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
124974412 12497441 2 F 20160630 20160624 20160708 EXP US-JAZZ-2016-US-011556 JAZZ 0.00 F Y 0.00000 20160708 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
124974412 12497441 1 PS XYREM SODIUM OXYBATE 1 Oral 2.25 G, BID U 21196 2.25 G ORAL SOLUTION
124974412 12497441 2 SS XYREM SODIUM OXYBATE 1 Oral DOSE ADJUSTMENTS U 21196 ORAL SOLUTION
124974412 12497441 3 SS XYREM SODIUM OXYBATE 1 Oral 4.5 G, BID U 21196 4.5 G ORAL SOLUTION
124974412 12497441 4 SS XYREM SODIUM OXYBATE 1 Oral 1.25 G, BID U 21196 1.25 G ORAL SOLUTION
124974412 12497441 5 SS GABAPENTIN. GABAPENTIN 1 UNK 0 TABLET
124974412 12497441 6 C REGLAN METOCLOPRAMIDE HYDROCHLORIDE 1 UNK 0 TABLET
124974412 12497441 7 C Calcium +D CALCIUMVITAMIN D 1 UNK 0 CHEWABLE TABLET
124974412 12497441 8 C ADDERALL AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE 1 UNK 0 TABLET
124974412 12497441 9 C Omega 3 fish oil FISH OILOMEGA-3 FATTY ACIDS 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124974412 12497441 1 Narcolepsy
124974412 12497441 2 Cataplexy
124974412 12497441 5 Product used for unknown indication
124974412 12497441 6 Product used for unknown indication
124974412 12497441 7 Product used for unknown indication
124974412 12497441 8 Product used for unknown indication
124974412 12497441 9 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
124974412 12497441 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
124974412 12497441 Intervertebral disc protrusion
124974412 12497441 Somnolence

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
124974412 12497441 1 201410 201410 0
124974412 12497441 2 201410 201411 0
124974412 12497441 3 201411 2014 0
124974412 12497441 4 201603 0
124974412 12497441 5 201606 201606 0
124974412 12497441 6 20141021 0
124974412 12497441 7 20131001 0
124974412 12497441 8 20110901 0