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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123865254 | 12386525 | 4 | F | 2015 | 20160714 | 20160519 | 20160722 | EXP | US-JAZZ-2016-US-008868 | JAZZ | 65.77 | YR | F | Y | 122.45000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123865254 | 12386525 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 123865254 | 12386525 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 123865254 | 12386525 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, QD | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 123865254 | 12386525 | 4 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | 500 MG, QD | U | 0 | 500 | MG | TABLET | |||||||
| 123865254 | 12386525 | 5 | C | Chondroitin sulfate w/Glucosamine hydrochloride | 2 | UNK | U | 0 | |||||||||||
| 123865254 | 12386525 | 6 | C | Multivitamins w/minerals | MINERALSVITAMINS | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 7 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | 325 MG, QD | U | 0 | 325 | MG | ||||||||
| 123865254 | 12386525 | 8 | C | Fish oil | FISH OIL | 1 | 1000 MG, BID | U | 0 | 1000 | MG | ||||||||
| 123865254 | 12386525 | 9 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 123865254 | 12386525 | 10 | C | CHROMIUM | CHROMIC CHLORIDECHROMIUM | 1 | 400 ?G, QD | U | 0 | 400 | UG | TABLET | |||||||
| 123865254 | 12386525 | 11 | C | Vitamin a | VITAMIN A | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123865254 | 12386525 | 12 | C | Super b complex | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 123865254 | 12386525 | 13 | C | Zinc gluconate | ZINC GLUCONATE | 1 | 50 MG, QD | U | 0 | 50 | MG | TABLET | |||||||
| 123865254 | 12386525 | 14 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | 400 MG, QD | U | 0 | 400 | MG | TABLET | |||||||
| 123865254 | 12386525 | 15 | C | Vitamin c TR | 2 | 1000, ONCE DAILY | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 16 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 123865254 | 12386525 | 17 | C | Biotin | BIOTIN | 1 | 10 MG, QD | U | 0 | 10 | MG | TABLET | |||||||
| 123865254 | 12386525 | 18 | C | Arginine hcl | ARGININE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 123865254 | 12386525 | 19 | C | Calcium with Vitamin D | CALCIUMVITAMIN D | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 20 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123865254 | 12386525 | 21 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123865254 | 12386525 | 22 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 23 | C | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 24 | C | Atorvastatin | ATORVASTATIN | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 25 | C | BUDEPRION | BUPROPION HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 26 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 27 | C | CHLORZOXAZONE. | CHLORZOXAZONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123865254 | 12386525 | 28 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 29 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 30 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 123865254 | 12386525 | 31 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | U | 0 | CAPSULE | ||||||||||
| 123865254 | 12386525 | 32 | C | FEXOFENADINE HCL | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 33 | C | FIBERCON | CALCIUM POLYCARBOPHIL | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 34 | C | FUROSEMIDE. | FUROSEMIDE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 35 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | CAPSULE | ||||||||||
| 123865254 | 12386525 | 36 | C | GEMFIBROZIL. | GEMFIBROZIL | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 37 | C | GLIPIZIDE. | GLIPIZIDE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 38 | C | INVEGA | PALIPERIDONE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 39 | C | Iron | IRON | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 40 | C | L-Arginine | ARGININE | 1 | ONCE DAILY | U | 0 | TABLET | |||||||||
| 123865254 | 12386525 | 41 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 42 | C | MELOXICAM. | MELOXICAM | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 43 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 44 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 45 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 46 | C | Multivitamin | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 47 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 48 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 49 | C | ROPINIROLE. | ROPINIROLE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 50 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 51 | C | TOPAMAX | TOPIRAMATE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 52 | C | TRICOR | FENOFIBRATE | 1 | UNK | U | 0 | ||||||||||
| 123865254 | 12386525 | 53 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | U | 0 | TABLET | ||||||||||
