rosuvastatin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antihyperlipidaemic substances, HMG CoA reductase inhibitors 2406 287714-41-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rosuvastatin
  • rosuvastatin calcium
  • crestor
  • rosuvastatin zinc
  • ZD4522
A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.
  • Molecular weight: 481.54
  • Formula: C22H28FN3O6S
  • CLOGP: 1.90
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 3
  • TPSA: 140.92
  • ALOGS: -3.74
  • ROTB: 9

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.19 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 30 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 20 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 11 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.12 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 12, 2003 FDA IPR

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Rhabdomyolysis 820.52 9.69 759 121446 41150 46522707
Myalgia 711.22 9.69 1206 120999 121882 46441975
Blood creatine phosphokinase increased 333.76 9.69 387 121818 27337 46536520
Low density lipoprotein increased 197.53 9.69 147 122058 5853 46558004
Myopathy 195.57 9.69 172 122033 8709 46555148
Maternal exposure during pregnancy 194.17 9.69 21 122184 102528 46461329
Exposure during pregnancy 161.33 9.69 42 122163 108170 46455687
Completed suicide 136.58 9.69 109 122096 145811 46418046
Angina pectoris 133.09 9.69 246 121959 26529 46537328
Death 128.81 9.69 449 121756 335099 46228758
High density lipoprotein decreased 123.84 9.69 70 122135 1724 46562133
Blood triglycerides increased 110.33 9.69 145 122060 11638 46552219
Treatment failure 109.96 9.69 53 122152 93034 46470823
Acute kidney injury 101.23 9.69 1002 121203 234853 46329004
Muscle spasms 99.93 9.69 607 121598 122506 46441351
Sedation complication 99.68 9.69 80 122125 3565 46560292
Blood cholesterol increased 98.23 9.69 278 121927 39735 46524122
Systemic lupus erythematosus 83.48 9.69 33 122172 65147 46498710
Drug ineffective 82.38 9.69 1265 120940 676573 45887284
Creatinine renal clearance decreased 82.24 9.69 96 122109 6824 46557033
Pemphigus 81.41 9.69 11 122194 45263 46518594
Toxicity to various agents 81.36 9.69 283 121922 211483 46352374
Drug abuse 79.74 9.69 33 122172 63375 46500482
Liver disorder 73.78 9.69 240 121965 37006 46526851
Immune-mediated myositis 72.18 9.69 39 122166 877 46562980
Orthostatic hypotension 69.21 9.69 180 122025 24478 46539379
Cognitive disorder 62.83 9.69 226 121979 36657 46527200
Abortion spontaneous 61.20 9.69 19 122186 43627 46520230
Renal failure 58.95 9.69 503 121702 113091 46450766
Blood glucose increased 58.34 9.69 355 121850 71658 46492199
Dyslipidaemia 57.89 9.69 72 122133 5468 46558389
Blood pressure systolic increased 56.57 9.69 185 122020 28602 46535255
Dermatitis allergic 54.29 9.69 109 122096 12494 46551363
Device expulsion 53.77 9.69 5 122200 27537 46536320
Pregnancy 52.78 9.69 5 122200 27132 46536725
Contraindicated product administered 52.41 9.69 80 122125 79867 46483990
Diabetic ketoacidosis 52.20 9.69 134 122071 18076 46545781
Blood pressure increased 51.75 9.69 533 121672 126133 46437724
Seizure 50.26 9.69 160 122045 122894 46440963
Febrile neutropenia 49.30 9.69 109 122096 94518 46469339
Low density lipoprotein decreased 48.95 9.69 19 122186 190 46563667
Disease progression 46.88 9.69 106 122099 91194 46472663
Rheumatoid arthritis 46.72 9.69 403 121802 239812 46324045
Asthenia 45.76 9.69 1101 121104 309974 46253883
Intentional overdose 45.51 9.69 62 122143 64882 46498975
Pain in extremity 44.77 9.69 937 121268 257743 46306114
Euglycaemic diabetic ketoacidosis 44.29 9.69 39 122166 1977 46561880
Hepatitis 43.93 9.69 184 122021 32031 46531826
Pancreatitis 43.89 9.69 228 121977 43399 46520458
Muscular weakness 43.15 9.69 398 121807 91446 46472411
Foetal acidosis 42.58 9.69 10 122195 10 46563847
Bone erosion 42.27 9.69 83 122122 9360 46554497
Foetal exposure during pregnancy 42.02 9.69 14 122191 30733 46533124
Off label use 41.87 9.69 721 121484 379120 46184737
Arterial occlusive disease 41.73 9.69 57 122148 4747 46559110
Drug interaction 41.67 9.69 755 121450 202339 46361518
Synovitis 41.11 9.69 60 122145 61015 46502842
Hypoglycaemia 40.32 9.69 262 121943 54087 46509770
Burning sensation 39.22 9.69 224 121981 44187 46519670
General physical health deterioration 39.04 9.69 163 122042 115606 46448251
Pancytopenia 38.78 9.69 105 122100 84953 46478904
Ulnar tunnel syndrome 38.32 9.69 9 122196 9 46563848
Neutropenia 38.25 9.69 219 121986 142985 46420872
Premature delivery 38.19 9.69 6 122199 22063 46541794
Balance disorder 37.93 9.69 294 121911 64227 46499630
Blood calcium decreased 37.58 9.69 108 122097 15565 46548292
Hand deformity 37.41 9.69 22 122183 34552 46529305
Glossodynia 36.85 9.69 37 122168 44336 46519521
Muscle discomfort 35.94 9.69 12 122193 74 46563783
Glycosylated haemoglobin increased 35.37 9.69 84 122121 10792 46553065
Leukopenia 34.55 9.69 80 122125 68263 46495594
Infection 34.24 9.69 207 121998 133385 46430472
Red blood cell sedimentation rate abnormal 33.65 9.69 95 122110 13554 46550303
Intentional self-injury 33.03 9.69 11 122194 24155 46539702
Lactic acidosis 32.59 9.69 175 122030 33734 46530123
Cardio-respiratory arrest 31.97 9.69 68 122137 59801 46504056
Coma 31.39 9.69 66 122139 58283 46505574
