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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127442572 | 12744257 | 2 | F | 2006 | 20160920 | 20160914 | 20160928 | EXP | US-JAZZ-2016-US-017186 | JAZZ | 0.00 | M | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127442572 | 12744257 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | U | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 127442572 | 12744257 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | U | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 127442572 | 12744257 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127442572 | 12744257 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 127442572 | 12744257 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 127442572 | 12744257 | 6 | SS | Cocaine | COCAINE | 1 | UNK | U | 0 | ||||||||||
| 127442572 | 12744257 | 7 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | ||||||||||
| 127442572 | 12744257 | 8 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 9 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 5-325 MG | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 10 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 7.5-325 MG | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 11 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 12 | C | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 13 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 14 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 15 | C | ALLEGRA D-12 HOUR | FEXOFENADINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 16 | C | Hydrocodone / Ibuprofen | HYDROCODONE BITARTRATEIBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 127442572 | 12744257 | 17 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127442572 | 12744257 | 18 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 127442572 | 12744257 | 19 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 127442572 | 12744257 | 20 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127442572 | 12744257 | 1 | Narcolepsy |
| 127442572 | 12744257 | 2 | Cataplexy |
| 127442572 | 12744257 | 7 | Product used for unknown indication |
| 127442572 | 12744257 | 8 | Product used for unknown indication |
| 127442572 | 12744257 | 9 | Product used for unknown indication |
| 127442572 | 12744257 | 11 | Product used for unknown indication |
| 127442572 | 12744257 | 12 | Product used for unknown indication |
| 127442572 | 12744257 | 13 | Product used for unknown indication |
| 127442572 | 12744257 | 14 | Product used for unknown indication |
| 127442572 | 12744257 | 15 | Product used for unknown indication |
| 127442572 | 12744257 | 16 | Product used for unknown indication |
| 127442572 | 12744257 | 17 | Product used for unknown indication |
| 127442572 | 12744257 | 18 | Product used for unknown indication |
| 127442572 | 12744257 | 19 | Product used for unknown indication |
| 127442572 | 12744257 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127442572 | 12744257 | OT |
| 127442572 | 12744257 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127442572 | 12744257 | Ankle fracture | |
| 127442572 | 12744257 | Depression | |
| 127442572 | 12744257 | Foot fracture | |
| 127442572 | 12744257 | Gastrooesophageal reflux disease | |
| 127442572 | 12744257 | Hallucination | |
| 127442572 | 12744257 | Laceration | |
| 127442572 | 12744257 | Neck injury | |
| 127442572 | 12744257 | Respiratory arrest | |
| 127442572 | 12744257 | Road traffic accident | |
| 127442572 | 12744257 | Substance abuse | |
| 127442572 | 12744257 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 127442572 | 12744257 | 1 | 200608 | 200611 | 0 | |
| 127442572 | 12744257 | 2 | 200611 | 2008 | 0 | |
| 127442572 | 12744257 | 3 | 201412 | 201412 | 0 | |
| 127442572 | 12744257 | 4 | 201412 | 2016 | 0 | |
| 127442572 | 12744257 | 5 | 201512 | 2016 | 0 | |
| 127442572 | 12744257 | 6 | 2009 | 0 | ||
| 127442572 | 12744257 | 7 | 20150807 | 0 | ||
| 127442572 | 12744257 | 8 | 20150803 | 201607 | 0 | |
| 127442572 | 12744257 | 9 | 20150803 | 0 | ||
| 127442572 | 12744257 | 11 | 20150803 | 201607 | 0 | |
| 127442572 | 12744257 | 12 | 20150126 | 201607 | 0 | |
| 127442572 | 12744257 | 13 | 20150126 | 201508 | 0 | |
| 127442572 | 12744257 | 14 | 20150126 | 201507 | 0 | |
| 127442572 | 12744257 | 15 | 20100101 | 201608 | 0 | |
| 127442572 | 12744257 | 16 | 20100101 | 201507 | 0 | |
| 127442572 | 12744257 | 17 | 20090101 | 201507 | 0 | |
| 127442572 | 12744257 | 18 | 20060101 | 0 | ||
| 127442572 | 12744257 | 19 | 201608 | 0 |