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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126707241 | 12670724 | 1 | I | 20160328 | 20160822 | 20160822 | PER | US-JAZZ-2016-US-005884 | JAZZ | 0.00 | F | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126707241 | 12670724 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126707241 | 12670724 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126707241 | 12670724 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126707241 | 12670724 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | 0 | |||||||||||
| 126707241 | 12670724 | 5 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 6 | C | TESSALON | BENZONATATE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 7 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 8 | C | MINASTRIN 24 FE | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 9 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 10 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 11 | C | Niferex forte | 2 | U | 0 | ||||||||||||
| 126707241 | 12670724 | 12 | C | Multigen plus | 2 | U | 0 | ||||||||||||
| 126707241 | 12670724 | 13 | C | BENZOYL PEROXIDE. | BENZOYL PEROXIDE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 14 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | U | 0 | |||||||||||
| 126707241 | 12670724 | 15 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126707241 | 12670724 | 1 | Narcolepsy |
| 126707241 | 12670724 | 2 | Cataplexy |
| 126707241 | 12670724 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126707241 | 12670724 | Aggression | |
| 126707241 | 12670724 | Agitation | |
| 126707241 | 12670724 | Fatigue | |
| 126707241 | 12670724 | Impatience | |
| 126707241 | 12670724 | Irritability | |
| 126707241 | 12670724 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126707241 | 12670724 | 1 | 201004 | 201007 | 0 | |
| 126707241 | 12670724 | 3 | 201509 | 0 |