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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125860311 | 12586031 | 1 | I | 201510 | 20160202 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-001969 | JAZZ | 60.56 | YR | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125860311 | 12586031 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125860311 | 12586031 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | 21196 | ORAL SOLUTION | |||||||||
| 125860311 | 12586031 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 125860311 | 12586031 | 4 | SS | LISINOPRIL. | LISINOPRIL | 1 | U | U | 0 | ||||||||||
| 125860311 | 12586031 | 5 | SS | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | U | 0 | TABLET | ||||||||
| 125860311 | 12586031 | 6 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | U | 0 | TABLET | ||||||||
| 125860311 | 12586031 | 7 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 8 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 9 | C | PATADAY | OLOPATADINE HYDROCHLORIDE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 125860311 | 12586031 | 10 | C | POTASSIUM CITRATE. | POTASSIUM CITRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 11 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | ||||||||||
| 125860311 | 12586031 | 12 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 13 | C | Duloxetine hcl | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125860311 | 12586031 | 14 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 15 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 16 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 17 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125860311 | 12586031 | 18 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 19 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 20 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 21 | C | PATANOL | OLOPATADINE HYDROCHLORIDE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 125860311 | 12586031 | 22 | C | Diltiazem hcl | DILTIAZEM HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125860311 | 12586031 | 23 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 24 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 25 | C | EXFORGE HCT | AMLODIPINE BESYLATEHYDROCHLOROTHIAZIDEVALSARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 26 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 27 | C | TRIBENZOR | AMLODIPINE BESYLATEHYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 28 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 29 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 30 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125860311 | 12586031 | 31 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 32 | C | Clonidine Hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 33 | C | IMDUR | ISOSORBIDE MONONITRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 34 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 35 | C | AVAPRO | IRBESARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125860311 | 12586031 | 36 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 125860311 | 12586031 | 37 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125860311 | 12586031 | 1 | Narcolepsy |
| 125860311 | 12586031 | 2 | Cataplexy |
| 125860311 | 12586031 | 4 | Product used for unknown indication |
| 125860311 | 12586031 | 5 | Product used for unknown indication |
| 125860311 | 12586031 | 6 | Product used for unknown indication |
| 125860311 | 12586031 | 7 | Product used for unknown indication |
| 125860311 | 12586031 | 8 | Product used for unknown indication |
| 125860311 | 12586031 | 9 | Product used for unknown indication |
| 125860311 | 12586031 | 10 | Product used for unknown indication |
| 125860311 | 12586031 | 11 | Product used for unknown indication |
| 125860311 | 12586031 | 12 | Product used for unknown indication |
| 125860311 | 12586031 | 13 | Product used for unknown indication |
| 125860311 | 12586031 | 14 | Product used for unknown indication |
| 125860311 | 12586031 | 15 | Product used for unknown indication |
| 125860311 | 12586031 | 16 | Product used for unknown indication |
| 125860311 | 12586031 | 17 | Product used for unknown indication |
| 125860311 | 12586031 | 18 | Product used for unknown indication |
| 125860311 | 12586031 | 19 | Product used for unknown indication |
| 125860311 | 12586031 | 20 | Product used for unknown indication |
| 125860311 | 12586031 | 21 | Product used for unknown indication |
| 125860311 | 12586031 | 22 | Product used for unknown indication |
| 125860311 | 12586031 | 23 | Product used for unknown indication |
| 125860311 | 12586031 | 24 | Product used for unknown indication |
| 125860311 | 12586031 | 25 | Product used for unknown indication |
| 125860311 | 12586031 | 26 | Product used for unknown indication |
| 125860311 | 12586031 | 27 | Product used for unknown indication |
| 125860311 | 12586031 | 28 | Product used for unknown indication |
| 125860311 | 12586031 | 29 | Product used for unknown indication |
| 125860311 | 12586031 | 30 | Product used for unknown indication |
| 125860311 | 12586031 | 31 | Product used for unknown indication |
| 125860311 | 12586031 | 32 | Product used for unknown indication |
| 125860311 | 12586031 | 33 | Product used for unknown indication |
| 125860311 | 12586031 | 34 | Product used for unknown indication |
| 125860311 | 12586031 | 35 | Product used for unknown indication |
| 125860311 | 12586031 | 36 | Product used for unknown indication |
| 125860311 | 12586031 | 37 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125860311 | 12586031 | Anxiety | |
| 125860311 | 12586031 | Blood pressure fluctuation | |
| 125860311 | 12586031 | Chest discomfort | |
| 125860311 | 12586031 | Depression | |
| 125860311 | 12586031 | Drug hypersensitivity | |
| 125860311 | 12586031 | Dyspnoea | |
| 125860311 | 12586031 | Fall | |
| 125860311 | 12586031 | Rotator cuff syndrome | |
| 125860311 | 12586031 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125860311 | 12586031 | 1 | 201301 | 201301 | 0 | |
| 125860311 | 12586031 | 3 | 201306 | 0 | ||
| 125860311 | 12586031 | 5 | 20140331 | 20140718 | 0 | |
| 125860311 | 12586031 | 6 | 20151202 | 20151230 | 0 | |
| 125860311 | 12586031 | 7 | 20160113 | 0 | ||
| 125860311 | 12586031 | 8 | 20160113 | 0 | ||
| 125860311 | 12586031 | 9 | 20160113 | 0 | ||
| 125860311 | 12586031 | 10 | 20160113 | 20160202 | 0 | |
| 125860311 | 12586031 | 11 | 20160113 | 0 | ||
| 125860311 | 12586031 | 12 | 20160113 | 0 | ||
| 125860311 | 12586031 | 13 | 20160112 | 0 | ||
| 125860311 | 12586031 | 14 | 20151202 | 20151230 | 0 | |
| 125860311 | 12586031 | 15 | 20151201 | 20160202 | 0 | |
| 125860311 | 12586031 | 16 | 20151201 | 20160202 | 0 | |
| 125860311 | 12586031 | 17 | 20150701 | 0 | ||
| 125860311 | 12586031 | 18 | 20150701 | 20160202 | 0 | |
| 125860311 | 12586031 | 19 | 20150428 | 0 | ||
| 125860311 | 12586031 | 20 | 20150428 | 0 | ||
| 125860311 | 12586031 | 21 | 20150428 | 0 | ||
| 125860311 | 12586031 | 22 | 20150427 | 0 | ||
| 125860311 | 12586031 | 23 | 20150225 | 0 | ||
| 125860311 | 12586031 | 24 | 20141022 | 20160202 | 0 | |
| 125860311 | 12586031 | 25 | 20140718 | 20150428 | 0 | |
| 125860311 | 12586031 | 26 | 20140130 | 0 | ||
| 125860311 | 12586031 | 27 | 20130626 | 20140718 | 0 | |
| 125860311 | 12586031 | 28 | 20121001 | 20150427 | 0 | |
| 125860311 | 12586031 | 29 | 20120601 | 20150428 | 0 | |
| 125860311 | 12586031 | 30 | 20120601 | 20141201 | 0 | |
| 125860311 | 12586031 | 31 | 20120101 | 0 | ||
| 125860311 | 12586031 | 32 | 20120101 | 20160202 | 0 | |
| 125860311 | 12586031 | 33 | 20120101 | 20150428 | 0 | |
| 125860311 | 12586031 | 34 | 20120101 | 20160202 | 0 | |
| 125860311 | 12586031 | 35 | 20080101 | 20150428 | 0 |