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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124394803 | 12439480 | 3 | F | 2016 | 20160921 | 20160606 | 20160929 | EXP | US-JAZZ-2016-US-010054 | JAZZ | 0.00 | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124394803 | 12439480 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124394803 | 12439480 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 124394803 | 12439480 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124394803 | 12439480 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, FIRST DOSE | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 124394803 | 12439480 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124394803 | 12439480 | 6 | SS | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 7 | SS | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 8 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 25 MG, QD | U | 0 | 25 | MG | TABLET | |||||||
| 124394803 | 12439480 | 9 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 10 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 124394803 | 12439480 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124394803 | 12439480 | 12 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 13 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 14 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124394803 | 12439480 | 15 | C | PEPCID AC | FAMOTIDINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 16 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124394803 | 12439480 | 17 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124394803 | 12439480 | 18 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124394803 | 12439480 | 19 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | POWDER | |||||||||
| 124394803 | 12439480 | 20 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 124394803 | 12439480 | 21 | C | VENLAFAXINE HYDROCHLORIDE. | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124394803 | 12439480 | 1 | Narcolepsy |
| 124394803 | 12439480 | 2 | Cataplexy |
| 124394803 | 12439480 | 6 | Hypertension |
| 124394803 | 12439480 | 7 | Product used for unknown indication |
| 124394803 | 12439480 | 8 | Hypertension |
| 124394803 | 12439480 | 9 | Product used for unknown indication |
| 124394803 | 12439480 | 10 | Product used for unknown indication |
| 124394803 | 12439480 | 11 | Product used for unknown indication |
| 124394803 | 12439480 | 12 | Product used for unknown indication |
| 124394803 | 12439480 | 13 | Product used for unknown indication |
| 124394803 | 12439480 | 14 | Product used for unknown indication |
| 124394803 | 12439480 | 15 | Product used for unknown indication |
| 124394803 | 12439480 | 16 | Product used for unknown indication |
| 124394803 | 12439480 | 17 | Product used for unknown indication |
| 124394803 | 12439480 | 18 | Product used for unknown indication |
| 124394803 | 12439480 | 19 | Product used for unknown indication |
| 124394803 | 12439480 | 20 | Product used for unknown indication |
| 124394803 | 12439480 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124394803 | 12439480 | HO |
| 124394803 | 12439480 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124394803 | 12439480 | Fall | |
| 124394803 | 12439480 | Hallucination | |
| 124394803 | 12439480 | Insomnia | |
| 124394803 | 12439480 | Limb injury | |
| 124394803 | 12439480 | Mobility decreased | |
| 124394803 | 12439480 | Oxygen saturation decreased | |
| 124394803 | 12439480 | Pollakiuria | |
| 124394803 | 12439480 | Swelling | |
| 124394803 | 12439480 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 124394803 | 12439480 | 1 | 200306 | 2003 | 0 | |
| 124394803 | 12439480 | 2 | 200309 | 201304 | 0 | |
| 124394803 | 12439480 | 3 | 201304 | 20160523 | 0 | |
| 124394803 | 12439480 | 4 | 2016 | 0 | ||
| 124394803 | 12439480 | 5 | 2016 | 0 | ||
| 124394803 | 12439480 | 6 | 20151229 | 0 | ||
| 124394803 | 12439480 | 7 | 20160528 | 0 | ||
| 124394803 | 12439480 | 9 | 20151229 | 0 | ||
| 124394803 | 12439480 | 10 | 20151229 | 0 | ||
| 124394803 | 12439480 | 11 | 20151229 | 0 | ||
| 124394803 | 12439480 | 12 | 20151229 | 0 | ||
| 124394803 | 12439480 | 13 | 20130924 | 0 | ||
| 124394803 | 12439480 | 14 | 20130924 | 20151229 | 0 | |
| 124394803 | 12439480 | 15 | 20130601 | 20151229 | 0 | |
| 124394803 | 12439480 | 16 | 20130430 | 20130901 | 0 | |
| 124394803 | 12439480 | 17 | 20010101 | 20151229 | 0 | |
| 124394803 | 12439480 | 18 | 20010101 | 0 | ||
| 124394803 | 12439480 | 20 | 20160526 | 0 | ||
| 124394803 | 12439480 | 21 | 201604 | 0 |