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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127227361 | 12722736 | 1 | I | 2013 | 20160830 | 20160907 | 20160907 | EXP | US-JAZZ-2016-US-016762 | JAZZ | 0.00 | F | Y | 0.00000 | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127227361 | 12722736 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127227361 | 12722736 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 127227361 | 12722736 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127227361 | 12722736 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127227361 | 12722736 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 127227361 | 12722736 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127227361 | 12722736 | 7 | SS | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 8 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 10 MG | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 10 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 20 MG | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 11 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227361 | 12722736 | 12 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 127227361 | 12722736 | 13 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 127227361 | 12722736 | 14 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227361 | 12722736 | 15 | C | Calcium magnesium zinc | CALCIUMMAGNESIUMINC | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 16 | C | Fish oil omega-3 ec | 2 | UNK | U | 0 | |||||||||||
| 127227361 | 12722736 | 17 | C | Flonase allergy rlf | 2 | UNK | U | 0 | SPRAY | ||||||||||
| 127227361 | 12722736 | 18 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 19 | C | L-lysine | LYSINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 20 | C | Lecithin | LECITHIN | 1 | UNK | U | 0 | ||||||||||
| 127227361 | 12722736 | 21 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 22 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 23 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 24 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 25 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 26 | C | PRENATAL PLUS IRON | .ALPHA.-TOCOPHEROL ACETATE, DL-.BETA.-CAROTENEASCORBIC ACIDCALCIUM CARBONATECHOLECALCIFEROLCUPRIC OXIDECYANOCOBALAMINFERROUS FUMARATEFOLIC ACIDNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVINTHIAMINE MONONITRATEVITAMIN A ACETATEINC OXIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 27 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 127227361 | 12722736 | 28 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 127227361 | 12722736 | 29 | C | St. john's wort | ST. JOHN'S WORT | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227361 | 12722736 | 30 | C | Valacyclovir hcl | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 31 | C | Valacyclovir hcl | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 32 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 127227361 | 12722736 | 33 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 34 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 35 | C | Hydrocodone | HYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 127227361 | 12722736 | 36 | C | JANTOVEN | WARFARIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 37 | C | Nitroglycerin er | NITROGLYCERIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127227361 | 12722736 | 38 | C | AMBIEN CR | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 39 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 40 | C | SKELAXIN | METAXALONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 41 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 42 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | POWDER | |||||||||
| 127227361 | 12722736 | 43 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127227361 | 12722736 | 44 | C | ZONISAMIDE. | ZONISAMIDE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127227361 | 12722736 | 1 | Narcolepsy |
| 127227361 | 12722736 | 7 | Product used for unknown indication |
| 127227361 | 12722736 | 8 | Product used for unknown indication |
| 127227361 | 12722736 | 9 | Product used for unknown indication |
| 127227361 | 12722736 | 11 | Product used for unknown indication |
| 127227361 | 12722736 | 12 | Product used for unknown indication |
| 127227361 | 12722736 | 13 | Cardiac disorder |
| 127227361 | 12722736 | 14 | Product used for unknown indication |
| 127227361 | 12722736 | 15 | Product used for unknown indication |
| 127227361 | 12722736 | 16 | Arthralgia |
