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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125525721 | 12552572 | 1 | I | 20160630 | 20160713 | 20160713 | EXP | DE-CONCORDIA PHARMACEUTICALS INC.-CO-PL-DE-2016-377 | CONCORDIA | ABDIN A,POESS J,REIL J,FUERNAU G,KANDOLF R,THIELE H. HYDROXYCHLOROQUINE-INDUCED CARDIOMYOPATHY IN A PATIENT WITH LIMITED CUTANEOUS SYSTEMIC SCLEROSIS.. EUR J HEART FAIL. 2016 MAY 01;SUPPL 1:303. | 58.00 | YR | F | Y | 0.00000 | 20160713 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125525721 | 12552572 | 1 | PS | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | 9768 | ||||||||||||
| 125525721 | 12552572 | 2 | C | SILDENAFIL. | SILDENAFIL | 1 | 0 | ||||||||||||
| 125525721 | 12552572 | 3 | C | ILOPROST | ILOPROST | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125525721 | 12552572 | 1 | Systemic scleroderma |
| 125525721 | 12552572 | 2 | Product used for unknown indication |
| 125525721 | 12552572 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125525721 | 12552572 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125525721 | 12552572 | Cardiomyopathy | |
| 125525721 | 12552572 | Dyspnoea | |
| 125525721 | 12552572 | Ejection fraction decreased | |
| 125525721 | 12552572 | Fibrosis | |
| 125525721 | 12552572 | Left ventricular end-diastolic pressure increased | |
| 125525721 | 12552572 | Left ventricular hypertrophy | |
| 125525721 | 12552572 | N-terminal prohormone brain natriuretic peptide increased | |
| 125525721 | 12552572 | Peripheral swelling |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |