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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125414871 | 12541487 | 1 | I | 20160628 | 20160708 | 20160708 | EXP | US-TEVA-674768USA | TEVA | 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. PEDIATRIC DERMATOLOGY. 2016 | 40.00 | WK | F | Y | 0.00000 | 20160708 | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125414871 | 12541487 | 1 | PS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | 70233 | |||||||||||
| 125414871 | 12541487 | 2 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | 70233 | 2 | MG/KG | |||||||||
| 125414871 | 12541487 | 3 | C | Timolol 0.5% gel-forming solution | 2 | Topical | ONE DROP ON THE EYELID | Y | 0 | .52 | MG/KG | BID | |||||||
| 125414871 | 12541487 | 4 | C | Timolol 0.5% gel-forming solution | 2 | Intraocular | ONE DROP INTRAOCULARLY | Y | 0 | .52 | MG/KG | BID | |||||||
| 125414871 | 12541487 | 5 | C | TIMOLOL. | TIMOLOL | 1 | Y | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125414871 | 12541487 | 3 | Eyelid ptosis |
| 125414871 | 12541487 | 4 | Eyelid ptosis |
| 125414871 | 12541487 | 5 | Haemangioma of skin |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125414871 | 12541487 | OT |
| 125414871 | 12541487 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125414871 | 12541487 | Bradycardia | |
| 125414871 | 12541487 | Hypothermia | |
| 125414871 | 12541487 | Lethargy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |