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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127788521 | 12778852 | 1 | I | 20160608 | 20160926 | 20160926 | PER | US-JAZZ-2016-US-010788 | JAZZ | 0.00 | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127788521 | 12778852 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127788521 | 12778852 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127788521 | 12778852 | 3 | SS | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 4 | SS | LYRICA | PREGABALIN | 1 | 300 MG | Y | 0 | CAPSULE | |||||||||
| 127788521 | 12778852 | 5 | SS | LYRICA | PREGABALIN | 1 | 225 MG | Y | 0 | CAPSULE | |||||||||
| 127788521 | 12778852 | 6 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127788521 | 12778852 | 7 | SS | METOPROLOL. | METOPROLOL | 1 | 50 MG | U | 0 | TABLET | |||||||||
| 127788521 | 12778852 | 8 | SS | LISINOPRIL. | LISINOPRIL | 1 | 20 MG | U | 0 | TABLET | |||||||||
| 127788521 | 12778852 | 9 | SS | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | 120 MG | U | 0 | TABLET | |||||||||
| 127788521 | 12778852 | 10 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 11 | C | Biotin | BIOTIN | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 12 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 13 | C | ALAVERT ALLERGY | LORATADINE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 14 | C | B Complete | 2 | U | 0 | ||||||||||||
| 127788521 | 12778852 | 15 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 16 | C | Bupropion Hcl | BUPROPION HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 17 | C | Calcium +D | CALCIUMVITAMIN D | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 18 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 19 | C | FINASTERIDE. | FINASTERIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 20 | C | Fish oil 1-a-day + vitamin D3 | 2 | U | 0 | ||||||||||||
| 127788521 | 12778852 | 21 | C | Iron | IRON | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 22 | C | L-METHYLFOLATE CALCIUM | LEVOMEFOLATE CALCIUM | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 23 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 24 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 25 | C | NAMENDA | MEMANTINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 26 | C | NAPROXEN. | NAPROXEN | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 27 | C | Neuro | 2 | U | 0 | ||||||||||||
| 127788521 | 12778852 | 28 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 29 | C | NUVARING | ETHINYL ESTRADIOLETONOGESTREL | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 30 | C | SUDAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 31 | C | VIAGRA | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 32 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 33 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 34 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 35 | C | Zinc gluconate | ZINC GLUCONATE | 1 | U | 0 | |||||||||||
| 127788521 | 12778852 | 36 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127788521 | 12778852 | 1 | Narcolepsy |
| 127788521 | 12778852 | 2 | Cataplexy |
| 127788521 | 12778852 | 3 | Blood pressure abnormal |
| 127788521 | 12778852 | 4 | Product used for unknown indication |
| 127788521 | 12778852 | 6 | Product used for unknown indication |
| 127788521 | 12778852 | 7 | Product used for unknown indication |
| 127788521 | 12778852 | 8 | Product used for unknown indication |
| 127788521 | 12778852 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127788521 | 12778852 | Asthenia | |
| 127788521 | 12778852 | Blood pressure abnormal | |
| 127788521 | 12778852 | Blood pressure decreased | |
| 127788521 | 12778852 | Condition aggravated | |
| 127788521 | 12778852 | Dehydration | |
| 127788521 | 12778852 | Depression | |
| 127788521 | 12778852 | Fatigue | |
| 127788521 | 12778852 | Feeling abnormal | |
| 127788521 | 12778852 | Heart rate decreased | |
| 127788521 | 12778852 | Memory impairment | |
| 127788521 | 12778852 | Therapeutic response decreased | |
| 127788521 | 12778852 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127788521 | 12778852 | 1 | 201505 | 2015 | 0 | |
| 127788521 | 12778852 | 2 | 2015 | 0 | ||
| 127788521 | 12778852 | 4 | 20150512 | 0 | ||
| 127788521 | 12778852 | 5 | 20150512 | 0 | ||
| 127788521 | 12778852 | 6 | 20150512 | 20151231 | 0 | |
| 127788521 | 12778852 | 7 | 20160101 | 0 | ||
| 127788521 | 12778852 | 8 | 20150512 | 0 | ||
| 127788521 | 12778852 | 9 | 20150512 | 0 |