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
101493835 10149383 5 F 20080428 20160721 20140502 20160726 EXP JP-ASTELLAS-2011JP000953 ASTELLAS 47.00 YR F Y 0.00000 20160726 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
101493835 10149383 1 PS TACROLIMUS. TACROLIMUS 1 Oral 1203 MG 50708 3 MG CAPSULE QD
101493835 10149383 2 SS TACROLIMUS. TACROLIMUS 1 Oral 1203 MG 50708 2 MG CAPSULE QD
101493835 10149383 3 SS TACROLIMUS. TACROLIMUS 1 Oral 1203 MG 50708 1 MG CAPSULE QD
101493835 10149383 4 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 20 MG PER ORAL NOS QOD
101493835 10149383 5 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 15 MG PER ORAL NOS QOD
101493835 10149383 6 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 12.5 MG PER ORAL NOS QOD
101493835 10149383 7 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 10 MG PER ORAL NOS QOD
101493835 10149383 8 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 5 MG PER ORAL NOS QOD
101493835 10149383 9 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 10 MG PER ORAL NOS QOD
101493835 10149383 10 SS PREDNISOLONE. PREDNISOLONE 1 Oral 1025 MG 0 10 MG PER ORAL NOS QD
101493835 10149383 11 C LAMISIL TERBINAFINE HYDROCHLORIDE 1 Oral 32250 MG U 0 125 MG TABLET QD
101493835 10149383 12 C PLETAAL CILOSTAZOL 1 Oral U 0 100 MG PER ORAL NOS QD
101493835 10149383 13 C PLETAAL CILOSTAZOL 1 Oral U 0 100 MG PER ORAL NOS QD
101493835 10149383 14 C DIART AZOSEMIDE 1 Oral U 0 30 MG TABLET QD
101493835 10149383 15 C GASTER FAMOTIDINE 1 Oral U 0 20 MG ORODISPERSIBLE TABLET QD
101493835 10149383 16 C ASPARA K POTASSIUM ASPARTATE 1 Oral 136500 MG U 0 600 MG TABLET QD
101493835 10149383 17 C ASPARA K POTASSIUM ASPARTATE 1 Oral 136500 MG U 0 300 MG TABLET QD
101493835 10149383 18 C ASPARA K POTASSIUM ASPARTATE 1 Oral 136500 MG U 0 600 MG TABLET QD
101493835 10149383 19 C ASPARA K POTASSIUM ASPARTATE 1 Oral 136500 MG U 0 600 MG TABLET QD
101493835 10149383 20 C ASPARA K POTASSIUM ASPARTATE 1 Oral 136500 MG U 0 300 MG TABLET QD
101493835 10149383 21 C ASPARA K POTASSIUM ASPARTATE 1 Oral 136500 MG U 0 600 MG TABLET QD
101493835 10149383 22 C PRERAN TRANDOLAPRIL 1 Oral U 0 1 MG TABLET QD
101493835 10149383 23 C PRERAN TRANDOLAPRIL 1 Oral U 0 2 MG TABLET QD
101493835 10149383 24 C PRERAN TRANDOLAPRIL 1 Oral U 0 2 MG TABLET QD
101493835 10149383 25 C CHOLEBINE COLESTILAN CHLORIDE 1 Oral 912 DF U 0 2 DF GRANULES QD
101493835 10149383 26 C SELBEX TEPRENONE 1 Oral 91500 MG U 0 150 MG CAPSULE QD
101493835 10149383 27 C SELBEX TEPRENONE 1 Oral 91500 MG U 0 100 MG CAPSULE QD
101493835 10149383 28 C HANGEKOUBOKUTOU HERBALS 1 Oral 1055 G U 0 5 G GRANULES QD
101493835 10149383 29 C HANGEKOUBOKUTOU HERBALS 1 1055 G U 0 GRANULES
101493835 10149383 30 C NU-LOTAN LOSARTAN POTASSIUM 1 Oral 2450 MG U 0 50 MG TABLET QD
101493835 10149383 31 C ARTIST CARVEDILOL 1 Oral U 0 10 MG TABLET QD
101493835 10149383 32 C ARTIST CARVEDILOL 1 U 0 TABLET
101493835 10149383 33 C OMEPRAL /00661201/ OMEPRAZOLE 1 Oral 530 MG U 0 10 MG GASTRO-RESISTANT TABLET QD
101493835 10149383 34 C OMEPRAL /00661201/ OMEPRAZOLE 1 530 MG U 0 GASTRO-RESISTANT TABLET
101493835 10149383 35 C ZYLORIC ALLOPURINOL 1 Oral U 0 300 MG TABLET QD
101493835 10149383 36 C NOVAMIN /00013301/ PROCHLORPERAZINE MALEATE 1 Oral U 0 5 MG TABLET QD
101493835 10149383 37 C CRAVIT LEVOFLOXACIN 1 Oral U 0 500 MG PER ORAL NOS QD
101493835 10149383 38 C ALLEGRA FEXOFENADINE HYDROCHLORIDE 1 Oral U 0 120 MG PER ORAL NOS QD
101493835 10149383 39 C ALLEGRA FEXOFENADINE HYDROCHLORIDE 1 Oral U 0 120 MG PER ORAL NOS QD
101493835 10149383 40 C ALLEGRA FEXOFENADINE HYDROCHLORIDE 1 Oral U 0 120 MG PER ORAL NOS QD
101493835 10149383 41 C ALBUMIN TANNATE ALBUMIN BOVINETANNIC ACID 1 Oral U 0 3 G PER ORAL NOS QD
101493835 10149383 42 C SODIUM BICARBONATE. SODIUM BICARBONATE 1 Oral U 0 3 G PER ORAL NOS QD
101493835 10149383 43 C MAGNESIUM OXIDE. MAGNESIUM OXIDE 1 Oral U 0 990 MG PER ORAL NOS QD
101493835 10149383 44 C MAGNESIUM OXIDE. MAGNESIUM OXIDE 1 Oral U 0 990 MG PER ORAL NOS QD
101493835 10149383 45 C MAGNESIUM OXIDE. MAGNESIUM OXIDE 1 Oral U 0 990 MG PER ORAL NOS QD
101493835 10149383 46 C PURSENNIDE /00571901/ 2 Oral U 0 12 MG TABLET QD
101493835 10149383 47 C PURSENNIDE /00571901/ 2 Oral U 0 12 MG TABLET QD
101493835 10149383 48 C PURSENNIDE /00571901/ 2 Oral U 0 12 MG TABLET QD
101493835 10149383 49 C Myslee ZOLPIDEM TARTRATE 1 Oral U 0 5 MG TABLET QD
101493835 10149383 50 C GASMOTIN MOSAPRIDE CITRATE 1 Oral U 0 15 MG PER ORAL NOS QD
101493835 10149383 51 C TAKEPRON LANSOPRAZOLE 1 Oral U 0 30 MG ORODISPERSIBLE TABLET QD
101493835 10149383 52 C PARIET RABEPRAZOLE SODIUM 1 Oral U 0 10 MG TABLET QD
101493835 10149383 53 C PRIMPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Oral U 0 5 MG FORMULATION UNKNOWN QD
101493835 10149383 54 C IDAMYCIN IDARUBICIN HYDROCHLORIDE 1 Unknown U 0 19 MG INJECTION QD
101493835 10149383 55 C CYLOCIDE CYTARABINE 1 Unknown U 0 160 MG INJECTION QD
101493835 10149383 56 C PL ACETAMINOPHENCAFFEINEPROMETHAZINESALICYLAMIDE 1 Unknown U 0 1 G FORMULATION UNKNOWN TID
101493835 10149383 57 C Cefzon CEFDINIR 1 Unknown U 0 100 MG FORMULATION UNKNOWN TID
101493835 10149383 58 C SP TROCHE DEQUALINIUM CHLORIDE 1 Unknown U 0 1 DF LOZENGE TID
101493835 10149383 59 C SP TROCHE DEQUALINIUM CHLORIDE 1 Unknown U 0 1 DF LOZENGE TID
101493835 10149383 60 C LIDOMEX PREDNISOLONE VALERATE ACETATE 1 Unknown UNK UNK, UNKNOWN FREQ. U 0 OINTMENT
101493835 10149383 61 C ZEFNART 2 Unknown UNK UNK, UNKNOWN FREQ. U 0 CREAM
101493835 10149383 62 C VOLLEY BUTENAFINE HYDROCHLORIDE 1 Unknown UNK UNK, UNKNOWN FREQ. U 0 CUTANEOUS SOLUTION
101493835 10149383 63 C RESTAMIN /00000401/ 2 Unknown UNK UNK, UNKNOWN FREQ. U 0 OINTMENT

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
101493835 10149383 1 Lupus nephritis
101493835 10149383 4 Lupus nephritis
101493835 10149383 11 Dermatophytosis of nail
101493835 10149383 12 Prophylaxis
101493835 10149383 14 Prophylaxis
101493835 10149383 15 Prophylaxis
101493835 10149383 16 Product used for unknown indication
101493835 10149383 22 Prophylaxis
101493835 10149383 25 Prophylaxis
101493835 10149383 26 Abdominal discomfort
101493835 10149383 27 Prophylaxis
101493835 10149383 28 Anxiety disorder
101493835 10149383 29 Prophylaxis
101493835 10149383 30 Hypertension
101493835 10149383 31 Hypertension
101493835 10149383 32 Hypertrophic cardiomyopathy
101493835 10149383 33 Prophylaxis
101493835 10149383 34 Abdominal discomfort
101493835 10149383 35 Hyperuricaemia
101493835 10149383 36 Nausea
101493835 10149383 37 Prophylaxis
101493835 10149383 38 Rhinitis allergic
101493835 10149383 39 Rash
101493835 10149383 41 Diarrhoea
101493835 10149383 42 Gastritis prophylaxis
101493835 10149383 43 Constipation
101493835 10149383 46 Constipation
101493835 10149383 49 Insomnia
101493835 10149383 50 Prophylaxis
101493835 10149383 51 Prophylaxis
101493835 10149383 52 Prophylaxis
101493835 10149383 53 Nausea
101493835 10149383 54 Acute myeloid leukaemia
101493835 10149383 55 Acute myeloid leukaemia
101493835 10149383 56 Pharyngitis
101493835 10149383 57 Pharyngitis
101493835 10149383 58 Pharyngitis
101493835 10149383 60 Eczema
101493835 10149383 61 Dermatophytosis of nail
101493835 10149383 62 Dermatophytosis of nail
101493835 10149383 63 Rash

Outcome of event

Event ID CASEID OUTC COD
101493835 10149383 OT
101493835 10149383 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
101493835 10149383 Abdominal discomfort
101493835 10149383 Acute myeloid leukaemia
101493835 10149383 Angiolipoma
101493835 10149383 Anxiety disorder
101493835 10149383 Conjunctival haemorrhage
101493835 10149383 Constipation
101493835 10149383 Dermatophytosis of nail
101493835 10149383 Diarrhoea
101493835 10149383 Dizziness
101493835 10149383 Eczema
101493835 10149383 Erythema
101493835 10149383 Hepatosplenic abscess
101493835 10149383 Hypertension
101493835 10149383 Hypertrophic cardiomyopathy
101493835 10149383 Hyperuricaemia
101493835 10149383 Insomnia
101493835 10149383 Myalgia
101493835 10149383 Nausea
101493835 10149383 Pancytopenia
101493835 10149383 Peripheral swelling
101493835 10149383 Pharyngitis
101493835 10149383 Rash
101493835 10149383 Rhinitis allergic

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
101493835 10149383 1 20080428 20081021 0
101493835 10149383 2 20081022 20090520 0
101493835 10149383 3 20090521 20100419 0
101493835 10149383 4 20081126 0
101493835 10149383 5 20081127 20090408 0
101493835 10149383 6 20090409 20090520 0
101493835 10149383 7 20090521 20090722 0
101493835 10149383 8 20090521 20090722 0
101493835 10149383 9 20090723 20091125 0
101493835 10149383 10 20091126 0
101493835 10149383 11 20080718 20090401 0
101493835 10149383 12 20100209 0
101493835 10149383 13 20100306 0
101493835 10149383 16 20081022 0
101493835 10149383 17 20081023 20081126 0
101493835 10149383 18 20090128 20090624 0
101493835 10149383 19 20091125 20100125 0
101493835 10149383 20 20100126 20100420 0
101493835 10149383 21 20100421 0
101493835 10149383 22 20081217 0
101493835 10149383 23 20081218 0
101493835 10149383 24 20081228 0
101493835 10149383 25 20081027 20100222 0
101493835 10149383 26 20080526 20100125 0
101493835 10149383 27 20100126 20100201 0
101493835 10149383 28 20081126 20090624 0
101493835 10149383 30 20090128 20090317 0
101493835 10149383 31 20090424 0
101493835 10149383 33 20090502 20090623 0
101493835 10149383 35 20100202 20100301 0
101493835 10149383 36 20100202 20100202 0
101493835 10149383 37 20100203 20100217 0
101493835 10149383 38 20100210 20100223 0
101493835 10149383 39 20100317 20100331 0
101493835 10149383 40 20100427 0
101493835 10149383 41 20100209 20100220 0
101493835 10149383 42 20100202 20100301 0
101493835 10149383 43 20100208 20100215 0
101493835 10149383 44 20100224 20100309 0
101493835 10149383 45 20100317 0
101493835 10149383 46 20100220 20100227 0
101493835 10149383 47 20100303 20100310 0
101493835 10149383 48 20100316 20100323 0
101493835 10149383 49 20100322 20100322 0
101493835 10149383 50 20100409 20100412 0
101493835 10149383 51 20100412 20100421 0
101493835 10149383 52 20100422 0
101493835 10149383 53 20100414 20100417 0
101493835 10149383 54 20100202 20100204 0
101493835 10149383 55 20100202 20100208 0
101493835 10149383 56 2008 2008 0
101493835 10149383 57 2008 2008 0
101493835 10149383 58 2008 2008 0
101493835 10149383 59 2008 2008 0