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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125648721 | 12564872 | 1 | I | 2016 | 20160119 | 20160718 | 20160718 | PER | US-JAZZ-2016-US-001045 | JAZZ | 0.00 | F | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125648721 | 12564872 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125648721 | 12564872 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 125648721 | 12564872 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125648721 | 12564872 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125648721 | 12564872 | 5 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | 0.75 G, UNK | 0 | .75 | G | |||||||||
| 125648721 | 12564872 | 6 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125648721 | 12564872 | 7 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 125648721 | 12564872 | 8 | C | Marijuana | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | UNK | U | 0 | ||||||||||
| 125648721 | 12564872 | 9 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125648721 | 12564872 | 10 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125648721 | 12564872 | 11 | C | Cetirizine hcl | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125648721 | 12564872 | 12 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125648721 | 12564872 | 13 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125648721 | 12564872 | 14 | C | TRINESSA | ETHINYL ESTRADIOLNORGESTIMATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125648721 | 12564872 | 1 | Narcolepsy |
| 125648721 | 12564872 | 5 | Product used for unknown indication |
| 125648721 | 12564872 | 6 | Product used for unknown indication |
| 125648721 | 12564872 | 7 | Product used for unknown indication |
| 125648721 | 12564872 | 8 | Product used for unknown indication |
| 125648721 | 12564872 | 9 | Product used for unknown indication |
| 125648721 | 12564872 | 10 | Product used for unknown indication |
| 125648721 | 12564872 | 11 | Product used for unknown indication |
| 125648721 | 12564872 | 12 | Product used for unknown indication |
| 125648721 | 12564872 | 13 | Product used for unknown indication |
| 125648721 | 12564872 | 14 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125648721 | 12564872 | Amnesia | |
| 125648721 | 12564872 | Depressed level of consciousness | |
| 125648721 | 12564872 | Fatigue | |
| 125648721 | 12564872 | Feeling abnormal | |
| 125648721 | 12564872 | Intentional product use issue | |
| 125648721 | 12564872 | Nausea | |
| 125648721 | 12564872 | Tremor | |
| 125648721 | 12564872 | Unevaluable event | |
| 125648721 | 12564872 | 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 |
|---|---|---|---|---|---|---|
| 125648721 | 12564872 | 1 | 201511 | 2015 | 0 | |
| 125648721 | 12564872 | 2 | 201512 | 201601 | 0 | |
| 125648721 | 12564872 | 3 | 201601 | 20160113 | 0 | |
| 125648721 | 12564872 | 4 | 20160114 | 0 | ||
| 125648721 | 12564872 | 5 | 20160107 | 0 | ||
| 125648721 | 12564872 | 6 | 20160119 | 0 | ||
| 125648721 | 12564872 | 7 | 20151124 | 0 | ||
| 125648721 | 12564872 | 8 | 20151124 | 20151124 | 0 | |
| 125648721 | 12564872 | 9 | 20151124 | 0 | ||
| 125648721 | 12564872 | 10 | 20151006 | 20160119 | 0 | |
| 125648721 | 12564872 | 11 | 20151006 | 20160119 | 0 | |
| 125648721 | 12564872 | 12 | 20151006 | 20160119 | 0 | |
| 125648721 | 12564872 | 13 | 20151006 | 0 | ||
| 125648721 | 12564872 | 14 | 20151006 | 0 |