Androgenetic alopecia 30.88 9.69 13 122192 163 46563694
Type 2 diabetes mellitus 30.68 9.69 118 122087 19757 46544100
Caesarean section 29.92 9.69 4 122201 16599 46547258
Wound 29.84 9.69 41 122164 42761 46521096
Pruritus 29.55 9.69 837 121368 241515 46322342
Lipids increased 29.44 9.69 23 122182 985 46562872
Chromaturia 29.03 9.69 96 122109 14923 46548934
Sepsis 28.77 9.69 223 121982 135791 46428066
Drug-induced liver injury 28.64 9.69 137 122068 25231 46538626
Product use issue 28.46 9.69 139 122066 94505 46469352
Diabetes mellitus inadequate control 27.85 9.69 87 122118 13127 46550730
Angina unstable 27.53 9.69 61 122144 7487 46556370
Amblyopia 27.38 9.69 13 122192 220 46563637
Hyperkeratosis 27.30 9.69 48 122157 4977 46558880
Respiratory arrest 26.07 9.69 30 122175 33786 46530071
Injection site reaction 25.84 9.69 54 122151 47795 46516062
Microalbuminuria 25.78 9.69 14 122191 318 46563539
Generalised tonic-clonic seizure 25.67 9.69 20 122185 27102 46536755
Confabulation 25.56 9.69 13 122192 257 46563600
Blood creatine phosphokinase 25.55 9.69 6 122199 6 46563851
Pertussis 25.11 9.69 17 122188 581 46563276
Chronic kidney disease 25.00 9.69 188 122017 40683 46523174
Extraocular muscle paresis 24.98 9.69 11 122194 155 46563702
Infusion site streaking 24.98 9.69 14 122191 339 46563518
Fall 24.71 9.69 1075 121130 328022 46235835
Myocardial infarction 24.16 9.69 374 121831 97154 46466703
Sedation 23.92 9.69 121 122084 22789 46541068
Polymyositis 23.66 9.69 25 122180 1590 46562267
Restrictive pulmonary disease 23.56 9.69 22 122183 1204 46562653
Transcription medication error 23.56 9.69 11 122194 179 46563678
Cataract 23.47 9.69 201 122004 45214 46518643
Malignant neoplasm progression 23.41 9.69 89 122116 64837 46499020
Plasma cell myeloma 23.35 9.69 51 122154 44427 46519430
Diabetes mellitus 23.02 9.69 216 121989 49849 46514008
Alanine aminotransferase increased 22.61 9.69 341 121864 88110 46475747
Blood creatinine increased 22.50 9.69 302 121903 76101 46487756
Myositis 22.48 9.69 58 122147 7846 46556011
Blood test abnormal 22.24 9.69 65 122140 9455 46554402
Metastases to bone 22.12 9.69 9 122196 17467 46546390
Dizziness 22.12 9.69 1096 121109 339318 46224539
Lipids abnormal 22.08 9.69 12 122193 273 46563584
Cerebral infarction 22.05 9.69 120 122085 23246 46540611
Psoriasis 22.05 9.69 308 121897 78296 46485561
Device dislocation 22.03 9.69 15 122190 21787 46542070
Cytomegalovirus infection 21.92 9.69 10 122195 18134 46545723
Dry mouth 21.87 9.69 230 121975 54696 46509161
Nephritic syndrome 21.85 9.69 10 122195 155 46563702
Thrombocytopenia 21.71 9.69 219 121986 126362 46437495
Product substitution issue 21.39 9.69 87 122118 14944 46548913
Blood pressure inadequately controlled 21.28 9.69 40 122165 4366 46559491
Hypereosinophilic syndrome 20.74 9.69 11 122194 238 46563619
Gangrene 20.69 9.69 41 122164 4654 46559203
Bursitis infective 20.49 9.69 20 122185 1157 46562700
Drug resistance 20.32 9.69 10 122195 17358 46546499
Glomerular filtration rate decreased 20.20 9.69 72 122133 11622 46552235
Chest discomfort 20.06 9.69 340 121865 89929 46473928
Product use in unapproved indication 20.03 9.69 146 122059 90127 46473730
Multiple sclerosis relapse 19.96 9.69 51 122154 42074 46521783
Arthralgia 19.91 9.69 1155 121050 363448 46200409
Procollagen type I C-terminal propeptide increased 19.90 9.69 6 122199 25 46563832
Serum procollagen type I N-terminal propeptide increased 19.90 9.69 6 122199 25 46563832
Poisoning 19.78 9.69 6 122199 13988 46549869
Infrequent bowel movements 19.61 9.69 19 122186 1089 46562768
Coronary artery occlusion 19.59 9.69 56 122149 8046 46555811
Anuria 19.42 9.69 70 122135 11361 46552496
Lung diffusion test decreased 19.39 9.69 15 122190 633 46563224
Blood pressure abnormal 19.24 9.69 73 122132 12144 46551713
Albuminuria 19.08 9.69 10 122195 211 46563646
Condition aggravated 19.04 9.69 492 121713 244560 46319297
Infected dermal cyst 19.03 9.69 13 122192 451 46563406
Blood glucose abnormal 19.02 9.69 49 122156 6623 46557234
Hyper IgE syndrome 18.99 9.69 10 122195 213 46563644
Encephalopathy 18.91 9.69 37 122168 33552 46530305
Pulmonary function test abnormal 18.89 9.69 20 122185 1275 46562582
Somnolence 18.87 9.69 292 121913 156229 46407628
Nasopharyngitis 18.78 9.69 532 121673 153466 46410391
Haemorrhage subcutaneous 18.77 9.69 30 122175 2876 46560981
Ischaemic stroke 18.66 9.69 90 122115 16632 46547225
Pulmonary embolism 18.56 9.69 188 122017 108397 46455460
Pancreatitis acute 18.50 9.69 120 122085 24752 46539105
Urine albumin/creatinine ratio increased 18.46 9.69 9 122196 162 46563695
Respiratory failure 18.42 9.69 159 122046 94657 46469200
Weight decreased 18.39 9.69 700 121505 210149 46353708
Muscle disorder 18.37 9.69 37 122168 4249 46559608
Blood cholesterol abnormal 18.26 9.69 26 122179 2251 46561606
Suicide attempt 18.22 9.69 78 122127 54958 46508899
Hypercreatininaemia 18.21 9.69 12 122193 392 46563465
Bone marrow failure 18.20 9.69 31 122174 29638 46534219
Aspartate aminotransferase increased 18.06 9.69 298 121907 78402 46485455
Neutrophil count decreased 18.04 9.69 56 122149 43370 46520487
Lichen planus 17.85 9.69 23 122182 1810 46562047
Cystitis 17.82 9.69 179 122026 42062 46521795
Obstructive airways disorder 17.81 9.69 76 122129 13336 46550521
Coronary artery disease 17.77 9.69 150 122055 33602 46530255
Polymyalgia rheumatica 17.70 9.69 26 122179 2316 46561541
Agitation 17.47 9.69 80 122125 55335 46508522
Chest pain 17.23 9.69 593 121612 175731 46388126
Anaemia 17.19 9.69 524 121681 255255 46308602
Reversible airways obstruction 16.92 9.69 13 122192 543 46563314
Pericarditis 16.60 9.69 23 122182 23904 46539953
Amylase increased 16.51 9.69 41 122164 5418 46558439
Unwanted awareness during anaesthesia 16.35 9.69 10 122195 286 46563571
Peripheral sensorimotor neuropathy 16.35 9.69 18 122187 1200 46562657
Hip arthroplasty 16.34 9.69 14 122191 18098 46545759
Obstructive pancreatitis 16.24 9.69 9 122196 213 46563644
Interstitial lung disease 16.19 9.69 214 121991 53735 46510122
Lymphopenia 16.16 9.69 10 122195 15283 46548574
Toxic epidermal necrolysis 15.87 9.69 21 122184 22257 46541600
Transplant rejection 15.75 9.69 3 122202 9593 46554264
Hypocholesterolaemia 15.69 9.69 7 122198 102 46563755
Sinus pain 15.60 9.69 22 122183 1888 46561969
Hepatocellular injury 15.43 9.69 131 122074 29391 46534466
Blood pressure fluctuation 15.33 9.69 134 122071 30314 46533543
Acute coronary syndrome 15.27 9.69 60 122145 10144 46553713
Overdose 15.26 9.69 182 122023 101797 46462060
Ligament pain 15.21 9.69 8 122197 170 46563687
Constipation 15.17 9.69 578 121627 173519 46390338
Vertigo 15.02 9.69 205 122000 51843 46512014
Status epilepticus 14.97 9.69 9 122196 13970 46549887
Neurotrophic keratopathy 14.84 9.69 3 122202 0 46563857
Device related infection 14.82 9.69 20 122185 21021 46542836
Apolipoprotein A-I decreased 14.56 9.69 5 122200 34 46563823
Listless 14.53 9.69 22 122183 2013 46561844
Blood cholesterol decreased 14.50 9.69 11 122194 451 46563406
Hyperlactacidaemia 14.49 9.69 23 122182 2192 46561665
Dyspnoea exertional 14.48 9.69 198 122007 50091 46513766
Neurotoxicity 14.46 9.69 9 122196 13708 46550149
Photosensitivity reaction 14.38 9.69 69 122136 12723 46551134
Croup infectious 14.32 9.69 10 122195 360 46563497
Coma acidotic 14.31 9.69 7 122198 127 46563730
Blood ketone body increased 14.31 9.69 9 122196 271 46563586
Acute myocardial infarction 14.30 9.69 137 122068 31787 46532070
Therapeutic product effect decreased 14.12 9.69 143 122062 82458 46481399
Premature baby 14.03 9.69 16 122189 18096 46545761
Drug intolerance 14.00 9.69 286 121919 146763 46417094
Haemorrhagic stroke 13.97 9.69 39 122166 5527 46558330
Ascites 13.94 9.69 49 122156 36535 46527322
Injection site erythema 13.93 9.69 126 122079 74301 46489556
Arthropathy 13.92 9.69 148 122057 84552 46479305
Hepatic steatosis 13.81 9.69 109 122096 23933 46539924
Pyrexia 13.52 9.69 761 121444 348041 46215816
Hypotension 13.48 9.69 741 121464 231848 46332009
Blood creatine increased 13.38 9.69 34 122171 4556 46559301
Polyglandular autoimmune syndrome type II 13.35 9.69 5 122200 45 46563812
Neonatal asphyxia 13.30 9.69 8 122197 222 46563635
Intensive care unit acquired weakness 13.29 9.69 12 122193 629 46563228
Head discomfort 13.24 9.69 58 122147 10293 46553564
Hepatic encephalopathy 13.23 9.69 5 122200 10152 46553705
Blood pressure systolic abnormal 13.21 9.69 38 122167 5479 46558378
Cardiac murmur 13.17 9.69 62 122143 11342 46552515
Sensorimotor disorder 13.14 9.69 10 122195 412 46563445
Device issue 13.08 9.69 20 122185 19960 46543897
Autoimmune nephritis 13.06 9.69 9 122196 317 46563540
Goitre 13.04 9.69 37 122168 5294 46558563
Erythema marginatum 12.85 9.69 4 122201 19 46563838
Necrotising myositis 12.81 9.69 9 122196 327 46563530
Arteriosclerosis 12.81 9.69 55 122150 9678 46554179
Immune thrombocytopenia 12.78 9.69 49 122156 8192 46555665
Cardiac valve fibroelastoma 12.77 9.69 3 122202 3 46563854
Mucosal inflammation 12.44 9.69 56 122149 38920 46524937
Mental disorder 12.37 9.69 25 122180 22400 46541457
Nightmare 12.29 9.69 80 122125 16518 46547339
No adverse event 12.28 9.69 47 122158 34184 46529673
Food interaction 12.27 9.69 11 122194 571 46563286
Impaired healing 12.21 9.69 52 122153 36691 46527166
Low density lipoprotein abnormal 12.21 9.69 6 122199 110 46563747
Posterior reversible encephalopathy syndrome 12.15 9.69 13 122192 15128 46548729
Device difficult to use 12.12 9.69 3 122202 8001 46555856
Malignant melanoma 12.09 9.69 56 122149 10178 46553679
Abdominal pain upper 12.08 9.69 480 121725 144825 46419032
Immunodeficiency 11.98 9.69 10 122195 13096 46550761
Cardiac neoplasm unspecified 11.93 9.69 5 122200 62 46563795
Giant cell arteritis 11.89 9.69 19 122186 1822 46562035
Therapeutic product effect incomplete 11.87 9.69 139 122066 78014 46485843
Hepatic enzyme abnormal 11.79 9.69 31 122174 4241 46559616
Respiratory depression 11.70 9.69 8 122197 11592 46552265
Anxiety 11.67 9.69 375 121830 181582 46382275
Palpitations 11.58 9.69 329 121876 94930 46468927
Eyelid disorder 11.54 9.69 15 122190 1191 46562666
Diabetic nephropathy 11.53 9.69 16 122189 1352 46562505
Foreign body 11.53 9.69 19 122186 1869 46561988
Tubulointerstitial nephritis 11.40 9.69 72 122133 14716 46549141
Muscle spasticity 11.39 9.69 8 122197 11432 46552425
Amyotrophy 11.39 9.69 6 122199 128 46563729
Campylobacter test positive 11.31 9.69 4 122201 30 46563827
Blood growth hormone increased 11.17 9.69 9 122196 403 46563454
Decubitus ulcer 11.13 9.69 6 122199 9892 46553965
Pancreatic neuroendocrine tumour 11.12 9.69 8 122197 302 46563555
Premature labour 11.12 9.69 8 122197 11291 46552566
Musculoskeletal pain 11.12 9.69 251 121954 69877 46493980
Cardiac arrest 11.10 9.69 168 122037 90231 46473626
Haemophagocytic lymphohistiocytosis 11.05 9.69 4 122201 8338 46555519
Urine ketone body present 11.04 9.69 20 122185 2122 46561735
Dystonia 11.04 9.69 8 122197 11249 46552608
Bronchiectasis 11.02 9.69 51 122154 9265 46554592
Mydriasis 11.02 9.69 7 122198 10546 46553311
Bronchopulmonary aspergillosis 10.99 9.69 3 122202 7493 46556364
Thrombotic microangiopathy 10.97 9.69 4 122201 8302 46555555
Malaise 10.97 9.69 1008 121197 330224 46233633
Pseudophaeochromocytoma 10.96 9.69 5 122200 77 46563780
Myoglobin blood increased 10.94 9.69 16 122189 1420 46562437
Blood calcium increased 10.86 9.69 44 122161 7543 46556314
Coronary artery stenosis 10.84 9.69 32 122173 4681 46559176
Dyspepsia 10.83 9.69 245 121960 68227 46495630
Cough 10.80 9.69 720 121485 229529 46334328
Post viral fatigue syndrome 10.79 9.69 6 122199 143 46563714
Injection site swelling 10.58 9.69 62 122143 40265 46523592
Lichenoid keratosis 10.54 9.69 15 122190 1298 46562559
Hyperkalaemia 10.54 9.69 189 122016 50520 46513337
Vital capacity decreased 10.53 9.69 10 122195 559 46563298
Blood creatine phosphokinase MM increased 10.49 9.69 4 122201 38 46563819
White blood cell count decreased 10.47 9.69 219 121986 112012 46451845
High density lipoprotein increased 10.46 9.69 11 122194 696 46563161
Abortion induced 10.45 9.69 7 122198 10253 46553604
Accidental exposure to product 10.39 9.69 25 122180 21056 46542801
Injection site pain 10.32 9.69 208 121997 106944 46456913
Pre-eclampsia 10.31 9.69 4 122201 7990 46555867
Adverse drug reaction 10.20 9.69 71 122134 44291 46519566
Acute myeloid leukaemia 10.13 9.69 16 122189 15762 46548095
Hepatic function abnormal 10.11 9.69 136 122069 34285 46529572
Tendonitis 10.08 9.69 68 122137 14209 46549648
Hypercholesterolaemia 10.07 9.69 58 122147 11472 46552385
Epileptic encephalopathy 10.07 9.69 7 122198 250 46563607
Tumour marker abnormal 10.05 9.69 6 122199 164 46563693
Intentional product use issue 10.03 9.69 89 122116 52691 46511166
Stent placement 10.02 9.69 26 122179 3530 46560327
Osteogenesis imperfecta 9.96 9.69 8 122197 357 46563500
Cholestasis 9.95 9.69 111 122094 26782 46537075
Ulcer 9.93 9.69 19 122186 17373 46546484
Brain injury 9.89 9.69 37 122168 6113 46557744
Injury 9.86 9.69 71 122134 43956 46519901
Blood glucose normal 9.86 9.69 3 122202 13 46563844
Duodenal ulcer perforation 9.79 9.69 5 122200 8497 46555360
Impaired fasting glucose 9.74 9.69 6 122199 174 46563683

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Myalgia 1085.63 10.36 1373 109005 75294 29766806
Rhabdomyolysis 807.92 10.36 1080 109298 62500 29779600
Blood creatine phosphokinase increased 470.14 10.36 687 109691 43161 29798939
Toxicity to various agents 280.52 10.36 152 110226 177031 29665069
High density lipoprotein decreased 212.92 10.36 138 110240 3072 29839028
Myopathy 210.18 10.36 226 110152 10360 29831740
Completed suicide 202.12 10.36 58 110320 99434 29742666
Death 202.11 10.36 661 109717 356622 29485478
Drug abuse 196.67 10.36 33 110345 82039 29760061
Low density lipoprotein increased 182.75 10.36 137 110241 3879 29838221
Blood triglycerides increased 136.30 10.36 210 110168 13807 29828293
Tendon rupture 116.60 10.36 137 110241 6927 29835173
Low density lipoprotein decreased 112.18 10.36 60 110318 921 29841179
Blood cholesterol increased 101.02 10.36 205 110173 16765 29825335
Rheumatoid factor negative 99.42 10.36 46 110332 507 29841593
Angina pectoris 97.46 10.36 284 110094 29234 29812866
Foetal exposure during pregnancy 97.29 10.36 11 110367 36860 29805240
Neutropenia 89.16 10.36 215 110163 128325 29713775
Overdose 87.77 10.36 109 110269 84228 29757872
Pyrexia 78.54 10.36 701 109677 293788 29548312
Acute kidney injury 78.06 10.36 1429 108949 272413 29569687
Muscle spasms 69.01 10.36 442 109936 64396 29777704
Intentional overdose 66.33 10.36 35 110343 41446 29800654
Pain in extremity 64.93 10.36 656 109722 109565 29732535
Chromaturia 61.61 10.36 149 110229 13716 29828384
Arthralgia 61.29 10.36 767 109611 135024 29707076
Bone erosion 60.27 10.36 57 110321 2236 29839864
Pneumonia 60.26 10.36 869 109509 333437 29508663
Febrile neutropenia 60.21 10.36 197 110181 106496 29735604
Disease progression 59.88 10.36 128 110250 79746 29762354
Blood pressure increased 58.82 10.36 460 109918 71468 29770632
Blood pressure systolic increased 58.39 10.36 154 110224 14956 29827144
Red blood cell sedimentation rate abnormal 56.22 10.36 49 110329 1726 29840374
Muscular weakness 55.37 10.36 413 109965 63232 29778868
White blood cell count decreased 50.89 10.36 150 110228 83797 29758303
Sepsis 50.50 10.36 324 110054 146071 29696029
Mucosal inflammation 49.83 10.36 25 110353 30469 29811631
Drug dependence 47.89 10.36 10 110368 21285 29820815
Leukopenia 47.28 10.36 84 110294 56075 29786025
Seizure 46.90 10.36 195 110183 98280 29743820
Diabetes mellitus 46.76 10.36 289 110089 41576 29800524
Hepatic enzyme increased 46.47 10.36 245 110133 33249 29808851
Angina unstable 46.08 10.36 124 110254 12186 29829914
Septic shock 45.96 10.36 104 110274 63503 29778597
Coronary artery occlusion 45.46 10.36 116 110262 11041 29831059
Erectile dysfunction 44.13 10.36 157 110221 17945 29824155
Pancytopenia 43.31 10.36 164 110214 84888 29757212
Asthenia 42.98 10.36 1093 109285 220197 29621903
Thrombocytopenia 42.93 10.36 312 110066 136732 29705368
5-hydroxyindolacetic acid in urine increased 42.59 10.36 19 110359 191 29841909
Myocardial infarction 42.32 10.36 674 109704 124951 29717149
Bone marrow failure 40.88 10.36 30 110348 29755 29812345
Acute coronary syndrome 39.54 10.36 125 110253 13448 29828652
Serotonin syndrome 39.02 10.36 9 110369 17882 29824218
Vascular stent stenosis 38.84 10.36 32 110346 1042 29841058
Blood mercury abnormal 38.36 10.36 17 110361 168 29841932
Plasma cell myeloma 38.15 10.36 88 110290 53374 29788726
Agitation 37.79 10.36 90 110288 53983 29788117
Fractured coccyx 37.50 10.36 16 110362 143 29841957
Chest pain 36.98 10.36 624 109754 117003 29725097
Coronary artery stenosis 36.64 10.36 94 110284 8976 29833124
Presyncope 36.38 10.36 136 110242 15920 29826180
Amyotrophic lateral sclerosis 36.18 10.36 30 110348 986 29841114
Intentional self-injury 35.78 10.36 4 110374 13528 29828572
Hepatic neoplasm 35.69 10.36 39 110339 1820 29840280
Multiple organ dysfunction syndrome 35.25 10.36 118 110260 63369 29778731
Malignant neoplasm progression 35.12 10.36 142 110236 72145 29769955
Chest discomfort 35.04 10.36 287 110091 45193 29796907
Cytomegalovirus infection 34.95 10.36 22 110356 23652 29818448
Glycosylated haemoglobin increased 34.92 10.36 95 110283 9396 29832704
Pancreatitis 34.14 10.36 241 110137 36249 29805851
Cardiac failure chronic 33.90 10.36 70 110308 5793 29836307
Product use in unapproved indication 33.80 10.36 148 110230 73545 29768555
Myositis 33.43 10.36 99 110279 10278 29831822
Left ventricular enlargement 33.43 10.36 23 110355 567 29841533
Gynaecomastia 33.17 10.36 86 110292 8265 29833835
Blood thyroid stimulating hormone abnormal 32.93 10.36 15 110363 159 29841941
Carotid arteriosclerosis 32.44 10.36 27 110351 892 29841208
Gait disturbance 32.24 10.36 419 109959 74358 29767742
N-terminal prohormone brain natriuretic peptide abnormal 32.04 10.36 13 110365 101 29841999
Ascites 31.81 10.36 52 110326 35869 29806231
Psychotic disorder 31.76 10.36 20 110358 21495 29820605
Coronary artery disease 31.72 10.36 301 110077 49411 29792689
Suicide attempt 31.69 10.36 54 110324 36643 29805457
Hospitalisation 31.57 10.36 73 110305 44246 29797854
General physical health deterioration 31.54 10.36 227 110151 99717 29742383
Muscle rupture 31.51 10.36 39 110339 2082 29840018
Blood glucose increased 31.41 10.36 356 110022 61174 29780926
Drug withdrawal syndrome 31.24 10.36 17 110361 19792 29822308
Nodular rash 30.69 10.36 11 110367 58 29842042
Plasmapheresis 30.64 10.36 18 110360 334 29841766
Haemorrhagic stroke 30.52 10.36 69 110309 6078 29836022
Immune-mediated myositis 30.12 10.36 30 110348 1255 29840845
Hepatitis C 30.11 10.36 6 110372 13199 29828901
Mental status changes 29.83 10.36 57 110321 37022 29805078
Blood cholesterol decreased 29.42 10.36 26 110352 933 29841167
Off label use 29.42 10.36 697 109681 248593 29593507
Diabetic ketoacidosis 28.72 10.36 126 110252 15860 29826240
Diabetic neuropathy 28.69 10.36 52 110326 3907 29838193
Neutropenic sepsis 28.64 10.36 4 110374 11405 29830695
Muscle disorder 28.33 10.36 39 110339 2313 29839787
Blood uric acid increased 28.13 10.36 66 110312 5957 29836143
Infection 27.80 10.36 171 110207 77903 29764197
Guillain-Barre syndrome 27.43 10.36 59 110319 5024 29837076
Blood pressure inadequately controlled 27.10 10.36 40 110338 2530 29839570
Respiratory failure 26.94 10.36 239 110139 100403 29741697
Brain natriuretic peptide abnormal 26.69 10.36 13 110365 162 29841938
Middle insomnia 26.68 10.36 63 110315 5710 29836390
Coronary artery restenosis 26.60 10.36 27 110351 1156 29840944
Pulmonary function test abnormal 26.30 10.36 29 110349 1367 29840733
Coma 26.18 10.36 70 110308 40379 29801721
Product substitution issue 26.16 10.36 89 110289 9946 29832154
Lung diffusion test decreased 26.02 10.36 20 110358 588 29841512
Blood count abnormal 25.82 10.36 98 110280 11554 29830546
Blood pressure fluctuation 25.63 10.36 130 110248 17373 29824727
Acute myocardial infarction 25.55 10.36 303 110075 52636 29789464
Premature baby 25.35 10.36 15 110363 16676 29825424
Respiratory arrest 25.31 10.36 43 110335 29215 29812885
Nipple inflammation 25.18 10.36 10 110368 73 29842027
Food aversion 24.90 10.36 15 110363 292 29841808
Lipoprotein (a) increased 24.88 10.36 9 110369 49 29842051
Lipoma 24.87 10.36 29 110349 1454 29840646
Vomiting 24.71 10.36 619 109759 219199 29622901
Tendonitis 24.32 10.36 75 110303 7961 29834139
Type 2 diabetes mellitus 24.20 10.36 107 110271 13515 29828585
Muscle atrophy 24.07 10.36 66 110312 6558 29835542
Muscle injury 24.00 10.36 26 110352 1201 29840899
Ill-defined disorder 23.92 10.36 89 110289 10395 29831705
Oxygen saturation increased 23.77 10.36 13 110365 209 29841891
Neutrophil count decreased 23.50 10.36 79 110299 42375 29799725
Pulmonary arterial pressure abnormal 23.41 10.36 12 110366 168 29841932
Electrocardiogram QRS complex abnormal 23.40 10.36 14 110364 269 29841831
Paraplegia 23.28 10.36 38 110340 2623 29839477
Mitral valve thickening 23.24 10.36 13 110365 219 29841881
Pruritus 23.21 10.36 585 109793 117619 29724481
Melanoderma 23.10 10.36 12 110366 173 29841927
Pancreatitis acute 23.04 10.36 168 110210 25527 29816573
Seronegative arthritis 22.89 10.36 21 110357 792 29841308
Peritonitis 22.87 10.36 27 110351 21348 29820752
Cerebral infarction 22.83 10.36 171 110207 26202 29815898
Platelet count decreased 22.64 10.36 266 110112 105863 29736237
Lipids abnormal 22.41 10.36 15 110363 353 29841747
Prinzmetal angina 22.35 10.36 22 110356 907 29841193
Breast pain 22.34 10.36 26 110352 1301 29840799
Right atrial enlargement 22.14 10.36 13 110365 241 29841859
Drug interaction 22.04 10.36 922 109456 198646 29643454
N-terminal prohormone brain natriuretic peptide increased 22.04 10.36 26 110352 1320 29840780
Somnolence 22.02 10.36 239 110139 96524 29745576
Drug resistance 22.01 10.36 25 110353 20108 29821992
Diabetes mellitus inadequate control 21.73 10.36 99 110279 12663 29829437
Candida infection 21.70 10.36 15 110363 15347 29826753
Weight decreased 21.67 10.36 718 109660 150203 29691897
Eczema 21.51 10.36 102 110276 13267 29828833
Exercise tolerance decreased 21.44 10.36 45 110333 3767 29838333
Encephalopathy 21.40 10.36 55 110323 32150 29809950
Skin laceration 21.23 10.36 90 110288 11161 29830939
Hemiplegia 20.94 10.36 63 110315 6598 29835502
Muscle rigidity 20.77 10.36 6 110372 10255 29831845
Polymyositis 20.68 10.36 26 110352 1410 29840690
Cardio-respiratory arrest 20.66 10.36 125 110253 57181 29784919
Ventricular hyperkinesia 20.56 10.36 12 110366 220 29841880
Muscle discomfort 20.52 10.36 7 110371 31 29842069
Cardiac arrest 20.07 10.36 232 110146 92618 29749482
Dizziness 20.07 10.36 894 109484 194015 29648085
Arteriosclerosis coronary artery 20.01 10.36 88 110290 11088 29831012
Eosinophilia 19.93 10.36 145 110233 22015 29820085
Transaminases abnormal 19.90 10.36 12 110366 234 29841866
Depressed level of consciousness 19.89 10.36 73 110305 38149 29803951
Hepatic encephalopathy 19.86 10.36 14 110364 14178 29827922
Cytokine release syndrome 19.76 10.36 6 110372 9927 29832173
Intermittent claudication 19.68 10.36 32 110346 2202 29839898
Lymphomatoid papulosis 19.68 10.36 11 110367 185 29841915
Ileus 19.67 10.36 17 110361 15538 29826562
Haematuria 19.64 10.36 252 110126 44582 29797518
Euglycaemic diabetic ketoacidosis 19.56 10.36 29 110349 1842 29840258
Aortic aneurysm 19.54 10.36 60 110318 6353 29835747
Conjunctivitis allergic 19.50 10.36 16 110362 518 29841582
Thrombotic microangiopathy 19.45 10.36 4 110374 8606 29833494
Meningitis eosinophilic 19.39 10.36 6 110372 18 29842082
Growth hormone deficiency 19.37 10.36 11 110367 191 29841909
Tachycardia 19.33 10.36 176 110202 73563 29768537
Haemophagocytic lymphohistiocytosis 19.32 10.36 6 110372 9785 29832315
Nipple disorder 19.32 10.36 11 110367 192 29841908
Lipase increased 19.25 10.36 73 110305 8603 29833497
Abnormal behaviour 19.23 10.36 41 110337 25582 29816518
Neuroleptic malignant syndrome 19.19 10.36 19 110359 16276 29825824
Total cholesterol/HDL ratio increased 19.14 10.36 10 110368 146 29841954
Muscle strength abnormal 19.12 10.36 5 110373 6 29842094
Diastolic dysfunction 19.08 10.36 46 110332 4225 29837875
Immune reconstitution inflammatory syndrome 19.03 10.36 5 110373 9096 29833004
Left atrial enlargement 18.92 10.36 15 110363 462 29841638
Device related infection 18.74 10.36 21 110357 16994 29825106
Hypochromasia 18.56 10.36 13 110365 330 29841770
Vascular stent thrombosis 18.56 10.36 32 110346 2311 29839789
Dyspepsia 18.53 10.36 182 110196 30147 29811953
Bacteraemia 18.49 10.36 18 110360 15542 29826558
Neurotoxicity 18.45 10.36 13 110365 13169 29828931
Musculoskeletal discomfort 18.33 10.36 58 110320 6242 29835858
Walking disability 18.31 10.36 18 110360 741 29841359
Loss of personal independence in daily activities 18.28 10.36 139 110239 21396 29820704
Fatigue 18.06 10.36 1393 108985 319280 29522820
Mycotic allergy 17.95 10.36 10 110368 167 29841933
Respiratory depression 17.95 10.36 10 110368 11493 29830607
Histamine level increased 17.88 10.36 7 110371 49 29842051
Oxygen consumption decreased 17.85 10.36 10 110368 169 29841931
Poisoning 17.61 10.36 10 110368 11372 29830728
Aggression 17.60 10.36 73 110305 36834 29805266
Staphylococcal infection 17.59 10.36 55 110323 30169 29811931
Productive cough 17.46 10.36 178 110200 29775 29812325
Ischaemic stroke 17.32 10.36 111 110267 16164 29825936
Blood cholesterol abnormal 17.22 10.36 23 110355 1325 29840775
Autoimmune hepatitis 17.22 10.36 40 110338 3587 29838513
Arteriosclerosis 16.95 10.36 82 110296 10751 29831349
Supine hypertension 16.92 10.36 11 110367 246 29841854
Pneumocystis jirovecii pneumonia 16.89 10.36 23 110355 17097 29825003
Mean platelet volume increased 16.69 10.36 13 110365 390 29841710
Lipids increased 16.49 10.36 19 110359 940 29841160
Inappropriate antidiuretic hormone secretion 16.33 10.36 11 110367 11411 29830689
Expired product administered 16.29 10.36 34 110344 2835 29839265
Transient ischaemic attack 16.27 10.36 153 110225 25047 29817053
Restlessness 16.27 10.36 37 110341 22562 29819538
Aldolase increased 16.27 10.36 7 110371 64 29842036
Blood creatine phosphokinase 16.27 10.36 7 110371 64 29842036
Myoglobin blood increased 16.23 10.36 26 110352 1767 29840333
Urine odour abnormal 16.19 10.36 19 110359 959 29841141
Unresponsive to stimuli 16.14 10.36 47 110331 26372 29815728
Decreased ventricular preload 16.10 10.36 6 110372 36 29842064
Bronchopulmonary aspergillosis 16.05 10.36 13 110365 12271 29829829
Neoplasm progression 16.04 10.36 26 110352 17997 29824103
Dyslipidaemia 16 10.36 52 110326 5675 29836425
Peripheral swelling 16 10.36 315 110063 60759 29781341
Interstitial lung disease 15.95 10.36 311 110067 59886 29782214
AST/ALT ratio abnormal 15.92 10.36 5 110373 16 29842084
Chronic kidney disease 15.87 10.36 211 110167 37627 29804473
Respiratory distress 15.86 10.36 65 110313 32907 29809193
Drug intolerance 15.59 10.36 244 110134 45047 29797053
Base excess decreased 15.57 10.36 10 110368 219 29841881
Paraesthesia 15.53 10.36 284 110094 54043 29788057
Blood chloride increased 15.53 10.36 31 110347 2504 29839596
Spirometry abnormal 15.45 10.36 11 110367 287 29841813
Musculoskeletal stiffness 15.43 10.36 201 110177 35680 29806420
Retroperitoneal fibrosis 15.38 10.36 11 110367 289 29841811
Cerebral haemorrhage 15.32 10.36 187 110191 32700 29809400
Arterial spasm 15.12 10.36 8 110370 120 29841980
Cardiac aneurysm 14.99 10.36 15 110363 631 29841469
Peritonitis bacterial 14.92 10.36 12 110366 11366 29830734
Cardiovascular somatic symptom disorder 14.64 10.36 6 110372 48 29842052
Very low density lipoprotein increased 14.51 10.36 5 110373 23 29842077
Peripheral arterial occlusive disease 14.51 10.36 47 110331 5121 29836979
Polymyalgia rheumatica 14.50 10.36 19 110359 1074 29841026
Posterior reversible encephalopathy syndrome 14.43 10.36 7 110371 8700 29833400
Dry mouth 14.39 10.36 138 110240 22712 29819388
Pneumonia aspiration 14.37 10.36 81 110297 37699 29804401
Anxiety 14.26 10.36 239 110139 89632 29752468
Mania 14.22 10.36 8 110370 9146 29832954
Blood creatinine increased 14.21 10.36 439 109939 90936 29751164
Electrocardiogram QT prolonged 14.08 10.36 76 110302 35759 29806341
Hepatic failure 14.05 10.36 71 110307 33972 29808128
Drug hypersensitivity 14.00 10.36 341 110037 68178 29773922
Blood triglycerides 13.82 10.36 3 110375 0 29842100
Pseudomonas infection 13.81 10.36 11 110367 10471 29831629
Gait inability 13.50 10.36 117 110261 18724 29823376
High density lipoprotein increased 13.49 10.36 11 110367 353 29841747
Body temperature increased 13.46 10.36 21 110357 14759 29827341
Atrial septal defect 13.42 10.36 4 110374 6697 29835403
Acute myeloid leukaemia 13.36 10.36 29 110349 17977 29824123
Mesenteric artery thrombosis 13.29 10.36 12 110366 443 29841657
Miosis 13.28 10.36 6 110372 7770 29834330
Stevens-Johnson syndrome 13.25 10.36 28 110350 17528 29824572
Toxic epidermal necrolysis 13.22 10.36 29 110349 17911 29824189
Hyperthyroidism 13.18 10.36 62 110316 8036 29834064
Dental caries 13.08 10.36 41 110337 4390 29837710
Enterococcal infection 13.05 10.36 7 110371 8217 29833883
Tumour lysis syndrome 13.03 10.36 17 110361 12868 29829232
Mite allergy 13.01 10.36 9 110369 224 29841876
Hypercholesterolaemia 13.00 10.36 59 110319 7533 29834567
Osteonecrosis of jaw 12.99 10.36 31 110347 18587 29823513
Transplant rejection 12.99 10.36 9 110369 9197 29832903
Delusion 12.98 10.36 15 110363 11974 29830126
No adverse event 12.97 10.36 28 110350 17391 29824709
Arthritis 12.81 10.36 142 110236 24259 29817841
Nasal inflammation 12.80 10.36 9 110369 230 29841870
Coordination abnormal 12.69 10.36 57 110321 7248 29834852
Flatulence 12.69 10.36 112 110266 18017 29824083
Albuminuria 12.61 10.36 10 110368 308 29841792
Myoglobinuria 12.60 10.36 15 110363 769 29841331
Aortic stenosis 12.45 10.36 38 110340 4010 29838090
Ureteric cancer 12.42 10.36 8 110370 176 29841924
Body temperature decreased 12.29 10.36 69 110309 9586 29832514
Stent placement 12.19 10.36 41 110337 4555 29837545
Gout 12.13 10.36 107 110271 17208 29824892
Angiocardiogram 12.07 10.36 8 110370 185 29841915
Emotional distress 12.02 10.36 25 110353 15740 29826360
Syncope 11.92 10.36 403 109975 84500 29757600
Dyskinesia 11.83 10.36 41 110337 21793 29820307
Discomfort 11.82 10.36 92 110286 14264 29827836
Cerebellar atrophy 11.79 10.36 11 110367 424 29841676
Clostridium difficile colitis 11.76 10.36 18 110360 12750 29829350
Confusional state 11.76 10.36 393 109985 134441 29707659
Troponin increased 11.74 10.36 64 110314 8793 29833307
Cardiac failure 11.73 10.36 396 109982 83022 29759078
Haemolysis 11.70 10.36 6 110372 7225 29834875
Left ventricular dilatation 11.68 10.36 13 110365 619 29841481
Left ventricular hypertrophy 11.67 10.36 50 110328 6228 29835872
Tendon disorder 11.65 10.36 26 110352 2270 29839830
Aspiration 11.64 10.36 13 110365 10538 29831562
Low density lipoprotein abnormal 11.64 10.36 9 110369 267 29841833
Hepatocellular carcinoma 11.56 10.36 11 110367 9599 29832501
Neck pain 11.51 10.36 123 110255 20821 29821279
Acute respiratory distress syndrome 11.46 10.36 46 110332 23426 29818674
Orthostatic hypotension 11.45 10.36 137 110241 23842 29818258
Dysphagia 11.36 10.36 144 110234 56554 29785546
Abscess of salivary gland 11.34 10.36 4 110374 20 29842080
Prostatic specific antigen abnormal 11.31 10.36 10 110368 359 29841741
Neoplasm 11.27 10.36 37 110341 4059 29838041
Familial periodic paralysis 11.22 10.36 6 110372 92 29842008
Impatience 11.17 10.36 9 110369 284 29841816
Liver function test abnormal 11.13 10.36 168 110210 30782 29811318
Stomatitis 11.11 10.36 86 110292 37193 29804907
Alcohol abuse 11.08 10.36 3 110375 5350 29836750
Pulmonary haemorrhage 11.00 10.36 11 110367 9381 29832719
Akathisia 10.98 10.36 4 110374 5900 29836200
Poisoning deliberate 10.98 10.36 4 110374 5900 29836200
Heart rate decreased 10.94 10.36 122 110256 20872 29821228
