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
120768633 12076863 3 F 20080716 20160715 20160215 20160721 EXP JP-ASTELLAS-2010JP003595 ASTELLAS 15.00 YR F Y 63.00000 KG 20160721 CN 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
120768633 12076863 1 PS TACROLIMUS. TACROLIMUS 1 Oral 182 MG 50708 1.5 MG CAPSULE QD
120768633 12076863 2 SS TACROLIMUS. TACROLIMUS 1 Oral 182 MG 50708 3 MG CAPSULE QD
120768633 12076863 3 SS TACROLIMUS. TACROLIMUS 1 Oral 182 MG U 50708 4 MG CAPSULE QD
120768633 12076863 4 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG 0 40 MG PER ORAL NOS QD
120768633 12076863 5 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG 0 36 MG PER ORAL NOS QD
120768633 12076863 6 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 12 MG PER ORAL NOS QD
120768633 12076863 7 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 11 MG PER ORAL NOS QD
120768633 12076863 8 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 10 MG PER ORAL NOS QD
120768633 12076863 9 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 9 MG PER ORAL NOS QD
120768633 12076863 10 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 8 MG PER ORAL NOS QD
120768633 12076863 11 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 7 MG PER ORAL NOS QD
120768633 12076863 12 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 6.5 MG PER ORAL NOS QD
120768633 12076863 13 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 6 MG PER ORAL NOS QD
120768633 12076863 14 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 5.5 MG PER ORAL NOS QD
120768633 12076863 15 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 5 MG PER ORAL NOS QD
120768633 12076863 16 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 4.5 MG PER ORAL NOS QD
120768633 12076863 17 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 5 MG PER ORAL NOS QD
120768633 12076863 18 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 10 MG PER ORAL NOS QD
120768633 12076863 19 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 7 MG PER ORAL NOS QD
120768633 12076863 20 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 10 MG PER ORAL NOS QD
120768633 12076863 21 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 9 MG PER ORAL NOS QD
120768633 12076863 22 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 8 MG PER ORAL NOS QD
120768633 12076863 23 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 7 MG PER ORAL NOS QD
120768633 12076863 24 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 6.5 MG PER ORAL NOS QD
120768633 12076863 25 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 6 MG PER ORAL NOS QD
120768633 12076863 26 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 5.5 MG PER ORAL NOS QD
120768633 12076863 27 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 6 MG PER ORAL NOS QD
120768633 12076863 28 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 5 MG PER ORAL NOS QD
120768633 12076863 29 SS PREDNISOLONE. PREDNISOLONE 1 Oral 252 MG U 0 4.5 MG PER ORAL NOS QD
120768633 12076863 30 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG 0 26 MG PER ORAL NOS QD
120768633 12076863 31 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG 0 24 MG PER ORAL NOS QD
120768633 12076863 32 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG 0 22 MG PER ORAL NOS QD
120768633 12076863 33 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG 0 20 MG PER ORAL NOS QD
120768633 12076863 34 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG 0 18 MG PER ORAL NOS QD
120768633 12076863 35 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 16 MG PER ORAL NOS QD
120768633 12076863 36 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 15 MG PER ORAL NOS QD
120768633 12076863 37 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 14 MG PER ORAL NOS QD
120768633 12076863 38 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 13 MG PER ORAL NOS QD
120768633 12076863 39 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 12 MG PER ORAL NOS QD
120768633 12076863 40 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 11 MG PER ORAL NOS QD
120768633 12076863 41 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Oral 1040 MG U 0 10 MG PER ORAL NOS QD
120768633 12076863 42 SS TRAMCET ACETAMINOPHENTRAMADOL 1 Unknown UNK UNK, UNKNOWN FREQ. 0 TABLET
120768633 12076863 43 SS TRAMCET ACETAMINOPHENTRAMADOL 1 Oral 4 TABLETS, ONCE DAILY 0 4 DF TABLET QD
120768633 12076863 44 C NU-LOTAN LOSARTAN POTASSIUM 1 Oral 3075 MG U 0 25 MG TABLET QD
120768633 12076863 45 C NU-LOTAN LOSARTAN POTASSIUM 1 Oral 3075 MG U 0 50 MG TABLET QD
120768633 12076863 46 C NU-LOTAN LOSARTAN POTASSIUM 1 Oral 3075 MG U 0 100 MG TABLET QD
120768633 12076863 47 C NU-LOTAN LOSARTAN POTASSIUM 1 Oral 3075 MG U 0 50 MG TABLET QD
120768633 12076863 48 C MUCOSTA REBAMIPIDE 1 Oral U 0 300 MG TABLET QD
120768633 12076863 49 C PARIET RABEPRAZOLE SODIUM 1 Oral U 0 10 MG TABLET QD
120768633 12076863 50 C SELBEX TEPRENONE 1 Oral U 0 100 MG CAPSULE QD
120768633 12076863 51 C ONEALFA ALFACALCIDOL 1 Oral 0.5 ?G, ONCE DAILY U 0 .5 UG PER ORAL NOS QD
120768633 12076863 52 C BENET RISEDRONATE SODIUM 1 Oral U 0 17.5 MG TABLET /wk
120768633 12076863 53 C WARFARIN WARFARIN 1 Oral U 0 3 MG TABLET QD
120768633 12076863 54 C WARFARIN WARFARIN 1 Oral U 0 3.5 MG TABLET QD
120768633 12076863 55 C WARFARIN WARFARIN 1 Oral U 0 3.5 MG TABLET QD
120768633 12076863 56 C WARFARIN WARFARIN 1 Oral U 0 4 MG TABLET QD
120768633 12076863 57 C WYPAX LORAZEPAM 1 Oral U 0 1.5 MG TABLET QD
120768633 12076863 58 C TRYPTANOL AMITRIPTYLINE 1 Oral 2320 MG U 0 30 MG TABLET QD
120768633 12076863 59 C TRYPTANOL AMITRIPTYLINE 1 Oral 2320 MG U 0 40 MG TABLET QD
120768633 12076863 60 C RIZE CLOTIAZEPAM 1 Oral 405 MG U 0 15 MG PER ORAL NOS QD
120768633 12076863 61 C BACTRAMIN SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 52 DF U 0 1 DF TABLET QD
120768633 12076863 62 C CRESTOR ROSUVASTATIN CALCIUM 1 Oral 205 MG U 0 5 MG TABLET QD
120768633 12076863 63 C LIPOVAS PRAVASTATIN SODIUM 1 Oral U 0 10 MG TABLET QD
120768633 12076863 64 C FOSAMAC ALENDRONATE SODIUM 1 Oral U 0 35 MG TABLET /wk
120768633 12076863 65 C IMURAN AZATHIOPRINE 1 Oral U 0 50 MG TABLET QD
120768633 12076863 66 C IMURAN AZATHIOPRINE 1 Oral U 0 75 MG TABLET QD
120768633 12076863 67 C IMURAN AZATHIOPRINE 1 Oral U 0 50 MG TABLET QD
120768633 12076863 68 C IMURAN AZATHIOPRINE 1 Oral U 0 75 MG TABLET QD
120768633 12076863 69 C IMURAN AZATHIOPRINE 1 Oral U 0 100 MG TABLET QD
120768633 12076863 70 C VOLTAREN DICLOFENAC SODIUM 1 Oral U 0 50 MG TABLET QD
120768633 12076863 71 C VOLTAREN DICLOFENAC SODIUM 1 Oral U 0 75 MG MODIFIED-RELEASE CAPSULE, HARD QD
120768633 12076863 72 C RIVOTRIL CLONAZEPAM 1 Oral 0.5 MG, ONCE DAILY U 0 .5 MG PER ORAL NOS QD
120768633 12076863 73 C LYRICA PREGABALIN 1 Oral UNK UNK, UNKNOWN FREQ. U 0 CAPSULE
120768633 12076863 74 C GASLON IRSOGLADINE MALEATE 1 Oral U 0 4 MG PER ORAL NOS QD
120768633 12076863 75 C GASLON IRSOGLADINE MALEATE 1 Oral U 0 6 MG PER ORAL NOS QD
120768633 12076863 76 C LOXONIN LOXOPROFEN SODIUM 1 Oral U 0 180 MG PER ORAL NOS QD
120768633 12076863 77 C FERROMIA /00023520/ 2 Oral U 0 50 MG PER ORAL NOS QD
120768633 12076863 78 C ENDOXAN /00021102/ CYCLOPHOSPHAMIDE 1 Unknown UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
120768633 12076863 79 C ENDOXAN /00021101/ CYCLOPHOSPHAMIDE 1 Unknown UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
120768633 12076863 80 C BACTRAMIN SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 52 DF U 0 1 DF TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
120768633 12076863 1 Lupus nephritis
120768633 12076863 4 Lupus nephritis
120768633 12076863 5 Pyrexia
120768633 12076863 30 Lupus nephritis
120768633 12076863 42 Osteonecrosis
120768633 12076863 44 Lupus nephritis
120768633 12076863 48 Gastric ulcer
120768633 12076863 49 Gastric ulcer
120768633 12076863 50 Gastric ulcer
120768633 12076863 51 Osteoporosis
120768633 12076863 52 Osteoporosis
120768633 12076863 53 Pulmonary infarction
120768633 12076863 57 Depression
120768633 12076863 58 Depression
120768633 12076863 60 Depression
120768633 12076863 61 Prophylaxis
120768633 12076863 62 Hyperlipidaemia
120768633 12076863 63 Hyperlipidaemia
120768633 12076863 64 Product used for unknown indication
120768633 12076863 65 Lupus nephritis
120768633 12076863 66 Pyrexia
120768633 12076863 70 Osteonecrosis
120768633 12076863 71 Osteonecrosis
120768633 12076863 72 Essential tremor
120768633 12076863 73 Hypoaesthesia
120768633 12076863 74 Product used for unknown indication
120768633 12076863 76 Product used for unknown indication
120768633 12076863 77 Iron deficiency anaemia
120768633 12076863 78 Product used for unknown indication
120768633 12076863 79 Product used for unknown indication
120768633 12076863 80 Prophylaxis

