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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125862581 | 12586258 | 1 | I | 20160205 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-002302 | JAZZ | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125862581 | 12586258 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125862581 | 12586258 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125862581 | 12586258 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | ||||||||
| 125862581 | 12586258 | 4 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125862581 | 12586258 | 5 | SS | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 0 | ||||||||||||
| 125862581 | 12586258 | 6 | C | RAMIPRIL. | RAMIPRIL | 1 | UNK | 0 | CAPSULE | ||||||||||
| 125862581 | 12586258 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 8 | C | Citracal + D | CALCIUM CITRATEVITAMIN D | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 9 | C | Multivitamins | VITAMINS | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 10 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 11 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 12 | C | DELSYM | DEXTROMETHORPHAN | 1 | UNK | 0 | |||||||||||
| 125862581 | 12586258 | 13 | C | CLARITIN | LORATADINE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 14 | C | Cod liver oil | COD LIVER OIL | 1 | UNK | 0 | |||||||||||
| 125862581 | 12586258 | 15 | C | MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDEGUAIFENESIN | 1 | 1200-60 MG | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 16 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 17 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 18 | C | Bupropion hcl | BUPROPION HYDROCHLORIDE | 1 | UNK | 0 | POWDER | ||||||||||
| 125862581 | 12586258 | 19 | C | Potassium cl | POTASSIUM CHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 20 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 21 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 22 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 23 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | 0 | CAPSULE | ||||||||||
| 125862581 | 12586258 | 24 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 25 | C | FENOFIBRATE. | FENOFIBRATE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 26 | C | Hydroxychloroquine | HYDROXYCHLOROQUINE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 27 | C | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125862581 | 12586258 | 28 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 10 MG, UNK | 0 | 10 | MG | TABLET | ||||||||
| 125862581 | 12586258 | 29 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 5 MG, UNK | 0 | 5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125862581 | 12586258 | 1 | Narcolepsy |
| 125862581 | 12586258 | 4 | Product used for unknown indication |
| 125862581 | 12586258 | 5 | Product used for unknown indication |
| 125862581 | 12586258 | 6 | Product used for unknown indication |
| 125862581 | 12586258 | 7 | Product used for unknown indication |
| 125862581 | 12586258 | 8 | Product used for unknown indication |
| 125862581 | 12586258 | 9 | Product used for unknown indication |
| 125862581 | 12586258 | 10 | Product used for unknown indication |
| 125862581 | 12586258 | 11 | Product used for unknown indication |
| 125862581 | 12586258 | 12 | Product used for unknown indication |
| 125862581 | 12586258 | 13 | Product used for unknown indication |
| 125862581 | 12586258 | 14 | Product used for unknown indication |
| 125862581 | 12586258 | 15 | Product used for unknown indication |
| 125862581 | 12586258 | 16 | Product used for unknown indication |
| 125862581 | 12586258 | 17 | Product used for unknown indication |
| 125862581 | 12586258 | 18 | Product used for unknown indication |
| 125862581 | 12586258 | 19 | Product used for unknown indication |
| 125862581 | 12586258 | 20 | Product used for unknown indication |
| 125862581 | 12586258 | 21 | Product used for unknown indication |
| 125862581 | 12586258 | 22 | Product used for unknown indication |
| 125862581 | 12586258 | 23 | Product used for unknown indication |
| 125862581 | 12586258 | 24 | Product used for unknown indication |
| 125862581 | 12586258 | 25 | Product used for unknown indication |
| 125862581 | 12586258 | 26 | Product used for unknown indication |
| 125862581 | 12586258 | 27 | Product used for unknown indication |
| 125862581 | 12586258 | 28 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125862581 | 12586258 | Aggression | |
| 125862581 | 12586258 | Feeling abnormal |
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 |
|---|---|---|---|---|---|---|
| 125862581 | 12586258 | 1 | 201407 | 201407 | 0 | |
| 125862581 | 12586258 | 3 | 201506 | 0 | ||
| 125862581 | 12586258 | 8 | 20151005 | 0 | ||
| 125862581 | 12586258 | 9 | 20151005 | 0 | ||
| 125862581 | 12586258 | 10 | 20151005 | 0 | ||
| 125862581 | 12586258 | 11 | 20150929 | 0 | ||
| 125862581 | 12586258 | 12 | 20150929 | 20151005 | 0 | |
| 125862581 | 12586258 | 13 | 20150518 | 20151005 | 0 | |
| 125862581 | 12586258 | 14 | 20141208 | 20151005 | 0 | |
| 125862581 | 12586258 | 15 | 20150929 | 0 | ||
| 125862581 | 12586258 | 16 | 20141128 | 0 | ||
| 125862581 | 12586258 | 17 | 20141101 | 0 | ||
| 125862581 | 12586258 | 18 | 20140701 | 20150929 | 0 | |
| 125862581 | 12586258 | 19 | 20140701 | 0 | ||
| 125862581 | 12586258 | 20 | 20140101 | 20151005 | 0 | |
| 125862581 | 12586258 | 21 | 20131101 | 0 | ||
| 125862581 | 12586258 | 22 | 20120701 | 0 | ||
| 125862581 | 12586258 | 23 | 20120701 | 0 | ||
| 125862581 | 12586258 | 24 | 20030701 | 0 | ||
| 125862581 | 12586258 | 25 | 20030701 | 0 | ||
| 125862581 | 12586258 | 26 | 20030701 | 0 | ||
| 125862581 | 12586258 | 27 | 20030701 | 0 | ||
| 125862581 | 12586258 | 28 | 20000701 | 0 |