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
124468522 12446852 2 F 2009 20160725 20160608 20160802 EXP CA-JNJFOC-20151125424 JANSSEN 37.31 YR A F Y 54.00000 KG 20160802 OT CA CA

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
124468522 12446852 1 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 LYOPHILIZED POWDER
124468522 12446852 2 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 3 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 4 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 5 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 6 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 7 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 LYOPHILIZED POWDER
124468522 12446852 8 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 9 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 10 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 11 SS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 0 400 MG LYOPHILIZED POWDER
124468522 12446852 12 PS REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) Y N FLM04014;FLM04014 103772 400 MG LYOPHILIZED POWDER
124468522 12446852 13 SS TYLENOL ACETAMINOPHEN 1 Oral U U 19872 500 MG UNSPECIFIED
124468522 12446852 14 SS TYLENOL ACETAMINOPHEN 1 Oral U U 19872 500 MG UNSPECIFIED
124468522 12446852 15 SS BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Unknown U U 0 UNSPECIFIED
124468522 12446852 16 SS BENADRYL DIPHENHYDRAMINE HYDROCHLORIDE 1 Unknown U U 999999 150 MG UNSPECIFIED
124468522 12446852 17 C DICLECTIN DOXYLAMINE SUCCINATEPYRIDOXINE HYDROCHLORIDE 1 Urethral 0 UNKNOWN
124468522 12446852 18 C INSULIN INSULIN NOS 1 Unknown 0 UNSPECIFIED
124468522 12446852 19 C SYNTHROID LEVOTHYROXINE SODIUM 1 Unknown 0 25 UG UNSPECIFIED
124468522 12446852 20 C HYDROCORTISONE. HYDROCORTISONE 1 Intravenous (not otherwise specified) 0 200 MG UNSPECIFIED
124468522 12446852 21 C SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE 1 Intravenous (not otherwise specified) 0 200 MG UNSPECIFIED
124468522 12446852 22 C AERIUS DESLORATADINE 1 Oral 0 5 MG UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124468522 12446852 1 Crohn's disease
124468522 12446852 2 Crohn's disease
124468522 12446852 3 Crohn's disease
124468522 12446852 4 Crohn's disease
124468522 12446852 5 Crohn's disease
124468522 12446852 6 Crohn's disease
124468522 12446852 7 Colitis ulcerative
124468522 12446852 8 Colitis ulcerative
124468522 12446852 9 Colitis ulcerative
124468522 12446852 10 Colitis ulcerative
124468522 12446852 11 Colitis ulcerative
124468522 12446852 12 Colitis ulcerative
124468522 12446852 13 Premedication
124468522 12446852 14 Premedication
124468522 12446852 15 Product used for unknown indication
124468522 12446852 16 Product used for unknown indication
124468522 12446852 20 Premedication
124468522 12446852 21 Premedication
124468522 12446852 22 Premedication

Outcome of event

Event ID CASEID OUTC COD
124468522 12446852 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
124468522 12446852 Caesarean section
124468522 12446852 Dry mouth
124468522 12446852 Erythema
124468522 12446852 Exposure during pregnancy
124468522 12446852 Infusion related reaction
124468522 12446852 Malaise
124468522 12446852 Nausea
124468522 12446852 Pruritus
124468522 12446852 Throat irritation
124468522 12446852 Urticaria

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
124468522 12446852 1 20160601 0
124468522 12446852 2 2008 0
124468522 12446852 3 2009 0
124468522 12446852 4 20160725 0
124468522 12446852 5 20160406 0
124468522 12446852 6 20081019 0
124468522 12446852 7 20160601 0
124468522 12446852 8 20081019 0
124468522 12446852 9 2009 0
124468522 12446852 10 2008 0
124468522 12446852 11 20160725 0
124468522 12446852 12 20160406 0
124468522 12446852 14 20160725 0
124468522 12446852 15 2009 0
124468522 12446852 16 20160725 0
124468522 12446852 21 20160725 0
124468522 12446852 22 20160725 0