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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126067552 | 12606755 | 2 | F | 20160720 | 20160729 | 20160802 | EXP | ES-ALVOGEN-2016-ALVOGEN-026610 | ALVOGEN | ACOSTA-MATERAN C, DIAZ-OLIVA E, FERNANDEZ-RODRIGUEZ D, HERNANDEZ-AFONSO J. QT INTERVAL PROLONGATION AND TORSADE DE POINTES: SYNERGISTIC EFFECT OF FLECAINIDE AND H1 RECEPTOR ANTAGONISTS. J PHARMACOL PHARMACOTHER. 2016 APR-JUN;7(2):102-5. | 65.00 | YR | F | Y | 0.00000 | 20160802 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126067552 | 12606755 | 1 | PS | FLECAINIDE | FLECAINIDE | 1 | U | 18830 | 50 | MG | |||||||||
| 126067552 | 12606755 | 2 | SS | LORATADINE. | LORATADINE | 1 | U | 0 | 10 | MG | |||||||||
| 126067552 | 12606755 | 3 | SS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | U | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126067552 | 12606755 | 1 | Sinus arrhythmia |
| 126067552 | 12606755 | 2 | Rash pruritic |
| 126067552 | 12606755 | 3 | Rash pruritic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126067552 | 12606755 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126067552 | 12606755 | Cardiac arrest | |
| 126067552 | 12606755 | Drug interaction | |
| 126067552 | 12606755 | Electrocardiogram QT prolonged | |
| 126067552 | 12606755 | Torsade de pointes | |
| 126067552 | 12606755 | Ventricular fibrillation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |