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
125884881 12588488 1 I 20160609 20160725 20160725 PER US-JNJFOC-20160613368 JANSSEN 0.00 A F Y 0.00000 20160725 CN 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
125884881 12588488 1 SS DIPHENHYDRAMINE HYDROCHLORIDE. DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral N 0 50 MG TABLET
125884881 12588488 2 SS DIPHENHYDRAMINE HYDROCHLORIDE. DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral N 0 25 MG TABLET
125884881 12588488 3 SS DIPHENHYDRAMINE HYDROCHLORIDE. DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral N 0 50 MG TABLET
125884881 12588488 4 SS DIPHENHYDRAMINE HYDROCHLORIDE. DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral N 0 25 MG TABLET
125884881 12588488 5 SS DIPHENHYDRAMINE HYDROCHLORIDE. DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral N 0 25 MG TABLET
125884881 12588488 6 PS DIPHENHYDRAMINE HYDROCHLORIDE. DIPHENHYDRAMINE HYDROCHLORIDE 1 Oral N 999999 25 MG TABLET
125884881 12588488 7 SS ACETAMINOPHEN. ACETAMINOPHEN 1 Oral N 19872 650 MG TABLET
125884881 12588488 8 SS ACETAMINOPHEN. ACETAMINOPHEN 1 Oral N 19872 650 MG TABLET
125884881 12588488 9 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 10 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 11 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 12 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 13 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 14 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 15 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 16 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 17 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 18 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 19 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 20 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 21 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 22 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 23 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER
125884881 12588488 24 C REMICADE INFLIXIMAB 1 Intravenous (not otherwise specified) 0 300 MG LYOPHILIZED POWDER

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125884881 12588488 1 Premedication
125884881 12588488 2 Premedication
125884881 12588488 3 Premedication
125884881 12588488 4 Premedication
125884881 12588488 5 Premedication
125884881 12588488 6 Premedication
125884881 12588488 7 Premedication
125884881 12588488 8 Premedication
125884881 12588488 9 Colitis ulcerative
125884881 12588488 10 Colitis ulcerative
125884881 12588488 11 Colitis ulcerative
125884881 12588488 12 Colitis ulcerative
125884881 12588488 13 Colitis ulcerative
125884881 12588488 14 Colitis ulcerative
125884881 12588488 15 Colitis ulcerative
125884881 12588488 16 Colitis ulcerative
125884881 12588488 17 Colitis ulcerative
125884881 12588488 18 Colitis ulcerative
125884881 12588488 19 Colitis ulcerative
125884881 12588488 20 Colitis ulcerative
125884881 12588488 21 Colitis ulcerative
125884881 12588488 22 Colitis ulcerative
125884881 12588488 23 Colitis ulcerative
125884881 12588488 24 Colitis ulcerative

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
125884881 12588488 Off label use
125884881 12588488 Product use issue

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
125884881 12588488 1 20150226 0
125884881 12588488 2 20150501 0
125884881 12588488 3 20150501 0
125884881 12588488 4 20151016 0
125884881 12588488 5 20160204 0
125884881 12588488 6 20160331 0
125884881 12588488 7 20160204 0
125884881 12588488 8 20160331 0
125884881 12588488 9 20150226 0
125884881 12588488 10 20151211 0
125884881 12588488 11 20150626 0
125884881 12588488 12 20150501 0
125884881 12588488 13 20151016 0
125884881 12588488 14 20151211 0
125884881 12588488 15 20160331 0
125884881 12588488 16 20160204 0
125884881 12588488 17 20150226 0
125884881 12588488 18 20151211 0
125884881 12588488 19 20150626 0
125884881 12588488 20 20150501 0
125884881 12588488 21 20151016 0
125884881 12588488 22 20151211 0
125884881 12588488 23 20160204 0
125884881 12588488 24 20160331 0