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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126650761 | 12665076 | 1 | I | 20160808 | 20160818 | 20160818 | EXP | US-IMPAX LABORATORIES, INC-2016-IPXL-00900 | IMPAX | ALANSARI A, QUIEL L, BOMA N. A ONE-TWO PUNCH: HYDRALAZINE-INDUCED LIVER INJURY IN A RECOVERING ISCHEMIC HEPATITIS. AMERICAN JOURNAL OF THERAPEUTICS. 2016;23:4:E1094-E1095 | 77.00 | YR | F | Y | 0.00000 | 20160818 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126650761 | 12665076 | 1 | PS | DIGOXIN. | DIGOXIN | 1 | Unknown | UNK | Y | 78556 | TABLET | ||||||||
| 126650761 | 12665076 | 2 | SS | ISOSORBIDE DINITRATE ER | ISOSORBIDE DINITRATE | 1 | Unknown | UNK | 0 | PROLONGED-RELEASE TABLET | |||||||||
| 126650761 | 12665076 | 3 | SS | WARFARIN | WARFARIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126650761 | 12665076 | 4 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK | 0 | ||||||||||
| 126650761 | 12665076 | 5 | SS | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 126650761 | 12665076 | 6 | SS | METOPROLOL. | METOPROLOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 126650761 | 12665076 | 7 | SS | LOSARTAN. | LOSARTAN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 126650761 | 12665076 | 8 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 126650761 | 12665076 | 9 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 126650761 | 12665076 | 10 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126650761 | 12665076 | 1 | Product used for unknown indication |
| 126650761 | 12665076 | 2 | Product used for unknown indication |
| 126650761 | 12665076 | 3 | Product used for unknown indication |
| 126650761 | 12665076 | 4 | Product used for unknown indication |
| 126650761 | 12665076 | 5 | Product used for unknown indication |
| 126650761 | 12665076 | 6 | Product used for unknown indication |
| 126650761 | 12665076 | 7 | Product used for unknown indication |
| 126650761 | 12665076 | 8 | Product used for unknown indication |
| 126650761 | 12665076 | 9 | Product used for unknown indication |
| 126650761 | 12665076 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126650761 | 12665076 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126650761 | 12665076 | Atrial fibrillation | |
| 126650761 | 12665076 | Blood pressure increased | |
| 126650761 | 12665076 | Hepatic enzyme increased | |
| 126650761 | 12665076 | Hypotension | |
| 126650761 | 12665076 | International normalised ratio increased | |
| 126650761 | 12665076 | Nausea | |
| 126650761 | 12665076 | Renal function test abnormal | |
| 126650761 | 12665076 | Troponin I increased | |
| 126650761 | 12665076 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |