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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127419011 | 12741901 | 1 | I | 20160907 | 20160914 | 20160914 | EXP | US-MYLANLABS-2016M1039074 | MYLAN | FROMMELT P, JUERN A, SIEGEL D, HOLLAND K, SEEFELDT M, YU J, ET AL. ADVERSE EVENTS IN YOUNG AND PRETERM INFANTS RECEIVING TOPICAL TIMOLOL FOR INFANTILE HEMANGIOMA. PEDIATR-DERMATOL 2016;33(4):405-414. | 0.00 | Y | 0.00000 | 20160914 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127419011 | 12741901 | 1 | PS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | 2 MG/KG/DAY, DIVIDED IN TO 2 DOSES | Y | U | 70213 | ||||||||
| 127419011 | 12741901 | 2 | SS | TIMOLOL. | TIMOLOL | 1 | Topical | 0.5% OF 0.52 MG/KG/DAY SOLUTION; FOLLOWED BY AN ADDITIONAL DROP | Y | U | 0 | ||||||||
| 127419011 | 12741901 | 3 | SS | TIMOLOL. | TIMOLOL | 1 | Intraocular | 0.5% OF 0.52 MG/KG/DAY ONE DROP | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127419011 | 12741901 | 1 | Infantile haemangioma |
| 127419011 | 12741901 | 2 | Infantile haemangioma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127419011 | 12741901 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127419011 | 12741901 | Bradycardia | |
| 127419011 | 12741901 | Hypothermia | |
| 127419011 | 12741901 | Lethargy | |
| 127419011 | 12741901 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |