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
727460313 7274603 13 F 20090807 20160627 20100209 20160708 EXP JP-ROCHE-GNE297760 ROCHE NAGAI H, YASUTERU S ET AL A CASE IN WHICH OMALIZUMAB IS RESPONSIVE TO SEVERE ASTHMA WITH INDETERMINATE ALLERGEN AT LOW SERUM IGE LEVEL. JAPANESE JOURNAL OF ALLERGOLOGY 2010;59(9,10):1470-. 49.08 YR F Y 55.96000 KG 20160708 MD JP JP

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
727460313 7274603 1 PS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, 1/MONTH NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG SOLUTION FOR INJECTION /month
727460313 7274603 2 SS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, 1/MONTH NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG POWDER FOR INJECTION /month
727460313 7274603 3 SS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, UNK NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG POWDER FOR INJECTION
727460313 7274603 4 SS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, UNK NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG POWDER FOR INJECTION
727460313 7274603 5 SS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, UNK NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG POWDER FOR INJECTION
727460313 7274603 6 SS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, Q3W NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG POWDER FOR INJECTION Q3W
727460313 7274603 7 SS Omalizumab OMALIZUMAB 1 Subcutaneous 150 MG, Q3W NOT REPORTED,NOT REPORTED,NOT REPOR 103976 150 MG POWDER FOR INJECTION Q3W
727460313 7274603 8 SS RINDERON V BETAMETHASONE VALERATE 1 Oral 1 MG, BID Y 0 1 MG BID
727460313 7274603 9 SS RINDERON V BETAMETHASONE VALERATE 1 Oral 1 MG, 2 TO 4 TIMES Y 0 1 MG
727460313 7274603 10 SS RINDERON V BETAMETHASONE VALERATE 1 Intravenous drip 4 MG, QD Y 0 4 MG QD
727460313 7274603 11 SS RINDERON V BETAMETHASONE VALERATE 1 Intravenous drip 4 MG, 1 TO 3 TIMES Y 0 4 MG
727460313 7274603 12 C ADVAIR HFA FLUTICASONE PROPIONATESALMETEROL XINAFOATE 1 Respiratory (inhalation) 500 UG, BID 0 500 UG BID
727460313 7274603 13 C ALVESCO CICLESONIDE 1 Respiratory (inhalation) 400 UG, BID 0 400 UG BID
727460313 7274603 14 C SINGULAIR MONTELUKAST SODIUM 1 Oral 10 MG, QD 0 10 MG QD
727460313 7274603 15 C ALLELOCK OLOPATADINE HYDROCHLORIDE 1 Oral 5 MG, BID U 0 5 MG BID
727460313 7274603 16 C ALLELOCK OLOPATADINE HYDROCHLORIDE 1 Oral 10 MG, BID U 0 10 MG BID
727460313 7274603 17 C IPD SUPLATAST TOSILATE 1 Oral 100 MG, TID 0 100 MG TID
727460313 7274603 18 C SULTANOL ALBUTEROL SULFATE 1 Respiratory (inhalation) 2 DF, PRN Y 0 2 DF
727460313 7274603 19 C SULTANOL ALBUTEROL SULFATE 1 Respiratory (inhalation) 1 DF, 2-9 TIMES Y 0 1 DF
727460313 7274603 20 C SULTANOL ALBUTEROL SULFATE 1 Respiratory (inhalation) 1 DF, 2-16 TIMES Y 0 2 DF
727460313 7274603 21 C SULTANOL ALBUTEROL SULFATE 1 Respiratory (inhalation) 1 DF, 10-12 TIMES Y 0 2 DF
727460313 7274603 22 C CEFTRIAXONE SODIUM. CEFTRIAXONE SODIUM 1 Unknown 2 G Y 0 2 G
727460313 7274603 23 C ZITHROMAC AZITHROMYCIN DIHYDRATE 1 Oral 2 G, UNK Y 0 2 G
727460313 7274603 24 C CRAVIT LEVOFLOXACIN 1 Oral 400 MG, UNK 0 400 MG
727460313 7274603 25 C HERBESSER DILTIAZEM HYDROCHLORIDE 1 Oral 200 MG, UNK 0 200 MG
727460313 7274603 26 C LIMAS LITHIUM CARBONATE 1 Oral 800 MG, UNK 0 800 MG
727460313 7274603 27 C CINAL ASCORBIC ACIDCALCIUM PANTOTHENATE 1 Oral 400 MG, BID U 0 400 MG TABLET BID
727460313 7274603 28 C ZYRTEC CETIRIZINE HYDROCHLORIDE 1 Oral 10 MG, QD U 0 10 MG TABLET QD
727460313 7274603 29 C LECTISOL DAPSONE 1 Oral 25 MG, TID U 0 25 MG TABLET TID
727460313 7274603 30 C HIRUDOID (MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER) 2 Transdermal 25 MG, UNK U 0 25 MG
727460313 7274603 31 C TEXMETEN 2 Transdermal 25 MG, UNK U 0 25 MG CREAM

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
727460313 7274603 1 Asthma
727460313 7274603 8 Asthma
727460313 7274603 12 Asthma
727460313 7274603 13 Asthma
727460313 7274603 14 Asthma
727460313 7274603 15 Asthma
727460313 7274603 17 Asthma
727460313 7274603 18 Asthma
727460313 7274603 22 Product used for unknown indication
727460313 7274603 23 Product used for unknown indication
727460313 7274603 24 Product used for unknown indication
727460313 7274603 25 Product used for unknown indication
727460313 7274603 26 Product used for unknown indication
727460313 7274603 27 Product used for unknown indication
727460313 7274603 28 Product used for unknown indication
727460313 7274603 29 Product used for unknown indication
727460313 7274603 30 Product used for unknown indication
727460313 7274603 31 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
727460313 7274603 HO
727460313 7274603 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
727460313 7274603 Altered state of consciousness
727460313 7274603 Asthma
727460313 7274603 Chronic respiratory failure
727460313 7274603 Drug eruption
727460313 7274603 Malaise
727460313 7274603 Nasopharyngitis
727460313 7274603 Pneumonia
727460313 7274603 Pruritus
727460313 7274603 Scleritis
727460313 7274603 Weight increased

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
727460313 7274603 1 20090807 20090908 0
727460313 7274603 2 20090908 20090908 0
727460313 7274603 3 20100118 0
727460313 7274603 4 20100225 0
727460313 7274603 5 20100318 0
727460313 7274603 6 20100108 0
727460313 7274603 7 20100426 0
727460313 7274603 8 20090204 0
727460313 7274603 9 20090815 0
727460313 7274603 10 20090824 20090907 0
727460313 7274603 11 20091001 20091114 0
727460313 7274603 12 20090204 0
727460313 7274603 13 20090204 0
727460313 7274603 14 20090513 0
727460313 7274603 15 20090204 0
727460313 7274603 17 20090914 0
727460313 7274603 18 20090204 0
727460313 7274603 19 20090815 20090818 0
727460313 7274603 20 20090824 20090907 0
727460313 7274603 21 20091001 20091114 0
727460313 7274603 22 20091210 20091214 0
727460313 7274603 23 19901217 20091210 0
727460313 7274603 24 20091215 20091219 0
727460313 7274603 25 20090807 0
727460313 7274603 26 20090807 0
727460313 7274603 27 20090807 0
727460313 7274603 28 20090807 0
727460313 7274603 30 20090807 0
727460313 7274603 31 20090807 0