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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127901421 | 12790142 | 1 | I | 2010 | 20160919 | 20160928 | 20160928 | EXP | US-JAZZ-2016-US-018542 | JAZZ | 0.00 | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127901421 | 12790142 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127901421 | 12790142 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 127901421 | 12790142 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 127901421 | 12790142 | 4 | SS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | 200 MG | Y | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 5 | SS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | 100 MG | Y | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 6 | SS | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 7 | SS | BELSOMRA | SUVOREXANT | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 8 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | 100 MG | U | 0 | CAPSULE | |||||||||
| 127901421 | 12790142 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | 400 MG | U | 0 | CAPSULE | |||||||||
| 127901421 | 12790142 | 11 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 12 | C | CLOBETASOL | CLOBETASOL | 1 | UNK | U | 0 | CREAM | |||||||||
| 127901421 | 12790142 | 13 | C | CLOBETASOL PROPIONATE. | CLOBETASOL PROPIONATE | 1 | UNK | U | 0 | ||||||||||
| 127901421 | 12790142 | 14 | C | FLUOCINONIDE. | FLUOCINONIDE | 1 | UNK | U | 0 | CREAM | |||||||||
| 127901421 | 12790142 | 15 | C | HUMIRA | ADALIMUMAB | 1 | UNK | U | 0 | ||||||||||
| 127901421 | 12790142 | 16 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 17 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 18 | C | NYSTATIN AND TRIAMCINOLONE | NYSTATINTRIAMCINOLONE ACETONIDE | 1 | UNK | U | 0 | CREAM | |||||||||
| 127901421 | 12790142 | 19 | C | TACROLIMUS. | TACROLIMUS | 1 | UNK | U | 0 | OINTMENT | |||||||||
| 127901421 | 12790142 | 20 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | GEL | |||||||||
| 127901421 | 12790142 | 21 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 22 | C | FAMOTIDINE. | FAMOTIDINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 23 | C | HYDROCODONE/ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 127901421 | 12790142 | 24 | C | PILOCARPINE HCL | PILOCARPINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 25 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 26 | C | FENTANYL. | FENTANYL | 1 | 100 ?G/HR | U | 0 | PATCH | |||||||||
| 127901421 | 12790142 | 27 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 28 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127901421 | 12790142 | 29 | C | MICROGESTIN FE 1.5 | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127901421 | 12790142 | 30 | C | RITUXAN | RITUXIMAB | 1 | UNK | U | 0 | ||||||||||
| 127901421 | 12790142 | 31 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127901421 | 12790142 | 32 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 33 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127901421 | 12790142 | 34 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 35 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 36 | C | FOLBEE PLUS | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127901421 | 12790142 | 37 | C | LOSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 38 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | ||||||||||
| 127901421 | 12790142 | 39 | C | METHYLPHENIDATE ER | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 40 | C | MORPHINE SULF CR | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127901421 | 12790142 | 41 | C | MULTIVITAMIN | VITAMINS | 1 | U | 0 | CHEWABLE TABLET | ||||||||||
| 127901421 | 12790142 | 42 | C | NAPROSYN-EC | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127901421 | 12790142 | 43 | C | NUCYNTA | TAPENTADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 44 | C | PAXIL CR | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 45 | C | SOMA | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 46 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127901421 | 12790142 | 47 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127901421 | 12790142 | 48 | C | ZIPSOR | DICLOFENAC POTASSIUM | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127901421 | 12790142 | 1 | Narcolepsy |
| 127901421 | 12790142 | 2 | Cataplexy |
| 127901421 | 12790142 | 4 | Product used for unknown indication |
| 127901421 | 12790142 | 6 | Product used for unknown indication |
| 127901421 | 12790142 | 7 | Product used for unknown indication |
| 127901421 | 12790142 | 8 | Product used for unknown indication |
| 127901421 | 12790142 | 9 | Fibromyalgia |
| 127901421 | 12790142 | 11 | Product used for unknown indication |
| 127901421 | 12790142 | 12 | Product used for unknown indication |
| 127901421 | 12790142 | 13 | Product used for unknown indication |
| 127901421 | 12790142 | 14 | Product used for unknown indication |
| 127901421 | 12790142 | 15 | Product used for unknown indication |
| 127901421 | 12790142 | 16 | Product used for unknown indication |
