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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125578731 | 12557873 | 1 | I | 20160113 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000685 | JAZZ | 0.00 | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125578731 | 12557873 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125578731 | 12557873 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125578731 | 12557873 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125578731 | 12557873 | 4 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 5 | SS | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125578731 | 12557873 | 6 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125578731 | 12557873 | 7 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 8 | C | COENZYME Q10 | UBIDECARENONE | 1 | UNK | U | 0 | ||||||||||
| 125578731 | 12557873 | 9 | C | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125578731 | 12557873 | 10 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 11 | C | PINDOLOL. | PINDOLOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 12 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125578731 | 12557873 | 13 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 14 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 15 | C | NIASPAN | NIACIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 16 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 17 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125578731 | 12557873 | 18 | C | CHANTIX | VARENICLINE TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 19 | C | ERRIN | NORETHINDRONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 20 | C | PROGESTERONE. | PROGESTERONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125578731 | 12557873 | 21 | C | Aspirin buffered | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 22 | C | LANTUS | INSULIN GLARGINE | 1 | UNK | U | 0 | ||||||||||
| 125578731 | 12557873 | 23 | C | ZOCOR | SIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 24 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 125578731 | 12557873 | 25 | C | Penicillin | PENICILLIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578731 | 12557873 | 26 | C | BYETTA | EXENATIDE | 1 | UNK | U | 0 | ||||||||||
| 125578731 | 12557873 | 27 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 125578731 | 12557873 | 28 | C | DETROL | TOLTERODINE TARTRATE | 1 | UNK | U | 0 | ||||||||||
| 125578731 | 12557873 | 29 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125578731 | 12557873 | 1 | Narcolepsy |
| 125578731 | 12557873 | 2 | Cataplexy |
| 125578731 | 12557873 | 4 | Product used for unknown indication |
| 125578731 | 12557873 | 5 | Bruxism |
| 125578731 | 12557873 | 6 | Product used for unknown indication |
| 125578731 | 12557873 | 7 | Product used for unknown indication |
| 125578731 | 12557873 | 8 | Product used for unknown indication |
| 125578731 | 12557873 | 9 | Product used for unknown indication |
| 125578731 | 12557873 | 10 | Product used for unknown indication |
| 125578731 | 12557873 | 11 | Product used for unknown indication |
| 125578731 | 12557873 | 12 | Product used for unknown indication |
| 125578731 | 12557873 | 13 | Product used for unknown indication |
| 125578731 | 12557873 | 14 | Product used for unknown indication |
| 125578731 | 12557873 | 15 | Product used for unknown indication |
| 125578731 | 12557873 | 16 | Product used for unknown indication |
| 125578731 | 12557873 | 17 | Product used for unknown indication |
| 125578731 | 12557873 | 18 | Product used for unknown indication |
| 125578731 | 12557873 | 19 | Product used for unknown indication |
| 125578731 | 12557873 | 20 | Product used for unknown indication |
| 125578731 | 12557873 | 21 | Product used for unknown indication |
| 125578731 | 12557873 | 22 | Product used for unknown indication |
| 125578731 | 12557873 | 23 | Product used for unknown indication |
| 125578731 | 12557873 | 24 | Product used for unknown indication |
| 125578731 | 12557873 | 25 | Product used for unknown indication |
| 125578731 | 12557873 | 26 | Product used for unknown indication |
| 125578731 | 12557873 | 27 | Product used for unknown indication |
| 125578731 | 12557873 | 28 | Product used for unknown indication |
| 125578731 | 12557873 | 29 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125578731 | 12557873 | Bruxism | |
| 125578731 | 12557873 | Feeling jittery | |
| 125578731 | 12557873 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125578731 | 12557873 | 1 | 200401 | 200402 | 0 | |
| 125578731 | 12557873 | 3 | 200602 | 0 | ||
| 125578731 | 12557873 | 4 | 20160105 | 0 | ||
| 125578731 | 12557873 | 6 | 20160105 | 0 | ||
| 125578731 | 12557873 | 7 | 20160105 | 0 | ||
| 125578731 | 12557873 | 8 | 20160105 | 0 | ||
| 125578731 | 12557873 | 9 | 20160105 | 20160113 | 0 | |
| 125578731 | 12557873 | 10 | 20160105 | 0 | ||
| 125578731 | 12557873 | 11 | 20160105 | 0 | ||
| 125578731 | 12557873 | 12 | 20151013 | 20160113 | 0 | |
| 125578731 | 12557873 | 13 | 20151013 | 0 | ||
| 125578731 | 12557873 | 14 | 20151013 | 0 | ||
| 125578731 | 12557873 | 15 | 20151013 | 20160113 | 0 | |
| 125578731 | 12557873 | 16 | 20151013 | 20160113 | 0 | |
| 125578731 | 12557873 | 17 | 20151013 | 20160113 | 0 | |
| 125578731 | 12557873 | 18 | 20141229 | 0 | ||
| 125578731 | 12557873 | 19 | 20130709 | 20151020 | 0 | |
| 125578731 | 12557873 | 20 | 20130707 | 20131106 | 0 | |
| 125578731 | 12557873 | 21 | 20130412 | 20160113 | 0 | |
| 125578731 | 12557873 | 22 | 20130412 | 0 | ||
| 125578731 | 12557873 | 23 | 20130412 | 20160113 | 0 | |
| 125578731 | 12557873 | 24 | 20130218 | 0 | ||
| 125578731 | 12557873 | 25 | 20130218 | 20130224 | 0 | |
| 125578731 | 12557873 | 26 | 20130412 | 0 | ||
| 125578731 | 12557873 | 27 | 20130412 | 0 | ||
| 125578731 | 12557873 | 28 | 20130412 | 0 | ||
| 125578731 | 12557873 | 29 | 20130412 | 0 |