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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125539332 | 12553933 | 2 | F | 20160812 | 20160713 | 20160813 | EXP | IT-TEVA-675315ACC | TEVA | POGLIANI D,POZZI A,LAUDI C,RIMOLDI L,SOGNI E,FARFAGLIA P. NONCONVULSIVE STATUS EPILEPTICUS DUE TO FENTANYL INTOXICATION IN HEMODIALYSED PATIENTS: TWO CASE REPORTS AND REVIEW OF THE LITERATURE. ITALIAN JOURNAL OF NEPHROLOGY. 2016 JAN 01;1-10. | 82.00 | YR | F | Y | 0.00000 | 20160813 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125539332 | 12553933 | 1 | PS | FENTANYL. | FENTANYL | 1 | Transdermal | 600 MICROGRAM DAILY; | Y | 20747 | 600 | UG | TRANSDERMAL PATCH | ||||||
| 125539332 | 12553933 | 2 | I | FENTANYL. | FENTANYL | 1 | Transdermal | 288 MICROGRAM DAILY; | Y | 20747 | 288 | UG | TRANSDERMAL PATCH | ||||||
| 125539332 | 12553933 | 3 | I | FENTANYL. | FENTANYL | 1 | Oral | Y | 20747 | 100 | UG | TABLET | |||||||
| 125539332 | 12553933 | 4 | I | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MILLIGRAM DAILY; | U | 76361 | 500 | MG | |||||||
| 125539332 | 12553933 | 5 | I | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | U | 76361 | 125 | MG | ||||||||
| 125539332 | 12553933 | 6 | I | Rifampicin | RIFAMPIN | 1 | Intravenous (not otherwise specified) | 300 MILLIGRAM DAILY; | U | 0 | 300 | MG | INJECTION | ||||||
| 125539332 | 12553933 | 7 | I | Vancomycin | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 1 GRAM DAILY; | U | 0 | 1 | G | |||||||
| 125539332 | 12553933 | 8 | I | Vancomycin | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | U | 0 | 500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125539332 | 12553933 | 1 | Ischaemic limb pain |
| 125539332 | 12553933 | 2 | Procedural pain |
| 125539332 | 12553933 | 4 | Staphylococcal infection |
| 125539332 | 12553933 | 6 | Staphylococcal infection |
| 125539332 | 12553933 | 7 | Staphylococcal infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125539332 | 12553933 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125539332 | 12553933 | Altered state of consciousness | |
| 125539332 | 12553933 | Drug interaction | |
| 125539332 | 12553933 | Hallucination | |
| 125539332 | 12553933 | Miosis | |
| 125539332 | 12553933 | Overdose | |
| 125539332 | 12553933 | Product use issue | |
| 125539332 | 12553933 | Somnolence | |
| 125539332 | 12553933 | Status epilepticus | |
| 125539332 | 12553933 | Tremor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125539332 | 12553933 | 1 | 20150528 | 20150602 | 0 | |
| 125539332 | 12553933 | 2 | 20150521 | 20150527 | 0 | |
| 125539332 | 12553933 | 3 | 20150602 | 20150602 | 0 | |
| 125539332 | 12553933 | 4 | 20150521 | 20150521 | 0 | |
| 125539332 | 12553933 | 5 | 20150522 | 0 | ||
| 125539332 | 12553933 | 6 | 20150521 | 0 | ||
| 125539332 | 12553933 | 7 | 20150521 | 20150521 | 0 | |
| 125539332 | 12553933 | 8 | 20150522 | 0 |