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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124576363 | 12457636 | 3 | F | 2016 | 20160913 | 20160610 | 20160920 | EXP | US-JAZZ-2016-US-010340 | JAZZ | 0.00 | F | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124576363 | 12457636 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124576363 | 12457636 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124576363 | 12457636 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | U | 21196 | ORAL SOLUTION | ||||||||
| 124576363 | 12457636 | 4 | SS | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124576363 | 12457636 | 5 | SS | CLARITIN | LORATADINE | 1 | U | 0 | TABLET | ||||||||||
| 124576363 | 12457636 | 6 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | U | 0 | TABLET | |||||||||
| 124576363 | 12457636 | 7 | C | ADVIL | IBUPROFEN | 1 | U | 0 | |||||||||||
| 124576363 | 12457636 | 8 | C | Fish oil | FISH OIL | 1 | U | 0 | |||||||||||
| 124576363 | 12457636 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | CAPSULE | ||||||||||
| 124576363 | 12457636 | 10 | C | Gildess Fe | ETHINYL ESTRADIOLNORETHINDRONE | 1 | U | 0 | TABLET | ||||||||||
| 124576363 | 12457636 | 11 | C | Multivitamin | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 124576363 | 12457636 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 124576363 | 12457636 | 13 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124576363 | 12457636 | 14 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | TABLET | ||||||||||
| 124576363 | 12457636 | 15 | C | Turmeric | TURMERIC | 1 | U | 0 | POWDER | ||||||||||
| 124576363 | 12457636 | 16 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 124576363 | 12457636 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 124576363 | 12457636 | 18 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124576363 | 12457636 | 1 | Narcolepsy |
| 124576363 | 12457636 | 2 | Cataplexy |
| 124576363 | 12457636 | 4 | Product used for unknown indication |
| 124576363 | 12457636 | 5 | Product used for unknown indication |
| 124576363 | 12457636 | 6 | Product used for unknown indication |
| 124576363 | 12457636 | 7 | Product used for unknown indication |
| 124576363 | 12457636 | 8 | Product used for unknown indication |
| 124576363 | 12457636 | 9 | Product used for unknown indication |
| 124576363 | 12457636 | 10 | Product used for unknown indication |
| 124576363 | 12457636 | 11 | Product used for unknown indication |
| 124576363 | 12457636 | 12 | Product used for unknown indication |
| 124576363 | 12457636 | 13 | Product used for unknown indication |
| 124576363 | 12457636 | 14 | Product used for unknown indication |
| 124576363 | 12457636 | 15 | Product used for unknown indication |
| 124576363 | 12457636 | 16 | Product used for unknown indication |
| 124576363 | 12457636 | 17 | Product used for unknown indication |
| 124576363 | 12457636 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124576363 | 12457636 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124576363 | 12457636 | Aphonia | |
| 124576363 | 12457636 | Eye irritation | |
| 124576363 | 12457636 | Multiple allergies | |
| 124576363 | 12457636 | Respiratory tract infection | |
| 124576363 | 12457636 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 124576363 | 12457636 | 1 | 201605 | 201605 | 0 | |
| 124576363 | 12457636 | 2 | 201605 | 2016 | 0 | |
| 124576363 | 12457636 | 3 | 2016 | 0 | ||
| 124576363 | 12457636 | 4 | 201606 | 0 | ||
| 124576363 | 12457636 | 6 | 201505 | 201606 | 0 | |
| 124576363 | 12457636 | 18 | 201605 | 0 |