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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127227293 | 12722729 | 3 | F | 20160919 | 20160907 | 20160927 | EXP | US-JAZZ-2016-US-016763 | JAZZ | 0.00 | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127227293 | 12722729 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127227293 | 12722729 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127227293 | 12722729 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 127227293 | 12722729 | 4 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227293 | 12722729 | 5 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227293 | 12722729 | 6 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 7 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227293 | 12722729 | 8 | C | IBUPROFEN IB | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 127227293 | 12722729 | 9 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 10 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 11 | C | NUVIGIL | ARMODAFINIL | 1 | 150 MG | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | 250 MG | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 13 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 14 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 15 | C | WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227293 | 12722729 | 16 | C | NORETHINDRONE. | NORETHINDRONE | 1 | U | 0 | TABLET | ||||||||||
| 127227293 | 12722729 | 17 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127227293 | 12722729 | 1 | Narcolepsy |
| 127227293 | 12722729 | 4 | Neuralgia |
| 127227293 | 12722729 | 5 | Product used for unknown indication |
| 127227293 | 12722729 | 6 | Product used for unknown indication |
| 127227293 | 12722729 | 7 | Product used for unknown indication |
| 127227293 | 12722729 | 8 | Product used for unknown indication |
| 127227293 | 12722729 | 9 | Product used for unknown indication |
| 127227293 | 12722729 | 10 | Product used for unknown indication |
| 127227293 | 12722729 | 11 | Product used for unknown indication |
| 127227293 | 12722729 | 13 | Product used for unknown indication |
| 127227293 | 12722729 | 14 | Product used for unknown indication |
| 127227293 | 12722729 | 15 | Product used for unknown indication |
| 127227293 | 12722729 | 16 | Product used for unknown indication |
| 127227293 | 12722729 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127227293 | 12722729 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127227293 | 12722729 | Chest pain | |
| 127227293 | 12722729 | Drug ineffective | |
| 127227293 | 12722729 | Headache | |
| 127227293 | 12722729 | Mitral valve incompetence | |
| 127227293 | 12722729 | Nausea | |
| 127227293 | 12722729 | Neuralgia | |
| 127227293 | 12722729 | Neuropathy peripheral | |
| 127227293 | 12722729 | Sleep apnoea syndrome | |
| 127227293 | 12722729 | Snoring | |
| 127227293 | 12722729 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127227293 | 12722729 | 1 | 201601 | 201601 | 0 | |
| 127227293 | 12722729 | 2 | 201601 | 201605 | 0 | |
| 127227293 | 12722729 | 3 | 201605 | 0 | ||
| 127227293 | 12722729 | 4 | 20160601 | 0 | ||
| 127227293 | 12722729 | 5 | 201608 | 0 | ||
| 127227293 | 12722729 | 6 | 201603 | 0 | ||
| 127227293 | 12722729 | 7 | 20160112 | 201602 | 0 | |
| 127227293 | 12722729 | 8 | 20160112 | 0 | ||
| 127227293 | 12722729 | 9 | 20160112 | 0 | ||
| 127227293 | 12722729 | 10 | 20160112 | 201602 | 0 | |
| 127227293 | 12722729 | 11 | 20160112 | 20160112 | 0 | |
| 127227293 | 12722729 | 12 | 20160112 | 201603 | 0 | |
| 127227293 | 12722729 | 13 | 20160112 | 201602 | 0 | |
| 127227293 | 12722729 | 14 | 20160112 | 201602 | 0 | |
| 127227293 | 12722729 | 15 | 20160112 | 201602 | 0 | |
| 127227293 | 12722729 | 17 | 201601 | 0 |