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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125986441 | 12598644 | 1 | I | 201604 | 20160413 | 20160726 | 20160726 | EXP | US-JAZZ-2016-US-007018 | JAZZ | 32.89 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125986441 | 12598644 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125986441 | 12598644 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | 21196 | ORAL SOLUTION | |||||||||||
| 125986441 | 12598644 | 3 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 125986441 | 12598644 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 5 | SS | LORAZEPAM. | LORAZEPAM | 1 | 0 | ||||||||||||
| 125986441 | 12598644 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 7 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 8 | C | NITROSTAT | NITROGLYCERIN | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 9 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 10 | C | Ondansetron | ONDANSETRON | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 11 | C | PYRIDOSTIGMINE BROMIDE. | PYRIDOSTIGMINE BROMIDE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 12 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 13 | C | Clonidine Hcl er | CLONIDINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 14 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 15 | C | FUROSEMIDE. | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 16 | C | METAXALONE. | METAXALONE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 17 | C | Minocycline hcl | MINOCYCLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 18 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 19 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 20 | C | GAMMAGARD | HUMAN IMMUNOGLOBULIN G | 1 | U | 0 | |||||||||||
| 125986441 | 12598644 | 21 | C | LACTATED RINGERS | CALCIUM CHLORIDEPOTASSIUM CHLORIDESODIUM CHLORIDESODIUM LACTATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125986441 | 12598644 | 1 | Narcolepsy |
| 125986441 | 12598644 | 2 | Cataplexy |
| 125986441 | 12598644 | 3 | Product used for unknown indication |
| 125986441 | 12598644 | 4 | Product used for unknown indication |
| 125986441 | 12598644 | 5 | Product used for unknown indication |
| 125986441 | 12598644 | 6 | Product used for unknown indication |
| 125986441 | 12598644 | 7 | Product used for unknown indication |
| 125986441 | 12598644 | 8 | Product used for unknown indication |
| 125986441 | 12598644 | 9 | Product used for unknown indication |
| 125986441 | 12598644 | 10 | Product used for unknown indication |
| 125986441 | 12598644 | 11 | Product used for unknown indication |
| 125986441 | 12598644 | 12 | Product used for unknown indication |
| 125986441 | 12598644 | 13 | Product used for unknown indication |
| 125986441 | 12598644 | 14 | Product used for unknown indication |
| 125986441 | 12598644 | 15 | Product used for unknown indication |
| 125986441 | 12598644 | 16 | Product used for unknown indication |
| 125986441 | 12598644 | 17 | Product used for unknown indication |
| 125986441 | 12598644 | 18 | Product used for unknown indication |
| 125986441 | 12598644 | 19 | Product used for unknown indication |
| 125986441 | 12598644 | 20 | Product used for unknown indication |
| 125986441 | 12598644 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125986441 | 12598644 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125986441 | 12598644 | Feeling abnormal | |
| 125986441 | 12598644 | Insomnia | |
| 125986441 | 12598644 | Malaise | |
| 125986441 | 12598644 | Withdrawal syndrome | |
| 125986441 | 12598644 | 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 |
|---|---|---|---|---|---|---|
| 125986441 | 12598644 | 1 | 201604 | 0 |