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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123517123 | 12351712 | 3 | F | 20160706 | 20160510 | 20160713 | EXP | US-JAZZ-2016-US-008266 | JAZZ | 0.00 | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123517123 | 12351712 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 123517123 | 12351712 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 123517123 | 12351712 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 123517123 | 12351712 | 4 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 5 | C | Doxepin | DOXEPIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123517123 | 12351712 | 6 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 7 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 8 | C | SONATA | ZALEPLON | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123517123 | 12351712 | 9 | C | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 10 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 11 | C | LAMOTRIGINE EXTENDED RELEASE | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 12 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123517123 | 12351712 | 13 | C | PREVALITE | CHOLESTYRAMINE | 1 | UNK | U | 0 | ||||||||||
| 123517123 | 12351712 | 14 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 123517123 | 12351712 | 15 | C | SAPHRIS | ASENAPINE MALEATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 16 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 17 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 123517123 | 12351712 | 18 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 123517123 | 12351712 | 19 | C | BELSOMRA | SUVOREXANT | 1 | UNK | U | 0 | TABLET | |||||||||
| 123517123 | 12351712 | 20 | C | Lorazepam powder | 2 | UNK | U | 0 | POWDER | ||||||||||
| 123517123 | 12351712 | 21 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123517123 | 12351712 | 1 | Insomnia |
| 123517123 | 12351712 | 4 | Product used for unknown indication |
| 123517123 | 12351712 | 5 | Product used for unknown indication |
| 123517123 | 12351712 | 6 | Product used for unknown indication |
| 123517123 | 12351712 | 7 | Product used for unknown indication |
| 123517123 | 12351712 | 8 | Product used for unknown indication |
| 123517123 | 12351712 | 9 | Product used for unknown indication |
| 123517123 | 12351712 | 10 | Product used for unknown indication |
| 123517123 | 12351712 | 11 | Product used for unknown indication |
| 123517123 | 12351712 | 12 | Product used for unknown indication |
| 123517123 | 12351712 | 13 | Product used for unknown indication |
| 123517123 | 12351712 | 14 | Product used for unknown indication |
| 123517123 | 12351712 | 15 | Product used for unknown indication |
| 123517123 | 12351712 | 16 | Product used for unknown indication |
| 123517123 | 12351712 | 17 | Product used for unknown indication |
| 123517123 | 12351712 | 18 | Product used for unknown indication |
| 123517123 | 12351712 | 19 | Product used for unknown indication |
| 123517123 | 12351712 | 20 | Product used for unknown indication |
| 123517123 | 12351712 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123517123 | 12351712 | HO |
| 123517123 | 12351712 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123517123 | 12351712 | Accidental overdose | |
| 123517123 | 12351712 | Delirium | |
| 123517123 | 12351712 | Drug ineffective for unapproved indication | |
| 123517123 | 12351712 | Feeling abnormal | |
| 123517123 | 12351712 | Hallucination | |
| 123517123 | 12351712 | Incoherent |
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 |
|---|---|---|---|---|---|---|
| 123517123 | 12351712 | 1 | 201008 | 201008 | 0 | |
| 123517123 | 12351712 | 2 | 2010 | 2010 | 0 | |
| 123517123 | 12351712 | 3 | 2010 | 201604 | 0 | |
| 123517123 | 12351712 | 4 | 20150920 | 20150920 | 0 | |
| 123517123 | 12351712 | 5 | 20150920 | 201603 | 0 | |
| 123517123 | 12351712 | 6 | 20150920 | 0 | ||
| 123517123 | 12351712 | 7 | 20150920 | 20150920 | 0 | |
| 123517123 | 12351712 | 8 | 20150920 | 20150920 | 0 | |
| 123517123 | 12351712 | 9 | 20150101 | 0 | ||
| 123517123 | 12351712 | 10 | 20150101 | 0 | ||
| 123517123 | 12351712 | 11 | 20150101 | 0 | ||
| 123517123 | 12351712 | 12 | 20150101 | 0 | ||
| 123517123 | 12351712 | 13 | 20150101 | 201603 | 0 | |
| 123517123 | 12351712 | 14 | 20150101 | 0 | ||
| 123517123 | 12351712 | 15 | 20150101 | 201603 | 0 | |
| 123517123 | 12351712 | 16 | 20150101 | 0 | ||
| 123517123 | 12351712 | 17 | 20150101 | 0 | ||
| 123517123 | 12351712 | 19 | 20160314 | 0 | ||
| 123517123 | 12351712 | 20 | 201603 | 0 | ||
| 123517123 | 12351712 | 21 | 201603 | 0 |