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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777711 | 12777771 | 1 | I | 2016 | 20160606 | 20160924 | 20160924 | PER | US-JAZZ-2016-US-010540 | JAZZ | 0.00 | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777711 | 12777771 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127777711 | 12777771 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127777711 | 12777771 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127777711 | 12777771 | 4 | SS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 127777711 | 12777771 | 5 | SS | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | 15 MG, UNK | U | 0 | 15 | MG | ||||||||
| 127777711 | 12777771 | 6 | C | AMITIZA | LUBIPROSTONE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 7 | C | Fish oil concentrate | 2 | U | 0 | ||||||||||||
| 127777711 | 12777771 | 8 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 9 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 10 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 11 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 12 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 13 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 14 | C | NAPROXEN. | NAPROXEN | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 15 | C | NASONEX | MOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 16 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 17 | C | OCELLA | DROSPIRENONEETHINYL ESTRADIOL | 1 | U | 0 | |||||||||||
| 127777711 | 12777771 | 18 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127777711 | 12777771 | 1 | Narcolepsy |
| 127777711 | 12777771 | 2 | Cataplexy |
| 127777711 | 12777771 | 4 | Anxiety |
| 127777711 | 12777771 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127777711 | 12777771 | Anxiety | |
| 127777711 | 12777771 | Drug ineffective | |
| 127777711 | 12777771 | Hyperphagia | |
| 127777711 | 12777771 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 127777711 | 12777771 | 1 | 201601 | 201601 | 0 | |
| 127777711 | 12777771 | 2 | 201601 | 201601 | 0 | |
| 127777711 | 12777771 | 3 | 201601 | 0 |