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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124892582 | 12489258 | 2 | F | 20160728 | 20160622 | 20160802 | EXP | US-ALLERGAN-1660298US | ALLERGAN | GILL K, BAYART C, DESAI R, GOLDEN A, RAIMER P, AND TAMBURRO J. BRIMONIDINE TOXICITY SECONDARY TO TOPICAL USE FOR AN ULCERATED HEMANGIOMA. PEDIATRIC DERMATOLOGY. 2016;33(4):1-3 | 8.00 | WK | F | Y | 3.15000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124892582 | 12489258 | 1 | PS | BRIMONIDINE | BRIMONIDINE TARTRATE | 1 | Topical | 2 GTT, FOUR HOURS LATER APPLIED IN THE SAME AMOUNT | Y | U | 20613 | 2 | GTT | EYE DROPS, SOLUTION | |||||
| 124892582 | 12489258 | 2 | SS | TIMOLOL MALEATE. | TIMOLOL MALEATE | 1 | Topical | 2 GTT, FOUR HOURS LATER APPLIED IN THE SAME AMOUNT | Y | U | 0 | 2 | GTT | EYE DROPS, SOLUTION | |||||
| 124892582 | 12489258 | 3 | C | PROPRANOLOL HCL 10mg Tab | 2 | Oral | 4 MG/KG, QD | 0 | 4 | MG/KG | TABLET | QD | |||||||
| 124892582 | 12489258 | 4 | C | PROPRANOLOL HCL 10mg Tab | 2 | 3 MG/KG, QD | 0 | 3 | MG/KG | TABLET | QD | ||||||||
| 124892582 | 12489258 | 5 | C | PROPRANOLOL HCL 10mg Tab | 2 | 1 MG/KG, QD | 0 | 1 | MG/KG | TABLET | QD | ||||||||
| 124892582 | 12489258 | 6 | C | PREDNISOLONE ACETATE, 1.0% | PREDNISOLONE ACETATE | 1 | Oral | 2 MG/KG, QD | 0 | 2 | MG/KG | EYE DROPS, SUSPENSION | QD | ||||||
| 124892582 | 12489258 | 7 | C | PREDNISOLONE ACETATE, 1.0% | PREDNISOLONE ACETATE | 1 | Oral | 1 MG/KG, QD | 0 | 1 | MG/KG | EYE DROPS, SUSPENSION | QD | ||||||
| 124892582 | 12489258 | 8 | C | LIDOCAINE. | LIDOCAINE | 1 | Topical | UNK, UNK | 0 | ||||||||||
| 124892582 | 12489258 | 9 | C | OXYCODONE | OXYCODONE | 1 | Oral | .05 MG/KG, UNK | Y | U | 0 | .05 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124892582 | 12489258 | 1 | Ulcerated haemangioma |
| 124892582 | 12489258 | 2 | Ulcerated haemangioma |
| 124892582 | 12489258 | 3 | Ulcerated haemangioma |
| 124892582 | 12489258 | 6 | Ulcerated haemangioma |
| 124892582 | 12489258 | 8 | Ulcerated haemangioma |
| 124892582 | 12489258 | 9 | Ulcerated haemangioma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124892582 | 12489258 | HO |
| 124892582 | 12489258 | OT |
| 124892582 | 12489258 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124892582 | 12489258 | Depressed level of consciousness | |
| 124892582 | 12489258 | Hypothermia | |
| 124892582 | 12489258 | Hypotonia | |
| 124892582 | 12489258 | Infantile apnoea | |
| 124892582 | 12489258 | Lethargy | |
| 124892582 | 12489258 | Off label use | |
| 124892582 | 12489258 | Respiratory depression | |
| 124892582 | 12489258 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |