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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126507641 | 12650764 | 1 | I | 20160310 | 20160815 | 20160815 | PER | US-JAZZ-2016-US-004845 | JAZZ | 0.00 | M | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126507641 | 12650764 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126507641 | 12650764 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126507641 | 12650764 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126507641 | 12650764 | 4 | SS | ESZOPICLONE. | ESZOPICLONE | 1 | 0 | ||||||||||||
| 126507641 | 12650764 | 5 | SS | ZALEPLON. | ZALEPLON | 1 | 0 | ||||||||||||
| 126507641 | 12650764 | 6 | SS | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 126507641 | 12650764 | 7 | C | Probiotic | PROBIOTICS NOS | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 9 | C | TRANSDERM SCOP | SCOPOLAMINE | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 10 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 11 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 12 | C | COENZYME Q10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 13 | C | NIACIN. | NIACIN | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 14 | C | Omega 3 fish oil | FISH OILOMEGA-3 FATTY ACIDS | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 15 | C | VITAMIN B2 | RIBOFLAVIN | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 16 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 17 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 18 | C | VALPROIC ACID. | VALPROIC ACID | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 19 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126507641 | 12650764 | 20 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126507641 | 12650764 | 1 | Insomnia |
| 126507641 | 12650764 | 4 | Product used for unknown indication |
| 126507641 | 12650764 | 5 | Product used for unknown indication |
| 126507641 | 12650764 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126507641 | 12650764 | Anxiety | |
| 126507641 | 12650764 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 126507641 | 12650764 | 1 | 201002 | 201002 | 0 | |
| 126507641 | 12650764 | 3 | 201506 | 0 |