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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126863842 | 12686384 | 2 | F | 20160412 | 20160825 | 20160912 | PER | US-JAZZ-2016-US-006961 | JAZZ | 0.00 | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126863842 | 12686384 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126863842 | 12686384 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126863842 | 12686384 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126863842 | 12686384 | 4 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 5 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 6 | C | FENTANYL. | FENTANYL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 7 | C | VIIBRYD | VILAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 8 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 9 | C | BEPREVE | BEPOTASTINE BESILATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 10 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 11 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 12 | C | HORIZANT | GABAPENTIN ENACARBIL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 13 | C | XOLAIR | OMALIZUMAB | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 14 | C | Coq10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 15 | C | Magnesium gluconate | MAGNESIUM GLUCONATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 16 | C | Omega 3 fish oil | FISH OILOMEGA-3 FATTY ACIDS | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 17 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 18 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 19 | C | CELEBREX | CELECOXIB | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 20 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 21 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 22 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 23 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 24 | C | DONNATAL | ATROPINE SULFATEHYOSCYAMINE SULFATEPHENOBARBITALSCOPOLAMINE HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 25 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 26 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 27 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 28 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 29 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 30 | C | Hydroxyzine hcl | HYDROXYZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 31 | C | LEVOCETIRIZINE DIHYDROCHLORIDE. | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 32 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 33 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 34 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 35 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 36 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 37 | C | NASONEX | MOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 38 | C | NEUPRO | ROTIGOTINE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 39 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 40 | C | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 41 | C | PROVIGIL | MODAFINIL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 42 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 43 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 44 | C | VAGIFEM | ESTRADIOL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 45 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 46 | C | VIVELLE-DOT | ESTRADIOL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 47 | C | Iron | IRON | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 48 | C | METAXALONE. | METAXALONE | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 49 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | U | 0 | |||||||||||
| 126863842 | 12686384 | 50 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126863842 | 12686384 | 1 | Narcolepsy |
| 126863842 | 12686384 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126863842 | 12686384 | Alopecia | |
| 126863842 | 12686384 | Pain | |
| 126863842 | 12686384 | Pre-existing condition improved | |
| 126863842 | 12686384 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 126863842 | 12686384 | 1 | 201506 | 201507 | 0 | |
| 126863842 | 12686384 | 3 | 201507 | 0 |