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
103498746 10349874 6 F 20120704 20160907 20140730 20160913 EXP JP-ASTELLAS-2013JP007211 ASTELLAS 62.37 YR F Y 53.00000 KG 20160913 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
103498746 10349874 1 PS TACROLIMUS. TACROLIMUS 1 Oral 5115 MG 50708 3 MG CAPSULE QD
103498746 10349874 2 I TACROLIMUS. TACROLIMUS 1 Oral 5115 MG 50708 3 MG CAPSULE QD
103498746 10349874 3 I TACROLIMUS. TACROLIMUS 1 Oral 5115 MG 50708 2 MG CAPSULE QD
103498746 10349874 4 I TACROLIMUS. TACROLIMUS 1 Oral 5115 MG U 50708 1.5 MG CAPSULE QD
103498746 10349874 5 I TACROLIMUS. TACROLIMUS 1 Oral 5115 MG U 50708 2 MG CAPSULE QD
103498746 10349874 6 I TACROLIMUS. TACROLIMUS 1 Oral 5115 MG U 50708 1 MG CAPSULE QD
103498746 10349874 7 SS Funguard MICAFUNGIN SODIUM 1 Unknown 4500 MG 0 450 MG INJECTION QD
103498746 10349874 8 SS Funguard MICAFUNGIN SODIUM 1 4500 MG 0 INJECTION
103498746 10349874 9 I VFEND VORICONAZOLE 1 Oral 0 800 MG TABLET QD
103498746 10349874 10 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 15 MG PER ORAL NOS QD
103498746 10349874 11 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 12.5 MG PER ORAL NOS QD
103498746 10349874 12 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 10 MG PER ORAL NOS QD
103498746 10349874 13 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 9 MG PER ORAL NOS QD
103498746 10349874 14 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 8 MG PER ORAL NOS QD
103498746 10349874 15 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 7 MG PER ORAL NOS QD
103498746 10349874 16 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 6 MG PER ORAL NOS QD
103498746 10349874 17 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 5 MG PER ORAL NOS QD
103498746 10349874 18 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 4 MG PER ORAL NOS QD
103498746 10349874 19 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 3 MG PER ORAL NOS QD
103498746 10349874 20 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 2.5 MG PER ORAL NOS QD
103498746 10349874 21 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 2 MG PER ORAL NOS QD
103498746 10349874 22 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 30 MG PER ORAL NOS QD
103498746 10349874 23 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 27 MG PER ORAL NOS QD
103498746 10349874 24 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 25 MG PER ORAL NOS QD
103498746 10349874 25 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 40 MG PER ORAL NOS QD
103498746 10349874 26 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 35 MG PER ORAL NOS QD
103498746 10349874 27 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 30 MG PER ORAL NOS QD
103498746 10349874 28 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 25 MG PER ORAL NOS QD
103498746 10349874 29 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 20 MG PER ORAL NOS QD
103498746 10349874 30 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 18 MG PER ORAL NOS QD
103498746 10349874 31 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 17 MG PER ORAL NOS QD
103498746 10349874 32 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 16 MG PER ORAL NOS QD
103498746 10349874 33 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 15 MG PER ORAL NOS QD
103498746 10349874 34 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 14 MG PER ORAL NOS QD
103498746 10349874 35 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 10 MG PER ORAL NOS QD
103498746 10349874 36 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 9 MG PER ORAL NOS QD
103498746 10349874 37 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 8 MG PER ORAL NOS QD
103498746 10349874 38 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 7.5 MG PER ORAL NOS QD
