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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127267533 | 12726753 | 3 | F | 2016 | 20160922 | 20160908 | 20160930 | EXP | US-JAZZ-2016-US-016825 | JAZZ | 0.00 | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127267533 | 12726753 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | D | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127267533 | 12726753 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | D | 21196 | ORAL SOLUTION | ||||||||
| 127267533 | 12726753 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5.5 G, BID | D | 21196 | 5.5 | G | ORAL SOLUTION | ||||||
| 127267533 | 12726753 | 4 | SS | LYRICA | PREGABALIN | 1 | UNK | Y | 0 | CAPSULE | |||||||||
| 127267533 | 12726753 | 5 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | Y | 0 | ||||||||||
| 127267533 | 12726753 | 6 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127267533 | 12726753 | 7 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127267533 | 12726753 | 8 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127267533 | 12726753 | 9 | C | LO LOESTRIN FE | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127267533 | 12726753 | 10 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127267533 | 12726753 | 11 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | ||||||||||
| 127267533 | 12726753 | 12 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 127267533 | 12726753 | 13 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127267533 | 12726753 | 14 | C | Gralise er | 2 | U | 0 | TABLET | |||||||||||
| 127267533 | 12726753 | 15 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | U | 0 | |||||||||||
| 127267533 | 12726753 | 16 | C | UNITHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127267533 | 12726753 | 1 | Insomnia |
| 127267533 | 12726753 | 2 | Narcolepsy |
| 127267533 | 12726753 | 4 | Product used for unknown indication |
| 127267533 | 12726753 | 5 | Product used for unknown indication |
| 127267533 | 12726753 | 6 | Product used for unknown indication |
| 127267533 | 12726753 | 7 | Product used for unknown indication |
| 127267533 | 12726753 | 8 | Product used for unknown indication |
| 127267533 | 12726753 | 9 | Product used for unknown indication |
| 127267533 | 12726753 | 10 | Product used for unknown indication |
| 127267533 | 12726753 | 11 | Product used for unknown indication |
| 127267533 | 12726753 | 12 | Product used for unknown indication |
| 127267533 | 12726753 | 13 | Product used for unknown indication |
| 127267533 | 12726753 | 14 | Product used for unknown indication |
| 127267533 | 12726753 | 15 | Product used for unknown indication |
| 127267533 | 12726753 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127267533 | 12726753 | DE |
| 127267533 | 12726753 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127267533 | 12726753 | Blood sodium abnormal | |
| 127267533 | 12726753 | Brain injury | |
| 127267533 | 12726753 | Condition aggravated | |
| 127267533 | 12726753 | Death | |
| 127267533 | 12726753 | Diabetes insipidus | |
| 127267533 | 12726753 | Fibromyalgia | |
| 127267533 | 12726753 | Nasal septum deviation | |
| 127267533 | 12726753 | Premature menopause | |
| 127267533 | 12726753 | Sinus disorder | |
| 127267533 | 12726753 | Somnolence | |
| 127267533 | 12726753 | Upper airway resistance syndrome |
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 |
|---|---|---|---|---|---|---|
| 127267533 | 12726753 | 1 | 200611 | 200701 | 0 | |
| 127267533 | 12726753 | 2 | 200701 | 201506 | 0 | |
| 127267533 | 12726753 | 3 | 201506 | 0 | ||
| 127267533 | 12726753 | 4 | 20141124 | 201501 | 0 | |
| 127267533 | 12726753 | 5 | 201607 | 0 | ||
| 127267533 | 12726753 | 6 | 201608 | 0 | ||
| 127267533 | 12726753 | 7 | 20141124 | 0 | ||
| 127267533 | 12726753 | 8 | 20140814 | 201608 | 0 | |
| 127267533 | 12726753 | 9 | 200908 | 0 | ||
| 127267533 | 12726753 | 10 | 200808 | 0 | ||
| 127267533 | 12726753 | 11 | 201408 | 0 |