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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126660681 | 12666068 | 1 | I | 20160321 | 20160818 | 20160818 | PER | US-JAZZ-2016-US-005466 | JAZZ | 0.00 | M | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126660681 | 12666068 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126660681 | 12666068 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126660681 | 12666068 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126660681 | 12666068 | 4 | SS | PROVIGIL | MODAFINIL | 1 | 0 | ||||||||||||
| 126660681 | 12666068 | 5 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 8 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 9 | C | ACIPHEX | RABEPRAZOLE SODIUM | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 10 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 11 | C | CARISOPRODOL. | CARISOPRODOL | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 12 | C | Centrum silver | MINERALSVITAMINS | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 13 | C | CHLORTHALIDONE. | CHLORTHALIDONE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 14 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 15 | C | Fish oil | FISH OIL | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 16 | C | HYOSCYAMINE SULFATE. | HYOSCYAMINE SULFATE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 17 | C | MELOXICAM. | MELOXICAM | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 18 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 19 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 20 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 21 | C | Osteo-bi-flex | 2 | U | 0 | ||||||||||||
| 126660681 | 12666068 | 22 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 23 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 24 | C | SIMVASTATIN. | SIMVASTATIN | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 25 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 26 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 27 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 126660681 | 12666068 | 28 | C | XARELTO | RIVAROXABAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126660681 | 12666068 | 1 | Narcolepsy |
| 126660681 | 12666068 | 4 | Product used for unknown indication |
| 126660681 | 12666068 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126660681 | 12666068 | Blood pressure increased | |
| 126660681 | 12666068 | Drug hypersensitivity | |
| 126660681 | 12666068 | Pain | |
| 126660681 | 12666068 | Pre-existing condition improved |
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 |
|---|---|---|---|---|---|---|
| 126660681 | 12666068 | 1 | 201301 | 201303 | 0 | |
| 126660681 | 12666068 | 3 | 201403 | 0 |