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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 859130611 | 8591306 | 11 | F | 2009 | 20160826 | 20120601 | 20160901 | EXP | PHHY2012MX046300 | NOVARTIS | 82.11 | YR | F | Y | 61.00000 | KG | 20160901 | CN | COUNTRY NOT SPECIFIED | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 859130611 | 8591306 | 1 | PS | DIOVAN | VALSARTAN | 1 | Oral | 480 MG, 320MG, (ONE TABLET IN THE MORNING) AND 160MG (ONE TABLET IN THE EVENING) | Y | Z0059/ 20060/Z0048/20050 | 21283 | 480 | MG | TABLET | QD | ||||
| 859130611 | 8591306 | 2 | SS | DIOVAN | VALSARTAN | 1 | Oral | 320 MG BID (IN THE MORNINGS AND IN THE EVENINGS) DAILY | Y | 21283 | 320 | MG | TABLET | BID | |||||
| 859130611 | 8591306 | 3 | SS | VALSARTAN. | VALSARTAN | 1 | Unknown | 2 DF, UNK | 0 | 2 | DF | ||||||||
| 859130611 | 8591306 | 4 | C | TENORETIC | ATENOLOLCHLORTHALIDONE | 1 | Unknown | UNK UNK, QD | 0 | QD | |||||||||
| 859130611 | 8591306 | 5 | C | SOTOPER | 2 | Unknown | 160 MG, QD | U | 0 | 160 | MG | QD | |||||||
| 859130611 | 8591306 | 6 | C | SOTOPER | 2 | Unknown | 2 DF, QD | U | 0 | 2 | DF | QD | |||||||
| 859130611 | 8591306 | 7 | C | MODURETIC 5-50 | AMILORIDE HYDROCHLORIDEHYDROCHLOROTHIAZIDE | 1 | Unknown | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 859130611 | 8591306 | 8 | C | ANAPSIQUE | 2 | Unknown | Y | 0 | |||||||||||
| 859130611 | 8591306 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG, IN THE MORNING | U | 0 | 20 | MG | |||||||
| 859130611 | 8591306 | 10 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Unknown | U | 0 | ||||||||||
| 859130611 | 8591306 | 11 | C | URO-VAXOM | 2 | Unknown | 0 | ||||||||||||
| 859130611 | 8591306 | 12 | C | URO-VAXOM | 2 | Unknown | 1 DF, FOR 4 MONTHS | 0 | 1 | DF | |||||||||
| 859130611 | 8591306 | 13 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | 160 MG, QD | 0 | 160 | MG | QD | |||||||
| 859130611 | 8591306 | 14 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 859130611 | 8591306 | 15 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 859130611 | 8591306 | 16 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | 0.5 DF, QD | U | 0 | .5 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 859130611 | 8591306 | 1 | Hypertension |
| 859130611 | 8591306 | 3 | Product used for unknown indication |
| 859130611 | 8591306 | 4 | Hypertension |
| 859130611 | 8591306 | 5 | Product used for unknown indication |
| 859130611 | 8591306 | 7 | Diuretic therapy |
| 859130611 | 8591306 | 8 | Product used for unknown indication |
| 859130611 | 8591306 | 9 | Product used for unknown indication |
| 859130611 | 8591306 | 10 | Product used for unknown indication |
| 859130611 | 8591306 | 11 | Cystitis |
| 859130611 | 8591306 | 12 | Escherichia infection |
| 859130611 | 8591306 | 13 | Product used for unknown indication |
| 859130611 | 8591306 | 14 | Blood cholesterol abnormal |
| 859130611 | 8591306 | 15 | Blood triglycerides abnormal |
| 859130611 | 8591306 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 859130611 | 8591306 | OT |
| 859130611 | 8591306 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 859130611 | 8591306 | Abdominal discomfort | |
| 859130611 | 8591306 | Abdominal pain lower | |
| 859130611 | 8591306 | Anxiety | |
| 859130611 | 8591306 | Arrhythmia | |
| 859130611 | 8591306 | Benign breast neoplasm | |
| 859130611 | 8591306 | Blood pressure fluctuation | |
| 859130611 | 8591306 | Blood pressure increased | |
| 859130611 | 8591306 | Blood sodium decreased | |
| 859130611 | 8591306 | Burning sensation | |
| 859130611 | 8591306 | Cystitis escherichia | |
| 859130611 | 8591306 | Disease susceptibility | |
| 859130611 | 8591306 | Drug intolerance | |
| 859130611 | 8591306 | Dysphonia | |
| 859130611 | 8591306 | Fall | |
| 859130611 | 8591306 | Feeling abnormal | |
| 859130611 | 8591306 | Haemoglobin decreased | |
| 859130611 | 8591306 | Head discomfort | |
| 859130611 | 8591306 | Hypoacusis | |
| 859130611 | 8591306 | Intentional overdose | |
| 859130611 | 8591306 | Ligament rupture | |
| 859130611 | 8591306 | Ligament sprain | |
| 859130611 | 8591306 | Limb injury | |
| 859130611 | 8591306 | Localised oedema | |
| 859130611 | 8591306 | Lower limb fracture | |
| 859130611 | 8591306 | Rash pruritic | |
| 859130611 | 8591306 | Skin exfoliation | |
| 859130611 | 8591306 | Sleep disorder | |
| 859130611 | 8591306 | Swelling face | |
| 859130611 | 8591306 | Tachycardia | |
| 859130611 | 8591306 | Thyroid adenoma | |
| 859130611 | 8591306 | Tinnitus | |
| 859130611 | 8591306 | Urine analysis abnormal | |
| 859130611 | 8591306 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 859130611 | 8591306 | 1 | 201310 | 0 | ||
| 859130611 | 8591306 | 2 | 201310 | 201607 | 0 | |
| 859130611 | 8591306 | 3 | 201607 | 0 |