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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125436332 | 12543633 | 2 | F | 20160715 | 20160711 | 20160729 | EXP | US-JAZZ-2016-US-000418 | JAZZ | 0.00 | M | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125436332 | 12543633 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125436332 | 12543633 | 2 | I | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125436332 | 12543633 | 3 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 5.5 G, BID | U | 21196 | 5.5 | G | ORAL SOLUTION | ||||||
| 125436332 | 12543633 | 4 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125436332 | 12543633 | 5 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, QD | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125436332 | 12543633 | 6 | I | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNKNOWN DOSE | Y | 0 | ||||||||||
| 125436332 | 12543633 | 7 | SS | REMERON | MIRTAZAPINE | 1 | UNKNOWN DOSE | U | 0 | TABLET | |||||||||
| 125436332 | 12543633 | 8 | SS | KLONOPIN | CLONAZEPAM | 1 | UNK | Y | 0 | TABLET | |||||||||
| 125436332 | 12543633 | 9 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | UNKNOWN DOSE | U | 0 | TABLET | |||||||||
| 125436332 | 12543633 | 10 | C | ORPHENADRINE CITRATE. | ORPHENADRINE CITRATE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125436332 | 12543633 | 11 | C | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125436332 | 12543633 | 12 | C | ZALEPLON. | ZALEPLON | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125436332 | 12543633 | 13 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125436332 | 12543633 | 14 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125436332 | 12543633 | 15 | C | SOMA | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125436332 | 12543633 | 16 | C | COREG | CARVEDILOL | 1 | UNK | U | 0 | ||||||||||
| 125436332 | 12543633 | 17 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | ||||||||||
| 125436332 | 12543633 | 18 | C | LASIX | FUROSEMIDE | 1 | UNK | U | 0 | ||||||||||
| 125436332 | 12543633 | 19 | C | Potassium | POTASSIUM | 1 | UNK | U | 0 | ||||||||||
| 125436332 | 12543633 | 20 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125436332 | 12543633 | 1 | Narcolepsy |
| 125436332 | 12543633 | 2 | Cataplexy |
| 125436332 | 12543633 | 6 | Product used for unknown indication |
| 125436332 | 12543633 | 7 | Product used for unknown indication |
| 125436332 | 12543633 | 8 | Product used for unknown indication |
| 125436332 | 12543633 | 9 | Product used for unknown indication |
| 125436332 | 12543633 | 10 | Product used for unknown indication |
| 125436332 | 12543633 | 11 | Product used for unknown indication |
| 125436332 | 12543633 | 12 | Product used for unknown indication |
| 125436332 | 12543633 | 13 | Product used for unknown indication |
| 125436332 | 12543633 | 14 | Product used for unknown indication |
| 125436332 | 12543633 | 15 | Product used for unknown indication |
| 125436332 | 12543633 | 16 | Product used for unknown indication |
| 125436332 | 12543633 | 17 | Product used for unknown indication |
| 125436332 | 12543633 | 18 | Product used for unknown indication |
| 125436332 | 12543633 | 19 | Product used for unknown indication |
| 125436332 | 12543633 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125436332 | 12543633 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125436332 | 12543633 | Abnormal behaviour | |
| 125436332 | 12543633 | Anxiety | |
| 125436332 | 12543633 | Depression | |
| 125436332 | 12543633 | Drug dependence | |
| 125436332 | 12543633 | Drug effect variable | |
| 125436332 | 12543633 | Dry mouth | |
| 125436332 | 12543633 | Fatigue | |
| 125436332 | 12543633 | Hangover | |
| 125436332 | 12543633 | Hypertension | |
| 125436332 | 12543633 | Memory impairment | |
| 125436332 | 12543633 | Neuralgia | |
| 125436332 | 12543633 | Oedema | |
| 125436332 | 12543633 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 125436332 | 12543633 | 1 | 200808 | 200810 | 0 | |
| 125436332 | 12543633 | 2 | 200810 | 201402 | 0 | |
| 125436332 | 12543633 | 3 | 201402 | 2015 | 0 | |
| 125436332 | 12543633 | 4 | 201601 | 2016 | 0 | |
| 125436332 | 12543633 | 5 | 201607 | 0 | ||
| 125436332 | 12543633 | 8 | 20160122 | 0 | ||
| 125436332 | 12543633 | 10 | 20141201 | 0 | ||
| 125436332 | 12543633 | 11 | 20141201 | 0 | ||
| 125436332 | 12543633 | 12 | 20140410 | 0 | ||
| 125436332 | 12543633 | 13 | 20140407 | 0 | ||
| 125436332 | 12543633 | 14 | 20130524 | 20130618 | 0 | |
| 125436332 | 12543633 | 15 | 20130212 | 0 | ||
| 125436332 | 12543633 | 20 | 20110101 | 0 |