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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125805091 | 12580509 | 1 | I | 200706 | 20160128 | 20160721 | 20160721 | PER | US-JAZZ-2016-US-001613 | JAZZ | 44.93 | YR | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125805091 | 12580509 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125805091 | 12580509 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125805091 | 12580509 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | 21196 | 6 | G | ORAL SOLUTION | |||||||
| 125805091 | 12580509 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, SECOND DOSE | 21196 | 5 | G | ORAL SOLUTION | |||||||
| 125805091 | 12580509 | 5 | SS | TRICOR | FENOFIBRATE | 1 | UNK | 0 | |||||||||||
| 125805091 | 12580509 | 6 | C | TRULICITY | DULAGLUTIDE | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 7 | C | ACTOS | PIOGLITAZONE HYDROCHLORIDE | 1 | 1.5 MG/0.5 ML | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 8 | C | FENOFIBRATE. | FENOFIBRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 9 | C | Losartan - HTCZ | 2 | 100-12.5 MG | U | 0 | TABLET | ||||||||||
| 125805091 | 12580509 | 10 | C | VICTOZA | LIRAGLUTIDE | 1 | 18 MG /3 ML | U | 0 | ||||||||||
| 125805091 | 12580509 | 11 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 12 | C | NUCYNTA | TAPENTADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 13 | C | FENTANYL. | FENTANYL | 1 | 100 MCG/HR | U | 0 | PATCH | |||||||||
| 125805091 | 12580509 | 14 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 15 | C | REMICADE | INFLIXIMAB | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 16 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 17 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125805091 | 12580509 | 18 | C | BYETTA | EXENATIDE | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 19 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 125805091 | 12580509 | 20 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 21 | C | FORTEO | TERIPARATIDE | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 22 | C | LIDODERM | LIDOCAINE | 1 | UNK | U | 0 | PATCH | |||||||||
| 125805091 | 12580509 | 23 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 24 | C | Morphine sulphate | MORPHINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 25 | C | MTX | METHOTREXATE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 26 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 27 | C | RELPAX | ELETRIPTAN HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 28 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 29 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 30 | C | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125805091 | 12580509 | 31 | C | ZETIA | EZETIMIBE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125805091 | 12580509 | 32 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125805091 | 12580509 | 1 | Narcolepsy |
| 125805091 | 12580509 | 2 | Cataplexy |
| 125805091 | 12580509 | 5 | Product used for unknown indication |
| 125805091 | 12580509 | 6 | Product used for unknown indication |
| 125805091 | 12580509 | 7 | Product used for unknown indication |
| 125805091 | 12580509 | 8 | Product used for unknown indication |
| 125805091 | 12580509 | 9 | Product used for unknown indication |
| 125805091 | 12580509 | 10 | Product used for unknown indication |
| 125805091 | 12580509 | 11 | Product used for unknown indication |
| 125805091 | 12580509 | 12 | Product used for unknown indication |
| 125805091 | 12580509 | 13 | Product used for unknown indication |
| 125805091 | 12580509 | 14 | Product used for unknown indication |
| 125805091 | 12580509 | 15 | Product used for unknown indication |
| 125805091 | 12580509 | 16 | Product used for unknown indication |
| 125805091 | 12580509 | 17 | Product used for unknown indication |
| 125805091 | 12580509 | 18 | Product used for unknown indication |
| 125805091 | 12580509 | 19 | Product used for unknown indication |
| 125805091 | 12580509 | 20 | Product used for unknown indication |
| 125805091 | 12580509 | 21 | Product used for unknown indication |
| 125805091 | 12580509 | 22 | Product used for unknown indication |
| 125805091 | 12580509 | 23 | Product used for unknown indication |
| 125805091 | 12580509 | 24 | Product used for unknown indication |
| 125805091 | 12580509 | 25 | Product used for unknown indication |
| 125805091 | 12580509 | 26 | Product used for unknown indication |
| 125805091 | 12580509 | 27 | Product used for unknown indication |
| 125805091 | 12580509 | 28 | Product used for unknown indication |
| 125805091 | 12580509 | 29 | Product used for unknown indication |
| 125805091 | 12580509 | 30 | Product used for unknown indication |
| 125805091 | 12580509 | 31 | Product used for unknown indication |
| 125805091 | 12580509 | 32 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125805091 | 12580509 | Hepatic enzyme increased | |
| 125805091 | 12580509 | Hypertension |
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 |
|---|---|---|---|---|---|---|
| 125805091 | 12580509 | 1 | 200706 | 200712 | 0 | |
| 125805091 | 12580509 | 3 | 201206 | 0 | ||
| 125805091 | 12580509 | 4 | 201206 | 0 | ||
| 125805091 | 12580509 | 5 | 20150101 | 0 | ||
| 125805091 | 12580509 | 6 | 20151101 | 0 | ||
| 125805091 | 12580509 | 7 | 20150101 | 0 | ||
| 125805091 | 12580509 | 8 | 20150101 | 0 | ||
| 125805091 | 12580509 | 9 | 20150101 | 0 | ||
| 125805091 | 12580509 | 10 | 20140313 | 20140313 | 0 | |
| 125805091 | 12580509 | 11 | 20140113 | 0 | ||
| 125805091 | 12580509 | 12 | 20140101 | 0 | ||
| 125805091 | 12580509 | 13 | 20131111 | 0 | ||
| 125805091 | 12580509 | 14 | 20060101 | 0 | ||
| 125805091 | 12580509 | 15 | 20060101 | 0 | ||
| 125805091 | 12580509 | 18 | 20140313 | 0 | ||
| 125805091 | 12580509 | 21 | 20110101 | 0 | ||
| 125805091 | 12580509 | 22 | 20151001 | 0 | ||
| 125805091 | 12580509 | 23 | 20130101 | 0 | ||
| 125805091 | 12580509 | 24 | 20130101 | 0 | ||
| 125805091 | 12580509 | 25 | 20130101 | 0 | ||
| 125805091 | 12580509 | 30 | 20100101 | 0 |