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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127436402 | 12743640 | 2 | F | 20160922 | 20160914 | 20160930 | PER | US-JAZZ-2016-US-017199 | JAZZ | 0.00 | F | Y | 0.00000 | 20160930 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127436402 | 12743640 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127436402 | 12743640 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127436402 | 12743640 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127436402 | 12743640 | 4 | SS | CLONIDINE. | CLONIDINE | 1 | Y | 0 | PATCH | ||||||||||
| 127436402 | 12743640 | 5 | C | Clonidine hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 6 | C | Clonidine hcl er | CLONIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 7 | C | Dexilant dr | 2 | U | 0 | CAPSULE | |||||||||||
| 127436402 | 12743640 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 9 | C | DRONABINOL. | DRONABINOL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127436402 | 12743640 | 10 | C | DULOXETINE HYDROCHLORIDE. | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 127436402 | 12743640 | 11 | C | Flunarizine | FLUNARIZINE | 1 | U | 0 | |||||||||||
| 127436402 | 12743640 | 12 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 127436402 | 12743640 | 13 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | TABLET | ||||||||||
| 127436402 | 12743640 | 14 | C | INDOMETHACIN. | INDOMETHACIN | 1 | U | 0 | CAPSULE | ||||||||||
| 127436402 | 12743640 | 15 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 16 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | U | 0 | TABLET | ||||||||||
| 127436402 | 12743640 | 17 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | U | 0 | TABLET | ||||||||||
| 127436402 | 12743640 | 18 | C | Multivitamins | VITAMINS | 1 | U | 0 | CAPSULE | ||||||||||
| 127436402 | 12743640 | 19 | C | NAMENDA | MEMANTINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 20 | C | Naproxen ec | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 21 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127436402 | 12743640 | 22 | C | Nystatin w/triamcinolone | 2 | U | 0 | CREAM | |||||||||||
| 127436402 | 12743640 | 23 | C | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436402 | 12743640 | 24 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 127436402 | 12743640 | 25 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | CAPSULE | ||||||||||
| 127436402 | 12743640 | 26 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | U | 0 | CAPSULE | ||||||||||
| 127436402 | 12743640 | 27 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127436402 | 12743640 | 1 | Narcolepsy |
| 127436402 | 12743640 | 4 | Product used for unknown indication |
| 127436402 | 12743640 | 5 | Product used for unknown indication |
| 127436402 | 12743640 | 6 | Product used for unknown indication |
| 127436402 | 12743640 | 7 | Product used for unknown indication |
| 127436402 | 12743640 | 8 | Product used for unknown indication |
| 127436402 | 12743640 | 9 | Product used for unknown indication |
| 127436402 | 12743640 | 10 | Product used for unknown indication |
| 127436402 | 12743640 | 11 | Product used for unknown indication |
| 127436402 | 12743640 | 12 | Product used for unknown indication |
| 127436402 | 12743640 | 13 | Product used for unknown indication |
| 127436402 | 12743640 | 14 | Product used for unknown indication |
| 127436402 | 12743640 | 15 | Product used for unknown indication |
| 127436402 | 12743640 | 16 | Product used for unknown indication |
| 127436402 | 12743640 | 17 | Product used for unknown indication |
| 127436402 | 12743640 | 18 | Product used for unknown indication |
| 127436402 | 12743640 | 19 | Product used for unknown indication |
| 127436402 | 12743640 | 20 | Product used for unknown indication |
| 127436402 | 12743640 | 21 | Product used for unknown indication |
| 127436402 | 12743640 | 22 | Product used for unknown indication |
| 127436402 | 12743640 | 23 | Product used for unknown indication |
| 127436402 | 12743640 | 24 | Product used for unknown indication |
| 127436402 | 12743640 | 25 | Product used for unknown indication |
| 127436402 | 12743640 | 26 | Product used for unknown indication |
| 127436402 | 12743640 | 27 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127436402 | 12743640 | Drug ineffective | |
| 127436402 | 12743640 | Headache |
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 |
|---|---|---|---|---|---|---|
| 127436402 | 12743640 | 1 | 201604 | 201605 | 0 | |
| 127436402 | 12743640 | 2 | 201605 | 201605 | 0 | |
| 127436402 | 12743640 | 3 | 201605 | 0 | ||
| 127436402 | 12743640 | 5 | 201609 | 0 | ||
| 127436402 | 12743640 | 6 | 201608 | 0 | ||
| 127436402 | 12743640 | 8 | 20160424 | 0 | ||
| 127436402 | 12743640 | 12 | 201604 | 0 | ||
| 127436402 | 12743640 | 15 | 201604 | 0 | ||
| 127436402 | 12743640 | 20 | 201605 | 0 | ||
| 127436402 | 12743640 | 21 | 20160424 | 0 | ||
| 127436402 | 12743640 | 23 | 201604 | 0 |