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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125975471 | 12597547 | 1 | I | 20160716 | 20160726 | 20160726 | EXP | PHHY2016US098811 | SANDOZ | TRAN C, TAMBURRO J, RHEE A, GOLDEN A.. PROPRANOLOL FOR TREATMENT OF GENITAL INFANTILE HEMANGIOMA. JOURNAL OF UROLOGY. 2016;195(3):731-7 | 1.00 | MON | M | Y | 0.00000 | 20160726 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125975471 | 12597547 | 1 | PS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 1 MG/KG/DAY | 70663 | 1 | MG/KG | ||||||||
125975471 | 12597547 | 2 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 2.2 MG/KG/DAY | 70663 | 2.2 | MG/KG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125975471 | 12597547 | 1 | Infantile haemangioma |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125975471 | 12597547 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125975471 | 12597547 | Concomitant disease aggravated | |
125975471 | 12597547 | Cyanosis | |
125975471 | 12597547 | Drug effect incomplete | |
125975471 | 12597547 | Vasoconstriction |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |