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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111599434 | 11159943 | 4 | F | 20160915 | 20150603 | 20160923 | EXP | US-JAZZ-2014-US-013368 | JAZZ | 0.00 | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111599434 | 11159943 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 3069807 | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 111599434 | 11159943 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 111599434 | 11159943 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | Y | 3112102 | 21196 | 4 | G | ORAL SOLUTION | |||||
| 111599434 | 11159943 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, SECOND DOSE | Y | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 111599434 | 11159943 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 111599434 | 11159943 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, FIRST DOSE | Y | 21196 | 5 | G | ORAL SOLUTION | ||||||
| 111599434 | 11159943 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, SECOND DOSE | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 111599434 | 11159943 | 8 | C | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 9 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 10 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 11 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 12 | C | LITHIUM. | LITHIUM | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 13 | C | DIOVAN | VALSARTAN | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 14 | C | DEPLIN | LEVOMEFOLATE CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 15 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 16 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 17 | C | VITAMIN B2 | RIBOFLAVIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 18 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 19 | C | VIIBRYD | VILAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 20 | C | TRILIPIX | FENOFIBRIC ACID | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 111599434 | 11159943 | 21 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 22 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 23 | C | Prazosin | PRAZOSIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 111599434 | 11159943 | 24 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 111599434 | 11159943 | 25 | C | MUPIROCIN. | MUPIROCIN | 1 | UNK | U | 0 | CREAM | |||||||||
| 111599434 | 11159943 | 26 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 27 | C | DESONIDE. | DESONIDE | 1 | UNK | U | 0 | CREAM | |||||||||
| 111599434 | 11159943 | 28 | C | Clobetasol | CLOBETASOL | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 29 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 111599434 | 11159943 | 30 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 31 | C | Triamcinolone | TRIAMCINOLONE | 1 | UNK | U | 0 | CREAM | |||||||||
| 111599434 | 11159943 | 32 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 33 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 34 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 111599434 | 11159943 | 35 | C | COENZYME Q10 | UBIDECARENONE | 1 | UNK | U | 0 | GEL | |||||||||
| 111599434 | 11159943 | 36 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 37 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 111599434 | 11159943 | 38 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 111599434 | 11159943 | 39 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 40 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 41 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 111599434 | 11159943 | 42 | C | PREMARIN | ESTROGENS, CONJUGATED | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111599434 | 11159943 | 1 | Narcolepsy |
| 111599434 | 11159943 | 2 | Cataplexy |
| 111599434 | 11159943 | 8 | Product used for unknown indication |
| 111599434 | 11159943 | 9 | Product used for unknown indication |
| 111599434 | 11159943 | 10 | Product used for unknown indication |
| 111599434 | 11159943 | 11 | Product used for unknown indication |
| 111599434 | 11159943 | 12 | Product used for unknown indication |
| 111599434 | 11159943 | 13 | Product used for unknown indication |
| 111599434 | 11159943 | 14 | Product used for unknown indication |
| 111599434 | 11159943 | 15 | Product used for unknown indication |
| 111599434 | 11159943 | 16 | Product used for unknown indication |
| 111599434 | 11159943 | 17 | Product used for unknown indication |
| 111599434 | 11159943 | 18 | Product used for unknown indication |
