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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239401 | 12523940 | 1 | I | 20151223 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022455 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239401 | 12523940 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125239401 | 12523940 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125239401 | 12523940 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125239401 | 12523940 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125239401 | 12523940 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125239401 | 12523940 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125239401 | 12523940 | 7 | C | AMITIZA | LUBIPROSTONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239401 | 12523940 | 8 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 9 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 10 | C | COZAAR | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 11 | C | DIOVAN HCT | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 12 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239401 | 12523940 | 13 | C | FELODIPINEEXTENDED-RELEASE TABLETS | FELODIPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 14 | C | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 15 | C | NUCYNTA | TAPENTADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 16 | C | PANTOPRAZOLE SODIUM DR | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 17 | C | Propranolol er | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 125239401 | 12523940 | 18 | C | Propylthiouracile | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125239401 | 12523940 | 19 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239401 | 12523940 | 20 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239401 | 12523940 | 21 | C | Amphetamine | AMPHETAMINE | 1 | UNK | U | 0 | ||||||||||
| 125239401 | 12523940 | 22 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239401 | 12523940 | 1 | Narcolepsy |
| 125239401 | 12523940 | 7 | Product used for unknown indication |
| 125239401 | 12523940 | 8 | Product used for unknown indication |
| 125239401 | 12523940 | 9 | Product used for unknown indication |
| 125239401 | 12523940 | 10 | Product used for unknown indication |
| 125239401 | 12523940 | 11 | Product used for unknown indication |
| 125239401 | 12523940 | 12 | Product used for unknown indication |
| 125239401 | 12523940 | 13 | Product used for unknown indication |
| 125239401 | 12523940 | 14 | Product used for unknown indication |
| 125239401 | 12523940 | 15 | Product used for unknown indication |
| 125239401 | 12523940 | 16 | Product used for unknown indication |
| 125239401 | 12523940 | 17 | Product used for unknown indication |
| 125239401 | 12523940 | 18 | Product used for unknown indication |
| 125239401 | 12523940 | 19 | Product used for unknown indication |
| 125239401 | 12523940 | 20 | Product used for unknown indication |
| 125239401 | 12523940 | 21 | Product used for unknown indication |
| 125239401 | 12523940 | 22 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239401 | 12523940 | Fatigue | |
| 125239401 | 12523940 | Feeling abnormal | |
| 125239401 | 12523940 | Influenza like illness | |
| 125239401 | 12523940 | Malaise | |
| 125239401 | 12523940 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 125239401 | 12523940 | 1 | 200909 | 200909 | 0 | |
| 125239401 | 12523940 | 2 | 2009 | 2009 | 0 | |
| 125239401 | 12523940 | 3 | 200910 | 2010 | 0 | |
| 125239401 | 12523940 | 4 | 201304 | 201304 | 0 | |
| 125239401 | 12523940 | 6 | 201411 | 0 | ||
| 125239401 | 12523940 | 7 | 20140925 | 0 | ||
| 125239401 | 12523940 | 8 | 20140925 | 0 | ||
| 125239401 | 12523940 | 9 | 20140925 | 0 | ||
| 125239401 | 12523940 | 10 | 20140925 | 20140925 | 0 | |
| 125239401 | 12523940 | 11 | 20140925 | 0 | ||
| 125239401 | 12523940 | 12 | 20140925 | 20140925 | 0 | |
| 125239401 | 12523940 | 13 | 20140925 | 20140925 | 0 | |
| 125239401 | 12523940 | 14 | 20150925 | 20150925 | 0 | |
| 125239401 | 12523940 | 15 | 20140925 | 20141019 | 0 | |
| 125239401 | 12523940 | 16 | 20140925 | 0 | ||
| 125239401 | 12523940 | 17 | 20140925 | 20140925 | 0 | |
| 125239401 | 12523940 | 18 | 20140925 | 20140925 | 0 | |
| 125239401 | 12523940 | 19 | 20140527 | 0 | ||
| 125239401 | 12523940 | 20 | 20130403 | 20130404 | 0 |