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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120646713 | 12064671 | 3 | F | 2011 | 20160809 | 20160210 | 20160816 | EXP | US-JAZZ-2016-US-002091 | JAZZ | 0.00 | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120646713 | 12064671 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 120646713 | 12064671 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 120646713 | 12064671 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 120646713 | 12064671 | 4 | C | NEUPRO | ROTIGOTINE | 1 | UNK | 0 | PATCH | ||||||||||
| 120646713 | 12064671 | 5 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 6 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | 0 | |||||||||||
| 120646713 | 12064671 | 7 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 8 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | 100 MG, UNK | U | 0 | 100 | MG | TABLET | |||||||
| 120646713 | 12064671 | 9 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | 50 MG, UNK | U | 0 | 50 | MG | TABLET | |||||||
| 120646713 | 12064671 | 10 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | 0 | |||||||||||
| 120646713 | 12064671 | 11 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | UNK | 0 | POWDER | ||||||||||
| 120646713 | 12064671 | 12 | C | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 13 | C | TEKTURNA | ALISKIREN HEMIFUMARATE | 1 | 150 MG, UNK | U | 0 | 150 | MG | TABLET | |||||||
| 120646713 | 12064671 | 14 | C | TEKTURNA | ALISKIREN HEMIFUMARATE | 1 | 300 MG, UNK | U | 0 | 300 | MG | TABLET | |||||||
| 120646713 | 12064671 | 15 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 16 | C | Fiorinal with codeine#3 | 2 | UNK | 0 | CAPSULE | |||||||||||
| 120646713 | 12064671 | 17 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 18 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 19 | C | CALTRATE WITH VITAMIN D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | UNK | 0 | CHEWABLE TABLET | ||||||||||
| 120646713 | 12064671 | 20 | C | CAMBIA | DICLOFENAC POTASSIUM | 1 | UNK | 0 | POWDER | ||||||||||
| 120646713 | 12064671 | 21 | C | Centrum silver | MINERALSVITAMINS | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 22 | C | Clonidine Hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 23 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 20 MG, UNK | U | 0 | 20 | MG | CAPSULE | |||||||
| 120646713 | 12064671 | 24 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 60 MG, UNK | U | 0 | 60 | MG | CAPSULE | |||||||
| 120646713 | 12064671 | 25 | C | FELODIPINEEXTENDED-RELEASE TABLETS | FELODIPINE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 26 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 27 | C | LASIX | FUROSEMIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 28 | C | LIOTHYRONINE SODIUM. | LIOTHYRONINE SODIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 29 | C | LIVALO | PITAVASTATIN CALCIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 30 | C | Magnesium | MAGNESIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 31 | C | PRAMIPEXOLE. | PRAMIPEXOLE | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 32 | C | TIROSINT | LEVOTHYROXINE SODIUM | 1 | UNK | 0 | CAPSULE | ||||||||||
| 120646713 | 12064671 | 33 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | 0 | TABLET | ||||||||||
| 120646713 | 12064671 | 34 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120646713 | 12064671 | 1 | Narcolepsy |
| 120646713 | 12064671 | 4 | Product used for unknown indication |
| 120646713 | 12064671 | 5 | Product used for unknown indication |
| 120646713 | 12064671 | 6 | Product used for unknown indication |
| 120646713 | 12064671 | 7 | Product used for unknown indication |
| 120646713 | 12064671 | 8 | Product used for unknown indication |
| 120646713 | 12064671 | 10 | Product used for unknown indication |
| 120646713 | 12064671 | 11 | Product used for unknown indication |
| 120646713 | 12064671 | 12 | Product used for unknown indication |
| 120646713 | 12064671 | 13 | Product used for unknown indication |
| 120646713 | 12064671 | 15 | Product used for unknown indication |
| 120646713 | 12064671 | 16 | Product used for unknown indication |
| 120646713 | 12064671 | 17 | Product used for unknown indication |
| 120646713 | 12064671 | 18 | Product used for unknown indication |
| 120646713 | 12064671 | 19 | Product used for unknown indication |
| 120646713 | 12064671 | 20 | Product used for unknown indication |
| 120646713 | 12064671 | 21 | Product used for unknown indication |
| 120646713 | 12064671 | 22 | Product used for unknown indication |
| 120646713 | 12064671 | 23 | Product used for unknown indication |
| 120646713 | 12064671 | 25 | Product used for unknown indication |
| 120646713 | 12064671 | 26 | Product used for unknown indication |
| 120646713 | 12064671 | 27 | Product used for unknown indication |
| 120646713 | 12064671 | 28 | Product used for unknown indication |
| 120646713 | 12064671 | 29 | Product used for unknown indication |
| 120646713 | 12064671 | 30 | Product used for unknown indication |
| 120646713 | 12064671 | 31 | Product used for unknown indication |
| 120646713 | 12064671 | 32 | Product used for unknown indication |
| 120646713 | 12064671 | 33 | Product used for unknown indication |
| 120646713 | 12064671 | 34 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120646713 | 12064671 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120646713 | 12064671 | Hypertension | |
| 120646713 | 12064671 | Pre-existing condition improved | |
| 120646713 | 12064671 | Renal disorder | |
| 120646713 | 12064671 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 120646713 | 12064671 | 1 | 200508 | 2009 | 0 | |
| 120646713 | 12064671 | 2 | 2009 | 2010 | 0 | |
| 120646713 | 12064671 | 3 | 2010 | 0 | ||
| 120646713 | 12064671 | 5 | 20150301 | 0 | ||
| 120646713 | 12064671 | 6 | 20150203 | 0 | ||
| 120646713 | 12064671 | 7 | 20140318 | 0 | ||
| 120646713 | 12064671 | 8 | 20140318 | 0 | ||
| 120646713 | 12064671 | 10 | 20140318 | 20160203 | 0 | |
| 120646713 | 12064671 | 11 | 20140318 | 20160203 | 0 | |
| 120646713 | 12064671 | 12 | 20140318 | 0 | ||
| 120646713 | 12064671 | 13 | 20140318 | 20160203 | 0 | |
| 120646713 | 12064671 | 14 | 20160203 | 0 | ||
| 120646713 | 12064671 | 15 | 20140318 | 20160203 | 0 | |
| 120646713 | 12064671 | 16 | 20130711 | 0 | ||
| 120646713 | 12064671 | 23 | 20160203 | 0 | ||
| 120646713 | 12064671 | 29 | 20160203 | 0 | ||
| 120646713 | 12064671 | 31 | 20160203 | 0 |