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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126685611 | 12668561 | 1 | I | 2015 | 20160812 | 20160819 | 20160819 | EXP | US-JAZZ-2016-US-015425 | JAZZ | 0.00 | F | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126685611 | 12668561 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126685611 | 12668561 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126685611 | 12668561 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126685611 | 12668561 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126685611 | 12668561 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126685611 | 12668561 | 6 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 7 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 8 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 9 | C | Ropinirole hcl | ROPINIROLE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 10 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685611 | 12668561 | 11 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685611 | 12668561 | 12 | C | Citracal + d | CALCIUM CITRATEVITAMIN D | 1 | UNK | U | 0 | ||||||||||
| 126685611 | 12668561 | 13 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126685611 | 12668561 | 14 | C | ECHINACEA | ECHINACEA, UNSPECIFIED | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685611 | 12668561 | 15 | C | ESTRACE | ESTRADIOL | 1 | UNK | U | 0 | ||||||||||
| 126685611 | 12668561 | 16 | C | ESTRADIOL TRANSDERMAL SYSTEM | ESTRADIOL | 1 | 0.075 MG/DAY | U | 0 | ||||||||||
| 126685611 | 12668561 | 17 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | ||||||||||
| 126685611 | 12668561 | 18 | C | MECLIZINE | MECLIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 19 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 126685611 | 12668561 | 20 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 21 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | ||||||||||
| 126685611 | 12668561 | 22 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126685611 | 12668561 | 23 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 24 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 25 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 26 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 27 | C | KLOR-CON M20 | POTASSIUM CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 28 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 29 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 30 | C | PRIMIDONE. | PRIMIDONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 31 | C | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685611 | 12668561 | 32 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685611 | 12668561 | 33 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126685611 | 12668561 | 1 | Narcolepsy |
| 126685611 | 12668561 | 2 | Cataplexy |
| 126685611 | 12668561 | 6 | Product used for unknown indication |
| 126685611 | 12668561 | 7 | Product used for unknown indication |
| 126685611 | 12668561 | 8 | Product used for unknown indication |
| 126685611 | 12668561 | 9 | Parkinson's disease |
| 126685611 | 12668561 | 10 | Product used for unknown indication |
| 126685611 | 12668561 | 11 | Product used for unknown indication |
| 126685611 | 12668561 | 12 | Product used for unknown indication |
| 126685611 | 12668561 | 13 | Product used for unknown indication |
| 126685611 | 12668561 | 14 | Product used for unknown indication |
| 126685611 | 12668561 | 15 | Product used for unknown indication |
| 126685611 | 12668561 | 16 | Product used for unknown indication |
| 126685611 | 12668561 | 17 | Product used for unknown indication |
| 126685611 | 12668561 | 18 | Product used for unknown indication |
| 126685611 | 12668561 | 19 | Product used for unknown indication |
| 126685611 | 12668561 | 20 | Product used for unknown indication |
| 126685611 | 12668561 | 21 | Product used for unknown indication |
| 126685611 | 12668561 | 22 | Product used for unknown indication |
| 126685611 | 12668561 | 23 | Product used for unknown indication |
| 126685611 | 12668561 | 24 | Product used for unknown indication |
| 126685611 | 12668561 | 25 | Product used for unknown indication |
| 126685611 | 12668561 | 26 | Product used for unknown indication |
| 126685611 | 12668561 | 27 | Product used for unknown indication |
| 126685611 | 12668561 | 28 | Product used for unknown indication |
| 126685611 | 12668561 | 29 | Product used for unknown indication |
| 126685611 | 12668561 | 30 | Product used for unknown indication |
| 126685611 | 12668561 | 31 | Product used for unknown indication |
| 126685611 | 12668561 | 32 | Product used for unknown indication |
| 126685611 | 12668561 | 33 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126685611 | 12668561 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126685611 | 12668561 | Ankle fracture | |
| 126685611 | 12668561 | Arthralgia | |
| 126685611 | 12668561 | Arthritis | |
| 126685611 | 12668561 | Back pain | |
| 126685611 | 12668561 | Blood urine present | |
| 126685611 | 12668561 | Fall | |
| 126685611 | 12668561 | Intentional product misuse | |
| 126685611 | 12668561 | Nephrolithiasis | |
| 126685611 | 12668561 | Skin reaction |
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 |
|---|---|---|---|---|---|---|
| 126685611 | 12668561 | 1 | 200612 | 200612 | 0 | |
| 126685611 | 12668561 | 2 | 200612 | 2008 | 0 | |
| 126685611 | 12668561 | 3 | 201012 | 2011 | 0 | |
| 126685611 | 12668561 | 4 | 201102 | 201302 | 0 | |
| 126685611 | 12668561 | 5 | 201302 | 0 | ||
| 126685611 | 12668561 | 6 | 20151208 | 0 | ||
| 126685611 | 12668561 | 7 | 20151214 | 0 | ||
| 126685611 | 12668561 | 8 | 20160803 | 0 | ||
| 126685611 | 12668561 | 9 | 201607 | 0 | ||
| 126685611 | 12668561 | 10 | 201606 | 0 | ||
| 126685611 | 12668561 | 11 | 20151214 | 0 | ||
| 126685611 | 12668561 | 12 | 20151214 | 201603 | 0 | |
| 126685611 | 12668561 | 13 | 20151214 | 20151214 | 0 | |
| 126685611 | 12668561 | 14 | 20151214 | 0 | ||
| 126685611 | 12668561 | 15 | 20151214 | 20151214 | 0 | |
| 126685611 | 12668561 | 16 | 20151214 | 0 | ||
| 126685611 | 12668561 | 17 | 20151214 | 20151214 | 0 | |
| 126685611 | 12668561 | 18 | 20151214 | 0 | ||
| 126685611 | 12668561 | 19 | 20151214 | 201606 | 0 | |
| 126685611 | 12668561 | 20 | 20151214 | 201603 | 0 | |
| 126685611 | 12668561 | 21 | 20151214 | 20151214 | 0 | |
| 126685611 | 12668561 | 22 | 20151214 | 20151214 | 0 | |
| 126685611 | 12668561 | 23 | 20151214 | 0 | ||
| 126685611 | 12668561 | 24 | 20151214 | 201603 | 0 | |
| 126685611 | 12668561 | 25 | 20151208 | 0 | ||
| 126685611 | 12668561 | 26 | 20151208 | 0 | ||
| 126685611 | 12668561 | 27 | 20151208 | 201603 | 0 | |
| 126685611 | 12668561 | 28 | 20151208 | 0 | ||
| 126685611 | 12668561 | 29 | 20151228 | 0 | ||
| 126685611 | 12668561 | 30 | 20151208 | 201602 | 0 | |
| 126685611 | 12668561 | 31 | 20151208 | 0 | ||
| 126685611 | 12668561 | 32 | 20151208 | 0 | ||
| 126685611 | 12668561 | 33 | 20130606 | 0 |