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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127938881 | 12793888 | 1 | I | 20160622 | 20160929 | 20160929 | PER | US-JAZZ-2016-US-011686 | JAZZ | 0.00 | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127938881 | 12793888 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127938881 | 12793888 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127938881 | 12793888 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127938881 | 12793888 | 4 | SS | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 127938881 | 12793888 | 5 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 6 | C | NORVASC | AMLODIPINE BESYLATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 8 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 9 | C | QUINAPRIL. | QUINAPRIL | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 10 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 11 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 12 | C | CORTISONE ACETATE. | CORTISONE ACETATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 13 | C | TOPAMAX | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 14 | C | TOPIRAMATE. | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 15 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 16 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 17 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 18 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 19 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 20 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 21 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 22 | C | TEMAZEPAM. | TEMAZEPAM | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 23 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 24 | C | RIZATRIPTAN. | RIZATRIPTAN | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 25 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 26 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938881 | 12793888 | 27 | C | MAXALT | RIZATRIPTAN BENZOATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127938881 | 12793888 | 1 | Narcolepsy |
| 127938881 | 12793888 | 2 | Cataplexy |
| 127938881 | 12793888 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127938881 | 12793888 | Blood pressure diastolic increased | |
| 127938881 | 12793888 | Condition aggravated | |
| 127938881 | 12793888 | Drug ineffective | |
| 127938881 | 12793888 | Pre-existing condition improved | |
| 127938881 | 12793888 | Somnolence | |
| 127938881 | 12793888 | 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 |
|---|---|---|---|---|---|---|
| 127938881 | 12793888 | 1 | 201407 | 201408 | 0 | |
| 127938881 | 12793888 | 2 | 201408 | 201409 | 0 | |
| 127938881 | 12793888 | 3 | 201409 | 0 | ||
| 127938881 | 12793888 | 4 | 20160701 | 0 |