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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124427072 | 12442707 | 2 | F | 20160719 | 20160607 | 20160726 | EXP | US-PFIZER INC-2016281144 | PFIZER | WIRIYATHIAN, S.. DILANTIN TOXICITY IN A PRETERM INFANT: PERSISTENT BRADYCARDIA AND LETHARGY. THE JOURNAL OF PEDIATRICS. 1982;100 (1):146-149 | 2.00 | DY | M | Y | 1.90000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124427072 | 12442707 | 1 | PS | PHENYTOIN SODIUM. | PHENYTOIN SODIUM | 1 | Intravenous (not otherwise specified) | 10 MG/KG, UNK (SECOND AND THIRD DAYS OF LIFE) | Y | 10151 | 10 | MG/KG | SOLUTION FOR INJECTION | ||||||
| 124427072 | 12442707 | 2 | SS | PHENYTOIN SODIUM. | PHENYTOIN SODIUM | 1 | Intravenous (not otherwise specified) | 5 MG/KG, DAILY (5 MG EVERY 12 HOURS (5 MG/KG-DAY)) | Y | 10151 | 5 | MG/KG | SOLUTION FOR INJECTION | ||||||
| 124427072 | 12442707 | 3 | SS | DILANTIN | PHENYTOIN | 1 | Oral | UNK | Y | 84427 | TABLET | ||||||||
| 124427072 | 12442707 | 4 | SS | PHENOBARBITONE | PHENOBARBITAL | 1 | Intravenous (not otherwise specified) | 10 MG/KG, UNK (SECOND AND THIRD DAYS OF LIFE) | Y | 0 | 10 | MG/KG | |||||||
| 124427072 | 12442707 | 5 | SS | PHENOBARBITONE | PHENOBARBITAL | 1 | Intravenous (not otherwise specified) | 10 MG/KG, DAILY (10 MG EVERY 12 HOURS (10 MG/KG, DAY)) | Y | 0 | 10 | MG/KG | |||||||
| 124427072 | 12442707 | 6 | SS | PHENOBARBITONE | PHENOBARBITAL | 1 | Oral | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124427072 | 12442707 | 1 | Seizure |
| 124427072 | 12442707 | 3 | Seizure |
| 124427072 | 12442707 | 4 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124427072 | 12442707 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124427072 | 12442707 | Bradycardia neonatal | |
| 124427072 | 12442707 | 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 |