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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126286671 | 12628667 | 1 | I | 20160304 | 20160808 | 20160808 | PER | US-JAZZ-2016-US-004455 | JAZZ | 0.00 | F | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126286671 | 12628667 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126286671 | 12628667 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126286671 | 12628667 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126286671 | 12628667 | 4 | SS | PROVIGIL | MODAFINIL | 1 | UNKNOWN DOSE | U | 0 | ||||||||||
| 126286671 | 12628667 | 5 | C | SOMA | CARISOPRODOL | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 6 | C | EPIPEN | EPINEPHRINE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 7 | C | LEVALBUTEROL. | LEVALBUTEROL | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 8 | C | Melatonin | MELATONIN | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 9 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 11 | C | Fluticasone proprionate | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 13 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 14 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 15 | C | XOPENEX HFA | LEVALBUTEROL TARTRATE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 16 | C | ZOFRAN ODT | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 17 | C | ZOVIRAX | ACYCLOVIR | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 18 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 19 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 20 | C | BIOFREEZE | MENTHOL | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 21 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 22 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 23 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 24 | C | MUPIROCIN. | MUPIROCIN | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 25 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 26 | C | CRYSELLE | ETHINYL ESTRADIOLNORGESTREL | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 27 | C | PATANASE | OLOPATADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 28 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 29 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 30 | C | WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 31 | C | Levalbuterol Hcl | LEVALBUTEROL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 32 | C | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 33 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 34 | C | LUNESTA | ESZOPICLONE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 35 | C | DITROPAN | OXYBUTYNIN CHLORIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 36 | C | REMERON | MIRTAZAPINE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 37 | C | NASACORT AQ | TRIAMCINOLONE ACETONIDE | 1 | U | 0 | |||||||||||
| 126286671 | 12628667 | 38 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126286671 | 12628667 | 1 | Narcolepsy |
| 126286671 | 12628667 | 2 | Cataplexy |
| 126286671 | 12628667 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126286671 | 12628667 | Abdominal discomfort | |
| 126286671 | 12628667 | Headache |
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 |
|---|---|---|---|---|---|---|
| 126286671 | 12628667 | 1 | 201209 | 201210 | 0 | |
| 126286671 | 12628667 | 2 | 201210 | 201211 | 0 | |
| 126286671 | 12628667 | 3 | 201211 | 0 |