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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122439543 | 12243954 | 3 | F | 2016 | 20160808 | 20160406 | 20160816 | EXP | US-JAZZ-2016-US-006131 | JAZZ | 0.00 | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122439543 | 12243954 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | U | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 122439543 | 12243954 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | U | 21196 | 3 | G | ORAL SOLUTION | |||||
| 122439543 | 12243954 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | Y | U | 21196 | ORAL SOLUTION | |||||||
| 122439543 | 12243954 | 4 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNKNOWN DOSE | Y | 0 | CAPSULE | |||||||||
| 122439543 | 12243954 | 5 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | Y | 0 | TABLET | |||||||||
| 122439543 | 12243954 | 6 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 122439543 | 12243954 | 7 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122439543 | 12243954 | 8 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 122439543 | 12243954 | 9 | C | SPRINTEC | ETHINYL ESTRADIOLNORGESTIMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122439543 | 12243954 | 10 | C | AMOXICILLIN. | AMOXICILLIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 122439543 | 12243954 | 11 | C | ASTELIN | AZELASTINE HYDROCHLORIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 122439543 | 12243954 | 12 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 122439543 | 12243954 | 13 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 122439543 | 12243954 | 14 | C | MEDROL | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 122439543 | 12243954 | 15 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122439543 | 12243954 | 16 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122439543 | 12243954 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122439543 | 12243954 | 1 | Narcolepsy |
| 122439543 | 12243954 | 2 | Cataplexy |
| 122439543 | 12243954 | 4 | Product used for unknown indication |
| 122439543 | 12243954 | 5 | Product used for unknown indication |
| 122439543 | 12243954 | 6 | Product used for unknown indication |
| 122439543 | 12243954 | 7 | Product used for unknown indication |
| 122439543 | 12243954 | 8 | Product used for unknown indication |
| 122439543 | 12243954 | 9 | Product used for unknown indication |
| 122439543 | 12243954 | 10 | Product used for unknown indication |
| 122439543 | 12243954 | 11 | Product used for unknown indication |
| 122439543 | 12243954 | 12 | Product used for unknown indication |
| 122439543 | 12243954 | 13 | Product used for unknown indication |
| 122439543 | 12243954 | 14 | Product used for unknown indication |
| 122439543 | 12243954 | 15 | Product used for unknown indication |
| 122439543 | 12243954 | 16 | Product used for unknown indication |
| 122439543 | 12243954 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122439543 | 12243954 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122439543 | 12243954 | Decreased appetite | |
| 122439543 | 12243954 | Dizziness | |
| 122439543 | 12243954 | Nausea | |
| 122439543 | 12243954 | Nervousness | |
| 122439543 | 12243954 | Tachycardia | |
| 122439543 | 12243954 | Thirst |
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 |
|---|---|---|---|---|---|---|
| 122439543 | 12243954 | 1 | 20160326 | 201603 | 0 | |
| 122439543 | 12243954 | 2 | 201603 | 2016 | 0 | |
| 122439543 | 12243954 | 3 | 2016 | 0 | ||
| 122439543 | 12243954 | 4 | 201601 | 2016 | 0 | |
| 122439543 | 12243954 | 5 | 201601 | 2016 | 0 | |
| 122439543 | 12243954 | 6 | 201601 | 0 | ||
| 122439543 | 12243954 | 7 | 201401 | 0 | ||
| 122439543 | 12243954 | 8 | 201401 | 0 | ||
| 122439543 | 12243954 | 9 | 201401 | 0 | ||
| 122439543 | 12243954 | 10 | 201603 | 0 | ||
| 122439543 | 12243954 | 11 | 201511 | 0 | ||
| 122439543 | 12243954 | 12 | 201601 | 0 | ||
| 122439543 | 12243954 | 13 | 201511 | 0 | ||
| 122439543 | 12243954 | 14 | 201602 | 0 | ||
| 122439543 | 12243954 | 15 | 201603 | 0 | ||
| 122439543 | 12243954 | 16 | 201601 | 0 | ||
| 122439543 | 12243954 | 17 | 201601 | 0 |