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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127143411 | 12714341 | 1 | I | 20160511 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008989 | JAZZ | 0.00 | M | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127143411 | 12714341 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127143411 | 12714341 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 127143411 | 12714341 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127143411 | 12714341 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127143411 | 12714341 | 5 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | SPRAY ONE SPRAY BY INTRANASAL ROUTE EVERY DAY IN EACH NOSTRIL AS NEEDED | U | 0 | ||||||||||
| 127143411 | 12714341 | 6 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | TAKE ONE TABLET BY ORAL ROUTE EVERY 4-8 HOUR AS NEEDED FOR PAIN | U | 0 | ||||||||||
| 127143411 | 12714341 | 7 | C | Pregnenolone | PREGNENOLONE | 1 | U | 0 | |||||||||||
| 127143411 | 12714341 | 8 | C | NUVIGIL | ARMODAFINIL | 1 | TAKE ONE BY ORAL ROUTE EVERY DAY | U | 0 | ||||||||||
| 127143411 | 12714341 | 9 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | TAKE ONE TABLET BY ORAL ROUTE EVERY DAY | U | 0 | ||||||||||
| 127143411 | 12714341 | 10 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | U | 0 | |||||||||||
| 127143411 | 12714341 | 11 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127143411 | 12714341 | 12 | C | LOVASTATIN. | LOVASTATIN | 1 | TAKE ONE TABLE BY ORAL ROUTE EVERY DAY WITH THE EVENING MEAL | U | 0 | ||||||||||
| 127143411 | 12714341 | 13 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | TAKE ONE TABLE BY ORAL ROUTE EVERY DAY WITH MORNING AND EVENING MEAL | U | 0 | ||||||||||
| 127143411 | 12714341 | 14 | C | VICODIN ES | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127143411 | 12714341 | 15 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127143411 | 12714341 | 16 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | Oral | 300 MG, QD | U | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127143411 | 12714341 | 1 | Narcolepsy |
| 127143411 | 12714341 | 2 | Cataplexy |
| 127143411 | 12714341 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127143411 | 12714341 | Breathing-related sleep disorder | |
| 127143411 | 12714341 | Drug ineffective | |
| 127143411 | 12714341 | Drug tolerance |
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 |
|---|---|---|---|---|---|---|
| 127143411 | 12714341 | 1 | 201212 | 201302 | 0 | |
| 127143411 | 12714341 | 3 | 201409 | 2016 | 0 |