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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126041671 | 12604167 | 1 | I | 20160209 | 20160728 | 20160728 | PER | US-JAZZ-2016-US-002470 | JAZZ | 0.00 | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126041671 | 12604167 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126041671 | 12604167 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126041671 | 12604167 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 126041671 | 12604167 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126041671 | 12604167 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, THIRD DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126041671 | 12604167 | 6 | SS | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 126041671 | 12604167 | 7 | C | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 8 | C | BUPRENORPHINE. | BUPRENORPHINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 9 | C | ALIGN | BIFIDOBACTERIUM LONGUM SUBSP. INFANTIS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126041671 | 12604167 | 10 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 126041671 | 12604167 | 11 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 12 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126041671 | 12604167 | 13 | C | SONATA | ZALEPLON | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126041671 | 12604167 | 14 | C | Ondansetron hcl | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 15 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 16 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 17 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 18 | C | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 19 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 20 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 21 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 22 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 23 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 24 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 25 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 26 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 27 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 28 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 126041671 | 12604167 | 29 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 30 | C | Drysol | ALUMINUM CHLORIDE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 126041671 | 12604167 | 31 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 126041671 | 12604167 | 32 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 33 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 34 | C | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126041671 | 12604167 | 35 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126041671 | 12604167 | 36 | C | ZARAH | DROSPIRENONEETHINYL ESTRADIOL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126041671 | 12604167 | 1 | Narcolepsy |
| 126041671 | 12604167 | 2 | Cataplexy |
| 126041671 | 12604167 | 6 | Muscle spasms |
| 126041671 | 12604167 | 7 | Product used for unknown indication |
| 126041671 | 12604167 | 8 | Product used for unknown indication |
| 126041671 | 12604167 | 9 | Product used for unknown indication |
| 126041671 | 12604167 | 10 | Product used for unknown indication |
| 126041671 | 12604167 | 11 | Product used for unknown indication |
| 126041671 | 12604167 | 12 | Product used for unknown indication |
| 126041671 | 12604167 | 13 | Product used for unknown indication |
| 126041671 | 12604167 | 14 | Product used for unknown indication |
| 126041671 | 12604167 | 15 | Product used for unknown indication |
| 126041671 | 12604167 | 16 | Product used for unknown indication |
| 126041671 | 12604167 | 17 | Product used for unknown indication |
| 126041671 | 12604167 | 18 | Product used for unknown indication |
| 126041671 | 12604167 | 19 | Product used for unknown indication |
| 126041671 | 12604167 | 20 | Product used for unknown indication |
| 126041671 | 12604167 | 21 | Product used for unknown indication |
| 126041671 | 12604167 | 22 | Product used for unknown indication |
| 126041671 | 12604167 | 23 | Product used for unknown indication |
| 126041671 | 12604167 | 24 | Product used for unknown indication |
| 126041671 | 12604167 | 25 | Product used for unknown indication |
| 126041671 | 12604167 | 26 | Product used for unknown indication |
| 126041671 | 12604167 | 27 | Product used for unknown indication |
| 126041671 | 12604167 | 28 | Product used for unknown indication |
| 126041671 | 12604167 | 29 | Product used for unknown indication |
| 126041671 | 12604167 | 30 | Product used for unknown indication |
| 126041671 | 12604167 | 31 | Product used for unknown indication |
| 126041671 | 12604167 | 32 | Product used for unknown indication |
| 126041671 | 12604167 | 33 | Product used for unknown indication |
| 126041671 | 12604167 | 34 | Product used for unknown indication |
| 126041671 | 12604167 | 35 | Product used for unknown indication |
| 126041671 | 12604167 | 36 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126041671 | 12604167 | Fatigue | |
| 126041671 | 12604167 | Feeling abnormal | |
| 126041671 | 12604167 | Muscle spasms |
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 |
|---|---|---|---|---|---|---|
| 126041671 | 12604167 | 1 | 201407 | 201407 | 0 | |
| 126041671 | 12604167 | 3 | 201410 | 0 | ||
| 126041671 | 12604167 | 4 | 201410 | 0 | ||
| 126041671 | 12604167 | 5 | 201410 | 0 | ||
| 126041671 | 12604167 | 6 | 20140626 | 20150201 | 0 | |
| 126041671 | 12604167 | 7 | 20150201 | 0 | ||
| 126041671 | 12604167 | 8 | 20141107 | 20160101 | 0 | |
| 126041671 | 12604167 | 9 | 20140909 | 0 | ||
| 126041671 | 12604167 | 10 | 20140909 | 0 | ||
| 126041671 | 12604167 | 11 | 20140909 | 20150701 | 0 | |
| 126041671 | 12604167 | 12 | 20140909 | 20150201 | 0 | |
| 126041671 | 12604167 | 13 | 20140828 | 0 | ||
| 126041671 | 12604167 | 14 | 20140822 | 20150201 | 0 | |
| 126041671 | 12604167 | 15 | 20140815 | 20150201 | 0 | |
| 126041671 | 12604167 | 16 | 20140805 | 20150201 | 0 | |
| 126041671 | 12604167 | 17 | 20140722 | 20140722 | 0 | |
| 126041671 | 12604167 | 18 | 20140626 | 20150201 | 0 | |
| 126041671 | 12604167 | 19 | 20140626 | 20150201 | 0 | |
| 126041671 | 12604167 | 20 | 20140626 | 20140630 | 0 | |
| 126041671 | 12604167 | 21 | 20140626 | 20150201 | 0 | |
| 126041671 | 12604167 | 22 | 20140625 | 20150701 | 0 | |
| 126041671 | 12604167 | 23 | 20140625 | 20160209 | 0 | |
| 126041671 | 12604167 | 24 | 20140625 | 20140626 | 0 | |
| 126041671 | 12604167 | 25 | 20140625 | 20141106 | 0 | |
| 126041671 | 12604167 | 26 | 20140625 | 20160209 | 0 | |
| 126041671 | 12604167 | 27 | 20060125 | 20140909 | 0 |