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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126707281 | 12670728 | 1 | I | 20160328 | 20160822 | 20160822 | PER | US-JAZZ-2016-US-005926 | JAZZ | 0.00 | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126707281 | 12670728 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126707281 | 12670728 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126707281 | 12670728 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126707281 | 12670728 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | UNKNOWN DOSE | 0 | |||||||||||
| 126707281 | 12670728 | 5 | SS | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126707281 | 12670728 | 6 | C | RESTASIS | CYCLOSPORINE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 8 | C | Calcium + vitamin d | CALCIUMVITAMIN D | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 9 | C | CELEBREX | CELECOXIB | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 10 | C | Fish oil concentrate | 2 | U | 0 | ||||||||||||
| 126707281 | 12670728 | 11 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 12 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 13 | C | SULFASALAZINE. | SULFASALAZINE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 14 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 15 | C | Acetaminophen er | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 16 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 17 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 18 | C | Glucosamine + Chondroitin | 2 | U | 0 | ||||||||||||
| 126707281 | 12670728 | 19 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 20 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 21 | C | DARVOCET | ACETAMINOPHENPROPOXYPHENE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 22 | C | EMBELINE | CLOBETASOL PROPIONATE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 23 | C | ENTEX T | GUAIFENESINPSEUDOEPHEDRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 24 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 25 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 26 | C | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 27 | C | PARAFON FORTE | CHLORZOXAZONE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 28 | C | RANITIDINE. | RANITIDINE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 29 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 30 | C | SKELAXIN | METAXALONE | 1 | U | 0 | |||||||||||
| 126707281 | 12670728 | 31 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126707281 | 12670728 | 1 | Narcolepsy |
| 126707281 | 12670728 | 4 | Product used for unknown indication |
| 126707281 | 12670728 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126707281 | 12670728 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126707281 | 12670728 | 1 | 200602 | 200603 | 0 | |
| 126707281 | 12670728 | 3 | 201201 | 0 |