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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126284451 | 12628445 | 1 | I | 20160301 | 20160808 | 20160808 | PER | US-JAZZ-2016-US-004074 | JAZZ | 0.00 | F | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126284451 | 12628445 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126284451 | 12628445 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126284451 | 12628445 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 126284451 | 12628445 | 4 | SS | ABILIFY | ARIPIPRAZOLE | 1 | UNK | 0 | |||||||||||
| 126284451 | 12628445 | 5 | C | B-Complex Plus B-12 | 2 | UNK | U | 0 | |||||||||||
| 126284451 | 12628445 | 6 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 7 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 8 | C | Mucuna Pruriens extrakt | 2 | UNK | U | 0 | |||||||||||
| 126284451 | 12628445 | 9 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 10 | C | Potassium gluconate | POTASSIUM GLUCONATE | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 11 | C | Probiotica | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 12 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 13 | C | Zinc gluconate | ZINC GLUCONATE | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 14 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 15 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 16 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 126284451 | 12628445 | 17 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126284451 | 12628445 | 1 | Narcolepsy |
| 126284451 | 12628445 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126284451 | 12628445 | Insomnia | |
| 126284451 | 12628445 | 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 |
|---|---|---|---|---|---|---|
| 126284451 | 12628445 | 1 | 200611 | 200701 | 0 | |
| 126284451 | 12628445 | 3 | 201509 | 0 |