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
125216223 12521622 3 F 20160513 20160726 20160701 20160804 EXP PHHY2016CN087882 NOVARTIS 52.37 YR F Y 59.70000 KG 20160804 MD CN CN

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
125216223 12521622 1 PS MYFORTIC MYCOPHENOLATE SODIUM 1 Oral 1440 MG, QD 23040 MG 50791 1440 MG QD
125216223 12521622 2 SS MYFORTIC MYCOPHENOLATE SODIUM 1 Oral 720 MG, QD 23040 MG 50791 720 MG QD
125216223 12521622 3 SS SIMULECT BASILIXIMAB 1 Intravenous (not otherwise specified) 20 MG, QD 20 MG 0 20 MG QD
125216223 12521622 4 SS SIMULECT BASILIXIMAB 1 Intravenous (not otherwise specified) 20 MG, QD 20 MG 0 20 MG QD
125216223 12521622 5 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Unknown 600 MG, QD 1500 MG Y 0 600 MG QD
125216223 12521622 6 SS METHYLPREDNISOLONE. METHYLPREDNISOLONE 1 Unknown 500 MG, QD 1500 MG Y 0 500 MG QD
125216223 12521622 7 SS PREDNISONE. PREDNISONE 1 Unknown 80 MG, QD 80 MG 0 80 MG TABLET QD
125216223 12521622 8 SS PREDNISONE. PREDNISONE 1 Unknown 60 MG, QD 80 MG 0 60 MG TABLET QD
125216223 12521622 9 SS PREDNISONE. PREDNISONE 1 Unknown 40 MG, QD 80 MG 0 40 MG TABLET QD
125216223 12521622 10 SS PREDNISONE. PREDNISONE 1 Unknown 20 MG, QD 80 MG 0 20 MG TABLET QD
125216223 12521622 11 SS PREDNISONE. PREDNISONE 1 Unknown 10 MG, QD 80 MG 0 10 MG TABLET QD
125216223 12521622 12 SS TACROLIMUS. TACROLIMUS 1 Unknown 2 MG, BID 16 MG 0 2 MG CAPSULE BID
125216223 12521622 13 SS TACROLIMUS. TACROLIMUS 1 Unknown 1 MG, BID 16 MG 0 1 MG CAPSULE BID
125216223 12521622 14 SS TACROLIMUS. TACROLIMUS 1 Unknown 3 MG, BID 16 MG 0 3 MG CAPSULE BID
125216223 12521622 15 SS TACROLIMUS. TACROLIMUS 1 Unknown 3 MG, BID 16 MG 0 3 MG CAPSULE BID
125216223 12521622 16 SS TACROLIMUS. TACROLIMUS 1 Unknown 1 MG, BID 16 MG 0 1 MG CAPSULE BID
125216223 12521622 17 C GLUTATHIONE GLUTATHIONE 1 Intravenous (not otherwise specified) 1.8 G, QD Y 0 1.8 G INJECTION QD
125216223 12521622 18 C ISOSORBIDE MONONITRATE. ISOSORBIDE MONONITRATE 1 Oral 30 MG, QD 450 MG 0 30 MG TABLET QD
125216223 12521622 19 C ISOSORBIDE MONONITRATE. ISOSORBIDE MONONITRATE 1 Oral 30 MG, QD 450 MG 0 30 MG TABLET QD
125216223 12521622 20 C ISOSORBIDE MONONITRATE. ISOSORBIDE MONONITRATE 1 450 MG 0 TABLET
125216223 12521622 21 C ZYBAN BUPROPION HYDROCHLORIDE 1 Unknown 30 MG, QD U 0 30 MG QD
125216223 12521622 22 C TARTARIC ACID TARTARIC ACID 1 Unknown U 0
125216223 12521622 23 C METOPROLOL. METOPROLOL 1 Unknown 25 MG, BID U 0 25 MG BID
125216223 12521622 24 C AMLODIPINE AMLODIPINE BESYLATE 1 Unknown 2.5 MG, BID U 0 2.5 MG BID
125216223 12521622 25 C DILTIAZEM HYDROCHLORIDE. DILTIAZEM HYDROCHLORIDE 1 Unknown 30 MG, BID U 0 30 MG BID
125216223 12521622 26 C DILTIAZEM HYDROCHLORIDE. DILTIAZEM HYDROCHLORIDE 1 Oral 30 MG, BID 660 MG 0 30 MG TABLET BID
125216223 12521622 27 C DILTIAZEM HYDROCHLORIDE. DILTIAZEM HYDROCHLORIDE 1 Oral 30 MG, BID 660 MG 0 30 MG TABLET BID
125216223 12521622 28 C AMBROXOL HYDROCHLORIDE AMBROXOL HYDROCHLORIDE 1 Respiratory (inhalation) 30 MG, BID 360 MG Y 0 30 MG INJECTION BID
125216223 12521622 29 C AMBROXOL HYDROCHLORIDE AMBROXOL HYDROCHLORIDE 1 Intravenous (not otherwise specified) 30 MG, BID 360 MG Y 0 30 MG INJECTION BID
125216223 12521622 30 C AMBROXOL HYDROCHLORIDE AMBROXOL HYDROCHLORIDE 1 Respiratory (inhalation) 30 MG, BID 360 MG Y 0 30 MG INJECTION BID
125216223 12521622 31 C AMOXICILLIN SODIUM AMOXICILLIN SODIUM 1 Intravenous (not otherwise specified) 1.2 G, BID 19.2000008 G Y 0 1.2 G INJECTION BID
125216223 12521622 32 C AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLINCLAVULANATE POTASSIUM 1 Intravenous (not otherwise specified) 1.2 G, BID 21.6000004 G Y 0 1.2 G BID
125216223 12521622 33 C ASPIRIN. ASPIRIN 1 Oral 100 MG, QD 0 100 MG TABLET QD
125216223 12521622 34 C BICYCLOL BICYCLOL 1 Oral 25 MG, TID Y 0 25 MG TID
125216223 12521622 35 C COMPOUND AMINO ACIDS 2 Intravenous (not otherwise specified) 250 ML, BID 2000 ML Y 0 250 ML BID
125216223 12521622 36 C COMPOUND SULFAMETHOXAZOLE 2 Oral 1 DF, BID 0 1 DF TABLET BID
125216223 12521622 37 C DOPAMINE DOPAMINEDOPAMINE HYDROCHLORIDE 1 Unknown 6 MG, 6 ML/HR Y 0 6 MG
125216223 12521622 38 C FENOFIBRATE. FENOFIBRATE 1 Oral 0.2 G, QD Y 0 .2 G QD
125216223 12521622 39 C FUROSEMIDE. FUROSEMIDE 1 Unknown 2 ML, QH 240 ML Y 0 2 ML /hr
125216223 12521622 40 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, QD 240 ML Y 0 20 MG QD
125216223 12521622 41 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, QD 240 ML Y 0 20 MG QD
125216223 12521622 42 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, QD 240 ML Y 0 20 MG QD
125216223 12521622 43 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, QD 240 ML Y 0 20 MG QD
125216223 12521622 44 C FUROSEMIDE. FUROSEMIDE 1 Oral 40 MG, QD 40 MG Y 0 40 MG TABLET QD
125216223 12521622 45 C GANCICLOVIR. GANCICLOVIR 1 Intravenous (not otherwise specified) 300 MG, BID 2400 MG Y 0 300 MG BID
125216223 12521622 46 C GANCICLOVIR. GANCICLOVIR 1 Intravenous (not otherwise specified) 300 MG, BID 2400 MG Y 0 300 MG BID
125216223 12521622 47 C HEPATITIS B HUMAN IMMUNOGLOBULIN 2 Intramuscular 100 IU, QD 100 IU Y 0 100 IU QD
125216223 12521622 48 C HUMAN BLOOD ALBUMIN 2 Intravenous (not otherwise specified) 12.5 G, QD 25 G Y 0 12.5 G QD
125216223 12521622 49 C HUMAN BLOOD ALBUMIN 2 Intravenous (not otherwise specified) 10 G, QD 25 G Y 0 10 G QD
125216223 12521622 50 C INSULIN INSULIN NOS 1 Intravenous (not otherwise specified) 6 IU, QD 6 IU Y 0 6 IU QD
125216223 12521622 51 C LACTULOSE. LACTULOSE 1 Oral 15 ML, QD 30 ML Y 0 15 ML QD
125216223 12521622 52 C LANSOPRAZOLE. LANSOPRAZOLE 1 Oral 30 MG, BID 0 30 MG CAPSULE BID
125216223 12521622 53 C LEVAMLODIPINE BESILATE LEVAMLODIPINE BESYLATE 1 Oral 2.5 MG, QD 22.5 MG 0 2.5 MG QD
125216223 12521622 54 C LEVAMLODIPINE BESILATE LEVAMLODIPINE BESYLATE 1 Oral 2.5 MG, BID 22.5 MG 0 2.5 MG BID
125216223 12521622 55 C LOSARTAN POTASSIUM. LOSARTAN POTASSIUM 1 Oral 0.1 G, BID 0 .1 G BID
125216223 12521622 56 C MAGNESIUM ISOGLYCYRRHIZINATE MAGNESIUM ISOGLYCYRRHIZINATE 1 Intravenous (not otherwise specified) 200 MG, QD Y 0 200 MG QD
125216223 12521622 57 C MANNITOL. MANNITOL 1 Intravenous (not otherwise specified) 125 ML, QD 125 ML Y 0 125 ML QD
125216223 12521622 58 C METOPROLOL TARTRATE. METOPROLOL TARTRATE 1 Oral 6.25 MG, BID 87.5 MG 0 6.25 MG BID
125216223 12521622 59 C METOPROLOL TARTRATE. METOPROLOL TARTRATE 1 Oral 25 MG, QD 87.5 MG 0 25 MG QD
125216223 12521622 60 C METOPROLOL TARTRATE. METOPROLOL TARTRATE 1 Oral 25 MG, QD 87.5 MG 0 25 MG QD
125216223 12521622 61 C OMEPRAZOLE SODIUM OMEPRAZOLE SODIUM 1 Intravenous (not otherwise specified) 40 MG, BID 560 MG Y 0 40 MG BID
125216223 12521622 62 C POTASSIUM CHLORIDE. POTASSIUM CHLORIDE 1 Intravenous (not otherwise specified) 3 G, QD 9 G Y 0 3 G INJECTION QD
125216223 12521622 63 C POTASSIUM CHLORIDE. POTASSIUM CHLORIDE 1 Oral 3 G, QD 3 G Y 0 3 G TABLET QD
125216223 12521622 64 C PROTAMINE SULFATE. PROTAMINE SULFATE 1 Intravenous (not otherwise specified) 50 MG, QD 50 MG Y 0 50 MG QD
125216223 12521622 65 C REDUCED GLUTATHIONE 2 Intravenous (not otherwise specified) 1.8 G, QD 10.8000002 G Y 0 1.8 G QD
125216223 12521622 66 C REDUCED GLUTATHIONE 2 Intravenous (not otherwise specified) 1.8 G, QD 10.8000002 G Y 0 1.8 G QD
125216223 12521622 67 C SALMON CALCITONIN 2 Intravenous (not otherwise specified) 50 IU, QD Y 0 50 IU QD
125216223 12521622 68 C SILYMARIN MILK THISTLE 1 Oral 70 MG, TID Y 0 70 MG CAPSULE TID
125216223 12521622 69 C SIMVASTATIN. SIMVASTATIN 1 Oral 40 MG, QN Y 0 40 MG TABLET
125216223 12521622 70 C SODIUM BICARBONATE. SODIUM BICARBONATE 1 Oral 1 G, TID Y 0 1 G TABLET TID
125216223 12521622 71 C SPIRONOLACTONE. SPIRONOLACTONE 1 Oral 20 MG, QD Y 0 20 MG QD
125216223 12521622 72 C SPIRONOLACTONE. SPIRONOLACTONE 1 Oral 20 MG, QD Y 0 20 MG QD
125216223 12521622 73 C VITAMIN B6 PYRIDOXINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 200 MG, QD 800 MG Y 0 200 MG QD
125216223 12521622 74 C VITAMIN C ASCORBIC ACID 1 Intravenous (not otherwise specified) 2 G, QD 8 G Y 0 2 G QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125216223 12521622 1 Renal transplant
125216223 12521622 2 Prophylaxis against transplant rejection
125216223 12521622 3 Immunosuppressant drug therapy
125216223 12521622 5 Product used for unknown indication
125216223 12521622 7 Prophylaxis against transplant rejection
125216223 12521622 12 Prophylaxis against transplant rejection
125216223 12521622 17 Prophylaxis
125216223 12521622 18 Product used for unknown indication
125216223 12521622 19 Capillary disorder
125216223 12521622 20 Blood pressure increased
125216223 12521622 21 Product used for unknown indication
125216223 12521622 22 Product used for unknown indication
125216223 12521622 23 Product used for unknown indication
125216223 12521622 24 Product used for unknown indication
125216223 12521622 25 Product used for unknown indication
125216223 12521622 26 Blood pressure increased
125216223 12521622 28 Prophylaxis
125216223 12521622 31 Inflammation
125216223 12521622 32 Inflammation
125216223 12521622 33 Coagulopathy
125216223 12521622 34 Liver disorder
125216223 12521622 35 Supplementation therapy
125216223 12521622 36 Inflammation
125216223 12521622 37 Capillary disorder
125216223 12521622 38 Lipids increased
125216223 12521622 39 Polyuria
125216223 12521622 44 Polyuria
125216223 12521622 45 Prophylaxis
125216223 12521622 47 Hepatitis B
125216223 12521622 48 Supplementation therapy
125216223 12521622 50 Infusion
125216223 12521622 51 Constipation
125216223 12521622 52 Gastric disorder
125216223 12521622 53 Blood pressure increased
125216223 12521622 55 Blood pressure increased
125216223 12521622 56 Liver disorder
125216223 12521622 57 Oedema
125216223 12521622 58 Blood pressure increased
125216223 12521622 61 Gastric disorder
125216223 12521622 62 Mineral supplementation
125216223 12521622 63 Mineral supplementation
125216223 12521622 64 Coagulopathy
125216223 12521622 65 Liver disorder
125216223 12521622 67 Mineral supplementation
125216223 12521622 68 Liver disorder
125216223 12521622 69 Lipids increased
125216223 12521622 70 Blood uric acid abnormal
125216223 12521622 71 Swelling
125216223 12521622 72 Polyuria
125216223 12521622 73 Supplementation therapy
125216223 12521622 74 Supplementation therapy

Outcome of event

Event ID CASEID OUTC COD
125216223 12521622 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125216223 12521622 Alanine aminotransferase increased
125216223 12521622 Aspartate aminotransferase increased
125216223 12521622 Blood glucose increased
125216223 12521622 Blood urea increased
125216223 12521622 Blood urine present
125216223 12521622 C-reactive protein increased
125216223 12521622 Haemoglobin decreased
125216223 12521622 Incision site pain
125216223 12521622 Lymphocyte count decreased
125216223 12521622 Neutrophil count increased
125216223 12521622 Protein urine present
125216223 12521622 White blood cell count 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
125216223 12521622 1 20160512 20160530 0
125216223 12521622 2 20160530 0
125216223 12521622 3 20160512 20160512 0
125216223 12521622 4 20160516 20160516 0
125216223 12521622 5 20160512 20160512 0
125216223 12521622 6 20160513 20160515 0
125216223 12521622 7 20160516 20160516 0
125216223 12521622 8 20160517 20160517 0
125216223 12521622 9 20160518 20160518 0
125216223 12521622 10 20160519 20160519 0
125216223 12521622 11 20160519 0
125216223 12521622 12 20160517 20160520 0
125216223 12521622 13 20160603 20160607 0
125216223 12521622 14 20160607 20160610 0
125216223 12521622 15 20160610 20160618 0
125216223 12521622 16 20160618 0
125216223 12521622 17 20160513 20160518 0
125216223 12521622 18 20160513 20160601 0
125216223 12521622 19 20160601 0
125216223 12521622 25 20160513 0
125216223 12521622 26 20160517 20160530 0
125216223 12521622 27 20160607 0
125216223 12521622 28 20160513 20160518 0
125216223 12521622 29 20160513 20160520 0
125216223 12521622 30 20160603 20160609 0
125216223 12521622 31 20160513 20160520 0
125216223 12521622 32 20160512 20160520 0
125216223 12521622 33 20160603 0
125216223 12521622 34 20160601 20160614 0
125216223 12521622 35 20160513 20160516 0
125216223 12521622 36 20160623 0
125216223 12521622 37 20160513 20160518 0
125216223 12521622 38 20160603 20160617 0
125216223 12521622 39 20160513 20160517 0
125216223 12521622 40 20160520 20160520 0
125216223 12521622 41 20160522 20160522 0
125216223 12521622 42 20160525 20160525 0
125216223 12521622 43 20160528 20160528 0
125216223 12521622 44 20160524 20160524 0
125216223 12521622 45 20160524 20160530 0
125216223 12521622 46 20160609 20160623 0
125216223 12521622 47 20160512 20160512 0
125216223 12521622 48 20160512 20160513 0
125216223 12521622 49 20160513 20160520 0
125216223 12521622 50 20160514 20160514 0
125216223 12521622 51 20160519 20160520 0
125216223 12521622 52 20160518 0
125216223 12521622 53 20160516 20160524 0
125216223 12521622 54 20160524 0
125216223 12521622 55 20160626 0
125216223 12521622 56 20160609 20160616 0
125216223 12521622 57 20160512 20160512 0
125216223 12521622 58 20160513 20160519 0
125216223 12521622 59 20160516 20160601 0
125216223 12521622 60 20160601 0
125216223 12521622 61 20160512 20160518 0
125216223 12521622 62 20160513 20160515 0
125216223 12521622 63 20160520 20160520 0
125216223 12521622 64 20160512 20160512 0
125216223 12521622 65 20160513 20160518 0
125216223 12521622 66 20160520 20160617 0
125216223 12521622 67 20160603 20160609 0
125216223 12521622 68 20160601 20160619 0
125216223 12521622 69 20160603 20160617 0
125216223 12521622 70 20160623 0
125216223 12521622 71 20160527 20160530 0
125216223 12521622 72 20160603 20160609 0
125216223 12521622 73 20160513 20160516 0
125216223 12521622 74 20160513 20160516 0