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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125311012 | 12531101 | 2 | F | 2007 | 20160711 | 20160706 | 20160719 | EXP | US-JAZZ-2016-US-012101 | JAZZ | 0.00 | F | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125311012 | 12531101 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125311012 | 12531101 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125311012 | 12531101 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125311012 | 12531101 | 4 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 125311012 | 12531101 | 5 | SS | ADVIL | IBUPROFEN | 1 | UNK | 0 | |||||||||||
| 125311012 | 12531101 | 6 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 125311012 | 12531101 | 7 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125311012 | 12531101 | 8 | C | ALEVE | NAPROXEN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125311012 | 12531101 | 9 | C | Calcium + d3 | CALCIUMCHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 125311012 | 12531101 | 10 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 125311012 | 12531101 | 11 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | TABLET | ||||||||||
| 125311012 | 12531101 | 12 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 125311012 | 12531101 | 13 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 125311012 | 12531101 | 14 | C | PREVACID | LANSOPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 125311012 | 12531101 | 15 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125311012 | 12531101 | 1 | Fibromyalgia |
| 125311012 | 12531101 | 4 | Product used for unknown indication |
| 125311012 | 12531101 | 5 | Product used for unknown indication |
| 125311012 | 12531101 | 6 | Product used for unknown indication |
| 125311012 | 12531101 | 7 | Product used for unknown indication |
| 125311012 | 12531101 | 8 | Product used for unknown indication |
| 125311012 | 12531101 | 9 | Product used for unknown indication |
| 125311012 | 12531101 | 10 | Product used for unknown indication |
| 125311012 | 12531101 | 11 | Product used for unknown indication |
| 125311012 | 12531101 | 12 | Product used for unknown indication |
| 125311012 | 12531101 | 13 | Product used for unknown indication |
| 125311012 | 12531101 | 14 | Product used for unknown indication |
| 125311012 | 12531101 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125311012 | 12531101 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125311012 | 12531101 | Asthenia | |
| 125311012 | 12531101 | Drug ineffective | |
| 125311012 | 12531101 | Feeling abnormal | |
| 125311012 | 12531101 | Glucose tolerance impaired | |
| 125311012 | 12531101 | Nausea | |
| 125311012 | 12531101 | Somnolence | |
| 125311012 | 12531101 | Thyroidectomy |
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 |
|---|---|---|---|---|---|---|
| 125311012 | 12531101 | 1 | 200607 | 201012 | 0 | |
| 125311012 | 12531101 | 2 | 201012 | 201112 | 0 | |
| 125311012 | 12531101 | 3 | 201112 | 0 | ||
| 125311012 | 12531101 | 4 | 201606 | 0 | ||
| 125311012 | 12531101 | 5 | 201606 | 0 | ||
| 125311012 | 12531101 | 6 | 20160201 | 0 | ||
| 125311012 | 12531101 | 7 | 20160101 | 0 | ||
| 125311012 | 12531101 | 8 | 20130101 | 0 | ||
| 125311012 | 12531101 | 14 | 201606 | 0 | ||
| 125311012 | 12531101 | 15 | 201606 | 0 |