| 111599434 | 11159943 | 19 | Product used for unknown indication |
| 111599434 | 11159943 | 20 | Product used for unknown indication |
| 111599434 | 11159943 | 21 | Product used for unknown indication |
| 111599434 | 11159943 | 22 | Product used for unknown indication |
| 111599434 | 11159943 | 23 | Product used for unknown indication |
| 111599434 | 11159943 | 24 | Product used for unknown indication |
| 111599434 | 11159943 | 25 | Product used for unknown indication |
| 111599434 | 11159943 | 26 | Product used for unknown indication |
| 111599434 | 11159943 | 27 | Product used for unknown indication |
| 111599434 | 11159943 | 28 | Product used for unknown indication |
| 111599434 | 11159943 | 29 | Product used for unknown indication |
| 111599434 | 11159943 | 30 | Product used for unknown indication |
| 111599434 | 11159943 | 31 | Product used for unknown indication |
| 111599434 | 11159943 | 32 | Product used for unknown indication |
| 111599434 | 11159943 | 33 | Product used for unknown indication |
| 111599434 | 11159943 | 34 | Product used for unknown indication |
| 111599434 | 11159943 | 35 | Product used for unknown indication |
| 111599434 | 11159943 | 36 | Product used for unknown indication |
| 111599434 | 11159943 | 37 | Product used for unknown indication |
| 111599434 | 11159943 | 38 | Product used for unknown indication |
| 111599434 | 11159943 | 39 | Product used for unknown indication |
| 111599434 | 11159943 | 40 | Product used for unknown indication |
| 111599434 | 11159943 | 41 | Product used for unknown indication |
| 111599434 | 11159943 | 42 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111599434 | 11159943 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111599434 | 11159943 | Agoraphobia | |
| 111599434 | 11159943 | Anxiety | |
| 111599434 | 11159943 | Attention deficit/hyperactivity disorder | |
| 111599434 | 11159943 | Chronic obstructive pulmonary disease | |
| 111599434 | 11159943 | Condition aggravated | |
| 111599434 | 11159943 | Depression | |
| 111599434 | 11159943 | Gingival disorder | |
| 111599434 | 11159943 | Headache | |
| 111599434 | 11159943 | Hypertension | |
| 111599434 | 11159943 | Libido increased | |
| 111599434 | 11159943 | Loss of consciousness | |
| 111599434 | 11159943 | Nightmare | |
| 111599434 | 11159943 | Oedema | |
| 111599434 | 11159943 | Panic attack | |
| 111599434 | 11159943 | Pericardial effusion | |
| 111599434 | 11159943 | Post-traumatic stress disorder | |
| 111599434 | 11159943 | Tooth loss | |
| 111599434 | 11159943 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 111599434 | 11159943 | 1 | 200903 | 2009 | 0 | |
| 111599434 | 11159943 | 3 | 201403 | 2014 | 0 | |
| 111599434 | 11159943 | 4 | 201403 | 2014 | 0 | |
| 111599434 | 11159943 | 5 | 201410 | 2015 | 0 | |
| 111599434 | 11159943 | 6 | 201503 | 0 | ||
| 111599434 | 11159943 | 7 | 201503 | 0 | ||
| 111599434 | 11159943 | 8 | 20130508 | 0 | ||
| 111599434 | 11159943 | 9 | 20130924 | 0 | ||
| 111599434 | 11159943 | 11 | 20130508 | 0 | ||
| 111599434 | 11159943 | 12 | 20130508 | 0 | ||
| 111599434 | 11159943 | 13 | 20130508 | 0 | ||
| 111599434 | 11159943 | 14 | 20130508 | 0 | ||
| 111599434 | 11159943 | 15 | 20130924 | 0 | ||
| 111599434 | 11159943 | 16 | 20130508 | 0 | ||
| 111599434 | 11159943 | 17 | 20130508 | 20130924 | 0 | |
| 111599434 | 11159943 | 18 | 20130508 | 0 | ||
| 111599434 | 11159943 | 19 | 20130508 | 20130819 | 0 | |
| 111599434 | 11159943 | 20 | 20130508 | 20130924 | 0 | |
| 111599434 | 11159943 | 21 | 20130508 | 20150526 | 0 | |
| 111599434 | 11159943 | 22 | 20130508 | 0 | ||
| 111599434 | 11159943 | 23 | 20130508 | 0 | ||
| 111599434 | 11159943 | 24 | 20130508 | 20150209 | 0 | |
| 111599434 | 11159943 | 25 | 20130508 | 20141013 | 0 | |
| 111599434 | 11159943 | 26 | 20130508 | 20130924 | 0 | |
| 111599434 | 11159943 | 27 | 20130508 | 20130924 | 0 | |
| 111599434 | 11159943 | 28 | 20130508 | 20130924 | 0 | |
| 111599434 | 11159943 | 29 | 20130508 | 20141013 | 0 | |
| 111599434 | 11159943 | 30 | 20141013 | 0 | ||
| 111599434 | 11159943 | 31 | 20130611 | 20130924 | 0 | |
| 111599434 | 11159943 | 32 | 20130924 | 20141013 | 0 | |
| 111599434 | 11159943 | 33 | 20130924 | 0 | ||
| 111599434 | 11159943 | 34 | 20130924 | 0 | ||
| 111599434 | 11159943 | 35 | 20130924 | 20141013 | 0 | |
| 111599434 | 11159943 | 36 | 20131218 | 20131220 | 0 | |
| 111599434 | 11159943 | 37 | 20141013 | 0 | ||
| 111599434 | 11159943 | 38 | 20141013 | 0 | ||
| 111599434 | 11159943 | 39 | 20141013 | 0 | ||
| 111599434 | 11159943 | 40 | 20150209 | 20150526 | 0 | |
| 111599434 | 11159943 | 41 | 20150430 | 20150526 | 0 |