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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126254002 | 12625400 | 2 | F | 20160725 | 20160805 | 20160808 | EXP | FR-TEVA-679218ISR | TEVA | MECHINEAUD M, NICAISE D, MARTIN L. HEMANGIOMA IN AN INFANT WHOSE MOTHER WAS RECEIVING LONG-TERM PROPRANOLOL TREATMENT DURING PREGNANCY. PEDIATR-DERMATOL 2016;33 (SUPPL. 1):S58. | 3.00 | DY | M | Y | 0.00000 | 20160808 | OT | FR | FR |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126254002 | 12625400 | 1 | PS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Transplacental | 40 MILLIGRAM DAILY; | 70233 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126254002 | 12625400 | 1 | Anxiety |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126254002 | 12625400 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126254002 | 12625400 | Exposure during breast feeding | |
126254002 | 12625400 | Foetal exposure during pregnancy | |
126254002 | 12625400 | Hypoglycaemia neonatal | |
126254002 | 12625400 | Infantile haemangioma |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |