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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127142461 | 12714246 | 1 | I | 20160509 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008666 | JAZZ | 0.00 | F | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127142461 | 12714246 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127142461 | 12714246 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127142461 | 12714246 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | 21196 | 6 | G | ORAL SOLUTION | |||||||
| 127142461 | 12714246 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127142461 | 12714246 | 5 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Y | 0 | |||||||||||
| 127142461 | 12714246 | 6 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127142461 | 12714246 | 7 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 8 | C | ABILIFY | ARIPIPRAZOLE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 9 | C | ATIVAN | LORAZEPAM | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 10 | C | Ezfe | 2 | U | 0 | ||||||||||||
| 127142461 | 12714246 | 11 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 12 | C | Probiotica | PROBIOTICS NOS | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 13 | C | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 14 | C | CIMZIA | CERTOLIZUMAB PEGOL | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 15 | C | CRYSELLE | ETHINYL ESTRADIOLNORGESTREL | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 16 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 17 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 18 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 19 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 20 | C | CEPHALEXIN. | CEPHALEXIN | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 21 | C | HUMIRA | ADALIMUMAB | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 22 | C | GEODON | ZIPRASIDONE HYDROCHLORIDEIPRASIDONE MESYLATE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 23 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 24 | C | ASACOL HD | MESALAMINE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 25 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 26 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 127142461 | 12714246 | 27 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127142461 | 12714246 | 1 | Narcolepsy |
| 127142461 | 12714246 | 5 | Product used for unknown indication |
| 127142461 | 12714246 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127142461 | 12714246 | Condition aggravated | |
| 127142461 | 12714246 | Depression | |
| 127142461 | 12714246 | Hypertension |
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 |
|---|---|---|---|---|---|---|
| 127142461 | 12714246 | 1 | 201303 | 201303 | 0 | |
| 127142461 | 12714246 | 3 | 201501 | 0 | ||
| 127142461 | 12714246 | 4 | 201501 | 0 |