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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126662251 | 12666225 | 1 | I | 20160322 | 20160818 | 20160818 | PER | US-JAZZ-2016-US-005546 | JAZZ | 0.00 | F | Y | 0.00000 | 20160818 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126662251 | 12666225 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126662251 | 12666225 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, FIRST DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 10 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, SECOND DOSE | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126662251 | 12666225 | 11 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | UNK | Y | 0 | TABLET | |||||||||
| 126662251 | 12666225 | 12 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 60 MG, UNK | Y | 0 | 60 | MG | CAPSULE | |||||||
| 126662251 | 12666225 | 13 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 30 MG, UNK | Y | 0 | 30 | MG | CAPSULE | |||||||
| 126662251 | 12666225 | 14 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126662251 | 12666225 | 15 | C | Tylenol arthritis er | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126662251 | 12666225 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126662251 | 12666225 | 17 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126662251 | 12666225 | 18 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126662251 | 12666225 | 19 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126662251 | 12666225 | 20 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126662251 | 12666225 | 21 | C | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126662251 | 12666225 | 22 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126662251 | 12666225 | 23 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126662251 | 12666225 | 24 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126662251 | 12666225 | 25 | C | KLONOPIN | CLONAZEPAM | 1 | 0.5 MG, PRN | U | 0 | .5 | MG | TABLET | |||||||
| 126662251 | 12666225 | 26 | C | KLONOPIN | CLONAZEPAM | 1 | 0.5 MG, BID | U | 0 | .5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126662251 | 12666225 | 1 | Narcolepsy |
| 126662251 | 12666225 | 2 | Cataplexy |
| 126662251 | 12666225 | 11 | Product used for unknown indication |
| 126662251 | 12666225 | 12 | Product used for unknown indication |
| 126662251 | 12666225 | 14 | Product used for unknown indication |
| 126662251 | 12666225 | 15 | Product used for unknown indication |
| 126662251 | 12666225 | 16 | Product used for unknown indication |
| 126662251 | 12666225 | 17 | Product used for unknown indication |
| 126662251 | 12666225 | 18 | Product used for unknown indication |
| 126662251 | 12666225 | 19 | Product used for unknown indication |
| 126662251 | 12666225 | 20 | Product used for unknown indication |
| 126662251 | 12666225 | 21 | Product used for unknown indication |
| 126662251 | 12666225 | 22 | Product used for unknown indication |
| 126662251 | 12666225 | 23 | Product used for unknown indication |
| 126662251 | 12666225 | 24 | Product used for unknown indication |
| 126662251 | 12666225 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126662251 | 12666225 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126662251 | 12666225 | Anxiety | |
| 126662251 | 12666225 | Sedation | |
| 126662251 | 12666225 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 126662251 | 12666225 | 1 | 201002 | 201003 | 0 | |
| 126662251 | 12666225 | 3 | 201106 | 2011 | 0 | |
| 126662251 | 12666225 | 4 | 201202 | 2012 | 0 | |
| 126662251 | 12666225 | 5 | 201311 | 2013 | 0 | |
| 126662251 | 12666225 | 6 | 201406 | 2014 | 0 | |
| 126662251 | 12666225 | 7 | 201502 | 2015 | 0 | |
| 126662251 | 12666225 | 8 | 201602 | 2016 | 0 | |
| 126662251 | 12666225 | 9 | 2016 | 0 | ||
| 126662251 | 12666225 | 10 | 2016 | 0 | ||
| 126662251 | 12666225 | 11 | 20131024 | 20140801 | 0 | |
| 126662251 | 12666225 | 12 | 20160111 | 20160322 | 0 | |
| 126662251 | 12666225 | 14 | 201602 | 0 | ||
| 126662251 | 12666225 | 15 | 201602 | 0 | ||
| 126662251 | 12666225 | 16 | 201602 | 0 | ||
| 126662251 | 12666225 | 17 | 20160111 | 0 | ||
| 126662251 | 12666225 | 18 | 20140605 | 20140617 | 0 | |
| 126662251 | 12666225 | 19 | 20131024 | 20140801 | 0 | |
| 126662251 | 12666225 | 20 | 20100210 | 20150101 | 0 | |
| 126662251 | 12666225 | 21 | 20060601 | 20140606 | 0 |