| 123865254 | 12386525 | 54 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123865254 | 12386525 | 1 | Narcolepsy |
| 123865254 | 12386525 | 2 | Somnolence |
| 123865254 | 12386525 | 4 | Pain |
| 123865254 | 12386525 | 5 | Product used for unknown indication |
| 123865254 | 12386525 | 6 | Product used for unknown indication |
| 123865254 | 12386525 | 7 | Product used for unknown indication |
| 123865254 | 12386525 | 8 | Product used for unknown indication |
| 123865254 | 12386525 | 9 | Product used for unknown indication |
| 123865254 | 12386525 | 10 | Product used for unknown indication |
| 123865254 | 12386525 | 11 | Product used for unknown indication |
| 123865254 | 12386525 | 12 | Product used for unknown indication |
| 123865254 | 12386525 | 13 | Product used for unknown indication |
| 123865254 | 12386525 | 14 | Product used for unknown indication |
| 123865254 | 12386525 | 15 | Product used for unknown indication |
| 123865254 | 12386525 | 16 | Product used for unknown indication |
| 123865254 | 12386525 | 17 | Product used for unknown indication |
| 123865254 | 12386525 | 18 | Product used for unknown indication |
| 123865254 | 12386525 | 19 | Product used for unknown indication |
| 123865254 | 12386525 | 20 | Product used for unknown indication |
| 123865254 | 12386525 | 21 | Product used for unknown indication |
| 123865254 | 12386525 | 22 | Product used for unknown indication |
| 123865254 | 12386525 | 23 | Product used for unknown indication |
| 123865254 | 12386525 | 24 | Product used for unknown indication |
| 123865254 | 12386525 | 25 | Product used for unknown indication |
| 123865254 | 12386525 | 26 | Product used for unknown indication |
| 123865254 | 12386525 | 27 | Product used for unknown indication |
| 123865254 | 12386525 | 28 | Product used for unknown indication |
| 123865254 | 12386525 | 29 | Product used for unknown indication |
| 123865254 | 12386525 | 30 | Product used for unknown indication |
| 123865254 | 12386525 | 31 | Product used for unknown indication |
| 123865254 | 12386525 | 32 | Product used for unknown indication |
| 123865254 | 12386525 | 33 | Product used for unknown indication |
| 123865254 | 12386525 | 34 | Product used for unknown indication |
| 123865254 | 12386525 | 35 | Product used for unknown indication |
| 123865254 | 12386525 | 36 | Product used for unknown indication |
| 123865254 | 12386525 | 37 | Product used for unknown indication |
| 123865254 | 12386525 | 38 | Product used for unknown indication |
| 123865254 | 12386525 | 39 | Product used for unknown indication |
| 123865254 | 12386525 | 40 | Product used for unknown indication |
| 123865254 | 12386525 | 41 | Product used for unknown indication |
| 123865254 | 12386525 | 42 | Product used for unknown indication |
| 123865254 | 12386525 | 43 | Product used for unknown indication |
| 123865254 | 12386525 | 44 | Product used for unknown indication |
| 123865254 | 12386525 | 45 | Product used for unknown indication |
| 123865254 | 12386525 | 46 | Product used for unknown indication |
| 123865254 | 12386525 | 47 | Product used for unknown indication |
| 123865254 | 12386525 | 48 | Product used for unknown indication |
| 123865254 | 12386525 | 49 | Product used for unknown indication |
| 123865254 | 12386525 | 50 | Product used for unknown indication |
| 123865254 | 12386525 | 51 | Product used for unknown indication |
| 123865254 | 12386525 | 52 | Product used for unknown indication |
| 123865254 | 12386525 | 53 | Product used for unknown indication |
| 123865254 | 12386525 | 54 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123865254 | 12386525 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123865254 | 12386525 | Aortic valve incompetence | |
| 123865254 | 12386525 | Chronic obstructive pulmonary disease | |
| 123865254 | 12386525 | Condition aggravated | |
| 123865254 | 12386525 | Depressed level of consciousness | |
| 123865254 | 12386525 | Fungal infection | |
| 123865254 | 12386525 | Peripheral venous disease | |
| 123865254 | 12386525 | Pulmonary hypertension | |
| 123865254 | 12386525 | Rash | |
| 123865254 | 12386525 | Skin lesion | |
| 123865254 | 12386525 | Tinea pedis |
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 |
|---|---|---|---|---|---|---|
| 123865254 | 12386525 | 1 | 200809 | 200810 | 0 | |
| 123865254 | 12386525 | 2 | 200810 | 201208 | 0 | |
| 123865254 | 12386525 | 3 | 201208 | 0 | ||
| 123865254 | 12386525 | 20 | 20130313 | 201604 | 0 | |
| 123865254 | 12386525 | 21 | 20010101 | 0 | ||
| 123865254 | 12386525 | 23 | 201604 | 0 | ||
| 123865254 | 12386525 | 26 | 201604 | 0 | ||
| 123865254 | 12386525 | 27 | 201604 | 0 | ||
| 123865254 | 12386525 | 28 | 201604 | 0 | ||
| 123865254 | 12386525 | 29 | 201604 | 0 | ||
| 123865254 | 12386525 | 33 | 201604 | 0 | ||
| 123865254 | 12386525 | 38 | 201604 | 0 | ||
| 123865254 | 12386525 | 44 | 201604 | 0 | ||
| 123865254 | 12386525 | 47 | 201604 | 0 | ||
| 123865254 | 12386525 | 52 | 201604 | 0 | ||
| 123865254 | 12386525 | 54 | 201604 | 0 |