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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090871 | 12709087 | 1 | I | 201605 | 20160503 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008291 | JAZZ | 36.52 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090871 | 12709087 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127090871 | 12709087 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | Y | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 127090871 | 12709087 | 3 | SS | Fish oil | FISH OIL | 1 | UNK | Y | U | 0 | |||||||||
| 127090871 | 12709087 | 4 | C | ADVIL | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 5 | C | ALLEGRA-D | FEXOFENADINEPSEUDOEPHEDRINE | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 6 | C | Biotin | BIOTIN | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 7 | C | Clindamycin/Benzoyl Peroxide | 2 | U | 0 | ||||||||||||
| 127090871 | 12709087 | 8 | C | EVAMIST | ESTRADIOL | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 10 | C | Glucosamine | GLUCOSAMINE | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 11 | C | PROGESTERONE. | PROGESTERONE | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 12 | C | RESTASIS | CYCLOSPORINE | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 13 | C | Multivitamin | VITAMINS | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 14 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 15 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 16 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 127090871 | 12709087 | 17 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127090871 | 12709087 | 1 | Narcolepsy |
| 127090871 | 12709087 | 2 | Cataplexy |
| 127090871 | 12709087 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127090871 | 12709087 | Dry eye | |
| 127090871 | 12709087 | Dry mouth | |
| 127090871 | 12709087 | Hangover | |
| 127090871 | 12709087 | Nausea | |
| 127090871 | 12709087 | Palpitations | |
| 127090871 | 12709087 | Somnolence | |
| 127090871 | 12709087 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 127090871 | 12709087 | 1 | 201604 | 2016 | 0 | |
| 127090871 | 12709087 | 2 | 2016 | 2016 | 0 | |
| 127090871 | 12709087 | 3 | 2016 | 0 |