The Safety Rates Drug Report

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Drug     Injury     Quarter    

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
127472551 12747255 1 I 2011 20160523 20160915 20160915 PER US-JAZZ-2016-US-009613 JAZZ 0.00 F Y 0.00000 20160915 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
127472551 12747255 1 PS XYREM SODIUM OXYBATE 1 Oral 1.5 G, BID 21196 1.5 G ORAL SOLUTION
127472551 12747255 2 SS XYREM SODIUM OXYBATE 1 Oral DOSE ADJUSTMENTS 21196 4.5 G ORAL SOLUTION
127472551 12747255 3 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID 21196 4.5 G ORAL SOLUTION
127472551 12747255 4 SS PERCOCET ACETAMINOPHENOXYCODONE HYDROCHLORIDE 1 UNK Y 0 TABLET
127472551 12747255 5 SS NUCYNTA TAPENTADOL HYDROCHLORIDE 1 UNK Y 0 TABLET
127472551 12747255 6 C BENICAR HCT HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL 1 UNK U 0 TABLET
127472551 12747255 7 C INCRUSE ELLIPTA UMECLIDINIUM BROMIDE 1 UNK U 0 INHALER
127472551 12747255 8 C CEPHALEXIN. CEPHALEXIN 1 UNK U 0 CAPSULE
127472551 12747255 9 C DIAZEPAM. DIAZEPAM 1 UNK U 0 TABLET
127472551 12747255 10 C BACLOFEN. BACLOFEN 1 UNK U 0 TABLET
127472551 12747255 11 C Metformin hcl METFORMIN HYDROCHLORIDE 1 UNK U 0 TABLET
127472551 12747255 12 C VICTOZA LIRAGLUTIDE 1 UNK U 0
127472551 12747255 13 C ENALAPRIL MALEATE. ENALAPRIL MALEATE 1 UNK U 0 TABLET
127472551 12747255 14 C HYDROCODONE BITARTRATE. HYDROCODONE BITARTRATE 1 UNK U 0 POWDER
127472551 12747255 15 C OXYCODONE AND ACETAMINOPHEN ACETAMINOPHENOXYCODONE HYDROCHLORIDE 1 UNK U 0
127472551 12747255 16 C TRAMADOL HCL TRAMADOL HYDROCHLORIDE 1 UNK U 0 TABLET
127472551 12747255 17 C GABAPENTIN. GABAPENTIN 1 UNK U 0 CAPSULE
127472551 12747255 18 C ABILIFY ARIPIPRAZOLE 1 UNK U 0 TABLET
127472551 12747255 19 C CYMBALTA DULOXETINE HYDROCHLORIDE 1 UNK U 0 CAPSULE
127472551 12747255 20 C HYDROXYZINE PAMOATE. HYDROXYZINE PAMOATE 1 UNK U 0 CAPSULE
127472551 12747255 21 C ADVAIR HFA FLUTICASONE PROPIONATESALMETEROL XINAFOATE 1 UNK U 0
127472551 12747255 22 C ALLEGRA FEXOFENADINE HYDROCHLORIDE 1 UNK U 0
127472551 12747255 23 C AMLODIPINE BESYLATE. AMLODIPINE BESYLATE 1 U 0 TABLET
127472551 12747255 24 C VITAMIN B COMPLEX CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX 1 U 0 CAPSULE
127472551 12747255 25 C VITAMIN B12 CYANOCOBALAMIN 1 UNK U 0
127472551 12747255 26 C Calcium Citrate with Vitamin D3 2 U 0
127472551 12747255 27 C EFFEXOR VENLAFAXINE HYDROCHLORIDE 1 UNK U 0
127472551 12747255 28 C FLUTICASONE PROPIONATE. FLUTICASONE PROPIONATE 1 UNK U 0 CREAM
127472551 12747255 29 C Hydroxyzine Hcl HYDROXYZINE HYDROCHLORIDE 1 UNK U 0 TABLET
127472551 12747255 30 C LIPITOR ATORVASTATIN CALCIUM 1 UNK U 0
127472551 12747255 31 C LORATADINE. LORATADINE 1 UNK U 0 TABLET
127472551 12747255 32 C LOSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM 1 UNK U 0 TABLET
127472551 12747255 33 C LUNESTA ESZOPICLONE 1 UNK U 0
127472551 12747255 34 C LYRICA PREGABALIN 1 UNK U 0
127472551 12747255 35 C LYRICA PREGABALIN 1 U 0 CAPSULE
127472551 12747255 36 C MAGNESIUM OXIDE. MAGNESIUM OXIDE 1 U 0 TABLET
127472551 12747255 37 C MOBIC MELOXICAM 1 U 0 TABLET
127472551 12747255 38 C Multivitamins VITAMINS 1 U 0
127472551 12747255 39 C NEURONTIN GABAPENTIN 1 UNK U 0
127472551 12747255 40 C NUVIGIL ARMODAFINIL 1 U 0 TABLET
127472551 12747255 41 C PREMARIN ESTROGENS, CONJUGATED 1 UNK U 0 CREAM
127472551 12747255 42 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 U 0 CAPSULE
127472551 12747255 43 C PROVIGIL MODAFINIL 1 UNK U 0
127472551 12747255 44 C SINGULAIR MONTELUKAST SODIUM 1 U 0 TABLET
127472551 12747255 45 C SPIRIVA TIOTROPIUM BROMIDE MONOHYDRATE 1 UNK U 0
127472551 12747255 46 C VITAMIN D CHOLECALCIFEROL 1 U 0 TABLET
127472551 12747255 47 C VOLTAREN DICLOFENAC SODIUM 1 UNK U 0 GEL
127472551 12747255 48 C ZANAFLEX TIZANIDINE HYDROCHLORIDE 1 UNK U 0 CAPSULE

