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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125838182 | 12583818 | 2 | F | 20160811 | 20160722 | 20160819 | EXP | US-JAZZ-2016-US-013292 | JAZZ | 0.00 | F | Y | 0.00000 | 20160819 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125838182 | 12583818 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | N | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125838182 | 12583818 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | N | 21196 | ORAL SOLUTION | ||||||||
| 125838182 | 12583818 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | N | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 125838182 | 12583818 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, SECOND DOSE | N | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125838182 | 12583818 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 125838182 | 12583818 | 6 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | 0 | TABLET | ||||||||||
| 125838182 | 12583818 | 7 | C | GARLIC. | GARLIC | 1 | UNK | U | 0 | ||||||||||
| 125838182 | 12583818 | 8 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 11 | C | Amantadine | AMANTADINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125838182 | 12583818 | 12 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125838182 | 12583818 | 13 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 14 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 15 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 16 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 17 | C | PHENTERMINE. | PHENTERMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 18 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 19 | C | Vsl#3 | PROBIOTICS NOS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125838182 | 12583818 | 20 | C | YASMIN | DROSPIRENONEETHINYL ESTRADIOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 21 | C | DEMEROL | MEPERIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 22 | C | Acidophilus, Lactobacillus | 2 | UNK | U | 0 | POWDER | ||||||||||
| 125838182 | 12583818 | 23 | C | AVIANE | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 24 | C | Magnesium malate | 2 | UNK | U | 0 | |||||||||||
| 125838182 | 12583818 | 25 | C | N-acetyl-l-cysteine | ACETYLCYSTEINE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125838182 | 12583818 | 26 | C | Oregano oil | 2 | UNK | U | 0 | |||||||||||
| 125838182 | 12583818 | 27 | C | Pepsin | PEPSIN | 1 | UNK | U | 0 | POWDER | |||||||||
| 125838182 | 12583818 | 28 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125838182 | 12583818 | 29 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125838182 | 12583818 | 1 | Narcolepsy |
| 125838182 | 12583818 | 2 | Cataplexy |
| 125838182 | 12583818 | 5 | Product used for unknown indication |
| 125838182 | 12583818 | 6 | Product used for unknown indication |
| 125838182 | 12583818 | 7 | Product used for unknown indication |
| 125838182 | 12583818 | 8 | Product used for unknown indication |
| 125838182 | 12583818 | 9 | Product used for unknown indication |
| 125838182 | 12583818 | 10 | Product used for unknown indication |
| 125838182 | 12583818 | 11 | Product used for unknown indication |
| 125838182 | 12583818 | 12 | Product used for unknown indication |
| 125838182 | 12583818 | 13 | Product used for unknown indication |
| 125838182 | 12583818 | 14 | Product used for unknown indication |
| 125838182 | 12583818 | 15 | Product used for unknown indication |
| 125838182 | 12583818 | 16 | Product used for unknown indication |
| 125838182 | 12583818 | 17 | Product used for unknown indication |
| 125838182 | 12583818 | 18 | Product used for unknown indication |
| 125838182 | 12583818 | 19 | Product used for unknown indication |
| 125838182 | 12583818 | 20 | Product used for unknown indication |
| 125838182 | 12583818 | 21 | Product used for unknown indication |
| 125838182 | 12583818 | 22 | Product used for unknown indication |
| 125838182 | 12583818 | 23 | Product used for unknown indication |
| 125838182 | 12583818 | 24 | Product used for unknown indication |
| 125838182 | 12583818 | 25 | Product used for unknown indication |
| 125838182 | 12583818 | 26 | Product used for unknown indication |
| 125838182 | 12583818 | 27 | Product used for unknown indication |
| 125838182 | 12583818 | 28 | Product used for unknown indication |
| 125838182 | 12583818 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125838182 | 12583818 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125838182 | 12583818 | Insomnia | |
| 125838182 | 12583818 | Neuralgia | |
| 125838182 | 12583818 | Sinusitis | |
| 125838182 | 12583818 | Somnolence | |
| 125838182 | 12583818 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 125838182 | 12583818 | 1 | 201402 | 2014 | 0 | |
| 125838182 | 12583818 | 2 | 201408 | 201509 | 0 | |
| 125838182 | 12583818 | 3 | 201509 | 0 | ||
| 125838182 | 12583818 | 4 | 201509 | 0 | ||
| 125838182 | 12583818 | 5 | 201607 | 0 | ||
| 125838182 | 12583818 | 6 | 201607 | 0 | ||
| 125838182 | 12583818 | 7 | 201607 | 0 | ||
| 125838182 | 12583818 | 8 | 201606 | 0 | ||
| 125838182 | 12583818 | 9 | 201606 | 0 | ||
| 125838182 | 12583818 | 10 | 201605 | 0 | ||
| 125838182 | 12583818 | 11 | 20160115 | 20160115 | 0 | |
| 125838182 | 12583818 | 12 | 20160115 | 0 | ||
| 125838182 | 12583818 | 13 | 20160115 | 0 | ||
| 125838182 | 12583818 | 14 | 20160115 | 20160115 | 0 | |
| 125838182 | 12583818 | 15 | 20160115 | 20160115 | 0 | |
| 125838182 | 12583818 | 16 | 20160115 | 20160115 | 0 | |
| 125838182 | 12583818 | 17 | 20160115 | 0 | ||
| 125838182 | 12583818 | 18 | 20160115 | 0 | ||
| 125838182 | 12583818 | 19 | 20160115 | 0 | ||
| 125838182 | 12583818 | 20 | 20160115 | 20160115 | 0 | |
| 125838182 | 12583818 | 21 | 20150625 | 0 | ||
| 125838182 | 12583818 | 22 | 20140206 | 20160115 | 0 | |
| 125838182 | 12583818 | 23 | 20140206 | 201605 | 0 | |
| 125838182 | 12583818 | 24 | 20140206 | 0 | ||
| 125838182 | 12583818 | 25 | 20140206 | 201606 | 0 | |
| 125838182 | 12583818 | 26 | 20140206 | 20160115 | 0 | |
| 125838182 | 12583818 | 27 | 20140206 | 0 | ||
| 125838182 | 12583818 | 28 | 20140206 | 0 | ||
| 125838182 | 12583818 | 29 | 20160430 | 0 |