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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125578261 | 12557826 | 1 | I | 20160111 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000502 | JAZZ | 0.00 | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125578261 | 12557826 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125578261 | 12557826 | 9 | SS | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 50 ?G, QD | U | 0 | 50 | UG | ||||||||
| 125578261 | 12557826 | 10 | C | NORVASC | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125578261 | 12557826 | 11 | C | THYROID | LEVOTHYROXINELIOTHYRONINE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125578261 | 12557826 | 12 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | NASAL SPRAY | U | 0 | SPRAY | |||||||||
| 125578261 | 12557826 | 13 | C | RESTORIL | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125578261 | 12557826 | 14 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | ||||||||||
| 125578261 | 12557826 | 15 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | U | 0 | ||||||||||
| 125578261 | 12557826 | 16 | C | SINEMET | CARBIDOPALEVODOPA | 1 | UNK | U | 0 | ||||||||||
| 125578261 | 12557826 | 17 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125578261 | 12557826 | 18 | C | ZESTRIL | LISINOPRIL | 1 | UNK | U | 0 | ||||||||||
| 125578261 | 12557826 | 19 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125578261 | 12557826 | 20 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125578261 | 12557826 | 1 | Narcolepsy |
| 125578261 | 12557826 | 2 | Cataplexy |
| 125578261 | 12557826 | 9 | Product used for unknown indication |
| 125578261 | 12557826 | 10 | Product used for unknown indication |
| 125578261 | 12557826 | 11 | Product used for unknown indication |
| 125578261 | 12557826 | 12 | Product used for unknown indication |
| 125578261 | 12557826 | 13 | Product used for unknown indication |
| 125578261 | 12557826 | 14 | Product used for unknown indication |
| 125578261 | 12557826 | 15 | Product used for unknown indication |
| 125578261 | 12557826 | 16 | Product used for unknown indication |
| 125578261 | 12557826 | 17 | Product used for unknown indication |
| 125578261 | 12557826 | 18 | Product used for unknown indication |
| 125578261 | 12557826 | 19 | Product used for unknown indication |
| 125578261 | 12557826 | 20 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125578261 | 12557826 | Fatigue |
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 |
|---|---|---|---|---|---|---|
| 125578261 | 12557826 | 1 | 200403 | 200404 | 0 | |
| 125578261 | 12557826 | 2 | 200404 | 2004 | 0 | |
| 125578261 | 12557826 | 3 | 201002 | 201003 | 0 | |
| 125578261 | 12557826 | 4 | 201003 | 2010 | 0 | |
| 125578261 | 12557826 | 5 | 201101 | 2011 | 0 | |
| 125578261 | 12557826 | 6 | 201404 | 201506 | 0 | |
| 125578261 | 12557826 | 7 | 201506 | 0 | ||
| 125578261 | 12557826 | 8 | 201506 | 0 | ||
| 125578261 | 12557826 | 10 | 20140723 | 0 | ||
| 125578261 | 12557826 | 11 | 20140414 | 0 | ||
| 125578261 | 12557826 | 12 | 20140407 | 0 | ||
| 125578261 | 12557826 | 13 | 20140407 | 20140407 | 0 | |
| 125578261 | 12557826 | 14 | 20140407 | 0 | ||
| 125578261 | 12557826 | 15 | 20140407 | 0 | ||
| 125578261 | 12557826 | 17 | 20140407 | 0 | ||
| 125578261 | 12557826 | 18 | 20140407 | 0 | ||
| 125578261 | 12557826 | 19 | 20151229 | 0 | ||
| 125578261 | 12557826 | 20 | 20151229 | 0 |