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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124052253 | 12405225 | 3 | F | 201503 | 20160801 | 20160525 | 20160830 | EXP | CA-JAZZ-2016-CA-009651 | JAZZ | 33.22 | YR | F | Y | 0.00000 | 20160830 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124052253 | 12405225 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 8085159 | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 124052253 | 12405225 | 2 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124052253 | 12405225 | 3 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124052253 | 12405225 | 4 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | U | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 124052253 | 12405225 | 5 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124052253 | 12405225 | 6 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124052253 | 12405225 | 7 | I | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124052253 | 12405225 | 8 | I | Hydromorph contin | HYDROMORPHONE | 1 | Unknown | U | 0 | ||||||||||
| 124052253 | 12405225 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG | |||||||
| 124052253 | 12405225 | 10 | C | B-100 complex | DEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDE | 1 | Oral | U | 0 | ||||||||||
| 124052253 | 12405225 | 11 | C | CELEBREX | CELECOXIB | 1 | Oral | 100 MG, BID | U | 0 | 100 | MG | |||||||
| 124052253 | 12405225 | 12 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 3 MG, QD | U | 0 | 3 | MG | |||||||
| 124052253 | 12405225 | 13 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | Oral | 2 TABS IN AM AND 2 TABS IN PM | U | 0 | |||||||||
| 124052253 | 12405225 | 14 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | |||||||
| 124052253 | 12405225 | 15 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | Unknown | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 124052253 | 12405225 | 16 | C | Ciprolen | CIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | |||||||
| 124052253 | 12405225 | 17 | C | Ferrous Gluconate | FERROUS GLUCONATE | 1 | Unknown | MORNING (240 MG, QD) | U | 0 | 240 | MG | |||||||
| 124052253 | 12405225 | 18 | C | Hydromorphone | HYDROMORPHONE | 1 | ONE TAB IN AM 1 TAB AT 3 PM AND 1 TAB AT NIGHT AND 1 TAB WITH 2ND DOSE (8 MG, 3 IN 1 D) | U | 0 | ||||||||||
| 124052253 | 12405225 | 19 | C | Marijuana | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | Unknown | 1.5 G, UNK | U | 0 | 1.5 | G | |||||||
| 124052253 | 12405225 | 20 | C | LACTULOSE. | LACTULOSE | 1 | Unknown | 30 ML, PRN | U | 0 | 30 | ML | |||||||
| 124052253 | 12405225 | 21 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | U | 0 | 15 | MG | |||||||
| 124052253 | 12405225 | 22 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 1 MG, PRN | U | 0 | 1 | MG | |||||||
| 124052253 | 12405225 | 23 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | Oral | AS NEEDED, 5 MG | U | 0 | 5 | MG | |||||||
| 124052253 | 12405225 | 24 | C | CIPRALEX | ESCITALOPRAM OXALATE | 1 | 20 MG, BEDTIME | U | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124052253 | 12405225 | 1 | Cataplexy |
| 124052253 | 12405225 | 8 | Product used for unknown indication |
| 124052253 | 12405225 | 9 | Hypertension |
| 124052253 | 12405225 | 10 | Product used for unknown indication |
| 124052253 | 12405225 | 11 | Product used for unknown indication |
| 124052253 | 12405225 | 12 | Product used for unknown indication |
| 124052253 | 12405225 | 13 | Product used for unknown indication |
| 124052253 | 12405225 | 16 | Product used for unknown indication |
| 124052253 | 12405225 | 17 | Product used for unknown indication |
| 124052253 | 12405225 | 18 | Iliotibial band syndrome |
| 124052253 | 12405225 | 19 | Product used for unknown indication |
| 124052253 | 12405225 | 20 | Product used for unknown indication |
| 124052253 | 12405225 | 21 | Product used for unknown indication |
| 124052253 | 12405225 | 22 | Product used for unknown indication |
| 124052253 | 12405225 | 23 | Product used for unknown indication |
| 124052253 | 12405225 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124052253 | 12405225 | OT |
| 124052253 | 12405225 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124052253 | 12405225 | Cataplexy | |
| 124052253 | 12405225 | Colonoscopy | |
| 124052253 | 12405225 | Drug interaction | |
| 124052253 | 12405225 | Endoscopy | |
| 124052253 | 12405225 | Hunger | |
| 124052253 | 12405225 | Hypertension | |
| 124052253 | 12405225 | Iliotibial band syndrome | |
| 124052253 | 12405225 | Myoclonus | |
| 124052253 | 12405225 | Pain | |
| 124052253 | 12405225 | Sleep disorder | |
| 124052253 | 12405225 | Substance use | |
| 124052253 | 12405225 | Toxicity to various agents | |
| 124052253 | 12405225 | 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 |
|---|---|---|---|---|---|---|
| 124052253 | 12405225 | 1 | 20140414 | 0 | ||
| 124052253 | 12405225 | 2 | 201404 | 0 | ||
| 124052253 | 12405225 | 3 | 201404 | 0 | ||
| 124052253 | 12405225 | 4 | 201405 | 0 | ||
| 124052253 | 12405225 | 5 | 20140523 | 0 | ||
| 124052253 | 12405225 | 6 | 20140717 | 0 | ||
| 124052253 | 12405225 | 7 | 20141204 | 0 |