The Safety Rates Drug Report

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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
125293981 12529398 1 I 20160621 20160706 20160706 EXP ES-JNJFOC-20160700472 JOHNSON AND JOHNSON BLANCA-LOPEZ N, PEREZ-ALZATE D, ANDREU I, DONA I, AGUNDEZ JA, GARCIA-MARTIN E, ET AL. IMMEDIATE HYPERSENSITIVITY REACTIONS TO IBUPROFEN AND OTHER ARYLPROPIONIC ACID DERIVATIVES. ALLERGY (EUROPEAN JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY) 2016;71 (7):1048-1056. 26.00 YR A F Y 0.00000 20160705 OT ES ES

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
125293981 12529398 1 SS IBUPROFEN. IBUPROFEN 1 Unknown N 0 UNSPECIFIED
125293981 12529398 2 SS IBUPROFEN. IBUPROFEN 1 Unknown AT INCREMENTAL DOSES OF 50 MG, 100 MG, 150 MG AND 300 MG EVERY 60 MIN DURING ONE DAY N 0 UNSPECIFIED
125293981 12529398 3 PS IBUPROFEN. IBUPROFEN 1 Unknown AT INCREMENTAL DOSES OF 50 MG, 100 MG, 150 MG AND 300 MG EVERY 60 MIN DURING ONE DAY N 19012 UNSPECIFIED
125293981 12529398 4 SS IBUPROFEN. IBUPROFEN 1 Unknown N 19012 UNSPECIFIED
125293981 12529398 5 SS DEXKETOPROFEN DEXKETOPROFEN 1 Unknown U 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125293981 12529398 1 Drug provocation test
125293981 12529398 2 Drug provocation test
125293981 12529398 3 Product used for unknown indication
125293981 12529398 4 Product used for unknown indication
125293981 12529398 5 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125293981 12529398 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125293981 12529398 Angioedema
125293981 12529398 Off label use
125293981 12529398 Product use issue

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found