| 127901421 | 12790142 | 17 | Product used for unknown indication |
| 127901421 | 12790142 | 18 | Product used for unknown indication |
| 127901421 | 12790142 | 19 | Product used for unknown indication |
| 127901421 | 12790142 | 20 | Product used for unknown indication |
| 127901421 | 12790142 | 21 | Product used for unknown indication |
| 127901421 | 12790142 | 22 | Product used for unknown indication |
| 127901421 | 12790142 | 23 | Product used for unknown indication |
| 127901421 | 12790142 | 24 | Product used for unknown indication |
| 127901421 | 12790142 | 25 | Product used for unknown indication |
| 127901421 | 12790142 | 26 | Product used for unknown indication |
| 127901421 | 12790142 | 27 | Product used for unknown indication |
| 127901421 | 12790142 | 28 | Product used for unknown indication |
| 127901421 | 12790142 | 29 | Product used for unknown indication |
| 127901421 | 12790142 | 30 | Product used for unknown indication |
| 127901421 | 12790142 | 31 | Product used for unknown indication |
| 127901421 | 12790142 | 32 | Product used for unknown indication |
| 127901421 | 12790142 | 33 | Product used for unknown indication |
| 127901421 | 12790142 | 34 | Product used for unknown indication |
| 127901421 | 12790142 | 35 | Product used for unknown indication |
| 127901421 | 12790142 | 36 | Product used for unknown indication |
| 127901421 | 12790142 | 37 | Product used for unknown indication |
| 127901421 | 12790142 | 38 | Product used for unknown indication |
| 127901421 | 12790142 | 39 | Product used for unknown indication |
| 127901421 | 12790142 | 40 | Product used for unknown indication |
| 127901421 | 12790142 | 41 | Product used for unknown indication |
| 127901421 | 12790142 | 42 | Product used for unknown indication |
| 127901421 | 12790142 | 43 | Product used for unknown indication |
| 127901421 | 12790142 | 44 | Product used for unknown indication |
| 127901421 | 12790142 | 45 | Product used for unknown indication |
| 127901421 | 12790142 | 46 | Product used for unknown indication |
| 127901421 | 12790142 | 47 | Product used for unknown indication |
| 127901421 | 12790142 | 48 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127901421 | 12790142 | OT |
| 127901421 | 12790142 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127901421 | 12790142 | Anxiety | |
| 127901421 | 12790142 | Arthritis | |
| 127901421 | 12790142 | Depression | |
| 127901421 | 12790142 | Drug ineffective | |
| 127901421 | 12790142 | Drug interaction | |
| 127901421 | 12790142 | Gastrooesophageal reflux disease | |
| 127901421 | 12790142 | Hallucination | |
| 127901421 | 12790142 | Insomnia | |
| 127901421 | 12790142 | Psoriasis | |
| 127901421 | 12790142 | Sinusitis | |
| 127901421 | 12790142 | Sjogren's syndrome |
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 |
|---|---|---|---|---|---|---|
| 127901421 | 12790142 | 1 | 200601 | 200604 | 0 | |
| 127901421 | 12790142 | 2 | 200604 | 201409 | 0 | |
| 127901421 | 12790142 | 3 | 201409 | 0 | ||
| 127901421 | 12790142 | 4 | 201607 | 201607 | 0 | |
| 127901421 | 12790142 | 5 | 201607 | 0 | ||
| 127901421 | 12790142 | 6 | 201607 | 20160831 | 0 | |
| 127901421 | 12790142 | 7 | 20160905 | 0 | ||
| 127901421 | 12790142 | 8 | 20160831 | 0 | ||
| 127901421 | 12790142 | 9 | 20160712 | 20160807 | 0 | |
| 127901421 | 12790142 | 10 | 20160807 | 0 | ||
| 127901421 | 12790142 | 11 | 20160712 | 0 | ||
| 127901421 | 12790142 | 12 | 20160712 | 0 | ||
| 127901421 | 12790142 | 13 | 20160712 | 0 | ||
| 127901421 | 12790142 | 14 | 20160712 | 0 | ||
| 127901421 | 12790142 | 15 | 20160712 | 0 | ||
| 127901421 | 12790142 | 16 | 20160712 | 0 | ||
| 127901421 | 12790142 | 17 | 20160712 | 201607 | 0 | |
| 127901421 | 12790142 | 18 | 20160712 | 0 | ||
| 127901421 | 12790142 | 19 | 20160712 | 0 | ||
| 127901421 | 12790142 | 20 | 20160712 | 0 | ||
| 127901421 | 12790142 | 21 | 20140701 | 0 | ||
| 127901421 | 12790142 | 22 | 20140701 | 0 | ||
| 127901421 | 12790142 | 23 | 20140701 | 0 | ||
| 127901421 | 12790142 | 24 | 20140701 | 0 | ||
| 127901421 | 12790142 | 25 | 20140701 | 0 | ||
| 127901421 | 12790142 | 26 | 20130801 | 0 | ||
| 127901421 | 12790142 | 27 | 20130801 | 0 | ||
| 127901421 | 12790142 | 28 | 20130314 | 20130731 | 0 | |
| 127901421 | 12790142 | 29 | 20130314 | 0 | ||
| 127901421 | 12790142 | 30 | 20130314 | 20130731 | 0 | |
| 127901421 | 12790142 | 31 | 20130107 | 0 | ||
| 127901421 | 12790142 | 32 | 20120718 | 20140701 | 0 | |
| 127901421 | 12790142 | 33 | 20120710 | 20130731 | 0 | |
| 127901421 | 12790142 | 34 | 20120626 | 0 | ||
| 127901421 | 12790142 | 35 | 20120608 | 0 | ||
| 127901421 | 12790142 | 36 | 20130314 | 0 | ||
| 127901421 | 12790142 | 37 | 201012 | 0 | ||
| 127901421 | 12790142 | 38 | 201012 | 0 | ||
| 127901421 | 12790142 | 39 | 201012 | 0 | ||
| 127901421 | 12790142 | 40 | 20120615 | 0 | ||
| 127901421 | 12790142 | 42 | 20130731 | 0 | ||
| 127901421 | 12790142 | 43 | 20120130 | 0 | ||
| 127901421 | 12790142 | 44 | 20120608 | 0 | ||
| 127901421 | 12790142 | 45 | 20130731 | 0 | ||
| 127901421 | 12790142 | 46 | 20120615 | 0 | ||
| 127901421 | 12790142 | 47 | 20130314 | 0 | ||
| 127901421 | 12790142 | 48 | 20130731 | 0 |