAPSULE | ||||||||
| 124369093 | 12436909 | 18 | C | COQ10 | UBIDECARENONE | 1 | Oral | UNK UNK, QD (MORNING) | U | 0 | 1 | DF | QD | ||||||
| 124369093 | 12436909 | 19 | C | B6 | PYRIDOXINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD (MORNING) | U | 0 | 1 | DF | QD | ||||||
| 124369093 | 12436909 | 20 | C | B COMPLEX /00322001/ | 2 | Oral | 1 DF, QD (MORNING) | U | 0 | 1 | DF | QD | |||||||
| 124369093 | 12436909 | 21 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | BID | ||||||
| 124369093 | 12436909 | 22 | C | GAS-X | DIMETHICONE | 1 | Oral | 1 UNK, (DINNER + BED TIME) | U | 0 | SOFT GELATIN CAPSULE | ||||||||
| 124369093 | 12436909 | 23 | C | ZYTREC | 2 | Oral | 1 DF, QD (MORNING) | U | 0 | 1 | DF | QD | |||||||
| 124369093 | 12436909 | 24 | C | FOLIC | FOLIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 124369093 | 12436909 | 25 | C | BEANO | ASPERGILLUS NIGER .ALPHA.-GALACTOSIDASE | 1 | Oral | 1 UNK, (BEFORE A MEAL) | U | 0 | |||||||||
| 124369093 | 12436909 | 26 | C | NICOTINE. | NICOTINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124369093 | 12436909 | 1 | Blood pressure measurement |
| 124369093 | 12436909 | 3 | Product used for unknown indication |
| 124369093 | 12436909 | 4 | Vasodilatation |
| 124369093 | 12436909 | 5 | Chest pain |
| 124369093 | 12436909 | 6 | Swelling |
| 124369093 | 12436909 | 7 | Cardiac discomfort |
| 124369093 | 12436909 | 8 | Blood pressure abnormal |
| 124369093 | 12436909 | 9 | Cardiac discomfort |
| 124369093 | 12436909 | 10 | Blood pressure abnormal |
| 124369093 | 12436909 | 11 | Swelling |
| 124369093 | 12436909 | 12 | Prophylaxis |
| 124369093 | 12436909 | 13 | Thyroid disorder |
| 124369093 | 12436909 | 15 | Blood cholesterol abnormal |
| 124369093 | 12436909 | 16 | Abdominal discomfort |
| 124369093 | 12436909 | 17 | Sleep disorder |
| 124369093 | 12436909 | 18 | Product used for unknown indication |
| 124369093 | 12436909 | 19 | Product used for unknown indication |
| 124369093 | 12436909 | 20 | Product used for unknown indication |
| 124369093 | 12436909 | 21 | Product used for unknown indication |
| 124369093 | 12436909 | 22 | Product used for unknown indication |
| 124369093 | 12436909 | 23 | Hypersensitivity |
| 124369093 | 12436909 | 24 | Product used for unknown indication |
| 124369093 | 12436909 | 25 | Product used for unknown indication |
| 124369093 | 12436909 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124369093 | 12436909 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124369093 | 12436909 | Hypertension | |
| 124369093 | 12436909 | Product use issue | |
| 124369093 | 12436909 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 124369093 | 12436909 | 1 | 201605 | 0 | ||
| 124369093 | 12436909 | 2 | 20160507 | 0 |