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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127477581 | 12747758 | 1 | I | 2016 | 20160526 | 20160915 | 20160915 | PER | US-JAZZ-2016-US-010016 | JAZZ | 0.00 | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127477581 | 12747758 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127477581 | 12747758 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | N | 21196 | ORAL SOLUTION | ||||||||
| 127477581 | 12747758 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | N | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127477581 | 12747758 | 4 | SS | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 5 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 6 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 7 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 8 | C | Diclofenac sod | DICLOFENAC SODIUM | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 9 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 10 | C | NUVARING | ETHINYL ESTRADIOLETONOGESTREL | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127477581 | 12747758 | 12 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127477581 | 12747758 | 1 | Narcolepsy |
| 127477581 | 12747758 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127477581 | 12747758 | Anxiety | |
| 127477581 | 12747758 | Blood pressure increased | |
| 127477581 | 12747758 | Decreased appetite | |
| 127477581 | 12747758 | Diarrhoea | |
| 127477581 | 12747758 | Feeling drunk | |
| 127477581 | 12747758 | Malaise | |
| 127477581 | 12747758 | Pre-existing condition improved | |
| 127477581 | 12747758 | Therapeutic response unexpected | |
| 127477581 | 12747758 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127477581 | 12747758 | 1 | 201601 | 201601 | 0 | |
| 127477581 | 12747758 | 3 | 201602 | 0 |