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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144851 | 12714485 | 1 | I | 20160511 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008898 | JAZZ | 0.00 | F | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144851 | 12714485 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127144851 | 12714485 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127144851 | 12714485 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5.5 G, TID | 21196 | 5.5 | G | ORAL SOLUTION | |||||||
| 127144851 | 12714485 | 4 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 5 | SS | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNKNOWN DOSE | U | 0 | ||||||||||
| 127144851 | 12714485 | 6 | C | Boost calorie smart | 2 | UNK | U | 0 | LIQUID | ||||||||||
| 127144851 | 12714485 | 7 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | 1 MG, UNK | U | 0 | 1 | MG | TABLET | |||||||
| 127144851 | 12714485 | 8 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | 5 MG, UNK | U | 0 | 5 | MG | TABLET | |||||||
| 127144851 | 12714485 | 9 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | 4 MG, UNK | U | 0 | 4 | MG | TABLET | |||||||
| 127144851 | 12714485 | 10 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | 2 MG, UNK | U | 0 | 2 | MG | TABLET | |||||||
| 127144851 | 12714485 | 11 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 12 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 13 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 14 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 127144851 | 12714485 | 15 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | ||||||||||
| 127144851 | 12714485 | 16 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144851 | 12714485 | 17 | C | AMITIZA | LUBIPROSTONE | 1 | 8 ?G, UNK | U | 0 | 8 | UG | CAPSULE | |||||||
| 127144851 | 12714485 | 18 | C | AMITIZA | LUBIPROSTONE | 1 | 24 ?G, UNK | U | 0 | 24 | UG | CAPSULE | |||||||
| 127144851 | 12714485 | 19 | C | Methadone hcl | METHADONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 20 | C | AMBIEN CR | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 21 | C | DURAGESIC | FENTANYL | 1 | UNK | U | 0 | PATCH | |||||||||
| 127144851 | 12714485 | 22 | C | LIBRAX | CHLORDIAZEPOXIDE HYDROCHLORIDECLIDINIUM BROMIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144851 | 12714485 | 23 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 127144851 | 12714485 | 24 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | ||||||||||
| 127144851 | 12714485 | 25 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144851 | 12714485 | 26 | C | REMERON | MIRTAZAPINE | 1 | U | 0 | |||||||||||
| 127144851 | 12714485 | 27 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127144851 | 12714485 | 1 | Narcolepsy |
| 127144851 | 12714485 | 4 | Depression |
| 127144851 | 12714485 | 5 | Depression |
| 127144851 | 12714485 | 6 | Product used for unknown indication |
| 127144851 | 12714485 | 7 | Product used for unknown indication |
| 127144851 | 12714485 | 11 | Product used for unknown indication |
| 127144851 | 12714485 | 12 | Product used for unknown indication |
| 127144851 | 12714485 | 13 | Product used for unknown indication |
| 127144851 | 12714485 | 14 | Product used for unknown indication |
| 127144851 | 12714485 | 15 | Product used for unknown indication |
| 127144851 | 12714485 | 16 | Product used for unknown indication |
| 127144851 | 12714485 | 17 | Product used for unknown indication |
| 127144851 | 12714485 | 19 | Product used for unknown indication |
| 127144851 | 12714485 | 20 | Product used for unknown indication |
| 127144851 | 12714485 | 21 | Product used for unknown indication |
| 127144851 | 12714485 | 22 | Product used for unknown indication |
| 127144851 | 12714485 | 23 | Product used for unknown indication |
| 127144851 | 12714485 | 24 | Product used for unknown indication |
| 127144851 | 12714485 | 25 | Product used for unknown indication |
| 127144851 | 12714485 | 26 | Product used for unknown indication |
| 127144851 | 12714485 | 27 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127144851 | 12714485 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127144851 | 12714485 | Depression | |
| 127144851 | 12714485 | Nausea | |
| 127144851 | 12714485 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127144851 | 12714485 | 1 | 200709 | 200711 | 0 | |
| 127144851 | 12714485 | 2 | 200711 | 201208 | 0 | |
| 127144851 | 12714485 | 3 | 201208 | 0 | ||
| 127144851 | 12714485 | 4 | 20160425 | 0 | ||
| 127144851 | 12714485 | 6 | 201605 | 0 | ||
| 127144851 | 12714485 | 8 | 20010101 | 0 | ||
| 127144851 | 12714485 | 9 | 20150612 | 0 | ||
| 127144851 | 12714485 | 10 | 20151116 | 0 | ||
| 127144851 | 12714485 | 11 | 20151028 | 0 | ||
| 127144851 | 12714485 | 12 | 20151028 | 0 | ||
| 127144851 | 12714485 | 13 | 20151027 | 0 | ||
| 127144851 | 12714485 | 14 | 20151027 | 0 | ||
| 127144851 | 12714485 | 15 | 20151027 | 0 | ||
| 127144851 | 12714485 | 16 | 20151027 | 0 | ||
| 127144851 | 12714485 | 17 | 20150610 | 201602 | 0 | |
| 127144851 | 12714485 | 18 | 20150611 | 20151028 | 0 | |
| 127144851 | 12714485 | 19 | 20120703 | 0 | ||
| 127144851 | 12714485 | 20 | 20010101 | 20151028 | 0 | |
| 127144851 | 12714485 | 21 | 20010101 | 20151028 | 0 | |
| 127144851 | 12714485 | 22 | 20010101 | 201605 | 0 | |
| 127144851 | 12714485 | 23 | 20151028 | 0 | ||
| 127144851 | 12714485 | 24 | 20010101 | 20151028 | 0 | |
| 127144851 | 12714485 | 25 | 20010101 | 0 |