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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118596782 | 11859678 | 2 | F | 2008 | 20160812 | 20151221 | 20160819 | EXP | US-JAZZ-2015-US-021819 | JAZZ | 0.00 | F | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118596782 | 11859678 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 118596782 | 11859678 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 118596782 | 11859678 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 118596782 | 11859678 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 118596782 | 11859678 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 118596782 | 11859678 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.5 MG, TID | 0 | .5 | MG | TABLET | ||||||||
| 118596782 | 11859678 | 7 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | 0 | TABLET | ||||||||||
| 118596782 | 11859678 | 8 | C | PRIMIDONE. | PRIMIDONE | 1 | 100 MG, QD | 0 | 100 | MG | TABLET | ||||||||
| 118596782 | 11859678 | 9 | C | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 118596782 | 11859678 | 10 | C | NEURONTIN | GABAPENTIN | 1 | 3600 MG, TOTAL DAILY DOSE | 0 | TABLET | ||||||||||
| 118596782 | 11859678 | 11 | C | TOPAMAX | TOPIRAMATE | 1 | 100 MG, BID | 0 | 100 | MG | TABLET | ||||||||
| 118596782 | 11859678 | 12 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118596782 | 11859678 | 13 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 118596782 | 11859678 | 14 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118596782 | 11859678 | 15 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118596782 | 11859678 | 16 | SS | ROPINIROLE. | ROPINIROLE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118596782 | 11859678 | 1 | Narcolepsy |
| 118596782 | 11859678 | 2 | Cataplexy |
| 118596782 | 11859678 | 6 | Product used for unknown indication |
| 118596782 | 11859678 | 7 | Product used for unknown indication |
| 118596782 | 11859678 | 8 | Product used for unknown indication |
| 118596782 | 11859678 | 9 | Product used for unknown indication |
| 118596782 | 11859678 | 10 | Product used for unknown indication |
| 118596782 | 11859678 | 11 | Product used for unknown indication |
| 118596782 | 11859678 | 12 | Product used for unknown indication |
| 118596782 | 11859678 | 13 | Product used for unknown indication |
| 118596782 | 11859678 | 14 | Product used for unknown indication |
| 118596782 | 11859678 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118596782 | 11859678 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118596782 | 11859678 | Addison's disease | |
| 118596782 | 11859678 | Amnesia | |
| 118596782 | 11859678 | Atrophy | |
| 118596782 | 11859678 | Blood pressure increased | |
| 118596782 | 11859678 | Carotid artery occlusion | |
| 118596782 | 11859678 | Chest pain | |
| 118596782 | 11859678 | Condition aggravated | |
| 118596782 | 11859678 | Depression | |
| 118596782 | 11859678 | Diarrhoea | |
| 118596782 | 11859678 | Disturbance in attention | |
| 118596782 | 11859678 | Dizziness | |
| 118596782 | 11859678 | Drug hypersensitivity | |
| 118596782 | 11859678 | Dysstasia | |
| 118596782 | 11859678 | Fall | |
| 118596782 | 11859678 | Fibromyalgia | |
| 118596782 | 11859678 | Fluid retention | |
| 118596782 | 11859678 | Headache | |
| 118596782 | 11859678 | Hypertension | |
| 118596782 | 11859678 | Intervertebral disc degeneration | |
| 118596782 | 11859678 | Mitral valve incompetence | |
| 118596782 | 11859678 | Muscle atrophy | |
| 118596782 | 11859678 | Neuralgia | |
| 118596782 | 11859678 | Neuropathy peripheral | |
| 118596782 | 11859678 | Parkinson's disease | |
| 118596782 | 11859678 | Post-traumatic stress disorder | |
| 118596782 | 11859678 | Respiratory disorder | |
| 118596782 | 11859678 | Suicide attempt | |
| 118596782 | 11859678 | Tricuspid valve incompetence | |
| 118596782 | 11859678 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 118596782 | 11859678 | 1 | 200612 | 200612 | 0 | |
| 118596782 | 11859678 | 2 | 200612 | 2008 | 0 | |
| 118596782 | 11859678 | 3 | 201012 | 2011 | 0 | |
| 118596782 | 11859678 | 5 | 201302 | 0 | ||
| 118596782 | 11859678 | 6 | 20151208 | 0 | ||
| 118596782 | 11859678 | 7 | 20151208 | 0 | ||
| 118596782 | 11859678 | 8 | 20151208 | 0 | ||
| 118596782 | 11859678 | 9 | 20151208 | 0 | ||
| 118596782 | 11859678 | 10 | 20151208 | 0 | ||
| 118596782 | 11859678 | 11 | 20151208 | 0 | ||
| 118596782 | 11859678 | 12 | 20151208 | 0 | ||
| 118596782 | 11859678 | 13 | 20151208 | 0 | ||
| 118596782 | 11859678 | 14 | 20151208 | 0 | ||
| 118596782 | 11859678 | 15 | 20130606 | 0 |