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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125230361 | 12523036 | 1 | I | 2016 | 20160627 | 20160701 | 20160701 | EXP | US-JAZZ-2016-US-012091 | JAZZ | 0.00 | M | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125230361 | 12523036 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | Y | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 125230361 | 12523036 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125230361 | 12523036 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125230361 | 12523036 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DECREASED DOSE | Y | 21196 | ORAL SOLUTION | ||||||||
| 125230361 | 12523036 | 5 | C | Cetirizine hcl | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 6 | C | Chlorhexidine | CHLORHEXIDINE | 1 | UNK | U | 0 | ||||||||||
| 125230361 | 12523036 | 7 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 125230361 | 12523036 | 8 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 9 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 10 | C | VIAGRA | SILDENAFIL CITRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 11 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 12 | C | VICODIN ES | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 13 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125230361 | 12523036 | 14 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 15 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 16 | C | Pseudoephedrine | PSEUDOEPHEDRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 17 | C | DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125230361 | 12523036 | 18 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 19 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230361 | 12523036 | 20 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125230361 | 12523036 | 1 | Narcolepsy |
| 125230361 | 12523036 | 2 | Cataplexy |
| 125230361 | 12523036 | 5 | Product used for unknown indication |
| 125230361 | 12523036 | 6 | Product used for unknown indication |
| 125230361 | 12523036 | 7 | Product used for unknown indication |
| 125230361 | 12523036 | 8 | Product used for unknown indication |
| 125230361 | 12523036 | 9 | Product used for unknown indication |
| 125230361 | 12523036 | 10 | Product used for unknown indication |
| 125230361 | 12523036 | 11 | Product used for unknown indication |
| 125230361 | 12523036 | 12 | Product used for unknown indication |
| 125230361 | 12523036 | 13 | Product used for unknown indication |
| 125230361 | 12523036 | 14 | Product used for unknown indication |
| 125230361 | 12523036 | 15 | Product used for unknown indication |
| 125230361 | 12523036 | 16 | Product used for unknown indication |
| 125230361 | 12523036 | 17 | Product used for unknown indication |
| 125230361 | 12523036 | 18 | Product used for unknown indication |
| 125230361 | 12523036 | 19 | Product used for unknown indication |
| 125230361 | 12523036 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125230361 | 12523036 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125230361 | 12523036 | Fall | |
| 125230361 | 12523036 | Loss of consciousness | |
| 125230361 | 12523036 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125230361 | 12523036 | 1 | 200706 | 2007 | 0 | |
| 125230361 | 12523036 | 2 | 201109 | 201406 | 0 | |
| 125230361 | 12523036 | 3 | 201406 | 2016 | 0 | |
| 125230361 | 12523036 | 4 | 2016 | 0 | ||
| 125230361 | 12523036 | 5 | 20151009 | 0 | ||
| 125230361 | 12523036 | 6 | 20151009 | 0 | ||
| 125230361 | 12523036 | 7 | 20151009 | 0 | ||
| 125230361 | 12523036 | 8 | 20151009 | 0 | ||
| 125230361 | 12523036 | 9 | 20151009 | 0 | ||
| 125230361 | 12523036 | 10 | 20151009 | 0 | ||
| 125230361 | 12523036 | 11 | 20151009 | 0 | ||
| 125230361 | 12523036 | 12 | 20141016 | 20151021 | 0 | |
| 125230361 | 12523036 | 13 | 20140807 | 0 | ||
| 125230361 | 12523036 | 14 | 20130805 | 0 | ||
| 125230361 | 12523036 | 15 | 20130805 | 0 | ||
| 125230361 | 12523036 | 16 | 200506 | 0 | ||
| 125230361 | 12523036 | 17 | 200705 | 0 | ||
| 125230361 | 12523036 | 18 | 20130805 | 0 | ||
| 125230361 | 12523036 | 19 | 20130805 | 0 | ||
| 125230361 | 12523036 | 20 | 20130805 | 0 |