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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124575822 | 12457582 | 2 | F | 20160705 | 20160610 | 20160712 | EXP | US-JAZZ-2016-US-010419 | JAZZ | 0.00 | F | Y | 0.00000 | 20160712 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124575822 | 12457582 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 124575822 | 12457582 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 124575822 | 12457582 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124575822 | 12457582 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 124575822 | 12457582 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 124575822 | 12457582 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, TID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 124575822 | 12457582 | 7 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124575822 | 12457582 | 8 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124575822 | 12457582 | 9 | C | DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124575822 | 12457582 | 10 | C | PATADAY | OLOPATADINE HYDROCHLORIDE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 124575822 | 12457582 | 11 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 12 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124575822 | 12457582 | 13 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 124575822 | 12457582 | 14 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | OINTMENT | |||||||||
| 124575822 | 12457582 | 15 | C | Methamphetamine | METHAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 16 | C | OCEAN SALINE NASAL SPRAY | SODIUM CHLORIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 124575822 | 12457582 | 17 | C | VIVELLE-DOT | ESTRADIOL | 1 | 0.1 MG | U | 0 | PATCH | |||||||||
| 124575822 | 12457582 | 18 | C | VIVELLE-DOT | ESTRADIOL | 1 | 0.05 MG | U | 0 | PATCH | |||||||||
| 124575822 | 12457582 | 19 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 20 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 21 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 22 | C | Duoderm CGF | 2 | 2.5^/2.5^ DRESSING | U | 0 | |||||||||||
| 124575822 | 12457582 | 23 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 124575822 | 12457582 | 24 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 25 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 26 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124575822 | 12457582 | 27 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124575822 | 12457582 | 28 | C | Dexedrine spansules | 2 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124575822 | 12457582 | 1 | Narcolepsy |
| 124575822 | 12457582 | 2 | Cataplexy |
| 124575822 | 12457582 | 7 | Product used for unknown indication |
| 124575822 | 12457582 | 9 | Product used for unknown indication |
| 124575822 | 12457582 | 10 | Product used for unknown indication |
| 124575822 | 12457582 | 11 | Product used for unknown indication |
| 124575822 | 12457582 | 12 | Product used for unknown indication |
| 124575822 | 12457582 | 13 | Product used for unknown indication |
| 124575822 | 12457582 | 14 | Product used for unknown indication |
| 124575822 | 12457582 | 15 | Product used for unknown indication |
| 124575822 | 12457582 | 16 | Product used for unknown indication |
| 124575822 | 12457582 | 17 | Product used for unknown indication |
| 124575822 | 12457582 | 19 | Product used for unknown indication |
| 124575822 | 12457582 | 20 | Product used for unknown indication |
| 124575822 | 12457582 | 21 | Product used for unknown indication |
| 124575822 | 12457582 | 22 | Product used for unknown indication |
| 124575822 | 12457582 | 23 | Product used for unknown indication |
| 124575822 | 12457582 | 24 | Product used for unknown indication |
| 124575822 | 12457582 | 25 | Product used for unknown indication |
| 124575822 | 12457582 | 26 | Product used for unknown indication |
| 124575822 | 12457582 | 27 | Product used for unknown indication |
| 124575822 | 12457582 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124575822 | 12457582 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124575822 | 12457582 | Autoimmune disorder | |
| 124575822 | 12457582 | Blister | |
| 124575822 | 12457582 | Pre-existing condition improved | |
| 124575822 | 12457582 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 124575822 | 12457582 | 1 | 201405 | 201406 | 0 | |
| 124575822 | 12457582 | 2 | 201406 | 201407 | 0 | |
| 124575822 | 12457582 | 3 | 201407 | 2014 | 0 | |
| 124575822 | 12457582 | 4 | 201501 | 201503 | 0 | |
| 124575822 | 12457582 | 5 | 201503 | 201512 | 0 | |
| 124575822 | 12457582 | 6 | 201512 | 0 | ||
| 124575822 | 12457582 | 7 | 20140527 | 0 | ||
| 124575822 | 12457582 | 8 | 20151001 | 0 | ||
| 124575822 | 12457582 | 10 | 20151007 | 0 | ||
| 124575822 | 12457582 | 11 | 20151002 | 20151002 | 0 | |
| 124575822 | 12457582 | 12 | 20151001 | 0 | ||
| 124575822 | 12457582 | 13 | 20151001 | 0 | ||
| 124575822 | 12457582 | 14 | 20151001 | 0 | ||
| 124575822 | 12457582 | 15 | 20151001 | 0 | ||
| 124575822 | 12457582 | 16 | 20151001 | 0 | ||
| 124575822 | 12457582 | 17 | 20140523 | 20151007 | 0 | |
| 124575822 | 12457582 | 18 | 20151001 | 0 | ||
| 124575822 | 12457582 | 19 | 20150709 | 20151002 | 0 | |
| 124575822 | 12457582 | 20 | 20150504 | 20150727 | 0 | |
| 124575822 | 12457582 | 21 | 20140801 | 0 | ||
| 124575822 | 12457582 | 22 | 20140527 | 0 | ||
| 124575822 | 12457582 | 23 | 20140527 | 0 | ||
| 124575822 | 12457582 | 24 | 20140523 | 0 | ||
| 124575822 | 12457582 | 25 | 20140523 | 20150127 | 0 | |
| 124575822 | 12457582 | 26 | 20140520 | 20150127 | 0 | |
| 124575822 | 12457582 | 27 | 20120523 | 0 |