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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124067314 | 12406731 | 4 | F | 2010 | 20160823 | 20160526 | 20160831 | PER | US-JAZZ-2015-US-015583 | JAZZ | 0.00 | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124067314 | 12406731 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 124067314 | 12406731 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 124067314 | 12406731 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124067314 | 12406731 | 4 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 124067314 | 12406731 | 5 | SS | KLONOPIN | CLONAZEPAM | 1 | Y | 0 | |||||||||||
| 124067314 | 12406731 | 6 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | Y | 0 | ||||||||||
| 124067314 | 12406731 | 7 | SS | CIALIS | TADALAFIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124067314 | 12406731 | 8 | SS | VIAGRA | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 124067314 | 12406731 | 9 | C | ANDROGEL | TESTOSTERONE | 1 | 1.62%(1.25G) GEL PCKT | U | 0 | GEL | |||||||||
| 124067314 | 12406731 | 10 | C | Dexilant dr | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 124067314 | 12406731 | 11 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124067314 | 12406731 | 12 | C | LEVAQUIN | LEVOFLOXACIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124067314 | 12406731 | 13 | C | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124067314 | 12406731 | 14 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124067314 | 12406731 | 15 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124067314 | 12406731 | 1 | Narcolepsy |
| 124067314 | 12406731 | 2 | Cataplexy |
| 124067314 | 12406731 | 4 | Product used for unknown indication |
| 124067314 | 12406731 | 5 | Product used for unknown indication |
| 124067314 | 12406731 | 6 | Product used for unknown indication |
| 124067314 | 12406731 | 7 | Product used for unknown indication |
| 124067314 | 12406731 | 8 | Product used for unknown indication |
| 124067314 | 12406731 | 9 | Product used for unknown indication |
| 124067314 | 12406731 | 10 | Product used for unknown indication |
| 124067314 | 12406731 | 11 | Product used for unknown indication |
| 124067314 | 12406731 | 12 | Product used for unknown indication |
| 124067314 | 12406731 | 13 | Product used for unknown indication |
| 124067314 | 12406731 | 14 | Product used for unknown indication |
| 124067314 | 12406731 | 15 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124067314 | 12406731 | Blood creatine increased | |
| 124067314 | 12406731 | Blood triglycerides increased | |
| 124067314 | 12406731 | Depression | |
| 124067314 | 12406731 | Dyspepsia | |
| 124067314 | 12406731 | Hypertension | |
| 124067314 | 12406731 | No adverse event | |
| 124067314 | 12406731 | Sinusitis | |
| 124067314 | 12406731 | Therapeutic response unexpected | |
| 124067314 | 12406731 | Unevaluable event | |
| 124067314 | 12406731 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124067314 | 12406731 | 1 | 200304 | 200304 | 0 | |
| 124067314 | 12406731 | 2 | 200304 | 200810 | 0 | |
| 124067314 | 12406731 | 3 | 200810 | 0 | ||
| 124067314 | 12406731 | 4 | 20150911 | 0 | ||
| 124067314 | 12406731 | 7 | 20150911 | 0 | ||
| 124067314 | 12406731 | 9 | 20150911 | 0 | ||
| 124067314 | 12406731 | 10 | 20150911 | 0 | ||
| 124067314 | 12406731 | 11 | 20150911 | 0 | ||
| 124067314 | 12406731 | 12 | 20150911 | 0 | ||
| 124067314 | 12406731 | 13 | 20150911 | 0 | ||
| 124067314 | 12406731 | 14 | 20150911 | 0 | ||
| 124067314 | 12406731 | 15 | 20150911 | 0 |