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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127687031 | 12768703 | 1 | I | 20160531 | 20160921 | 20160921 | PER | US-JAZZ-2016-US-010129 | JAZZ | 0.00 | F | Y | 0.00000 | 20160921 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127687031 | 12768703 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127687031 | 12768703 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127687031 | 12768703 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127687031 | 12768703 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127687031 | 12768703 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127687031 | 12768703 | 6 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | 0 | TABLET | ||||||||||
| 127687031 | 12768703 | 7 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 10 MG, UNK | U | 0 | 10 | MG | TABLET | |||||||
| 127687031 | 12768703 | 8 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 5 MG, UNK | U | 0 | 5 | MG | TABLET | |||||||
| 127687031 | 12768703 | 9 | C | Biotin | BIOTIN | 1 | 2500 ?G, UNK | U | 0 | 2500 | UG | ||||||||
| 127687031 | 12768703 | 10 | C | Biotin | BIOTIN | 1 | 5000 ?G, UNK | U | 0 | 5000 | UG | ||||||||
| 127687031 | 12768703 | 11 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127687031 | 12768703 | 12 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127687031 | 12768703 | 13 | C | ALIGN | BIFIDOBACTERIUM LONGUM SUBSP. INFANTIS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127687031 | 12768703 | 14 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | ||||||||||
| 127687031 | 12768703 | 15 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127687031 | 12768703 | 16 | C | Calcium Magnesium with Vitamin D | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127687031 | 12768703 | 17 | C | ESTROGEL | ESTRADIOL | 1 | UNK | U | 0 | GEL | |||||||||
| 127687031 | 12768703 | 18 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | U | 0 | POWDER | |||||||||
| 127687031 | 12768703 | 19 | C | NASACORT AQ | TRIAMCINOLONE ACETONIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 127687031 | 12768703 | 20 | C | NASONEX | MOMETASONE FUROATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 127687031 | 12768703 | 21 | C | PROGESTERONE. | PROGESTERONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127687031 | 12768703 | 22 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 127687031 | 12768703 | 23 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 127687031 | 12768703 | 24 | C | COENZYME Q10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 127687031 | 12768703 | 25 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127687031 | 12768703 | 26 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | U | 0 | TABLET | ||||||||||
| 127687031 | 12768703 | 27 | C | Ester-c | CALCIUMVITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 127687031 | 12768703 | 28 | C | Fish oil | FISH OIL | 1 | U | 0 | |||||||||||
| 127687031 | 12768703 | 29 | C | Grapeseed extract | 2 | UNK | U | 0 | |||||||||||
| 127687031 | 12768703 | 30 | C | Levocetirizine | LEVOCETIRIZINE | 1 | U | 0 | TABLET | ||||||||||
| 127687031 | 12768703 | 31 | C | Red Yeast Rice | DIETARY SUPPLEMENT | 1 | U | 0 | CAPSULE | ||||||||||
| 127687031 | 12768703 | 32 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127687031 | 12768703 | 33 | C | Vitamin k2 | MENAQUINONE 6 | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127687031 | 12768703 | 1 | Narcolepsy |
| 127687031 | 12768703 | 2 | Cataplexy |
| 127687031 | 12768703 | 6 | Product used for unknown indication |
| 127687031 | 12768703 | 7 | Product used for unknown indication |
| 127687031 | 12768703 | 9 | Product used for unknown indication |
| 127687031 | 12768703 | 11 | Product used for unknown indication |
| 127687031 | 12768703 | 12 | Product used for unknown indication |
| 127687031 | 12768703 | 13 | Product used for unknown indication |
| 127687031 | 12768703 | 14 | Product used for unknown indication |
| 127687031 | 12768703 | 15 | Product used for unknown indication |
| 127687031 | 12768703 | 16 | Product used for unknown indication |
| 127687031 | 12768703 | 17 | Product used for unknown indication |
| 127687031 | 12768703 | 18 | Product used for unknown indication |
| 127687031 | 12768703 | 19 | Product used for unknown indication |
| 127687031 | 12768703 | 20 | Product used for unknown indication |
| 127687031 | 12768703 | 21 | Product used for unknown indication |
| 127687031 | 12768703 | 22 | Product used for unknown indication |
| 127687031 | 12768703 | 23 | Product used for unknown indication |
| 127687031 | 12768703 | 24 | Product used for unknown indication |
| 127687031 | 12768703 | 25 | Product used for unknown indication |
| 127687031 | 12768703 | 26 | Product used for unknown indication |
| 127687031 | 12768703 | 27 | Product used for unknown indication |
| 127687031 | 12768703 | 28 | Product used for unknown indication |
| 127687031 | 12768703 | 29 | Product used for unknown indication |
| 127687031 | 12768703 | 30 | Product used for unknown indication |
| 127687031 | 12768703 | 31 | Product used for unknown indication |
| 127687031 | 12768703 | 32 | Product used for unknown indication |
| 127687031 | 12768703 | 33 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127687031 | 12768703 | Anxiety | |
| 127687031 | 12768703 | Feeling jittery | |
| 127687031 | 12768703 | Gastrooesophageal reflux disease | |
| 127687031 | 12768703 | Nervousness | |
| 127687031 | 12768703 | Pre-existing condition improved | |
| 127687031 | 12768703 | 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 |
|---|---|---|---|---|---|---|
| 127687031 | 12768703 | 1 | 200705 | 200706 | 0 | |
| 127687031 | 12768703 | 2 | 200706 | 2011 | 0 | |
| 127687031 | 12768703 | 3 | 201212 | 201301 | 0 | |
| 127687031 | 12768703 | 4 | 201301 | 201301 | 0 | |
| 127687031 | 12768703 | 5 | 201301 | 0 | ||
| 127687031 | 12768703 | 6 | 20130422 | 201501 | 0 | |
| 127687031 | 12768703 | 7 | 20140711 | 20160523 | 0 | |
| 127687031 | 12768703 | 8 | 201605 | 0 | ||
| 127687031 | 12768703 | 9 | 20140205 | 201505 | 0 | |
| 127687031 | 12768703 | 11 | 20140205 | 0 | ||
| 127687031 | 12768703 | 12 | 20140205 | 0 | ||
| 127687031 | 12768703 | 13 | 20121220 | 0 | ||
| 127687031 | 12768703 | 14 | 20121220 | 0 | ||
| 127687031 | 12768703 | 15 | 20121220 | 201605 | 0 | |
| 127687031 | 12768703 | 16 | 20121220 | 201312 | 0 | |
| 127687031 | 12768703 | 17 | 20121220 | 0 | ||
| 127687031 | 12768703 | 18 | 20121220 | 201605 | 0 | |
| 127687031 | 12768703 | 19 | 20121220 | 201605 | 0 | |
| 127687031 | 12768703 | 20 | 20121220 | 201605 | 0 | |
| 127687031 | 12768703 | 21 | 20121220 | 0 | ||
| 127687031 | 12768703 | 22 | 20121220 | 201603 | 0 | |
| 127687031 | 12768703 | 25 | 201605 | 0 | ||
| 127687031 | 12768703 | 32 | 201112 | 0 |