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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111685472 | 11168547 | 2 | F | 20160827 | 20150605 | 20160907 | EXP | NL-IMPAX LABORATORIES, INC-2015-IPXL-00604 | IMPAX | ANDREWS L.M, PUIMAN P.J, SIJS H.V.D, BEYNUM I. M.V.. A BABY WITH DIGOXIN TOXICITY. NEDERLANDS TIJDSCHRIFT VOOR GENEESKUNDE. 2015;159:20:A8706 | 5.00 | MON | M | Y | 5.00000 | KG | 20160907 | OT | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111685472 | 11168547 | 1 | PS | DIGOXIN. | DIGOXIN | 1 | Unknown | (6 ?G/KG) PER DAY | 78556 | TABLET | |||||||||
| 111685472 | 11168547 | 2 | C | BUMETANIDE. | BUMETANIDE | 1 | Unknown | (0.3 MG/KG) PER DAY | 0 | ||||||||||
| 111685472 | 11168547 | 3 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | (1.2 MG/KG) PER DAY | 0 | ||||||||||
| 111685472 | 11168547 | 4 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Unknown | (2 MG/KG) PER DAY | 0 | ||||||||||
| 111685472 | 11168547 | 5 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | (0.2 MG/KG) PER DAY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111685472 | 11168547 | 1 | Cardiac failure |
| 111685472 | 11168547 | 2 | Cardiac failure |
| 111685472 | 11168547 | 3 | Cardiac failure |
| 111685472 | 11168547 | 4 | Cardiac failure |
| 111685472 | 11168547 | 5 | Cardiac failure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111685472 | 11168547 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111685472 | 11168547 | Accidental overdose | |
| 111685472 | 11168547 | Electrocardiogram P wave abnormal | |
| 111685472 | 11168547 | Electrocardiogram PR prolongation | |
| 111685472 | 11168547 | Electrocardiogram ST segment depression | |
| 111685472 | 11168547 | Feeding disorder | |
| 111685472 | 11168547 | Heart rate increased | |
| 111685472 | 11168547 | Hyperkalaemia | |
| 111685472 | 11168547 | Hyponatraemia | |
| 111685472 | 11168547 | Renal impairment | |
| 111685472 | 11168547 | Toxicity to various agents | |
| 111685472 | 11168547 | Vomiting | |
| 111685472 | 11168547 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |