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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125217091 | 12521709 | 1 | I | 20160620 | 20160701 | 20160701 | EXP | AT-VERNALIS THERAPEUTICS, INC.-2016VRN00037 | VERNALIS | ARIF T, BARTECKA-MINO K, HOLZER A, SCHIEL H, GENSER D. INGESTION OF CODEINE SYRUP IN CHILDREN: A 10-YEAR RETROSPECTIVE STUDY. CLIN TOXICOL. 2016;54(4):435 | 9.00 | MON | Y | 6.80000 | KG | 20160630 | OT | AT | AT |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125217091 | 12521709 | 1 | PS | CODEINE | CODEINE | 1 | Oral | 1.7 MG/KG, ONCE | U | 207768 | 1.7 | MG/KG | SYRUP | 1X |
Indications of drugs used
no results found |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125217091 | 12521709 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |