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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239041 | 12523904 | 1 | I | 20151222 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022298 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239041 | 12523904 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 125239041 | 12523904 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, FIRST DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125239041 | 12523904 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, SECOND DOSE | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 125239041 | 12523904 | 4 | C | DULCOLAX NOS | BISACODYL OR DOCUSATE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125239041 | 12523904 | 5 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 8 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | GEL | |||||||||
| 125239041 | 12523904 | 9 | C | ZETIA | EZETIMIBE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 10 | C | ZETIA | EZETIMIBE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 11 | C | METAXALONE. | METAXALONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 12 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239041 | 12523904 | 13 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | 10 MG, UNK | U | 0 | 10 | MG | TABLET | |||||||
| 125239041 | 12523904 | 14 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 15 | C | AMITIZA | LUBIPROSTONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239041 | 12523904 | 16 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239041 | 12523904 | 17 | C | FLAXSEED | FLAX SEED | 1 | UNK | U | 0 | ||||||||||
| 125239041 | 12523904 | 18 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 19 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239041 | 12523904 | 20 | C | Osteo-bi-flex | 2 | UNK | U | 0 | |||||||||||
| 125239041 | 12523904 | 21 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 22 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125239041 | 12523904 | 23 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 24 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125239041 | 12523904 | 25 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 26 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 27 | C | Calcium Magnesium with Vitamin D3 | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125239041 | 12523904 | 28 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 29 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239041 | 12523904 | 30 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239041 | 12523904 | 31 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239041 | 12523904 | 1 | Narcolepsy |
| 125239041 | 12523904 | 2 | Cataplexy |
| 125239041 | 12523904 | 4 | Product used for unknown indication |
| 125239041 | 12523904 | 5 | Product used for unknown indication |
| 125239041 | 12523904 | 6 | Product used for unknown indication |
| 125239041 | 12523904 | 7 | Product used for unknown indication |
| 125239041 | 12523904 | 8 | Product used for unknown indication |
| 125239041 | 12523904 | 9 | Product used for unknown indication |
| 125239041 | 12523904 | 11 | Product used for unknown indication |
| 125239041 | 12523904 | 12 | Product used for unknown indication |
| 125239041 | 12523904 | 13 | Product used for unknown indication |
| 125239041 | 12523904 | 15 | Product used for unknown indication |
| 125239041 | 12523904 | 16 | Product used for unknown indication |
| 125239041 | 12523904 | 17 | Product used for unknown indication |
| 125239041 | 12523904 | 18 | Product used for unknown indication |
| 125239041 | 12523904 | 19 | Product used for unknown indication |
| 125239041 | 12523904 | 20 | Product used for unknown indication |
| 125239041 | 12523904 | 21 | Product used for unknown indication |
| 125239041 | 12523904 | 22 | Product used for unknown indication |
| 125239041 | 12523904 | 23 | Product used for unknown indication |
| 125239041 | 12523904 | 24 | Product used for unknown indication |
| 125239041 | 12523904 | 25 | Product used for unknown indication |
| 125239041 | 12523904 | 26 | Product used for unknown indication |
| 125239041 | 12523904 | 27 | Product used for unknown indication |
| 125239041 | 12523904 | 28 | Product used for unknown indication |
| 125239041 | 12523904 | 29 | Product used for unknown indication |
| 125239041 | 12523904 | 30 | Product used for unknown indication |
| 125239041 | 12523904 | 31 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239041 | 12523904 | Fall | |
| 125239041 | 12523904 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 125239041 | 12523904 | 1 | 201303 | 2013 | 0 | |
| 125239041 | 12523904 | 2 | 2013 | 0 | ||
| 125239041 | 12523904 | 3 | 2013 | 0 | ||
| 125239041 | 12523904 | 5 | 20150825 | 0 | ||
| 125239041 | 12523904 | 6 | 20150825 | 0 | ||
| 125239041 | 12523904 | 7 | 20150825 | 0 | ||
| 125239041 | 12523904 | 8 | 20150825 | 0 | ||
| 125239041 | 12523904 | 9 | 20080301 | 20150902 | 0 | |
| 125239041 | 12523904 | 10 | 20150825 | 0 | ||
| 125239041 | 12523904 | 11 | 20130314 | 0 | ||
| 125239041 | 12523904 | 12 | 20130308 | 0 | ||
| 125239041 | 12523904 | 13 | 20130221 | 20150101 | 0 | |
| 125239041 | 12523904 | 14 | 20130308 | 0 | ||
| 125239041 | 12523904 | 15 | 20130201 | 20150101 | 0 | |
| 125239041 | 12523904 | 16 | 20130201 | 20150902 | 0 | |
| 125239041 | 12523904 | 17 | 20130201 | 20150902 | 0 | |
| 125239041 | 12523904 | 18 | 20130201 | 20150902 | 0 | |
| 125239041 | 12523904 | 19 | 20150201 | 0 | ||
| 125239041 | 12523904 | 20 | 20130201 | 0 | ||
| 125239041 | 12523904 | 21 | 20130201 | 20150101 | 0 | |
| 125239041 | 12523904 | 22 | 20130201 | 0 | ||
| 125239041 | 12523904 | 23 | 20130123 | 20150902 | 0 | |
| 125239041 | 12523904 | 24 | 20120301 | 20150902 | 0 | |
| 125239041 | 12523904 | 25 | 20120101 | 0 | ||
| 125239041 | 12523904 | 26 | 20100301 | 0 | ||
| 125239041 | 12523904 | 27 | 20090301 | 20150902 | 0 | |
| 125239041 | 12523904 | 28 | 20090301 | 0 | ||
| 125239041 | 12523904 | 29 | 20080301 | 20150902 | 0 | |
| 125239041 | 12523904 | 30 | 20080301 | 0 | ||
| 125239041 | 12523904 | 31 | 20060301 | 0 |