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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125065562 | 12506556 | 2 | F | 2014 | 20160713 | 20160628 | 20160721 | EXP | US-JAZZ-2016-US-011630 | JAZZ | 0.00 | F | Y | 0.00000 | 20160721 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125065562 | 12506556 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 125065562 | 12506556 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125065562 | 12506556 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125065562 | 12506556 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125065562 | 12506556 | 5 | SS | Amfetamine | AMPHETAMINE | 1 | U | 0 | |||||||||||
| 125065562 | 12506556 | 6 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 125065562 | 12506556 | 7 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 8 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 10 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 11 | C | FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 12 | C | MOTRIN IB | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 13 | C | VICTOZA | LIRAGLUTIDE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 14 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 15 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 16 | C | AMILORIDE HCL | AMILORIDE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 17 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125065562 | 12506556 | 18 | C | Protonix dr | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125065562 | 12506556 | 19 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125065562 | 12506556 | 20 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 21 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 125065562 | 12506556 | 22 | C | DETROL | TOLTERODINE TARTRATE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 23 | C | DYAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 24 | C | ESTROGEN | ESTRONESUS SCROFA OVARY | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 25 | C | HYOSCYAMINE. | HYOSCYAMINE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 26 | C | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 27 | C | Multivitamins | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 125065562 | 12506556 | 28 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 29 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 30 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 31 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 32 | C | SULAR | NISOLDIPINE | 1 | UNK | U | 0 | ||||||||||
| 125065562 | 12506556 | 33 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | U | 0 | INHALER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125065562 | 12506556 | 1 | Narcolepsy |
| 125065562 | 12506556 | 2 | Cataplexy |
| 125065562 | 12506556 | 5 | Product used for unknown indication |
| 125065562 | 12506556 | 6 | Product used for unknown indication |
| 125065562 | 12506556 | 7 | Product used for unknown indication |
| 125065562 | 12506556 | 8 | Product used for unknown indication |
| 125065562 | 12506556 | 9 | Product used for unknown indication |
| 125065562 | 12506556 | 10 | Product used for unknown indication |
| 125065562 | 12506556 | 11 | Product used for unknown indication |
| 125065562 | 12506556 | 12 | Product used for unknown indication |
| 125065562 | 12506556 | 13 | Product used for unknown indication |
| 125065562 | 12506556 | 14 | Product used for unknown indication |
| 125065562 | 12506556 | 15 | Product used for unknown indication |
| 125065562 | 12506556 | 16 | Product used for unknown indication |
| 125065562 | 12506556 | 17 | Product used for unknown indication |
| 125065562 | 12506556 | 18 | Product used for unknown indication |
| 125065562 | 12506556 | 19 | Product used for unknown indication |
| 125065562 | 12506556 | 20 | Product used for unknown indication |
| 125065562 | 12506556 | 21 | Product used for unknown indication |
| 125065562 | 12506556 | 22 | Product used for unknown indication |
| 125065562 | 12506556 | 23 | Product used for unknown indication |
| 125065562 | 12506556 | 24 | Product used for unknown indication |
| 125065562 | 12506556 | 25 | Product used for unknown indication |
| 125065562 | 12506556 | 26 | Product used for unknown indication |
| 125065562 | 12506556 | 27 | Product used for unknown indication |
| 125065562 | 12506556 | 28 | Product used for unknown indication |
| 125065562 | 12506556 | 29 | Product used for unknown indication |
| 125065562 | 12506556 | 30 | Product used for unknown indication |
| 125065562 | 12506556 | 31 | Product used for unknown indication |
| 125065562 | 12506556 | 32 | Product used for unknown indication |
| 125065562 | 12506556 | 33 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125065562 | 12506556 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125065562 | 12506556 | Anxiety | |
| 125065562 | 12506556 | Sleep apnoea syndrome | |
| 125065562 | 12506556 | Tooth disorder | |
| 125065562 | 12506556 | Type 2 diabetes mellitus | |
| 125065562 | 12506556 | Unevaluable event | |
| 125065562 | 12506556 | Weight decreased | |
| 125065562 | 12506556 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125065562 | 12506556 | 1 | 200804 | 2008 | 0 | |
| 125065562 | 12506556 | 2 | 200806 | 200807 | 0 | |
| 125065562 | 12506556 | 3 | 200807 | 2009 | 0 | |
| 125065562 | 12506556 | 4 | 201101 | 0 | ||
| 125065562 | 12506556 | 7 | 201604 | 201604 | 0 | |
| 125065562 | 12506556 | 8 | 201604 | 201604 | 0 | |
| 125065562 | 12506556 | 9 | 201602 | 0 | ||
| 125065562 | 12506556 | 10 | 201506 | 0 | ||
| 125065562 | 12506556 | 11 | 201506 | 0 | ||
| 125065562 | 12506556 | 12 | 20140829 | 20140910 | 0 | |
| 125065562 | 12506556 | 13 | 201406 | 0 | ||
| 125065562 | 12506556 | 14 | 201401 | 0 | ||
| 125065562 | 12506556 | 15 | 201206 | 0 | ||
| 125065562 | 12506556 | 16 | 201101 | 0 | ||
| 125065562 | 12506556 | 17 | 201101 | 0 | ||
| 125065562 | 12506556 | 18 | 201101 | 0 | ||
| 125065562 | 12506556 | 19 | 201512 | 0 | ||
| 125065562 | 12506556 | 20 | 201606 | 0 | ||
| 125065562 | 12506556 | 22 | 200912 | 0 | ||
| 125065562 | 12506556 | 23 | 201112 | 0 | ||
| 125065562 | 12506556 | 24 | 200812 | 0 | ||
| 125065562 | 12506556 | 25 | 201606 | 0 | ||
| 125065562 | 12506556 | 26 | 201506 | 0 | ||
| 125065562 | 12506556 | 28 | 201506 | 0 | ||
| 125065562 | 12506556 | 29 | 201606 | 0 | ||
| 125065562 | 12506556 | 30 | 201112 | 0 | ||
| 125065562 | 12506556 | 31 | 201306 | 0 | ||
| 125065562 | 12506556 | 32 | 201606 | 0 |