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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126238551 | 12623855 | 1 | I | 2016 | 20160204 | 20160804 | 20160804 | PER | US-JAZZ-2016-US-002131 | JAZZ | 44.22 | YR | M | Y | 81.63000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126238551 | 12623855 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126238551 | 12623855 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 126238551 | 12623855 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126238551 | 12623855 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 126238551 | 12623855 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126238551 | 12623855 | 6 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Y | 0 | |||||||||||
| 126238551 | 12623855 | 7 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | 10 MG, PRN AT 2 PM | U | 0 | 10 | MG | TABLET | |||||||
| 126238551 | 12623855 | 8 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | 54 MG QAM | U | 0 | TABLET | |||||||||
| 126238551 | 12623855 | 9 | C | ADVIL | IBUPROFEN | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126238551 | 12623855 | 1 | Narcolepsy |
| 126238551 | 12623855 | 2 | Cataplexy |
| 126238551 | 12623855 | 6 | Product used for unknown indication |
| 126238551 | 12623855 | 7 | Narcolepsy |
| 126238551 | 12623855 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126238551 | 12623855 | Chest discomfort | |
| 126238551 | 12623855 | Drug interaction | |
| 126238551 | 12623855 | Feeling abnormal | |
| 126238551 | 12623855 | Hallucination | |
| 126238551 | 12623855 | Head discomfort | |
| 126238551 | 12623855 | Heart rate increased | |
| 126238551 | 12623855 | Hypoaesthesia | |
| 126238551 | 12623855 | Hypokinesia | |
| 126238551 | 12623855 | Lip discolouration | |
| 126238551 | 12623855 | Paraesthesia | |
| 126238551 | 12623855 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126238551 | 12623855 | 1 | 20160202 | 201602 | 0 | |
| 126238551 | 12623855 | 2 | 201602 | 201602 | 0 | |
| 126238551 | 12623855 | 3 | 201602 | 2016 | 0 | |
| 126238551 | 12623855 | 4 | 2016 | 2016 | 0 | |
| 126238551 | 12623855 | 5 | 2016 | 0 | ||
| 126238551 | 12623855 | 7 | 20151229 | 0 | ||
| 126238551 | 12623855 | 8 | 20151229 | 0 |