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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124268263 | 12426826 | 3 | F | 201605 | 20160628 | 20160601 | 20160706 | EXP | US-JAZZ-2016-US-009721 | JAZZ | 44.19 | YR | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124268263 | 12426826 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124268263 | 12426826 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | N | 21196 | ORAL SOLUTION | ||||||||||
| 124268263 | 12426826 | 3 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | ||||||||||
| 124268263 | 12426826 | 4 | C | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124268263 | 12426826 | 5 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 6 | C | CELEBREX | CELECOXIB | 1 | U | 0 | CAPSULE | ||||||||||
| 124268263 | 12426826 | 7 | C | CLARITIN | LORATADINE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 8 | C | Flonase Allergy Rlf | 2 | U | 0 | SPRAY | |||||||||||
| 124268263 | 12426826 | 9 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 10 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 11 | C | LORAZEPAM. | LORAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 12 | C | NEURONTIN | GABAPENTIN | 1 | U | 0 | CAPSULE | ||||||||||
| 124268263 | 12426826 | 13 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 14 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 15 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 16 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124268263 | 12426826 | 17 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124268263 | 12426826 | 1 | Narcolepsy |
| 124268263 | 12426826 | 2 | Somnolence |
| 124268263 | 12426826 | 3 | Product used for unknown indication |
| 124268263 | 12426826 | 4 | Product used for unknown indication |
| 124268263 | 12426826 | 5 | Product used for unknown indication |
| 124268263 | 12426826 | 6 | Product used for unknown indication |
| 124268263 | 12426826 | 7 | Product used for unknown indication |
| 124268263 | 12426826 | 8 | Product used for unknown indication |
| 124268263 | 12426826 | 9 | Product used for unknown indication |
| 124268263 | 12426826 | 10 | Product used for unknown indication |
| 124268263 | 12426826 | 11 | Product used for unknown indication |
| 124268263 | 12426826 | 12 | Product used for unknown indication |
| 124268263 | 12426826 | 13 | Product used for unknown indication |
| 124268263 | 12426826 | 14 | Product used for unknown indication |
| 124268263 | 12426826 | 15 | Product used for unknown indication |
| 124268263 | 12426826 | 16 | Product used for unknown indication |
| 124268263 | 12426826 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124268263 | 12426826 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124268263 | 12426826 | Anxiety | |
| 124268263 | 12426826 | Bipolar disorder | |
| 124268263 | 12426826 | Condition aggravated | |
| 124268263 | 12426826 | Panic attack | |
| 124268263 | 12426826 | Stress | |
| 124268263 | 12426826 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 124268263 | 12426826 | 1 | 20160513 | 20160526 | 0 | |
| 124268263 | 12426826 | 3 | 20160508 | 0 |