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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580931 | 12558093 | 1 | I | 2015 | 20160112 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000620 | JAZZ | 0.00 | M | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580931 | 12558093 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125580931 | 12558093 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125580931 | 12558093 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125580931 | 12558093 | 4 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 5 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNKNOWN LOWER DOSE | N | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 6 | C | Trokendi | TOPIRAMATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 7 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 8 | C | CONZIP | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 9 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 10 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 11 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 12 | C | MEDROL | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 13 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 14 | C | BOTOX COSMETIC | ONABOTULINUMTOXINA | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 15 | C | SAPHRIS | ASENAPINE MALEATE | 1 | Sublingual | UNK | U | 0 | TABLET | ||||||||
| 125580931 | 12558093 | 16 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 17 | C | COENZYME Q10 | UBIDECARENONE | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 18 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 19 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 20 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 21 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 22 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580931 | 12558093 | 23 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 24 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 25 | C | PENNSAID | DICLOFENAC SODIUM | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 125580931 | 12558093 | 26 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 27 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125580931 | 12558093 | 28 | C | VERAMYST | FLUTICASONE FUROATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 125580931 | 12558093 | 29 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 30 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580931 | 12558093 | 31 | C | VITAMINS NOS | VITAMINS | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125580931 | 12558093 | 1 | Narcolepsy |
| 125580931 | 12558093 | 4 | Product used for unknown indication |
| 125580931 | 12558093 | 6 | Product used for unknown indication |
| 125580931 | 12558093 | 7 | Product used for unknown indication |
| 125580931 | 12558093 | 8 | Product used for unknown indication |
| 125580931 | 12558093 | 9 | Product used for unknown indication |
| 125580931 | 12558093 | 10 | Product used for unknown indication |
| 125580931 | 12558093 | 11 | Product used for unknown indication |
| 125580931 | 12558093 | 12 | Product used for unknown indication |
| 125580931 | 12558093 | 13 | Product used for unknown indication |
| 125580931 | 12558093 | 14 | Product used for unknown indication |
| 125580931 | 12558093 | 15 | Product used for unknown indication |
| 125580931 | 12558093 | 16 | Product used for unknown indication |
| 125580931 | 12558093 | 17 | Product used for unknown indication |
| 125580931 | 12558093 | 18 | Product used for unknown indication |
| 125580931 | 12558093 | 19 | Product used for unknown indication |
| 125580931 | 12558093 | 20 | Product used for unknown indication |
| 125580931 | 12558093 | 21 | Product used for unknown indication |
| 125580931 | 12558093 | 22 | Product used for unknown indication |
| 125580931 | 12558093 | 23 | Product used for unknown indication |
| 125580931 | 12558093 | 24 | Product used for unknown indication |
| 125580931 | 12558093 | 25 | Product used for unknown indication |
| 125580931 | 12558093 | 26 | Product used for unknown indication |
| 125580931 | 12558093 | 27 | Product used for unknown indication |
| 125580931 | 12558093 | 28 | Product used for unknown indication |
| 125580931 | 12558093 | 29 | Product used for unknown indication |
| 125580931 | 12558093 | 30 | Product used for unknown indication |
| 125580931 | 12558093 | 31 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125580931 | 12558093 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125580931 | 12558093 | Agitation | |
| 125580931 | 12558093 | Depression |
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 |
|---|---|---|---|---|---|---|
| 125580931 | 12558093 | 1 | 200709 | 2007 | 0 | |
| 125580931 | 12558093 | 3 | 2012 | 0 | ||
| 125580931 | 12558093 | 4 | 20150514 | 0 | ||
| 125580931 | 12558093 | 6 | 20150410 | 0 | ||
| 125580931 | 12558093 | 7 | 20141219 | 0 | ||
| 125580931 | 12558093 | 8 | 20140922 | 0 | ||
| 125580931 | 12558093 | 9 | 20140626 | 0 | ||
| 125580931 | 12558093 | 10 | 20140429 | 0 | ||
| 125580931 | 12558093 | 11 | 20130726 | 0 | ||
| 125580931 | 12558093 | 12 | 20130510 | 20130516 | 0 | |
| 125580931 | 12558093 | 13 | 20130215 | 0 | ||
| 125580931 | 12558093 | 14 | 20121219 | 0 | ||
| 125580931 | 12558093 | 15 | 20121219 | 20150814 | 0 | |
| 125580931 | 12558093 | 16 | 20120920 | 0 | ||
| 125580931 | 12558093 | 17 | 20120628 | 0 | ||
| 125580931 | 12558093 | 18 | 20010101 | 20150410 | 0 | |
| 125580931 | 12558093 | 25 | 20120628 | 0 | ||
| 125580931 | 12558093 | 26 | 20120628 | 0 | ||
| 125580931 | 12558093 | 27 | 20120628 | 0 | ||
| 125580931 | 12558093 | 28 | 20120628 | 0 | ||
| 125580931 | 12558093 | 31 | 20120628 | 0 |