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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127778951 | 12777895 | 1 | I | 2016 | 20160609 | 20160924 | 20160924 | PER | US-JAZZ-2016-US-010853 | JAZZ | 45.80 | YR | F | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127778951 | 12777895 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127778951 | 12777895 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127778951 | 12777895 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127778951 | 12777895 | 4 | SS | DOXYCYCLINE. | DOXYCYCLINE | 1 | UNK | U | 0 | ||||||||||
| 127778951 | 12777895 | 5 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 6 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 7 | C | ELMIRON | PENTOSAN POLYSULFATE SODIUM | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 9 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 10 | C | ANUSOL HC | HYDROCORTISONE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 11 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 12 | C | PROVIGIL | MODAFINIL | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 13 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 14 | C | PATANOL | OLOPATADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 15 | C | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 16 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 17 | C | CELEBREX | CELECOXIB | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 18 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 19 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 20 | C | SUDAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127778951 | 12777895 | 21 | C | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127778951 | 12777895 | 1 | Narcolepsy |
| 127778951 | 12777895 | 2 | Cataplexy |
| 127778951 | 12777895 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127778951 | 12777895 | Fibromyalgia | |
| 127778951 | 12777895 | Muscle spasms | |
| 127778951 | 12777895 | Muscle tightness | |
| 127778951 | 12777895 | Photosensitivity reaction | |
| 127778951 | 12777895 | Urine odour abnormal |
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 |
|---|---|---|---|---|---|---|
| 127778951 | 12777895 | 1 | 201604 | 201604 | 0 | |
| 127778951 | 12777895 | 2 | 201604 | 201605 | 0 | |
| 127778951 | 12777895 | 3 | 201605 | 0 |