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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127089121 | 12708912 | 1 | I | 20160504 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008406 | JAZZ | 0.00 | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127089121 | 12708912 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127089121 | 12708912 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127089121 | 12708912 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, FIRST DOSE | 21196 | 5 | G | ORAL SOLUTION | |||||||
| 127089121 | 12708912 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127089121 | 12708912 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, THIRD DOSE | 21196 | 2 | G | ORAL SOLUTION | |||||||
| 127089121 | 12708912 | 6 | SS | REMERON | MIRTAZAPINE | 1 | UNK | 0 | TABLET | ||||||||||
| 127089121 | 12708912 | 7 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 8 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 9 | C | NAPROXEN. | NAPROXEN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 10 | C | Acidophilus xtra | 2 | U | 0 | ||||||||||||
| 127089121 | 12708912 | 11 | C | AMOXICILLIN. | AMOXICILLIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 12 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 13 | C | Atorvastatin | ATORVASTATIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 14 | C | CATAPRES | CLONIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 15 | C | CLEOCIN | CLINDAMYCIN PHOSPHATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 16 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 17 | C | FENOFIBRATE. | FENOFIBRATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 18 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 19 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 20 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 21 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 22 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 23 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 24 | C | GABITRIL | TIAGABINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 25 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 26 | C | Calcium magnesium | CALCIUMMAGNESIUM | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 27 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 28 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 29 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 30 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 31 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 32 | C | FENOFIBRATE. | FENOFIBRATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 33 | C | GUAIFENESIN. | GUAIFENESIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 34 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 35 | C | ABILIFY | ARIPIPRAZOLE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 36 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 37 | C | Atorvastatin | ATORVASTATIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 38 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 39 | C | LISINOPRIL. | LISINOPRIL | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 40 | C | PARNATE | TRANYLCYPROMINE SULFATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 41 | C | Prazosin hcl | PRAZOSIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 42 | C | Protriptyline Hcl | 2 | U | 0 | ||||||||||||
| 127089121 | 12708912 | 43 | C | RILUTEK | RILUZOLE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 44 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 45 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 46 | C | VYTORIN | EZETIMIBESIMVASTATIN | 1 | U | 0 | |||||||||||
| 127089121 | 12708912 | 47 | C | ZYPREXA | OLANZAPINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127089121 | 12708912 | 1 | Sleep disorder |
| 127089121 | 12708912 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127089121 | 12708912 | 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 |
|---|---|---|---|---|---|---|
| 127089121 | 12708912 | 1 | 200611 | 200710 | 0 | |
| 127089121 | 12708912 | 3 | 201603 | 0 | ||
| 127089121 | 12708912 | 4 | 201603 | 0 | ||
| 127089121 | 12708912 | 5 | 201603 | 0 |