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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123958493 | 12395849 | 3 | F | 20160914 | 20160523 | 20160922 | EXP | US-JAZZ-2016-US-008105 | JAZZ | 0.00 | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123958493 | 12395849 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 123958493 | 12395849 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 123958493 | 12395849 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 123958493 | 12395849 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 123958493 | 12395849 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 123958493 | 12395849 | 6 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 7 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 123958493 | 12395849 | 8 | C | Duloxetine hcl | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 9 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123958493 | 12395849 | 10 | C | Trokendi | TOPIRAMATE | 1 | 100 MG | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 11 | C | Trokendi | TOPIRAMATE | 1 | 200 MG | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 12 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123958493 | 12395849 | 13 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 123958493 | 12395849 | 14 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 15 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 123958493 | 12395849 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 17 | C | FAMOTIDINE. | FAMOTIDINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123958493 | 12395849 | 18 | C | ACETAZOLAMIDE. | ACETAZOLAMIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123958493 | 12395849 | 19 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123958493 | 12395849 | 20 | C | NODOZ | CAFFEINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123958493 | 12395849 | 1 | Narcolepsy |
| 123958493 | 12395849 | 2 | Cataplexy |
| 123958493 | 12395849 | 6 | Product used for unknown indication |
| 123958493 | 12395849 | 7 | Product used for unknown indication |
| 123958493 | 12395849 | 8 | Product used for unknown indication |
| 123958493 | 12395849 | 9 | Product used for unknown indication |
| 123958493 | 12395849 | 10 | Product used for unknown indication |
| 123958493 | 12395849 | 12 | Product used for unknown indication |
| 123958493 | 12395849 | 13 | Product used for unknown indication |
| 123958493 | 12395849 | 14 | Product used for unknown indication |
| 123958493 | 12395849 | 15 | Product used for unknown indication |
| 123958493 | 12395849 | 16 | Product used for unknown indication |
| 123958493 | 12395849 | 17 | Product used for unknown indication |
| 123958493 | 12395849 | 18 | Product used for unknown indication |
| 123958493 | 12395849 | 19 | Product used for unknown indication |
| 123958493 | 12395849 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123958493 | 12395849 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123958493 | 12395849 | Abdominal discomfort | |
| 123958493 | 12395849 | Gastrointestinal disorder | |
| 123958493 | 12395849 | Insomnia | |
| 123958493 | 12395849 | Intervertebral disc compression | |
| 123958493 | 12395849 | Intervertebral disc protrusion | |
| 123958493 | 12395849 | Muscle spasms | |
| 123958493 | 12395849 | Neuropathy peripheral | |
| 123958493 | 12395849 | Spinal cord injury | |
| 123958493 | 12395849 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 123958493 | 12395849 | 1 | 201601 | 201601 | 0 | |
| 123958493 | 12395849 | 2 | 201601 | 201601 | 0 | |
| 123958493 | 12395849 | 6 | 201604 | 0 | ||
| 123958493 | 12395849 | 7 | 20160104 | 0 | ||
| 123958493 | 12395849 | 8 | 20151217 | 20160104 | 0 | |
| 123958493 | 12395849 | 9 | 20151217 | 201604 | 0 | |
| 123958493 | 12395849 | 10 | 20151217 | 201604 | 0 | |
| 123958493 | 12395849 | 12 | 20151216 | 0 | ||
| 123958493 | 12395849 | 13 | 20151124 | 20160104 | 0 | |
| 123958493 | 12395849 | 14 | 20151120 | 0 | ||
| 123958493 | 12395849 | 15 | 20151120 | 0 | ||
| 123958493 | 12395849 | 16 | 20151014 | 0 | ||
| 123958493 | 12395849 | 17 | 20150910 | 0 | ||
| 123958493 | 12395849 | 18 | 20150504 | 0 | ||
| 123958493 | 12395849 | 19 | 20150423 | 0 |