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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123390323 | 12339032 | 3 | F | 201603 | 20160627 | 20160505 | 20160701 | EXP | US-JAZZ-2016-US-007993 | JAZZ | 27.25 | YR | M | Y | 0.00000 | 20160701 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123390323 | 12339032 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 123390323 | 12339032 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 123390323 | 12339032 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 123390323 | 12339032 | 4 | SS | Doxepin | DOXEPIN | 1 | 50 MG, UNK | U | 0 | 50 | MG | CAPSULE | |||||||
| 123390323 | 12339032 | 5 | SS | Doxepin | DOXEPIN | 1 | 100 MG, UNK | U | 0 | 100 | MG | CAPSULE | |||||||
| 123390323 | 12339032 | 6 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | U | 0 | INHALER | ||||||||||
| 123390323 | 12339032 | 7 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123390323 | 12339032 | 8 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 9 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 10 | C | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 11 | C | Cetirizine hcl | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 12 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 13 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 14 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123390323 | 12339032 | 15 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 123390323 | 12339032 | 16 | C | Multivitamin | VITAMINS | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123390323 | 12339032 | 1 | Narcolepsy |
| 123390323 | 12339032 | 2 | Cataplexy |
| 123390323 | 12339032 | 4 | Product used for unknown indication |
| 123390323 | 12339032 | 6 | Product used for unknown indication |
| 123390323 | 12339032 | 7 | Product used for unknown indication |
| 123390323 | 12339032 | 8 | Product used for unknown indication |
| 123390323 | 12339032 | 9 | Product used for unknown indication |
| 123390323 | 12339032 | 10 | Product used for unknown indication |
| 123390323 | 12339032 | 11 | Product used for unknown indication |
| 123390323 | 12339032 | 12 | Product used for unknown indication |
| 123390323 | 12339032 | 13 | Product used for unknown indication |
| 123390323 | 12339032 | 14 | Product used for unknown indication |
| 123390323 | 12339032 | 15 | Product used for unknown indication |
| 123390323 | 12339032 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123390323 | 12339032 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123390323 | 12339032 | Fatigue | |
| 123390323 | 12339032 | Intentional product use issue | |
| 123390323 | 12339032 | Nephrolithiasis | |
| 123390323 | 12339032 | Seasonal affective disorder | |
| 123390323 | 12339032 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 123390323 | 12339032 | 1 | 201211 | 201212 | 0 | |
| 123390323 | 12339032 | 2 | 201212 | 2013 | 0 | |
| 123390323 | 12339032 | 3 | 2013 | 0 | ||
| 123390323 | 12339032 | 4 | 20120501 | 20140327 | 0 | |
| 123390323 | 12339032 | 5 | 201604 | 0 | ||
| 123390323 | 12339032 | 7 | 20151023 | 201601 | 0 | |
| 123390323 | 12339032 | 8 | 20151023 | 201604 | 0 | |
| 123390323 | 12339032 | 9 | 20150920 | 20151023 | 0 | |
| 123390323 | 12339032 | 10 | 20150918 | 20151023 | 0 | |
| 123390323 | 12339032 | 11 | 20150514 | 0 | ||
| 123390323 | 12339032 | 12 | 20120901 | 20150921 | 0 | |
| 123390323 | 12339032 | 13 | 20100101 | 0 | ||
| 123390323 | 12339032 | 14 | 20081101 | 0 |