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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117208743 | 11720874 | 3 | F | 2011 | 20160628 | 20151110 | 20160707 | EXP | US-JAZZ-2015-US-018608 | JAZZ | 0.00 | F | Y | 99.32000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117208743 | 11720874 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 117208743 | 11720874 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 117208743 | 11720874 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 117208743 | 11720874 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 117208743 | 11720874 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 117208743 | 11720874 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 117208743 | 11720874 | 7 | SS | TOPAMAX | TOPIRAMATE | 1 | 100 MG, UNK | Y | 0 | 100 | MG | TABLET | |||||||
| 117208743 | 11720874 | 8 | SS | TOPAMAX | TOPIRAMATE | 1 | 50 MG, UNK | Y | 0 | 50 | MG | TABLET | |||||||
| 117208743 | 11720874 | 9 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 117208743 | 11720874 | 10 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | |||||||||
| 117208743 | 11720874 | 11 | C | EPIPEN | EPINEPHRINE | 1 | UNK, PRN | U | 0 | ||||||||||
| 117208743 | 11720874 | 12 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 117208743 | 11720874 | 13 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 117208743 | 11720874 | 14 | C | Probiotic acidophilus | LACTOBACILLUS ACIDOPHILUS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 117208743 | 11720874 | 15 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 117208743 | 11720874 | 16 | C | SONATA | ZALEPLON | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 117208743 | 11720874 | 17 | C | Oxycodone | OXYCODONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 117208743 | 11720874 | 18 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 117208743 | 11720874 | 19 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117208743 | 11720874 | 1 | Narcolepsy |
| 117208743 | 11720874 | 2 | Cataplexy |
| 117208743 | 11720874 | 7 | Product used for unknown indication |
| 117208743 | 11720874 | 10 | Hypersensitivity |
| 117208743 | 11720874 | 11 | Hypersensitivity |
| 117208743 | 11720874 | 12 | Hypothyroidism |
| 117208743 | 11720874 | 13 | Vitamin supplementation |
| 117208743 | 11720874 | 14 | Supplementation therapy |
| 117208743 | 11720874 | 15 | Vitamin supplementation |
| 117208743 | 11720874 | 16 | Product used for unknown indication |
| 117208743 | 11720874 | 17 | Product used for unknown indication |
| 117208743 | 11720874 | 18 | Product used for unknown indication |
| 117208743 | 11720874 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117208743 | 11720874 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117208743 | 11720874 | Anxiety | |
| 117208743 | 11720874 | Exposure during pregnancy | |
| 117208743 | 11720874 | Parasomnia | |
| 117208743 | 11720874 | Sleep apnoea syndrome | |
| 117208743 | 11720874 | Somnambulism | |
| 117208743 | 11720874 | Umbilical hernia | |
| 117208743 | 11720874 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 117208743 | 11720874 | 1 | 200512 | 2006 | 0 | |
| 117208743 | 11720874 | 2 | 2006 | 2006 | 0 | |
| 117208743 | 11720874 | 3 | 2006 | 2008 | 0 | |
| 117208743 | 11720874 | 4 | 200907 | 2009 | 0 | |
| 117208743 | 11720874 | 6 | 2015 | 20150929 | 0 | |
| 117208743 | 11720874 | 7 | 2011 | 0 | ||
| 117208743 | 11720874 | 8 | 2015 | 2015 | 0 | |
| 117208743 | 11720874 | 9 | 2015 | 0 | ||
| 117208743 | 11720874 | 10 | 20151102 | 0 | ||
| 117208743 | 11720874 | 11 | 20151102 | 0 | ||
| 117208743 | 11720874 | 12 | 20151102 | 0 | ||
| 117208743 | 11720874 | 13 | 20151102 | 0 | ||
| 117208743 | 11720874 | 14 | 20151102 | 0 | ||
| 117208743 | 11720874 | 15 | 20151102 | 0 | ||
| 117208743 | 11720874 | 16 | 20151102 | 0 | ||
| 117208743 | 11720874 | 17 | 20140215 | 20140218 | 0 | |
| 117208743 | 11720874 | 18 | 20130826 | 20131219 | 0 | |
| 117208743 | 11720874 | 19 | 20130826 | 0 |