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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125469691 | 12546969 | 1 | I | 2015 | 20160630 | 20160711 | 20160711 | EXP | US-JAZZ-2016-US-012304 | JAZZ | 0.00 | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125469691 | 12546969 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125469691 | 12546969 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125469691 | 12546969 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 125469691 | 12546969 | 4 | SS | TYLENOL | ACETAMINOPHEN | 1 | UNKNOWN DOSE | Y | 0 | ||||||||||
| 125469691 | 12546969 | 5 | SS | TYLENOL | ACETAMINOPHEN | 1 | UNKNOWN DECREASED DOSE | Y | 0 | ||||||||||
| 125469691 | 12546969 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | 600 MG | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | 800 MG | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 8 | C | TRANSDERM SCOP | SCOPOLAMINE | 1 | UNK | U | 0 | ||||||||||
| 125469691 | 12546969 | 9 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | 7.5 MG | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 10 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | 4 MG | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 11 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 12 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 13 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 14 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 15 | C | ACIDOPHILUS | LACTOBACILLUS ACIDOPHILUS | 1 | UNK | U | 0 | ||||||||||
| 125469691 | 12546969 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 17 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125469691 | 12546969 | 18 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 19 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 20 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 21 | C | Levothyroxin | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 22 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125469691 | 12546969 | 23 | C | Milk thistle | MILK THISTLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125469691 | 12546969 | 24 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125469691 | 12546969 | 1 | Narcolepsy |
| 125469691 | 12546969 | 2 | Cataplexy |
| 125469691 | 12546969 | 4 | Product used for unknown indication |
| 125469691 | 12546969 | 6 | Product used for unknown indication |
| 125469691 | 12546969 | 8 | Product used for unknown indication |
| 125469691 | 12546969 | 9 | Product used for unknown indication |
| 125469691 | 12546969 | 11 | Product used for unknown indication |
| 125469691 | 12546969 | 13 | Product used for unknown indication |
| 125469691 | 12546969 | 14 | Product used for unknown indication |
| 125469691 | 12546969 | 15 | Product used for unknown indication |
| 125469691 | 12546969 | 16 | Product used for unknown indication |
| 125469691 | 12546969 | 17 | Product used for unknown indication |
| 125469691 | 12546969 | 18 | Product used for unknown indication |
| 125469691 | 12546969 | 19 | Product used for unknown indication |
| 125469691 | 12546969 | 20 | Product used for unknown indication |
| 125469691 | 12546969 | 21 | Product used for unknown indication |
| 125469691 | 12546969 | 22 | Product used for unknown indication |
| 125469691 | 12546969 | 23 | Product used for unknown indication |
| 125469691 | 12546969 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125469691 | 12546969 | HO |
| 125469691 | 12546969 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125469691 | 12546969 | Disorientation | |
| 125469691 | 12546969 | Dysuria | |
| 125469691 | 12546969 | Food craving | |
| 125469691 | 12546969 | Hepatic enzyme abnormal | |
| 125469691 | 12546969 | Hospitalisation | |
| 125469691 | 12546969 | Pre-existing condition improved | |
| 125469691 | 12546969 | Therapeutic response unexpected | |
| 125469691 | 12546969 | 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 |
|---|---|---|---|---|---|---|
| 125469691 | 12546969 | 1 | 201502 | 201502 | 0 | |
| 125469691 | 12546969 | 2 | 201502 | 2015 | 0 | |
| 125469691 | 12546969 | 3 | 2016 | 0 | ||
| 125469691 | 12546969 | 6 | 20150105 | 201606 | 0 | |
| 125469691 | 12546969 | 7 | 201606 | 0 | ||
| 125469691 | 12546969 | 8 | 201606 | 201606 | 0 | |
| 125469691 | 12546969 | 9 | 20150105 | 201606 | 0 | |
| 125469691 | 12546969 | 10 | 201606 | 0 | ||
| 125469691 | 12546969 | 11 | 201511 | 0 | ||
| 125469691 | 12546969 | 12 | 20150129 | 201511 | 0 | |
| 125469691 | 12546969 | 13 | 20150312 | 0 | ||
| 125469691 | 12546969 | 14 | 20150129 | 0 | ||
| 125469691 | 12546969 | 15 | 20150129 | 201505 | 0 | |
| 125469691 | 12546969 | 16 | 20150129 | 201511 | 0 | |
| 125469691 | 12546969 | 17 | 20150105 | 201606 | 0 | |
| 125469691 | 12546969 | 18 | 20150105 | 201506 | 0 | |
| 125469691 | 12546969 | 19 | 20150105 | 0 | ||
| 125469691 | 12546969 | 20 | 20150105 | 0 | ||
| 125469691 | 12546969 | 21 | 20150105 | 201602 | 0 | |
| 125469691 | 12546969 | 22 | 20150105 | 20150129 | 0 | |
| 125469691 | 12546969 | 23 | 20150105 | 201602 | 0 | |
| 125469691 | 12546969 | 24 | 20150105 | 201606 | 0 |