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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125469682 | 12546968 | 2 | F | 2016 | 20160812 | 20160711 | 20160819 | EXP | US-JAZZ-2016-US-012450 | JAZZ | 0.00 | F | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125469682 | 12546968 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 125469682 | 12546968 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125469682 | 12546968 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125469682 | 12546968 | 4 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 5 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNKNOWN | U | 0 | CAPSULE | |||||||||
| 125469682 | 12546968 | 6 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNKNOWN (DOUBLE DOSE) | U | 0 | CAPSULE | |||||||||
| 125469682 | 12546968 | 7 | SS | Ondansetron hcl | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 8 | SS | PANTOPRAZOLE SODIUM DR | PANTOPRAZOLE SODIUM | 1 | UNK | N | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 9 | C | Aspirin e.c | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 10 | C | BUMETANIDE. | BUMETANIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 11 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | UNK | U | 0 | ||||||||||
| 125469682 | 12546968 | 12 | C | DIAZEPAM. | DIAZEPAM | 1 | 5 MG, UNK | U | 0 | 5 | MG | TABLET | |||||||
| 125469682 | 12546968 | 13 | C | DIAZEPAM. | DIAZEPAM | 1 | 10 MG, UNK | U | 0 | 10 | MG | TABLET | |||||||
| 125469682 | 12546968 | 14 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125469682 | 12546968 | 15 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 16 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 125469682 | 12546968 | 17 | C | MECLIZINE | MECLIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 18 | C | MOBIC | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 19 | C | Potassium cl | POTASSIUM CHLORIDE | 1 | 20 MEQ/ 15 ML | U | 0 | ||||||||||
| 125469682 | 12546968 | 20 | C | Slow-mag | MAGNESIUM CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 21 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125469682 | 12546968 | 22 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469682 | 12546968 | 23 | C | Multivitamins | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 125469682 | 12546968 | 24 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125469682 | 12546968 | 1 | Narcolepsy |
| 125469682 | 12546968 | 2 | Cataplexy |
| 125469682 | 12546968 | 4 | Product used for unknown indication |
| 125469682 | 12546968 | 5 | Product used for unknown indication |
| 125469682 | 12546968 | 7 | Product used for unknown indication |
| 125469682 | 12546968 | 8 | Product used for unknown indication |
| 125469682 | 12546968 | 9 | Product used for unknown indication |
| 125469682 | 12546968 | 10 | Product used for unknown indication |
| 125469682 | 12546968 | 11 | Product used for unknown indication |
| 125469682 | 12546968 | 12 | Product used for unknown indication |
| 125469682 | 12546968 | 14 | Product used for unknown indication |
| 125469682 | 12546968 | 15 | Product used for unknown indication |
| 125469682 | 12546968 | 16 | Product used for unknown indication |
| 125469682 | 12546968 | 17 | Product used for unknown indication |
| 125469682 | 12546968 | 18 | Product used for unknown indication |
| 125469682 | 12546968 | 19 | Product used for unknown indication |
| 125469682 | 12546968 | 20 | Product used for unknown indication |
| 125469682 | 12546968 | 21 | Product used for unknown indication |
| 125469682 | 12546968 | 22 | Product used for unknown indication |
| 125469682 | 12546968 | 23 | Product used for unknown indication |
| 125469682 | 12546968 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125469682 | 12546968 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125469682 | 12546968 | Anxiety | |
| 125469682 | 12546968 | Bronchitis | |
| 125469682 | 12546968 | Constipation | |
| 125469682 | 12546968 | Contusion | |
| 125469682 | 12546968 | Dyspnoea | |
| 125469682 | 12546968 | Feeling abnormal | |
| 125469682 | 12546968 | Feeling jittery | |
| 125469682 | 12546968 | Fibromyalgia | |
| 125469682 | 12546968 | Gastrooesophageal reflux disease | |
| 125469682 | 12546968 | Memory impairment | |
| 125469682 | 12546968 | Oedema | |
| 125469682 | 12546968 | Pneumonia | |
| 125469682 | 12546968 | Social fear | |
| 125469682 | 12546968 | Thirst | |
| 125469682 | 12546968 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125469682 | 12546968 | 1 | 201511 | 201511 | 0 | |
| 125469682 | 12546968 | 2 | 201511 | 201512 | 0 | |
| 125469682 | 12546968 | 3 | 201512 | 0 | ||
| 125469682 | 12546968 | 4 | 2016 | 0 | ||
| 125469682 | 12546968 | 5 | 20151111 | 201605 | 0 | |
| 125469682 | 12546968 | 6 | 201605 | 0 | ||
| 125469682 | 12546968 | 7 | 20151111 | 0 | ||
| 125469682 | 12546968 | 8 | 20151111 | 0 | ||
| 125469682 | 12546968 | 9 | 20151111 | 201607 | 0 | |
| 125469682 | 12546968 | 10 | 20151111 | 0 | ||
| 125469682 | 12546968 | 11 | 20151111 | 0 | ||
| 125469682 | 12546968 | 12 | 20151111 | 201607 | 0 | |
| 125469682 | 12546968 | 14 | 20151111 | 0 | ||
| 125469682 | 12546968 | 15 | 20151111 | 201607 | 0 | |
| 125469682 | 12546968 | 16 | 20151111 | 0 | ||
| 125469682 | 12546968 | 17 | 20151111 | 201607 | 0 | |
| 125469682 | 12546968 | 18 | 20151111 | 20160617 | 0 | |
| 125469682 | 12546968 | 19 | 20151111 | 0 | ||
| 125469682 | 12546968 | 20 | 20151111 | 0 | ||
| 125469682 | 12546968 | 21 | 20151111 | 0 | ||
| 125469682 | 12546968 | 22 | 20150111 | 0 |