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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125408592 | 12540859 | 2 | F | 20160712 | 20160708 | 20160719 | EXP | US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-01238 | WESTWARD | FROMMELT P,JUERN A,SIEGEL D,HOLLAND K,SEEFELDT M,YU J. ADVERSE EVENTS IN YOUNG AND PRETERM INFANTS RECEIVING TOPICAL TIMOLOL FOR INFANTILE HEMANGIOMA.. PEDIATRIC DERMATOLOGY 2016;. | 50.00 | DY | F | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125408592 | 12540859 | 1 | PS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | Y | 70979 | ||||||||||
| 125408592 | 12540859 | 2 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | Y | 70979 | BID | |||||||||
| 125408592 | 12540859 | 3 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | Y | 70979 | ||||||||||
| 125408592 | 12540859 | 4 | C | TIMOLOL. | TIMOLOL | 1 | Topical | Y | 0 | GEL | BID | ||||||||
| 125408592 | 12540859 | 5 | C | TIMOLOL. | TIMOLOL | 1 | Intraocular | Y | 0 | GEL | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125408592 | 12540859 | 1 | Product used for unknown indication |
| 125408592 | 12540859 | 4 | Eyelid ptosis |
| 125408592 | 12540859 | 5 | Haemangioma of skin |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125408592 | 12540859 | HO |
| 125408592 | 12540859 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125408592 | 12540859 | Bradycardia | |
| 125408592 | 12540859 | Hypothermia | |
| 125408592 | 12540859 | Lethargy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |