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
114806073 11480607 3 F 200807 20160830 20150909 20160907 EXP JP-ASTELLAS-2009JP002626 ASTELLAS 43.38 YR F Y 57.00000 KG 20160907 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
114806073 11480607 1 PS TACROLIMUS. TACROLIMUS 1 Oral 6282 MG N 50708 1.5 MG CAPSULE QD
114806073 11480607 2 SS TACROLIMUS. TACROLIMUS 1 Oral 6282 MG Y N 50708 3 MG CAPSULE QD
114806073 11480607 3 SS TACROLIMUS. TACROLIMUS 1 Oral 6282 MG U N 50708 3 MG CAPSULE QD
114806073 11480607 4 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 10 MG TABLET QD
114806073 11480607 5 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 9.5 MG TABLET QD
114806073 11480607 6 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 10 MG TABLET QD
114806073 11480607 7 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 9 MG TABLET QD
114806073 11480607 8 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 8 MG TABLET QD
114806073 11480607 9 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 20 MG TABLET QD
114806073 11480607 10 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 17.5 MG TABLET QD
114806073 11480607 11 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 15 MG TABLET QD
114806073 11480607 12 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 12.5 MG TABLET QD
114806073 11480607 13 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 10 MG TABLET QD
114806073 11480607 14 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 9 MG TABLET QD
114806073 11480607 15 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG U N 0 8 MG TABLET QD
114806073 11480607 16 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG U N 0 20 MG TABLET QD
114806073 11480607 17 SS PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 16813 MG N 0 10 MG TABLET QD
114806073 11480607 18 SS BAYASPIRIN ASPIRIN 1 Oral U 0 100 MG GASTRO-RESISTANT TABLET QD
114806073 11480607 19 SS DIOVAN VALSARTAN 1 Oral 80 MG U 0 40 MG TABLET QD
114806073 11480607 20 SS BLOPRESS CANDESARTAN CILEXETIL 1 Oral 254 MG U 0 2 MG TABLET QD
114806073 11480607 21 SS BREDININ MIZORIBINE 1 Oral 9955 MG U 0 150 MG TABLET QD
114806073 11480607 22 SS BREDININ MIZORIBINE 1 Oral 9955 MG U 0 350 MG TABLET QOD
114806073 11480607 23 SS BREDININ MIZORIBINE 1 Oral 9955 MG U 0 400 MG TABLET QOD
114806073 11480607 24 SS BREDININ MIZORIBINE 1 Oral 9955 MG U 0 600 MG TABLET QOD
114806073 11480607 25 SS IMURAN AZATHIOPRINE 1 Oral 52500 MG N 0 50 MG TABLET QD
114806073 11480607 26 SS IMURAN AZATHIOPRINE 1 Oral 52500 MG Y N 0 75 MG TABLET QD
114806073 11480607 27 SS IMURAN AZATHIOPRINE 1 Oral 52500 MG U N 0 75 MG TABLET QD
114806073 11480607 28 SS IMURAN AZATHIOPRINE 1 Oral 52500 MG U N 0 100 MG TABLET QD
114806073 11480607 29 SS IMURAN AZATHIOPRINE 1 Oral 52500 MG U N 0 50 MG TABLET QD
114806073 11480607 30 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 18 DF U 0 1 DF TABLET /wk
114806073 11480607 31 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 18 DF U 0 1 DF TABLET TIW
114806073 11480607 32 SS BAKTAR SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 18 DF U 0 1 DF TABLET QD
114806073 11480607 33 SS ERYTHROCIN /00020901/ ERYTHROMYCIN ETHYLSUCCINATE 1 Oral 73500 MG Y 0 600 MG PER ORAL NOS QD
114806073 11480607 34 SS ERYTHROCIN /00020901/ ERYTHROMYCIN ETHYLSUCCINATE 1 Oral 73500 MG Y 0 900 MG PER ORAL NOS QD
114806073 11480607 35 SS ERYTHROCIN /00020901/ ERYTHROMYCIN ETHYLSUCCINATE 1 Oral 73500 MG Y 0 1200 MG PER ORAL NOS QD
114806073 11480607 36 C PREDNISOLONE SODIUM SUCCINATE PREDNISOLONE SODIUM SUCCINATE 1 Unknown U 0 20 MG INJECTION QD
114806073 11480607 37 C HYDROCORTONE /00028603/ HYDROCORTISONE SODIUM PHOSPHATE 1 Unknown U 0 100 MG INJECTION QD
114806073 11480607 38 C ONEALFA ALFACALCIDOL 1 Oral U 0 1 UG PER ORAL NOS QD
114806073 11480607 39 C GLAKAY MENATETRENONE 1 Oral U 0 30 MG CAPSULE QD
114806073 11480607 40 C ACINON NIZATIDINE 1 Oral U 0 150 MG TABLET QD
114806073 11480607 41 C MAGNESIUM OXIDE. MAGNESIUM OXIDE 1 Oral U 0 500 MG PER ORAL NOS QD
114806073 11480607 42 C Myslee ZOLPIDEM TARTRATE 1 Oral U 0 10 MG TABLET QD
114806073 11480607 43 C BIOFERMIN BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS 1 Oral U 0 3 DF TABLET QD
114806073 11480607 44 C BIOFERMIN BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS 1 Oral UNK, AS NEEDED U 0 TABLET
114806073 11480607 45 C SELTOUCH FELBINAC 1 Topical UNK, AS NEEDED U 0 TAPE (INCLUDING POULTICE)
114806073 11480607 46 C SELTOUCH FELBINAC 1 Topical UNK, AS NEEDED U 0 TAPE (INCLUDING POULTICE)
114806073 11480607 47 C METHYCOBAL METHYLCOBALAMIN 1 Oral 492 MG U 0 1.5 MG PER ORAL NOS QD
114806073 11480607 48 C LIPITOR ATORVASTATIN CALCIUM 1 Oral 1050 MG U 0 5 MG TABLET QD
114806073 11480607 49 C ACECOL TEMOCAPRIL HYDROCHLORIDE 1 Oral 170 MG U 0 2 MG TABLET QD
114806073 11480607 50 C ACECOL TEMOCAPRIL HYDROCHLORIDE 1 Oral 170 MG U 0 4 MG TABLET QD
114806073 11480607 51 C CALNATE 2 Oral U 0 5 MG TABLET QD
114806073 11480607 52 C CALNATE 2 Oral U 0 10 MG TABLET QD
114806073 11480607 53 C PERSANTINE DIPYRIDAMOLE 1 Oral U 0 300 MG MODIFIED-RELEASE CAPSULE, HARD QD
114806073 11480607 54 C HOKUNALIN /00654901/ TULOBUTEROL 1 Transdermal 74 MG U 0 2 MG TAPE (INCLUDING POULTICE) QD
114806073 11480607 55 C HOKUNALIN /00654901/ TULOBUTEROL 1 Transdermal UNK, UNKNOWN FREQ. 74 MG U 0 TAPE (INCLUDING POULTICE)
114806073 11480607 56 C MEPTIN PROCATEROL HYDROCHLORIDE 1 Respiratory (inhalation) UNK, AS NEEDED U 0 AEROSOL (SPRAY AND INHALATION)
114806073 11480607 57 C ZITHROMAC AZITHROMYCIN DIHYDRATE 1 Oral 1500 MG U 0 500 MG PER ORAL NOS QD
114806073 11480607 58 C MEDICON /00048102/ DEXTROMETHORPHAN HYDROBROMIDE 1 Oral 135 MG U 0 45 MG PER ORAL NOS QD
114806073 11480607 59 C LOXONIN LOXOPROFEN SODIUM 1 Oral 840 MG U 0 120 MG PER ORAL NOS QD
114806073 11480607 60 C LOXONIN LOXOPROFEN SODIUM 1 Oral UNK, AS NEEDED 840 MG U 0 PER ORAL NOS
114806073 11480607 61 C ULGUT /00963802/ 2 Oral U 0 400 MG CAPSULE QD
114806073 11480607 62 C ALESION EPINASTINE HYDROCHLORIDE 1 Oral U 0 20 MG PER ORAL NOS
114806073 11480607 63 C ROZEREM RAMELTEON 1 Oral U 0 4 MG TABLET QD
114806073 11480607 64 C EDIROL ELDECALCITOL 1 Oral 0.75 ?G, ONCE DAILY U 0 .75 UG CAPSULE QD
114806073 11480607 65 C DERMOVATE CLOBETASOL 1 Topical UNK, TWICE DAILY U 0 LOTION (EXCEPT LOTION FOR EYE) BID
114806073 11480607 66 C ANTEBATE BETAMETHASONE DIPROPIONATE 1 Topical UNK, TWICE DAILY U 0 OINTMENT BID
114806073 11480607 67 C LOCOID HYDROCORTISONE BUTYRATE 1 Topical UNK, TWICE DAILY U 0 OINTMENT BID
114806073 11480607 68 C RECALBON MINODRONIC ACID 1 Oral U 0 50 MG TABLET /month
114806073 11480607 69 C MAGMITT MAGNESIUM OXIDE 1 Oral UNK, AS NEEDED U 0 TABLET
114806073 11480607 70 C SUMILU FELBINAC 1 Topical UNK, AS NEEDED U 0 OINTMENT
114806073 11480607 71 C RINDERON DP 2 Topical UNK, TWICE DAILY U 0 CUTANEOUS SOLUTION BID
114806073 11480607 72 C PL GRAN. UNSPECIFIED INGREDIENT 1 Oral UNK UNK, UNKNOWN FREQ. 24 G U 0 GRANULES
114806073 11480607 73 C PL GRAN. UNSPECIFIED INGREDIENT 1 Oral 24 G U 0 3 G GRANULES QD
114806073 11480607 74 C KLARICID /00984601/ CLARITHROMYCIN 1 Oral 26400 MG U 0 200 MG PER ORAL NOS QD
114806073 11480607 75 C KLARICID /00984601/ CLARITHROMYCIN 1 Oral 26400 MG U 0 400 MG PER ORAL NOS QD
114806073 11480607 76 C DEPAS ETIZOLAM 1 Oral UNK, AS NEEDED U 0 PER ORAL NOS
114806073 11480607 77 C ALFAROL ALFACALCIDOL 1 Oral 0.5 ?G, ONCE DAILY U 0 .5 UG PER ORAL NOS QD
114806073 11480607 78 C LUNESTA ESZOPICLONE 1 Oral UNK UNK, AS NEEDED U 0 PER ORAL NOS
114806073 11480607 79 C SHAKUYAKUKANZOTO HERBALS 1 Oral U 0 1 DF PER ORAL NOS

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
114806073 11480607 1 Lupus nephritis
114806073 11480607 4 Lupus nephritis
114806073 11480607 18 Prophylaxis
114806073 11480607 19 Lupus nephritis
114806073 11480607 20 Lupus nephritis
114806073 11480607 21 Lupus nephritis
114806073 11480607 25 Lupus nephritis
114806073 11480607 30 Pneumocystis jirovecii pneumonia
114806073 11480607 33 Drug level decreased
114806073 11480607 36 Lupus nephritis
114806073 11480607 37 Lupus nephritis
114806073 11480607 38 Prophylaxis
114806073 11480607 39 Prophylaxis
114806073 11480607 40 Prophylaxis
114806073 11480607 41 Product used for unknown indication
114806073 11480607 42 Insomnia
114806073 11480607 43 Product used for unknown indication
114806073 11480607 45 Product used for unknown indication
114806073 11480607 47 Sciatica
114806073 11480607 48 Hypercholesterolaemia
114806073 11480607 49 Lupus nephritis
114806073 11480607 51 Lupus nephritis
114806073 11480607 53 Lupus nephritis
114806073 11480607 54 Asthma
114806073 11480607 56 Asthma
114806073 11480607 57 Pharyngitis
114806073 11480607 58 Pharyngitis
114806073 11480607 59 Back pain
114806073 11480607 61 Prophylaxis
114806073 11480607 62 Systemic lupus erythematosus
114806073 11480607 63 Product used for unknown indication
114806073 11480607 64 Prophylaxis
114806073 11480607 65 Systemic lupus erythematosus
114806073 11480607 66 Systemic lupus erythematosus
114806073 11480607 67 Systemic lupus erythematosus
114806073 11480607 68 Prophylaxis
114806073 11480607 69 Product used for unknown indication
114806073 11480607 70 Product used for unknown indication
114806073 11480607 71 Systemic lupus erythematosus
114806073 11480607 72 Asthma
114806073 11480607 73 Nasopharyngitis
114806073 11480607 74 Drug level decreased
114806073 11480607 76 Neurosis
114806073 11480607 77 Prophylaxis
114806073 11480607 78 Product used for unknown indication
114806073 11480607 79 Muscle spasms

Outcome of event

Event ID CASEID OUTC COD
114806073 11480607 OT
114806073 11480607 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
114806073 11480607 Anaemia macrocytic
114806073 11480607 Asthma
114806073 11480607 Back pain
114806073 11480607 Colitis ischaemic
114806073 11480607 Dizziness
114806073 11480607 Enterocolitis viral
114806073 11480607 Hypercholesterolaemia
114806073 11480607 Muscle spasms
114806073 11480607 Nasopharyngitis
114806073 11480607 Nausea
114806073 11480607 Neurosis
114806073 11480607 Pharyngitis
114806073 11480607 Renal impairment Renal impairment
114806073 11480607 Sciatica
114806073 11480607 Systemic lupus erythematosus

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
114806073 11480607 1 20070807 20070905 0
114806073 11480607 2 20070906 20130515 0
114806073 11480607 3 20130525 0
114806073 11480607 4 20080910 0
114806073 11480607 5 20080911 20100813 0
114806073 11480607 6 20100814 20111215 0
114806073 11480607 7 20111216 20120404 0
114806073 11480607 8 20120405 20120527 0
114806073 11480607 9 20120528 20120620 0
114806073 11480607 10 20120621 20120704 0
114806073 11480607 11 20120705 20120801 0
114806073 11480607 12 20120802 20120906 0
114806073 11480607 13 20120907 20121011 0
114806073 11480607 14 20121012 20130117 0
114806073 11480607 15 20130118 20130515 0
114806073 11480607 16 20130521 20130523 0
114806073 11480607 17 20130524 0
114806073 11480607 19 20090618 20090619 0
114806073 11480607 20 20081120 20090326 0
114806073 11480607 21 20100204 0
114806073 11480607 22 20100205 20100610 0
114806073 11480607 23 20100611 20100901 0
114806073 11480607 24 20100902 20120614 0
114806073 11480607 25 20120615 20120704 0
114806073 11480607 26 20120705 20130514 0
114806073 11480607 27 20130525 20130717 0
114806073 11480607 28 20130718 20140313 0
114806073 11480607 29 20140313 0
114806073 11480607 30 20131018 20131114 0
114806073 11480607 31 20131115 20131212 0
114806073 11480607 32 20131213 0
114806073 11480607 33 20140314 20140410 0
114806073 11480607 34 20140411 20140612 0
114806073 11480607 35 20150409 0
114806073 11480607 36 20130517 20130520 0
114806073 11480607 37 20130516 20130516 0
114806073 11480607 38 20120404 0
114806073 11480607 39 20120209 0
114806073 11480607 42 20150204 0
114806073 11480607 43 20080703 0
114806073 11480607 45 20080801 0
114806073 11480607 46 20121114 20130919 0
114806073 11480607 47 20080705 20090528 0
114806073 11480607 48 20081120 20090617 0
114806073 11480607 49 20090423 20090521 0
114806073 11480607 50 20090522 20090618 0
114806073 11480607 51 20090623 0
114806073 11480607 53 20090813 0
114806073 11480607 54 20101019 20101124 0
114806073 11480607 56 20101019 20101124 0
114806073 11480607 57 20100406 20100408 0
114806073 11480607 58 20100406 20100408 0
114806073 11480607 59 20110727 20110802 0
114806073 11480607 60 20121114 0
114806073 11480607 61 20110727 20110802 0
114806073 11480607 62 20120405 20120524 0
114806073 11480607 63 20120405 20120414 0
114806073 11480607 64 20120405 20140807 0
114806073 11480607 65 20120524 20120802 0
114806073 11480607 66 20120524 20120802 0
114806073 11480607 67 20120524 20120802 0
114806073 11480607 68 20121115 0
114806073 11480607 70 20120314 0
114806073 11480607 71 20120628 0
114806073 11480607 73 20130906 20130913 0
114806073 11480607 74 20140104 20140109 0
114806073 11480607 75 20140110 20140313 0
114806073 11480607 76 20140109 0
114806073 11480607 77 20140808 0
114806073 11480607 78 20150205 0
114806073 11480607 79 20140612 0