Outcome of event

Event ID CASEID OUTC COD
120768633 12076863 DS

Reactions reported

Event ID CASEID DRUG REC ACT PT
120768633 12076863 Blood immunoglobulin G increased
120768633 12076863 Essential tremor
120768633 12076863 Hypoaesthesia
120768633 12076863 Intentional product use issue
120768633 12076863 Nausea
120768633 12076863 Osteonecrosis
120768633 12076863 Pyrexia

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
120768633 12076863 1 20080515 20080519 0
120768633 12076863 2 20080520 20111120 0
120768633 12076863 3 20111121 0
120768633 12076863 4 20080520 0
120768633 12076863 5 20080521 20080527 0
120768633 12076863 6 20090121 20090217 0
120768633 12076863 7 20090218 20090317 0
120768633 12076863 8 20090318 20090512 0
120768633 12076863 9 20090513 20090616 0
120768633 12076863 10 20090617 20090728 0
120768633 12076863 11 20090729 20090915 0
120768633 12076863 12 20090916 20091020 0
120768633 12076863 13 20091021 20091110 0
120768633 12076863 14 20091111 20100117 0
120768633 12076863 15 20100118 20100214 0
120768633 12076863 16 20100215 20100314 0
120768633 12076863 17 20100315 20100829 0
120768633 12076863 18 20100830 20100926 0
120768633 12076863 19 20100926 20101121 0
120768633 12076863 20 20101122 20110306 0
120768633 12076863 21 20110307 20110410 0
120768633 12076863 22 20110411 20110508 0
120768633 12076863 23 20110509 20110605 0
120768633 12076863 24 20110606 20110703 0
120768633 12076863 25 20110704 20110731 0
120768633 12076863 26 20110801 20111120 0
120768633 12076863 27 20111121 20140107 0
120768633 12076863 28 20140108 20140302 0
120768633 12076863 29 20140303 0
120768633 12076863 30 20080528 20080603 0
120768633 12076863 31 20080604 20080611 0
120768633 12076863 32 20080612 20080618 0
120768633 12076863 33 20080619 20080701 0
120768633 12076863 34 20080702 20080715 0
120768633 12076863 35 20080716 20080819 0
120768633 12076863 36 20080820 20080916 0
120768633 12076863 37 20080917 20081019 0
120768633 12076863 38 20081020 20081118 0
120768633 12076863 39 20081119 20081125 0
120768633 12076863 40 20081126 20081221 0
120768633 12076863 41 20081222 20090120 0
120768633 12076863 42 20080603 0
120768633 12076863 43 20121022 20130726 0
120768633 12076863 44 20080528 20080603 0
120768633 12076863 45 20080604 20080701 0
120768633 12076863 46 20080702 20110410 0
120768633 12076863 47 20110411 20121119 0
120768633 12076863 48 20080819 0
120768633 12076863 49 20080820 0
120768633 12076863 50 20080820 20120212 0
120768633 12076863 52 20090218 20090616 0
120768633 12076863 53 20090120 0
120768633 12076863 54 20090121 20090728 0
120768633 12076863 55 20090729 20090823 0
120768633 12076863 56 20090824 0
120768633 12076863 57 20080916 0
120768633 12076863 58 20080519 0
120768633 12076863 59 20080520 20081019 0
120768633 12076863 60 20080619 20080715 0
120768633 12076863 61 20080526 20090616 0
120768633 12076863 62 20080606 20080819 0
120768633 12076863 63 20080820 20090728 0
120768633 12076863 64 20100118 0
120768633 12076863 65 20101004 20101121 0
120768633 12076863 66 20101122 20101219 0
120768633 12076863 67 20101220 20121118 0
120768633 12076863 68 20121119 20130120 0
120768633 12076863 69 20130121 0
120768633 12076863 70 20100510 20110828 0
120768633 12076863 71 20110829 20121021 0
120768633 12076863 72 20110509 20120605 0
120768633 12076863 73 20110801 0
120768633 12076863 74 20120213 20121225 0
120768633 12076863 75 20121226 0
120768633 12076863 76 20121226 0
120768633 12076863 77 20120625 20130925 0
120768633 12076863 80 20080526 20090616 0