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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125316051 | 12531605 | 1 | I | 20160629 | 20160706 | 20160706 | EXP | ES-MYLANLABS-2016M1027900 | MYLAN | MARTIN PEREZ B, DUENAS LAITA A, CASTRO VILLAMOR MA. ATRIAL FIBRILLATION AFTER ADMINISTRATION OF FLUMAZENIL IN A PATIENT WITH ACUTE POISONING. EMERGENCIAS 2016;28(3):240. | 0.00 | Y | 0.00000 | 20160706 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125316051 | 12531605 | 1 | PS | FLUMAZENIL. | FLUMAZENIL | 1 | Intravenous bolus | 0.5 MG | U | U | 78595 | INJECTION | |||||||
| 125316051 | 12531605 | 2 | SS | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125316051 | 12531605 | 3 | SS | CLORAZEPIC ACID | CLORAZEPIC ACID | 1 | Unknown | U | U | 0 | |||||||||
| 125316051 | 12531605 | 4 | SS | BROMAZEPAM | BROMAZEPAM | 1 | Unknown | U | U | 0 | |||||||||
| 125316051 | 12531605 | 5 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | 10 MG/DAY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125316051 | 12531605 | 1 | Product used for unknown indication |
| 125316051 | 12531605 | 2 | Product used for unknown indication |
| 125316051 | 12531605 | 3 | Product used for unknown indication |
| 125316051 | 12531605 | 4 | Product used for unknown indication |
| 125316051 | 12531605 | 5 | Affective disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125316051 | 12531605 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125316051 | 12531605 | Atrial fibrillation | |
| 125316051 | 12531605 | Bradyphrenia | |
| 125316051 | 12531605 | Somnolence | |
| 125316051 | 12531605 | 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 |