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
125238851 12523885 1 I 20151222 20160704 20160704 PER US-JAZZ-2015-US-022416 JAZZ 0.00 F Y 0.00000 20160704 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
125238851 12523885 1 PS XYREM SODIUM OXYBATE 1 Oral 2.25 G, BID U 21196 2.25 G ORAL SOLUTION
125238851 12523885 2 SS XYREM SODIUM OXYBATE 1 U 21196 ORAL SOLUTION
125238851 12523885 3 C ADDERALL XR AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE 1 UNK U 0 CAPSULE
125238851 12523885 4 C LEXAPRO ESCITALOPRAM OXALATE 1 UNK U 0 TABLET
125238851 12523885 5 C NORCO ACETAMINOPHENHYDROCODONE BITARTRATE 1 UNK U 0 TABLET
125238851 12523885 6 C ARMOUR THYROID THYROID, PORCINE 1 UNK U 0 TABLET
125238851 12523885 7 C ATIVAN LORAZEPAM 1 UNK U 0 TABLET
125238851 12523885 8 C Clonidine hcl CLONIDINE HYDROCHLORIDE 1 UNK U 0 TABLET
125238851 12523885 9 C NUVIGIL ARMODAFINIL 1 UNK U 0 TABLET
125238851 12523885 10 C PROZAC FLUOXETINE HYDROCHLORIDE 1 UNK U 0
125238851 12523885 11 C TEMAZEPAM. TEMAZEPAM 1 UNK U 0 CAPSULE

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125238851 12523885 1 Narcolepsy
125238851 12523885 2 Cataplexy
125238851 12523885 3 Product used for unknown indication
125238851 12523885 4 Product used for unknown indication
125238851 12523885 5 Product used for unknown indication
125238851 12523885 6 Product used for unknown indication
125238851 12523885 7 Product used for unknown indication
125238851 12523885 8 Product used for unknown indication
125238851 12523885 9 Product used for unknown indication
125238851 12523885 10 Product used for unknown indication
125238851 12523885 11 Product used for unknown indication

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
125238851 12523885 Chapped lips
125238851 12523885 Dysarthria
125238851 12523885 Feeling abnormal
125238851 12523885 Hot flush
125238851 12523885 Nausea

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
125238851 12523885 1 201412 2015 0
125238851 12523885 3 20140219 0
125238851 12523885 4 20141219 0
125238851 12523885 5 20141219 0
125238851 12523885 6 20141218 0
125238851 12523885 7 20141218 0
125238851 12523885 8 20141218 0
125238851 12523885 9 20141218 0
125238851 12523885 10 20141218 20141219 0
125238851 12523885 11 20141014 20141201 0