| 127227361 | 12722736 | 17 | Product used for unknown indication |
| 127227361 | 12722736 | 18 | Pain |
| 127227361 | 12722736 | 19 | Product used for unknown indication |
| 127227361 | 12722736 | 20 | Product used for unknown indication |
| 127227361 | 12722736 | 21 | Product used for unknown indication |
| 127227361 | 12722736 | 22 | Product used for unknown indication |
| 127227361 | 12722736 | 24 | Product used for unknown indication |
| 127227361 | 12722736 | 25 | Product used for unknown indication |
| 127227361 | 12722736 | 26 | Product used for unknown indication |
| 127227361 | 12722736 | 27 | Product used for unknown indication |
| 127227361 | 12722736 | 29 | Product used for unknown indication |
| 127227361 | 12722736 | 30 | Product used for unknown indication |
| 127227361 | 12722736 | 32 | Product used for unknown indication |
| 127227361 | 12722736 | 33 | Product used for unknown indication |
| 127227361 | 12722736 | 34 | Product used for unknown indication |
| 127227361 | 12722736 | 35 | Product used for unknown indication |
| 127227361 | 12722736 | 36 | Product used for unknown indication |
| 127227361 | 12722736 | 37 | Product used for unknown indication |
| 127227361 | 12722736 | 38 | Product used for unknown indication |
| 127227361 | 12722736 | 39 | Product used for unknown indication |
| 127227361 | 12722736 | 40 | Product used for unknown indication |
| 127227361 | 12722736 | 41 | Product used for unknown indication |
| 127227361 | 12722736 | 42 | Product used for unknown indication |
| 127227361 | 12722736 | 43 | Product used for unknown indication |
| 127227361 | 12722736 | 44 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127227361 | 12722736 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127227361 | 12722736 | Catheterisation cardiac | |
| 127227361 | 12722736 | Drug ineffective | |
| 127227361 | 12722736 | Gallbladder pain | |
| 127227361 | 12722736 | Hypothyroidism | |
| 127227361 | 12722736 | Malaise | |
| 127227361 | 12722736 | Nephrolithiasis | |
| 127227361 | 12722736 | Obsessive thoughts | |
| 127227361 | 12722736 | Oral herpes | |
| 127227361 | 12722736 | Peripheral venous disease | |
| 127227361 | 12722736 | Pre-existing condition improved | |
| 127227361 | 12722736 | Sleep disorder | |
| 127227361 | 12722736 | Stress | |
| 127227361 | 12722736 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 127227361 | 12722736 | 1 | 201205 | 201205 | 0 | |
| 127227361 | 12722736 | 2 | 201205 | 201503 | 0 | |
| 127227361 | 12722736 | 3 | 201503 | 2015 | 0 | |
| 127227361 | 12722736 | 4 | 201603 | 201604 | 0 | |
| 127227361 | 12722736 | 5 | 201604 | 201604 | 0 | |
| 127227361 | 12722736 | 6 | 201604 | 0 | ||
| 127227361 | 12722736 | 7 | 201608 | 0 | ||
| 127227361 | 12722736 | 8 | 20160816 | 0 | ||
| 127227361 | 12722736 | 9 | 20151130 | 201603 | 0 | |
| 127227361 | 12722736 | 11 | 20151130 | 0 | ||
| 127227361 | 12722736 | 12 | 20151130 | 0 | ||
| 127227361 | 12722736 | 13 | 20151130 | 0 | ||
| 127227361 | 12722736 | 14 | 20151130 | 0 | ||
| 127227361 | 12722736 | 15 | 20151130 | 0 | ||
| 127227361 | 12722736 | 16 | 20151130 | 0 | ||
| 127227361 | 12722736 | 17 | 20151130 | 0 | ||
| 127227361 | 12722736 | 18 | 20151130 | 0 | ||
| 127227361 | 12722736 | 19 | 20151130 | 0 | ||
| 127227361 | 12722736 | 20 | 20151130 | 0 | ||
| 127227361 | 12722736 | 21 | 20151130 | 20160816 | 0 | |
| 127227361 | 12722736 | 22 | 20151130 | 0 | ||
| 127227361 | 12722736 | 23 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 24 | 20151130 | 0 | ||
| 127227361 | 12722736 | 25 | 20151130 | 0 | ||
| 127227361 | 12722736 | 26 | 20151130 | 0 | ||
| 127227361 | 12722736 | 27 | 20151130 | 0 | ||
| 127227361 | 12722736 | 28 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 29 | 20151130 | 0 | ||
| 127227361 | 12722736 | 30 | 20151130 | 0 | ||
| 127227361 | 12722736 | 31 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 32 | 20151130 | 0 | ||
| 127227361 | 12722736 | 33 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 34 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 35 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 36 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 37 | 20150728 | 20150728 | 0 | |
| 127227361 | 12722736 | 38 | 20150727 | 20150728 | 0 | |
| 127227361 | 12722736 | 39 | 20130614 | 20150728 | 0 | |
| 127227361 | 12722736 | 40 | 20130101 | 20140318 | 0 | |
| 127227361 | 12722736 | 41 | 20120927 | 20150728 | 0 | |
| 127227361 | 12722736 | 42 | 20140318 | 0 | ||
| 127227361 | 12722736 | 43 | 201603 | 0 | ||
| 127227361 | 12722736 | 44 | 20140318 | 0 |