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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125806431 | 12580643 | 1 | I | 20160129 | 20160721 | 20160721 | PER | US-JAZZ-2016-US-001790 | JAZZ | 0.00 | F | Y | 0.00000 | 20160721 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125806431 | 12580643 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125806431 | 12580643 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125806431 | 12580643 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125806431 | 12580643 | 4 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125806431 | 12580643 | 5 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125806431 | 12580643 | 6 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 7 | C | GUAIFENESIN. | GUAIFENESIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 8 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125806431 | 12580643 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 10 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 11 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 125806431 | 12580643 | 12 | C | Omega 3 | OMEGA-3 FATTY ACIDS | 1 | UNK | U | 0 | ||||||||||
| 125806431 | 12580643 | 13 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 125806431 | 12580643 | 14 | C | VITAMIN B6 | PYRIDOXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 15 | C | Atomoxetine | ATOMOXETINE | 1 | UNK | U | 0 | ||||||||||
| 125806431 | 12580643 | 16 | C | Donepezil HCl | DONEPEZIL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125806431 | 12580643 | 18 | C | Bupropion hcl | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 19 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 20 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125806431 | 12580643 | 21 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125806431 | 12580643 | 1 | Narcolepsy |
| 125806431 | 12580643 | 4 | Product used for unknown indication |
| 125806431 | 12580643 | 5 | Product used for unknown indication |
| 125806431 | 12580643 | 6 | Product used for unknown indication |
| 125806431 | 12580643 | 7 | Product used for unknown indication |
| 125806431 | 12580643 | 8 | Product used for unknown indication |
| 125806431 | 12580643 | 9 | Product used for unknown indication |
| 125806431 | 12580643 | 10 | Product used for unknown indication |
| 125806431 | 12580643 | 11 | Product used for unknown indication |
| 125806431 | 12580643 | 12 | Product used for unknown indication |
| 125806431 | 12580643 | 13 | Product used for unknown indication |
| 125806431 | 12580643 | 14 | Product used for unknown indication |
| 125806431 | 12580643 | 15 | Product used for unknown indication |
| 125806431 | 12580643 | 16 | Product used for unknown indication |
| 125806431 | 12580643 | 17 | Product used for unknown indication |
| 125806431 | 12580643 | 18 | Product used for unknown indication |
| 125806431 | 12580643 | 19 | Product used for unknown indication |
| 125806431 | 12580643 | 20 | Product used for unknown indication |
| 125806431 | 12580643 | 21 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125806431 | 12580643 | Anxiety | |
| 125806431 | 12580643 | Energy increased | |
| 125806431 | 12580643 | Feeling abnormal | |
| 125806431 | 12580643 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 125806431 | 12580643 | 1 | 201407 | 201407 | 0 | |
| 125806431 | 12580643 | 2 | 201407 | 201510 | 0 | |
| 125806431 | 12580643 | 3 | 201510 | 0 | ||
| 125806431 | 12580643 | 6 | 20151009 | 0 | ||
| 125806431 | 12580643 | 7 | 20151009 | 0 | ||
| 125806431 | 12580643 | 8 | 20150901 | 0 | ||
| 125806431 | 12580643 | 9 | 20150901 | 0 | ||
| 125806431 | 12580643 | 10 | 20150901 | 0 | ||
| 125806431 | 12580643 | 11 | 20140625 | 0 | ||
| 125806431 | 12580643 | 12 | 20140625 | 0 | ||
| 125806431 | 12580643 | 13 | 20140625 | 0 | ||
| 125806431 | 12580643 | 14 | 20140625 | 20151009 | 0 | |
| 125806431 | 12580643 | 15 | 20120625 | 20151008 | 0 | |
| 125806431 | 12580643 | 16 | 20120625 | 20151009 | 0 | |
| 125806431 | 12580643 | 17 | 20120625 | 20151009 | 0 | |
| 125806431 | 12580643 | 18 | 20110625 | 0 | ||
| 125806431 | 12580643 | 19 | 20110625 | 0 | ||
| 125806431 | 12580643 | 20 | 20110625 | 0 | ||
| 125806431 | 12580643 | 21 | 20100625 | 0 |