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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126237241 | 12623724 | 1 | I | 20160221 | 20160225 | 20160804 | 20160804 | PER | US-JAZZ-2016-US-003834 | JAZZ | 44.65 | YR | F | Y | 47.16000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126237241 | 12623724 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | 21196 | 2 | G | ORAL SOLUTION | |||||||
| 126237241 | 12623724 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126237241 | 12623724 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.75 G, FIRST DOSE | 21196 | 4.75 | G | ORAL SOLUTION | |||||||
| 126237241 | 12623724 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, SECOND DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 126237241 | 12623724 | 5 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126237241 | 12623724 | 6 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126237241 | 12623724 | 7 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | TABLET | ||||||||||
| 126237241 | 12623724 | 8 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 50 MCG DAILY | U | 0 | TABLET | |||||||||
| 126237241 | 12623724 | 9 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126237241 | 12623724 | 10 | C | ALEVE | NAPROXEN SODIUM | 1 | CAPLET | U | 0 | ||||||||||
| 126237241 | 12623724 | 11 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126237241 | 12623724 | 1 | Insomnia |
| 126237241 | 12623724 | 5 | Insomnia |
| 126237241 | 12623724 | 6 | Anxiety |
| 126237241 | 12623724 | 7 | Depression |
| 126237241 | 12623724 | 8 | Hypothyroidism |
| 126237241 | 12623724 | 9 | Product used for unknown indication |
| 126237241 | 12623724 | 10 | Product used for unknown indication |
| 126237241 | 12623724 | 11 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126237241 | 12623724 | Headache | |
| 126237241 | 12623724 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 126237241 | 12623724 | 1 | 201101 | 201103 | 0 | |
| 126237241 | 12623724 | 5 | 20160220 | 0 | ||
| 126237241 | 12623724 | 8 | 201511 | 0 | ||
| 126237241 | 12623724 | 9 | 20151115 | 0 | ||
| 126237241 | 12623724 | 10 | 20151009 | 0 | ||
| 126237241 | 12623724 | 11 | 20151009 | 0 |