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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126685502 | 12668550 | 2 | F | 2015 | 20160831 | 20160819 | 20160908 | EXP | US-JAZZ-2016-US-015351 | JAZZ | 38.89 | YR | M | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126685502 | 12668550 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126685502 | 12668550 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126685502 | 12668550 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126685502 | 12668550 | 4 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 5 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685502 | 12668550 | 6 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 5 MG | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 7 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 20 MG | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 8 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 126685502 | 12668550 | 9 | C | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685502 | 12668550 | 10 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 11 | C | RITALIN SR | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 12 | C | PANTOPRAZOLE SODIUM DR | PANTOPRAZOLE SODIUM | 1 | 40 MG | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 13 | C | PANTOPRAZOLE SODIUM DR | PANTOPRAZOLE SODIUM | 1 | 20 MG | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 14 | C | BUPROPION HYDROCHLORIDE SR | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 15 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685502 | 12668550 | 16 | C | IBUPROFEN IB | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 126685502 | 12668550 | 17 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 126685502 | 12668550 | 18 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685502 | 12668550 | 19 | C | Emergen c | MINERALSVITAMINS | 1 | UNK | U | 0 | ||||||||||
| 126685502 | 12668550 | 20 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 126685502 | 12668550 | 21 | C | ADVIL | IBUPROFEN | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126685502 | 12668550 | 1 | Narcolepsy |
| 126685502 | 12668550 | 4 | Product used for unknown indication |
| 126685502 | 12668550 | 5 | Product used for unknown indication |
| 126685502 | 12668550 | 6 | Product used for unknown indication |
| 126685502 | 12668550 | 8 | Product used for unknown indication |
| 126685502 | 12668550 | 9 | Product used for unknown indication |
| 126685502 | 12668550 | 10 | Product used for unknown indication |
| 126685502 | 12668550 | 11 | Product used for unknown indication |
| 126685502 | 12668550 | 12 | Product used for unknown indication |
| 126685502 | 12668550 | 14 | Product used for unknown indication |
| 126685502 | 12668550 | 15 | Product used for unknown indication |
| 126685502 | 12668550 | 16 | Product used for unknown indication |
| 126685502 | 12668550 | 17 | Product used for unknown indication |
| 126685502 | 12668550 | 18 | Product used for unknown indication |
| 126685502 | 12668550 | 19 | Product used for unknown indication |
| 126685502 | 12668550 | 20 | Product used for unknown indication |
| 126685502 | 12668550 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126685502 | 12668550 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126685502 | 12668550 | Accidental overdose | |
| 126685502 | 12668550 | Apathy | |
| 126685502 | 12668550 | Dehydration | |
| 126685502 | 12668550 | Enuresis | |
| 126685502 | 12668550 | Feeling abnormal | |
| 126685502 | 12668550 | Food craving | |
| 126685502 | 12668550 | Influenza | |
| 126685502 | 12668550 | Intentional product use issue | |
| 126685502 | 12668550 | Loss of consciousness | |
| 126685502 | 12668550 | Pollakiuria | |
| 126685502 | 12668550 | Unevaluable event | |
| 126685502 | 12668550 | Weight decreased | |
| 126685502 | 12668550 | 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 |
|---|---|---|---|---|---|---|
| 126685502 | 12668550 | 1 | 201312 | 201401 | 0 | |
| 126685502 | 12668550 | 2 | 201401 | 201505 | 0 | |
| 126685502 | 12668550 | 3 | 201505 | 0 | ||
| 126685502 | 12668550 | 4 | 201506 | 0 | ||
| 126685502 | 12668550 | 5 | 20150831 | 0 | ||
| 126685502 | 12668550 | 6 | 20150608 | 201608 | 0 | |
| 126685502 | 12668550 | 7 | 20140820 | 0 | ||
| 126685502 | 12668550 | 8 | 20150417 | 0 | ||
| 126685502 | 12668550 | 9 | 201501 | 201607 | 0 | |
| 126685502 | 12668550 | 10 | 20141110 | 0 | ||
| 126685502 | 12668550 | 11 | 20140820 | 0 | ||
| 126685502 | 12668550 | 12 | 20131028 | 0 | ||
| 126685502 | 12668550 | 13 | 20140619 | 201608 | 0 | |
| 126685502 | 12668550 | 14 | 20131203 | 20150625 | 0 | |
| 126685502 | 12668550 | 15 | 20131203 | 0 | ||
| 126685502 | 12668550 | 16 | 20131203 | 20150625 | 0 | |
| 126685502 | 12668550 | 17 | 20131203 | 0 | ||
| 126685502 | 12668550 | 18 | 20131203 | 201608 | 0 | |
| 126685502 | 12668550 | 19 | 201101 | 0 | ||
| 126685502 | 12668550 | 20 | 201101 | 0 | ||
| 126685502 | 12668550 | 21 | 20080808 | 0 |