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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125861191 | 12586119 | 1 | I | 20160204 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-002180 | JAZZ | 0.00 | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125861191 | 12586119 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125861191 | 12586119 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125861191 | 12586119 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125861191 | 12586119 | 4 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125861191 | 12586119 | 5 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 125861191 | 12586119 | 6 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 7 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 8 | C | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 9 | C | CALTRATE WITH VITAMIN D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 10 | C | CLEOCIN T | CLINDAMYCIN PHOSPHATE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 125861191 | 12586119 | 11 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 125861191 | 12586119 | 12 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 13 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 125861191 | 12586119 | 14 | C | MUCINEX | GUAIFENESIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 15 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 16 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 17 | C | PREVACID | LANSOPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125861191 | 12586119 | 18 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125861191 | 12586119 | 19 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | ||||||||||
| 125861191 | 12586119 | 20 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861191 | 12586119 | 21 | C | ZYRTEC-D | CETIRIZINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125861191 | 12586119 | 1 | Narcolepsy |
| 125861191 | 12586119 | 4 | Product used for unknown indication |
| 125861191 | 12586119 | 5 | Product used for unknown indication |
| 125861191 | 12586119 | 6 | Product used for unknown indication |
| 125861191 | 12586119 | 7 | Product used for unknown indication |
| 125861191 | 12586119 | 8 | Product used for unknown indication |
| 125861191 | 12586119 | 9 | Product used for unknown indication |
| 125861191 | 12586119 | 10 | Product used for unknown indication |
| 125861191 | 12586119 | 11 | Product used for unknown indication |
| 125861191 | 12586119 | 12 | Product used for unknown indication |
| 125861191 | 12586119 | 13 | Product used for unknown indication |
| 125861191 | 12586119 | 14 | Product used for unknown indication |
| 125861191 | 12586119 | 15 | Product used for unknown indication |
| 125861191 | 12586119 | 16 | Product used for unknown indication |
| 125861191 | 12586119 | 17 | Product used for unknown indication |
| 125861191 | 12586119 | 18 | Product used for unknown indication |
| 125861191 | 12586119 | 19 | Product used for unknown indication |
| 125861191 | 12586119 | 20 | Product used for unknown indication |
| 125861191 | 12586119 | 21 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125861191 | 12586119 | Drug intolerance | |
| 125861191 | 12586119 | Hypotension | |
| 125861191 | 12586119 | Insomnia | |
| 125861191 | 12586119 | Pre-existing condition improved | |
| 125861191 | 12586119 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 125861191 | 12586119 | 1 | 201110 | 201110 | 0 | |
| 125861191 | 12586119 | 2 | 201110 | 201112 | 0 | |
| 125861191 | 12586119 | 3 | 201112 | 0 | ||
| 125861191 | 12586119 | 5 | 20130808 | 20160204 | 0 | |
| 125861191 | 12586119 | 6 | 20130808 | 20160204 | 0 | |
| 125861191 | 12586119 | 8 | 20160204 | 0 | ||
| 125861191 | 12586119 | 17 | 20160204 | 0 | ||
| 125861191 | 12586119 | 19 | 20160204 | 0 | ||
| 125861191 | 12586119 | 20 | 20150904 | 0 |