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127472551 12747255 1 Narcolepsy
127472551 12747255 2 Cataplexy
127472551 12747255 4 Product used for unknown indication
127472551 12747255 5 Product used for unknown indication
127472551 12747255 6 Product used for unknown indication
127472551 12747255 7 Product used for unknown indication
127472551 12747255 8 Product used for unknown indication
127472551 12747255 9 Product used for unknown indication
127472551 12747255 10 Product used for unknown indication
127472551 12747255 11 Product used for unknown indication
127472551 12747255 12 Product used for unknown indication
127472551 12747255 13 Product used for unknown indication
127472551 12747255 14 Product used for unknown indication
127472551 12747255 15 Product used for unknown indication
127472551 12747255 16 Product used for unknown indication
127472551 12747255 17 Product used for unknown indication
127472551 12747255 18 Product used for unknown indication
127472551 12747255 19 Product used for unknown indication
127472551 12747255 20 Product used for unknown indication
127472551 12747255 21 Product used for unknown indication
127472551 12747255 22 Product used for unknown indication
127472551 12747255 23 Product used for unknown indication
127472551 12747255 24 Product used for unknown indication
127472551 12747255 25 Product used for unknown indication
127472551 12747255 26 Product used for unknown indication
127472551 12747255 27 Product used for unknown indication
127472551 12747255 28 Product used for unknown indication
127472551 12747255 29 Product used for unknown indication
127472551 12747255 30 Product used for unknown indication
127472551 12747255 31 Product used for unknown indication
127472551 12747255 32 Product used for unknown indication
127472551 12747255 33 Product used for unknown indication
127472551 12747255 34 Product used for unknown indication
127472551 12747255 35 Product used for unknown indication
127472551 12747255 36 Product used for unknown indication
127472551 12747255 37 Product used for unknown indication
127472551 12747255 39 Product used for unknown indication
127472551 12747255 40 Product used for unknown indication
127472551 12747255 41 Product used for unknown indication
127472551 12747255 42 Product used for unknown indication
127472551 12747255 43 Product used for unknown indication
127472551 12747255 44 Product used for unknown indication
127472551 12747255 45 Product used for unknown indication
127472551 12747255 46 Product used for unknown indication
127472551 12747255 47 Product used for unknown indication
127472551 12747255 48 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
127472551 12747255 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127472551 12747255 Feeling abnormal
127472551 12747255 Impaired driving ability
127472551 12747255 Mental impairment
127472551 12747255 Respiratory depression
127472551 12747255 Sedation
127472551 12747255 Somnolence
127472551 12747255 Suicide attempt

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
127472551 12747255 1 200905 200907 0
127472551 12747255 2 200907 201202 0
127472551 12747255 3 201202 0
127472551 12747255 4 20150529 201604 0
127472551 12747255 5 20160520 2016 0
127472551 12747255 6 201604 0
127472551 12747255 7 201603 0
127472551 12747255 8 20150529 201603 0
127472551 12747255 9 20150529 0
127472551 12747255 10 20150112 0
127472551 12747255 11 20150112 201603 0
127472551 12747255 12 20150112 0
127472551 12747255 13 20140610 201603 0
127472551 12747255 14 20130720 201603 0
127472551 12747255 15 20130204 20130204 0
127472551 12747255 16 20130204 201603 0
127472551 12747255 17 20121220 201603 0
127472551 12747255 18 20121204 0
127472551 12747255 19 20121204 0
127472551 12747255 20 20121204 201603 0
127472551 12747255 21 201603 0
127472551 12747255 22 20120101 0
127472551 12747255 25 201603 0
127472551 12747255 27 20121012 0
127472551 12747255 28 201605 0
127472551 12747255 29 201603 0
127472551 12747255 30 20121001 0
127472551 12747255 31 201603 0
127472551 12747255 32 201604 0
127472551 12747255 33 20120101 0
127472551 12747255 34 20120101 0
127472551 12747255 39 20121010 0
127472551 12747255 41 20160330 0
127472551 12747255 43 20121010 0
127472551 12747255 45 201603 0
127472551 12747255 47 201603 0
127472551 12747255 48 201603 0