103498746 10349874 39 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 7 MG PER ORAL NOS QD
103498746 10349874 40 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 6 MG PER ORAL NOS QD
103498746 10349874 41 SS PREDNISOLONE. PREDNISOLONE 1 Oral 11145 MG Y 0 5 MG PER ORAL NOS QD
103498746 10349874 42 SS SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE 1 Unknown 4500 MG 0 300 MG INJECTION QD
103498746 10349874 43 SS SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE 1 Unknown 4500 MG 0 300 MG INJECTION QD
103498746 10349874 44 SS SOLU-CORTEF HYDROCORTISONE SODIUM SUCCINATE 1 Unknown 4500 MG 0 300 MG INJECTION QD
103498746 10349874 45 SS PREDNISOLONE SODIUM SUCCINATE PREDNISOLONE SODIUM SUCCINATE 1 Unknown 150 MG 0 50 MG INJECTION QD
103498746 10349874 46 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 84 G 0 4 G PER ORAL NOS QD
103498746 10349874 47 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 84 G 0 1 G PER ORAL NOS QD
103498746 10349874 48 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 84 G 0 4 G PER ORAL NOS QD
103498746 10349874 49 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 84 G 0 1 G PER ORAL NOS QD
103498746 10349874 50 SS MEROPEN /01250501/ MEROPENEM 1 Unknown 12 G 0 3 G INJECTION QD
103498746 10349874 51 SS MEROPEN /01250501/ MEROPENEM 1 12 G 0 INJECTION
103498746 10349874 52 SS VANCOMYCIN /00314402/ VANCOMYCIN 1 Unknown 15 G 0 1.5 G INJECTION QD
103498746 10349874 53 SS VANCOMYCIN /00314402/ VANCOMYCIN 1 15 G 0 INJECTION
103498746 10349874 54 C GASTER FAMOTIDINE 1 Oral U 0 10 MG ORODISPERSIBLE TABLET QD
103498746 10349874 55 C BLOPRESS CANDESARTAN CILEXETIL 1 Oral U 0 8 MG TABLET QD
103498746 10349874 56 C EVISTA RALOXIFENE HYDROCHLORIDE 1 Oral U 0 60 MG TABLET QD
103498746 10349874 57 C LIPOVAS /00848101/ SIMVASTATIN 1 Oral U 0 5 MG TABLET QD
103498746 10349874 58 C ARTIST CARVEDILOL 1 Oral 6620 MG U 0 5 MG TABLET QD
103498746 10349874 59 C ZYLORIC ALLOPURINOL 1 Oral 59600 MG U 0 100 MG TABLET QD
103498746 10349874 60 C TAKEPRON LANSOPRAZOLE 1 Oral U 0 15 MG ORODISPERSIBLE TABLET QD
103498746 10349874 61 C MIYA-BM CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 1 Oral 30 G U 0 3 G FINE GRANULE QD
103498746 10349874 62 C HUMAN NORMAL IMMUNOGLOBULIN HUMAN IMMUNOGLOBULIN G 1 Unknown 15 G U 0 5 G INJECTION QD
103498746 10349874 63 C HUMAN NORMAL IMMUNOGLOBULIN HUMAN IMMUNOGLOBULIN G 1 15 G U 0 INJECTION
103498746 10349874 64 C ROZEREM RAMELTEON 1 Oral U 0 8 MG TABLET QD
103498746 10349874 65 C BIOFERMIN /01617201/ BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS 1 Oral U 0 3 G QD
103498746 10349874 66 C BIOFERMIN /01617201/ BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS 1 U 0
103498746 10349874 67 C LIPIDIL FENOFIBRATE 1 Oral U 0 80 MG PER ORAL NOS QD
103498746 10349874 68 C RHYTHMY RILMAZAFONE HYDROCHLORIDE 1 Oral U 0 2 MG PER ORAL NOS QD
103498746 10349874 69 C HYPEN /00340101/ 2 Oral U 0 400 MG PER ORAL NOS QD
103498746 10349874 70 C LIVALO PITAVASTATIN CALCIUM 1 Oral U 0 1 MG PER ORAL NOS QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
103498746 10349874 1 Lupus nephritis
103498746 10349874 7 Nocardiosis
103498746 10349874 8 Enterobacter pneumonia
103498746 10349874 9 Bronchopulmonary aspergillosis
103498746 10349874 10 Lupus nephritis
103498746 10349874 11 Arthralgia
103498746 10349874 12 Pyrexia
103498746 10349874 13 DNA antibody positive
103498746 10349874 42 Lupus nephritis
103498746 10349874 45 Lupus nephritis
103498746 10349874 46 Nocardiosis
103498746 10349874 47 Pneumonia
103498746 10349874 48 Prophylaxis
103498746 10349874 50 Nocardiosis
103498746 10349874 51 Pneumonia
103498746 10349874 52 Nocardiosis
103498746 10349874 53 Pneumonia
103498746 10349874 54 Prophylaxis
103498746 10349874 55 Product used for unknown indication
103498746 10349874 56 Prophylaxis
103498746 10349874 57 Product used for unknown indication
103498746 10349874 58 Product used for unknown indication
103498746 10349874 59 Product used for unknown indication
103498746 10349874 60 Prophylaxis against gastrointestinal ulcer
103498746 10349874 61 Diarrhoea
103498746 10349874 62 Nocardiosis
103498746 10349874 63 Pneumonia
103498746 10349874 64 Insomnia
103498746 10349874 65 Prophylaxis
103498746 10349874 66 Diarrhoea
103498746 10349874 67 Hyperlipidaemia
103498746 10349874 68 Insomnia
103498746 10349874 69 Arthralgia
103498746 10349874 70 Hyperlipidaemia

Outcome of event

Event ID CASEID OUTC COD
103498746 10349874 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
103498746 10349874 Arthralgia
103498746 10349874 Bronchopulmonary aspergillosis
103498746 10349874 DNA antibody positive
103498746 10349874 Diarrhoea
103498746 10349874 Drug interaction
103498746 10349874 Drug level increased
103498746 10349874 Hyperlipidaemia
103498746 10349874 Insomnia
103498746 10349874 Muscular weakness
103498746 10349874 Nocardiosis
103498746 10349874 Pneumonia
103498746 10349874 Pneumothorax
103498746 10349874 Pyrexia
103498746 10349874 Renal disorder

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
103498746 10349874 1 20080123 20120909 0
103498746 10349874 2 20120921 20121104 0
103498746 10349874 3 20121105 20121209 0
103498746 10349874 4 20121210 20150331 0
103498746 10349874 5 20150401 20151208 0
103498746 10349874 6 20151209 0
103498746 10349874 7 20120911 20120920 0
103498746 10349874 9 20121025 20121125 0
103498746 10349874 10 20080123 20080318 0
103498746 10349874 11 20080319 20080511 0
103498746 10349874 12 20080512 20080916 0
103498746 10349874 13 20080917 20081118 0
103498746 10349874 14 20081119 20090128 0
103498746 10349874 15 20090129 20090422 0
103498746 10349874 16 20090423 20090722 0
103498746 10349874 17 20090723 20100428 0
103498746 10349874 18 20100429 20101027 0
103498746 10349874 19 20101028 20110126 0
103498746 10349874 20 20110127 20110728 0
103498746 10349874 21 20110729 20120703 0
103498746 10349874 22 20120704 20120724 0
103498746 10349874 23 20120725 20120828 0
103498746 10349874 24 20120829 20120910 0
103498746 10349874 25 20120918 20121025 0
103498746 10349874 26 20121026 20121101 0
103498746 10349874 27 20121102 20121108 0
103498746 10349874 28 20121109 20121115 0
103498746 10349874 29 20121116 20121125 0
103498746 10349874 30 20121126 20121226 0
103498746 10349874 31 20121227 20130123 0
103498746 10349874 32 20130124 20130220 0
103498746 10349874 33 20130221 20130320 0
103498746 10349874 34 20130321 20130425 0
103498746 10349874 35 20131004 20140211 0
103498746 10349874 36 20140212 20140415 0
103498746 10349874 37 20140416 20150120 0
103498746 10349874 38 20150121 20150915 0
103498746 10349874 39 20150916 20151027 0
103498746 10349874 40 20151028 20160119 0
103498746 10349874 41 20160120 0
103498746 10349874 42 20120911 20120914 0
103498746 10349874 43 20120919 20120923 0
103498746 10349874 44 20120928 20121004 0
103498746 10349874 45 20120915 20120917 0
103498746 10349874 46 20120913 20130320 0
103498746 10349874 47 20130321 20140114 0
103498746 10349874 48 20140115 20150513 0
103498746 10349874 49 20150514 0
103498746 10349874 50 20120910 20120913 0
103498746 10349874 52 20120911 20120920 0
103498746 10349874 54 20091020 0
103498746 10349874 55 20120912 0
103498746 10349874 56 20120913 0
103498746 10349874 57 20100728 0
103498746 10349874 58 20090129 20120913 0
103498746 10349874 59 20110127 20120913 0
103498746 10349874 60 20120924 0
103498746 10349874 61 20120924 20131022 0
103498746 10349874 62 20120911 20120913 0
103498746 10349874 64 20130318 0
103498746 10349874 65 20131021 0
103498746 10349874 67 20131120 0
103498746 10349874 68 20130318 0
103498746 10349874 69 20131120 20150331 0
103498746 10349874 70 20130318 20131119 0