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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125861991 | 12586199 | 1 | I | 2015 | 20160201 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-001867 | JAZZ | 43.58 | YR | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125861991 | 12586199 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125861991 | 12586199 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJSUTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125861991 | 12586199 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.75 G, BID | 21196 | 2.75 | G | ORAL SOLUTION | |||||||
| 125861991 | 12586199 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 125861991 | 12586199 | 5 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | N | 0 | CAPSULE | |||||||||
| 125861991 | 12586199 | 6 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | N | 0 | CAPSULE | |||||||||
| 125861991 | 12586199 | 7 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861991 | 12586199 | 8 | C | Duloxetine HCL | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125861991 | 12586199 | 9 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125861991 | 12586199 | 10 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125861991 | 12586199 | 11 | C | Duloxetine HCL | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125861991 | 12586199 | 12 | C | Magnesium | MAGNESIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861991 | 12586199 | 13 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 125861991 | 12586199 | 14 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861991 | 12586199 | 15 | C | ESTRADIOL. | ESTRADIOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861991 | 12586199 | 16 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 125861991 | 12586199 | 17 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125861991 | 12586199 | 18 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | ||||||||||
| 125861991 | 12586199 | 19 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125861991 | 12586199 | 1 | Narcolepsy |
| 125861991 | 12586199 | 2 | Cataplexy |
| 125861991 | 12586199 | 5 | Product used for unknown indication |
| 125861991 | 12586199 | 7 | Product used for unknown indication |
| 125861991 | 12586199 | 8 | Product used for unknown indication |
| 125861991 | 12586199 | 9 | Product used for unknown indication |
| 125861991 | 12586199 | 10 | Product used for unknown indication |
| 125861991 | 12586199 | 11 | Product used for unknown indication |
| 125861991 | 12586199 | 12 | Product used for unknown indication |
| 125861991 | 12586199 | 13 | Product used for unknown indication |
| 125861991 | 12586199 | 14 | Product used for unknown indication |
| 125861991 | 12586199 | 15 | Product used for unknown indication |
| 125861991 | 12586199 | 16 | Product used for unknown indication |
| 125861991 | 12586199 | 17 | Product used for unknown indication |
| 125861991 | 12586199 | 18 | Product used for unknown indication |
| 125861991 | 12586199 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125861991 | 12586199 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125861991 | 12586199 | Decreased appetite | |
| 125861991 | 12586199 | Depression | |
| 125861991 | 12586199 | Hair growth abnormal | |
| 125861991 | 12586199 | Hallucinations, mixed | |
| 125861991 | 12586199 | Hyperhidrosis | |
| 125861991 | 12586199 | Paraesthesia | |
| 125861991 | 12586199 | Retching | |
| 125861991 | 12586199 | Snoring | |
| 125861991 | 12586199 | Unevaluable event | |
| 125861991 | 12586199 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125861991 | 12586199 | 1 | 201508 | 2015 | 0 | |
| 125861991 | 12586199 | 5 | 20100724 | 20160125 | 0 | |
| 125861991 | 12586199 | 6 | 20160125 | 0 | ||
| 125861991 | 12586199 | 7 | 20160114 | 0 | ||
| 125861991 | 12586199 | 8 | 20160105 | 0 | ||
| 125861991 | 12586199 | 9 | 20151013 | 20151013 | 0 | |
| 125861991 | 12586199 | 10 | 20150811 | 20150901 | 0 | |
| 125861991 | 12586199 | 11 | 20150424 | 20160105 | 0 | |
| 125861991 | 12586199 | 12 | 20140724 | 0 | ||
| 125861991 | 12586199 | 13 | 20140724 | 0 | ||
| 125861991 | 12586199 | 14 | 20140724 | 0 | ||
| 125861991 | 12586199 | 15 | 20130901 | 0 | ||
| 125861991 | 12586199 | 16 | 20130724 | 0 | ||
| 125861991 | 12586199 | 17 | 20120724 | 0 | ||
| 125861991 | 12586199 | 18 | 20120724 | 0 | ||
| 125861991 | 12586199 | 19 | 20000724 | 0 |