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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125353042 | 12535304 | 2 | F | 20160705 | 20160707 | 20160719 | EXP | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-119725 | RANBAXY | 7.00 | MON | F | Y | 6.10000 | KG | 20160719 | OT | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125353042 | 12535304 | 1 | PS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Oral | THREE 6MG/KG DOSES | U | 0 | 6 | MG/KG | SUSPENSION | Q8H | |||||
| 125353042 | 12535304 | 2 | C | Amoxicillin 600mg, Potassium clavulanate 42.9mg/5 mL | 2 | Oral | 49 MG/KG, BID | 0 | 49 | MG/KG | SUSPENSION | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125353042 | 12535304 | 1 | Haemangioma |
| 125353042 | 12535304 | 2 | Otitis media |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125353042 | 12535304 | HO |
| 125353042 | 12535304 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125353042 | 12535304 | Accidental overdose | |
| 125353042 | 12535304 | Cyanosis | |
| 125353042 | 12535304 | Depressed level of consciousness | |
| 125353042 | 12535304 | Drug administration error | |
| 125353042 | 12535304 | Hypotension | |
| 125353042 | 12535304 | Hypotonia | |
| 125353042 | 12535304 | Lethargy | |
| 125353042 | 12535304 | Sinus bradycardia | |
| 125353042 | 12535304 | Tachypnoea | |
| 125353042 | 12535304 | 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 |