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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120648203 | 12064820 | 3 | F | 20160210 | 20160706 | 20160210 | 20160713 | EXP | US-JAZZ-2016-US-002033 | JAZZ | 29.80 | YR | M | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120648203 | 12064820 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | U | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 120648203 | 12064820 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 120648203 | 12064820 | 3 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 4 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 5 | C | LYRICA | PREGABALIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 120648203 | 12064820 | 6 | C | MODAFINIL. | MODAFINIL | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 7 | C | OLANZAPINE. | OLANZAPINE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 8 | C | STRATTERA | ATOMOXETINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 120648203 | 12064820 | 9 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 10 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 11 | C | ATENOLOL. | ATENOLOL | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 120648203 | 12064820 | 13 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 14 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 15 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 16 | C | NAPROXEN. | NAPROXEN | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 17 | C | Olanzapine ODT | OLANZAPINE | 1 | UNK | U | 0 | ||||||||||
| 120648203 | 12064820 | 18 | C | Potassium citrate er | 2 | UNK | 0 | TABLET | |||||||||||
| 120648203 | 12064820 | 19 | C | Topiramate er | 2 | 100 MG | 0 | CAPSULE | |||||||||||
| 120648203 | 12064820 | 20 | C | Topiramate er | 2 | 25 MG | 0 | CAPSULE | |||||||||||
| 120648203 | 12064820 | 21 | C | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 22 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | 0 | CAPSULE | ||||||||||
| 120648203 | 12064820 | 23 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 24 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 25 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | 0 | TABLET | ||||||||||
| 120648203 | 12064820 | 26 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120648203 | 12064820 | 1 | Narcolepsy |
| 120648203 | 12064820 | 3 | Product used for unknown indication |
| 120648203 | 12064820 | 4 | Product used for unknown indication |
| 120648203 | 12064820 | 5 | Product used for unknown indication |
| 120648203 | 12064820 | 6 | Product used for unknown indication |
| 120648203 | 12064820 | 7 | Product used for unknown indication |
| 120648203 | 12064820 | 8 | Product used for unknown indication |
| 120648203 | 12064820 | 9 | Product used for unknown indication |
| 120648203 | 12064820 | 10 | Product used for unknown indication |
| 120648203 | 12064820 | 11 | Product used for unknown indication |
| 120648203 | 12064820 | 12 | Product used for unknown indication |
| 120648203 | 12064820 | 13 | Product used for unknown indication |
| 120648203 | 12064820 | 14 | Product used for unknown indication |
| 120648203 | 12064820 | 15 | Product used for unknown indication |
| 120648203 | 12064820 | 16 | Product used for unknown indication |
| 120648203 | 12064820 | 17 | Product used for unknown indication |
| 120648203 | 12064820 | 18 | Product used for unknown indication |
| 120648203 | 12064820 | 19 | Product used for unknown indication |
| 120648203 | 12064820 | 21 | Product used for unknown indication |
| 120648203 | 12064820 | 22 | Product used for unknown indication |
| 120648203 | 12064820 | 23 | Product used for unknown indication |
| 120648203 | 12064820 | 24 | Product used for unknown indication |
| 120648203 | 12064820 | 25 | Product used for unknown indication |
| 120648203 | 12064820 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120648203 | 12064820 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120648203 | 12064820 | Pre-existing condition improved | |
| 120648203 | 12064820 | Spinal operation | |
| 120648203 | 12064820 | 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 |
|---|---|---|---|---|---|---|
| 120648203 | 12064820 | 1 | 201505 | 201507 | 0 | |
| 120648203 | 12064820 | 2 | 201507 | 0 | ||
| 120648203 | 12064820 | 3 | 20151218 | 20160203 | 0 | |
| 120648203 | 12064820 | 4 | 20151218 | 20160203 | 0 | |
| 120648203 | 12064820 | 5 | 20151218 | 20160203 | 0 | |
| 120648203 | 12064820 | 6 | 20151218 | 0 | ||
| 120648203 | 12064820 | 7 | 20151218 | 0 | ||
| 120648203 | 12064820 | 8 | 20151218 | 20160203 | 0 | |
| 120648203 | 12064820 | 9 | 20151218 | 20160203 | 0 | |
| 120648203 | 12064820 | 10 | 20150506 | 0 | ||
| 120648203 | 12064820 | 11 | 20150506 | 0 | ||
| 120648203 | 12064820 | 12 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 13 | 20150506 | 0 | ||
| 120648203 | 12064820 | 14 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 15 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 16 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 17 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 18 | 20150506 | 0 | ||
| 120648203 | 12064820 | 19 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 20 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 21 | 20150506 | 20160203 | 0 | |
| 120648203 | 12064820 | 22 | 20150506 | 0 | ||
| 120648203 | 12064820 | 23 | 20100506 | 0 |