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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127936871 | 12793687 | 1 | I | 20160622 | 20160929 | 20160929 | PER | US-JAZZ-2016-US-011718 | JAZZ | 0.00 | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127936871 | 12793687 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127936871 | 12793687 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127936871 | 12793687 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127936871 | 12793687 | 4 | SS | CARVEDILOL. | CARVEDILOL | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 5 | SS | Magnesium gluconate | MAGNESIUM GLUCONATE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 6 | C | Cyclafem | 2 | U | 0 | ||||||||||||
| 127936871 | 12793687 | 7 | C | CALTRATE | CALCIUM CARBONATE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 8 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 9 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 10 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 11 | C | VALIUM | DIAZEPAM | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 12 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 13 | C | Melatonin | MELATONIN | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 14 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 15 | C | CELEBREX | CELECOXIB | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 16 | C | Valacyclovir hcl | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 17 | C | Dhea | PRASTERONE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 18 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 19 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 20 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 21 | C | Chelated magnesium | 2 | U | 0 | ||||||||||||
| 127936871 | 12793687 | 22 | C | Naltrexone | NALTREXONE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 23 | C | LIOTHYRONINE SODIUM. | LIOTHYRONINE SODIUM | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 24 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 25 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 26 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 27 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 28 | C | ATIVAN | LORAZEPAM | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 29 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 127936871 | 12793687 | 30 | C | XANAX | ALPRAZOLAM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127936871 | 12793687 | 1 | Narcolepsy |
| 127936871 | 12793687 | 2 | Cataplexy |
| 127936871 | 12793687 | 4 | Product used for unknown indication |
| 127936871 | 12793687 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127936871 | 12793687 | Blood corticotrophin decreased | |
| 127936871 | 12793687 | Blood cortisol increased | |
| 127936871 | 12793687 | Diarrhoea | |
| 127936871 | 12793687 | Feeling abnormal | |
| 127936871 | 12793687 | Somnolence | |
| 127936871 | 12793687 | 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 |
|---|---|---|---|---|---|---|
| 127936871 | 12793687 | 1 | 201509 | 201509 | 0 | |
| 127936871 | 12793687 | 2 | 201509 | 201510 | 0 | |
| 127936871 | 12793687 | 3 | 201510 | 0 |