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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113625792 | 11362579 | 2 | F | 20150727 | 20150810 | 20160729 | EXP | US-MYLANLABS-2015M1026295 | MYLAN | SEREBRUANY VL, KIPSHIDZE N, PERSHUKOV IV, KULICZKOWSKI W, CARNES J, ATAR D. FATAL SEPSIS AND SYSTEMIC INFLAMMATORY RESPONSE SYNDROME AFTER OFF-LABEL PRASUGREL: A CASE REPORT. AM-J-THER 2014; 21(6):E229-E233. | 0.00 | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113625792 | 11362579 | 1 | PS | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Unknown | DOUBLE DAILY DOSE 150 MG FOR THE INITIAL 13 MONTHS THEN | 77665 | ||||||||||
| 113625792 | 11362579 | 2 | SS | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Unknown | THEN 75 MG /DAY ; FOR }4 YEARS OVERALL DURATION | 77665 | ||||||||||
| 113625792 | 11362579 | 3 | SS | PRASUGREL | PRASUGREL | 1 | Unknown | 10 MG/ DAY | 0 | ||||||||||
| 113625792 | 11362579 | 4 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | 81 MG/ DAY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113625792 | 11362579 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113625792 | 11362579 | DE |
| 113625792 | 11362579 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113625792 | 11362579 | Off label use | |
| 113625792 | 11362579 | Sepsis | |
| 113625792 | 11362579 | Systemic inflammatory response syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |