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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126146431 | 12614643 | 1 | I | 201601 | 20160217 | 20160802 | 20160802 | PER | US-JAZZ-2016-US-003121 | JAZZ | 17.44 | YR | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126146431 | 12614643 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 126146431 | 12614643 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126146431 | 12614643 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126146431 | 12614643 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, SECOND DOSE | 21196 | 5 | G | ORAL SOLUTION | |||||||
| 126146431 | 12614643 | 5 | SS | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | 300 MG, UNK | N | 0 | 300 | MG | CAPSULE | |||||||
| 126146431 | 12614643 | 6 | SS | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | 150 MG, UNK | N | 0 | 150 | MG | CAPSULE | |||||||
| 126146431 | 12614643 | 7 | C | Desipramine | DESIPRAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 8 | C | ADVIL | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 126146431 | 12614643 | 9 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 10 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126146431 | 12614643 | 11 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 12 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 126146431 | 12614643 | 13 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 14 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 15 | C | Methylphenidate er | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 16 | C | TAMIFLU | OSELTAMIVIR PHOSPHATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126146431 | 12614643 | 17 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 18 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 126146431 | 12614643 | 19 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | N | 0 | ||||||||||
| 126146431 | 12614643 | 20 | C | Fluticasone proprionate | FLUTICASONE PROPIONATE | 1 | UNK | N | 0 | SPRAY |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126146431 | 12614643 | 1 | Narcolepsy |
| 126146431 | 12614643 | 2 | Cataplexy |
| 126146431 | 12614643 | 5 | Product used for unknown indication |
| 126146431 | 12614643 | 7 | Product used for unknown indication |
| 126146431 | 12614643 | 8 | Product used for unknown indication |
| 126146431 | 12614643 | 9 | Product used for unknown indication |
| 126146431 | 12614643 | 10 | Product used for unknown indication |
| 126146431 | 12614643 | 11 | Product used for unknown indication |
| 126146431 | 12614643 | 12 | Product used for unknown indication |
| 126146431 | 12614643 | 13 | Product used for unknown indication |
| 126146431 | 12614643 | 15 | Product used for unknown indication |
| 126146431 | 12614643 | 16 | Product used for unknown indication |
| 126146431 | 12614643 | 17 | Product used for unknown indication |
| 126146431 | 12614643 | 18 | Product used for unknown indication |
| 126146431 | 12614643 | 19 | Product used for unknown indication |
| 126146431 | 12614643 | 20 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126146431 | 12614643 | Aggression | |
| 126146431 | 12614643 | Dysarthria | |
| 126146431 | 12614643 | Hypoaesthesia | |
| 126146431 | 12614643 | Mood altered | |
| 126146431 | 12614643 | Overdose | |
| 126146431 | 12614643 | Paranasal sinus discomfort | |
| 126146431 | 12614643 | Sleep-related eating disorder | |
| 126146431 | 12614643 | 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 |
|---|---|---|---|---|---|---|
| 126146431 | 12614643 | 1 | 201108 | 201108 | 0 | |
| 126146431 | 12614643 | 3 | 201601 | 0 | ||
| 126146431 | 12614643 | 4 | 201601 | 0 | ||
| 126146431 | 12614643 | 7 | 20160122 | 0 | ||
| 126146431 | 12614643 | 8 | 20150922 | 0 | ||
| 126146431 | 12614643 | 9 | 20150922 | 0 | ||
| 126146431 | 12614643 | 10 | 20150922 | 0 | ||
| 126146431 | 12614643 | 11 | 20150826 | 20160122 | 0 | |
| 126146431 | 12614643 | 13 | 20121004 | 20141017 | 0 | |
| 126146431 | 12614643 | 14 | 20150120 | 0 | ||
| 126146431 | 12614643 | 15 | 20150120 | 0 | ||
| 126146431 | 12614643 | 16 | 20150120 | 20150125 | 0 | |
| 126146431 | 12614643 | 17 | 20141017 | 20150120 | 0 | |
| 126146431 | 12614643 | 18 | 20140221 | 20150120 | 0 | |
| 126146431 | 12614643 | 19 | 20121106 | 20140324 | 0 |