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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125195591 | 12519559 | 1 | I | 20150828 | 20160701 | 20160701 | PER | US-LUPIN PHARMACEUTICALS INC.-2015-02703 | LUPIN | SCHULTZ A, SNIDER M, BLAIS D, GULATI M. STATIN DESENSITIZATION IN A PATIENT WITH PROBABLE FAMILIAL HYPERCHOLESTEROLEMIA. JOURNAL OF CLINICAL LIPIDOLOGY. 2015;9:597-601. | 29.00 | YR | F | Y | 0.00000 | 20160620 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125195591 | 12519559 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 20 MG | UNKNOWN | 78103 | |||||||||
| 125195591 | 12519559 | 2 | SS | Atorvastatin | ATORVASTATIN | 1 | Unknown | Y | UNKNOWN | 0 | 5 | MG | |||||||
| 125195591 | 12519559 | 3 | SS | ROSUVASTATIN. | ROSUVASTATIN | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125195591 | 12519559 | 4 | SS | ROSUVASTATIN. | ROSUVASTATIN | 1 | Unknown | 10 MG | UNKNOWN | 0 | |||||||||
| 125195591 | 12519559 | 5 | C | Colesevelam | COLESEVELAM | 1 | Unknown | TITRATED UP TO 3.75 G DAILY | 0 | ||||||||||
| 125195591 | 12519559 | 6 | C | Colesevelam | COLESEVELAM | 1 | Unknown | 0 | |||||||||||
| 125195591 | 12519559 | 7 | C | Niacin extended release | NIACIN | 1 | Unknown | TITRATED UP TO 1.5 G DAILY | 0 | ||||||||||
| 125195591 | 12519559 | 8 | C | Niacin extended release | NIACIN | 1 | Unknown | 0 | |||||||||||
| 125195591 | 12519559 | 9 | C | EZETIMIBE. | EZETIMIBE | 1 | Unknown | 10 MG DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125195591 | 12519559 | 1 | Type IIa hyperlipidaemia |
| 125195591 | 12519559 | 2 | Type IIa hyperlipidaemia |
| 125195591 | 12519559 | 3 | Type IIa hyperlipidaemia |
| 125195591 | 12519559 | 5 | Type IIa hyperlipidaemia |
| 125195591 | 12519559 | 7 | Type IIa hyperlipidaemia |
| 125195591 | 12519559 | 9 | Type IIa hyperlipidaemia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125195591 | 12519559 | Cough | |
| 125195591 | 12519559 | Flushing | |
| 125195591 | 12519559 | Pruritus | |
| 125195591 | 12519559 | Respiratory tract oedema | |
| 125195591 | 12519559 | Urticaria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125195591 | 12519559 | 1 | 201010 | 0 | ||
| 125195591 | 12519559 | 2 | 201308 | 201308 | 0 | |
| 125195591 | 12519559 | 5 | 201207 | 201209 | 0 | |
| 125195591 | 12519559 | 7 | 201209 | 0 | ||
| 125195591 | 12519559 | 8 | 201311 | 0 |