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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124393742 | 12439374 | 2 | F | 20160525 | 20160630 | 20160606 | 20160706 | PER | US-JAZZ-2016-US-009880 | JAZZ | 63.00 | YR | M | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124393742 | 12439374 | 1 | PS | PRIALT | ZICONOTIDE ACETATE | 1 | Intrathecal | 3 ?G, SINGLE | Y | 21060 | 3 | UG | |||||||
| 124393742 | 12439374 | 2 | SS | PRIALT | ZICONOTIDE ACETATE | 1 | Intrathecal | 3 ?G, SINGLE | Y | 21060 | 3 | UG | |||||||
| 124393742 | 12439374 | 3 | SS | PRIALT | ZICONOTIDE ACETATE | 1 | Intrathecal | 3 ?G, SINGLE | Y | 21060 | 3 | UG | |||||||
| 124393742 | 12439374 | 4 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 0.495 MG, QH | U | 0 | .495 | MG | |||||||
| 124393742 | 12439374 | 5 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 6 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 24.358 ?G, QH | U | 0 | 24.358 | UG | |||||||
| 124393742 | 12439374 | 7 | SS | FENTANYL. | FENTANYL | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 8 | C | METOPROLOL. | METOPROLOL | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 9 | C | PRAVASTATIN. | PRAVASTATIN | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 12 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 13 | C | KEFLEX | CEPHALEXIN | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 14 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 15 | C | TIZANIDINE. | TIZANIDINE | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 16 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 17 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 18 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | U | 0 | |||||||||||
| 124393742 | 12439374 | 19 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124393742 | 12439374 | 1 | Intervertebral disc degeneration |
| 124393742 | 12439374 | 2 | Spinal pain |
| 124393742 | 12439374 | 3 | Pain |
| 124393742 | 12439374 | 4 | Intervertebral disc degeneration |
| 124393742 | 12439374 | 5 | Spinal pain |
| 124393742 | 12439374 | 6 | Intervertebral disc degeneration |
| 124393742 | 12439374 | 7 | Spinal pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124393742 | 12439374 | Burning sensation | |
| 124393742 | 12439374 | Chills | |
| 124393742 | 12439374 | Dizziness | |
| 124393742 | 12439374 | Nausea | |
| 124393742 | 12439374 | Off label use | |
| 124393742 | 12439374 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 124393742 | 12439374 | 1 | 20160525 | 0 | ||
| 124393742 | 12439374 | 2 | 20160525 | 0 | ||
| 124393742 | 12439374 | 3 | 20160525 | 0 |