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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111049855 | 11104985 | 5 | F | 2005 | 20160727 | 20150511 | 20160803 | EXP | US-JAZZ-2015-US-006600 | JAZZ | 0.00 | F | Y | 73.00000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111049855 | 11104985 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | Y | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 111049855 | 11104985 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 111049855 | 11104985 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 111049855 | 11104985 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 8 G, QD | Y | 21196 | 8 | G | ORAL SOLUTION | ||||||
| 111049855 | 11104985 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 111049855 | 11104985 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 111049855 | 11104985 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 111049855 | 11104985 | 8 | C | Calcium citrate | CALCIUM CITRATE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 9 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 10 | C | DICYCLOMINE HYDROCHLORIDE. | DICYCLOMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 11 | C | Hydrocodone | HYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 12 | C | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 13 | C | K-phos | POTASSIUM PHOSPHATE, MONOBASIC | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 14 | C | KCL | POTASSIUM CHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 15 | C | NUVARING | ETHINYL ESTRADIOLETONOGESTREL | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 16 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 17 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 18 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 19 | C | SONATA | ZALEPLON | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 20 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 21 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 22 | C | VERAMYST | FLUTICASONE FUROATE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 23 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 24 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 25 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 26 | C | Quinacrine | QUINACRINE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 27 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 28 | C | ALLEGRA-D | FEXOFENADINEPSEUDOEPHEDRINE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 29 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.5 MG, QD | U | 0 | .5 | MG | ||||||||
| 111049855 | 11104985 | 30 | C | TRICLOSAN. | TRICLOSAN | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 31 | C | TIZANIDINE. | TIZANIDINE | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 32 | C | Ondansetron | ONDANSETRON | 1 | UNK | U | 0 | ||||||||||
| 111049855 | 11104985 | 33 | C | MIRENA | LEVONORGESTREL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111049855 | 11104985 | 1 | Narcolepsy |
| 111049855 | 11104985 | 2 | Cataplexy |
| 111049855 | 11104985 | 7 | Product used for unknown indication |
| 111049855 | 11104985 | 8 | Product used for unknown indication |
| 111049855 | 11104985 | 9 | SLE arthritis |
| 111049855 | 11104985 | 10 | Coeliac disease |
| 111049855 | 11104985 | 11 | Product used for unknown indication |
| 111049855 | 11104985 | 12 | Systemic lupus erythematosus |
| 111049855 | 11104985 | 13 | Product used for unknown indication |
| 111049855 | 11104985 | 14 | Product used for unknown indication |
| 111049855 | 11104985 | 15 | Product used for unknown indication |
| 111049855 | 11104985 | 16 | Dyspepsia |
| 111049855 | 11104985 | 17 | Product used for unknown indication |
| 111049855 | 11104985 | 18 | Hypersensitivity |
| 111049855 | 11104985 | 19 | Product used for unknown indication |
| 111049855 | 11104985 | 20 | Hypokalaemia |
| 111049855 | 11104985 | 21 | Migraine |
| 111049855 | 11104985 | 22 | Product used for unknown indication |
| 111049855 | 11104985 | 23 | Product used for unknown indication |
| 111049855 | 11104985 | 24 | Product used for unknown indication |
| 111049855 | 11104985 | 25 | Narcolepsy |
| 111049855 | 11104985 | 26 | Systemic lupus erythematosus |
| 111049855 | 11104985 | 27 | Hypersensitivity |
| 111049855 | 11104985 | 28 | Hypersensitivity |
| 111049855 | 11104985 | 29 | Central nervous system lupus |
| 111049855 | 11104985 | 30 | Central nervous system lupus |
| 111049855 | 11104985 | 31 | Muscle spasms |
| 111049855 | 11104985 | 32 | Nausea |
| 111049855 | 11104985 | 33 | Ovarian cyst |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111049855 | 11104985 | HO |
| 111049855 | 11104985 | DS |
| 111049855 | 11104985 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111049855 | 11104985 | Bone disorder | |
| 111049855 | 11104985 | Condition aggravated | |
| 111049855 | 11104985 | Deep vein thrombosis | |
| 111049855 | 11104985 | Drug dose omission | |
| 111049855 | 11104985 | Dysarthria | |
| 111049855 | 11104985 | Extra dose administered | |
| 111049855 | 11104985 | Fall | |
| 111049855 | 11104985 | Feeling abnormal | |
| 111049855 | 11104985 | Hip fracture | |
| 111049855 | 11104985 | Night sweats | |
| 111049855 | 11104985 | Renal tubular acidosis | |
| 111049855 | 11104985 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 111049855 | 11104985 | 1 | 200912 | 2010 | 0 | |
| 111049855 | 11104985 | 3 | 201407 | 201503 | 0 | |
| 111049855 | 11104985 | 4 | 201503 | 201503 | 0 | |
| 111049855 | 11104985 | 5 | 201503 | 2015 | 0 | |
| 111049855 | 11104985 | 7 | 20130325 | 0 |