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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127445441 | 12744544 | 1 | I | 20160520 | 20160914 | 20160914 | PER | US-JAZZ-2016-US-009556 | JAZZ | 0.00 | F | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127445441 | 12744544 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127445441 | 12744544 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127445441 | 12744544 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127445441 | 12744544 | 4 | SS | NIACIN. | NIACIN | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 5 | C | DIOVAN | VALSARTAN | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 6 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 7 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 8 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 9 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 10 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 11 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 12 | C | VISTARIL | HYDROXYZINE PAMOATE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 13 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 14 | C | Melatonin | MELATONIN | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 15 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 17 | C | VITAMIN K | PHYTONADIONE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 18 | C | Probiotic | PROBIOTICS NOS | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 19 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 20 | C | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 21 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 22 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 23 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 24 | C | ZOMIG | ZOLMITRIPTAN | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 25 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 26 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 27 | C | NASONEX | MOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 28 | C | Omega 3 fish oil | FISH OILOMEGA-3 FATTY ACIDS | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 29 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127445441 | 12744544 | 30 | C | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127445441 | 12744544 | 1 | Narcolepsy |
| 127445441 | 12744544 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127445441 | 12744544 | Condition aggravated | |
| 127445441 | 12744544 | Flushing | |
| 127445441 | 12744544 | Hypertension | |
| 127445441 | 12744544 | Migraine | |
| 127445441 | 12744544 | Seasonal allergy |
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 |
|---|---|---|---|---|---|---|
| 127445441 | 12744544 | 1 | 201504 | 201504 | 0 | |
| 127445441 | 12744544 | 3 | 201505 | 0 |