Venous occlusion 10.84 10.36 10 110368 380 29841720
Nephrolithiasis 10.67 10.36 139 110239 24671 29817429
Asthma 10.65 10.36 190 110188 35984 29806116
Breast mass 10.64 10.36 12 110366 580 29841520
Atheroembolism 10.62 10.36 8 110370 228 29841872
Urine albumin/creatinine ratio 10.55 10.36 3 110375 6 29842094
Supraventricular extrasystoles 10.50 10.36 31 110347 3213 29838887
Lethargy 10.49 10.36 94 110284 39425 29802675
Cytopenia 10.46 10.36 9 110369 8247 29833853
Cytomegalovirus viraemia 10.46 10.36 4 110374 5725 29836375
Coeliac disease 10.43 10.36 12 110366 593 29841507
Anaemia 10.42 10.36 644 109734 207348 29634752
Muscle fatigue 10.41 10.36 17 110361 1174 29840926

Pharmacologic Action:

SourceCodeDescription
ATC C10AA07 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
HMG CoA reductase inhibitors
ATC A10BH52 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC C10BA06 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA07 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA09 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BX05 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX07 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX09 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX10 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX13 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX14 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX16 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX17 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000121 Hydroxymethylglutaryl-CoA Reductase Inhibitors
FDA EPC N0000175589 HMG-CoA Reductase Inhibitor
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019161 Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
CHEBI has role CHEBI:35679 hypolipidemic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:49205 cholesteryl ester transfer protein inhibitor
CHEBI has role CHEBI:67079 antiinflammatory agents
CHEBI has role CHEBI:77307 cardioprotective agents
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Arteriosclerotic vascular disease indication 72092001
Cerebrovascular accident indication 230690007
Familial hypercholesterolemia - homozygous indication 238078005
Familial hypercholesterolemia - heterozygous indication 238079002
Mixed hyperlipidemia indication 267434003
Hypertriglyceridemia indication 302870006
Familial type 3 hyperlipoproteinemia indication 398796005 DOID:3145
Prevention of Transient Ischemic Attacks indication
Primary Prevention of Coronary Heart Disease indication
Myocardial Infarction Prevention indication
Alcoholism contraindication 7200002
Proteinuria contraindication 29738008 DOID:576
Dehydration contraindication 34095006
Blood in urine contraindication 34436003
Hypothyroidism contraindication 40930008 DOID:1459
Acute nephropathy contraindication 58574008
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Hemorrhagic cerebral infarction contraindication 230706003
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Pregnancy, function contraindication 289908002
Surgical procedure contraindication 387713003
Breastfeeding (mother) contraindication 413712001
Traumatic injury contraindication 417746004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.29 acidic
pKa2 13.84 acidic
pKa3 3.67 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10MG BASE CRESTOR IPR N021366 Aug. 12, 2003 RX TABLET ORAL May 27, 2023 AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)
EQ 20MG BASE CRESTOR IPR N021366 Aug. 12, 2003 RX TABLET ORAL May 27, 2023 AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)
EQ 40MG BASE CRESTOR IPR N021366 Aug. 12, 2003 RX TABLET ORAL May 27, 2023 AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)
EQ 5MG BASE CRESTOR IPR N021366 Aug. 12, 2003 RX TABLET ORAL May 27, 2023 AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme INHIBITOR Ki 9.05 CHEMBL CHEMBL
Phosphodiesterase 6D Enzyme Kd 5.90 CHEMBL
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme IC50 8.68 CHEMBL

External reference:

IDSource
4021405 VUID
N0000148821 NUI
D01915 KEGG_DRUG
147098-20-2 SECONDARY_CAS_RN
4021405 VANDF
C1098080 UMLSCUI
CHEBI:77249 CHEBI
FBI PDB_CHEM_ID
CHEMBL1744447 ChEMBL_ID
CHEMBL1496 ChEMBL_ID
D000068718 MESH_DESCRIPTOR_UI
5282455 PUBCHEM_CID
2954 IUPHAR_LIGAND_ID
8021 INN_ID
DB01098 DRUGBANK_ID
413KH5ZJ73 UNII
301542 RXNORM
107656 MMSL
17146 MMSL
17536 MMSL
34243 MMSL
46321 MMSL
d04851 MMSL
009902 NDDF
009903 NDDF
406435003 SNOMEDCT_US
700067006 SNOMEDCT_US
768151007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CRESTOR HUMAN PRESCRIPTION DRUG LABEL 1 0310-0751 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
CRESTOR HUMAN PRESCRIPTION DRUG LABEL 1 0310-0752 TABLET, FILM COATED 20 mg ORAL NDA 27 sections
CRESTOR HUMAN PRESCRIPTION DRUG LABEL 1 0310-0754 TABLET, FILM COATED 40 mg ORAL NDA 27 sections
CRESTOR HUMAN PRESCRIPTION DRUG LABEL 1 0310-0755 TABLET, FILM COATED 5 mg ORAL NDA 27 sections
Rosuvastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 0781-5400 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Rosuvastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 0781-5401 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Rosuvastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 0781-5402 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Rosuvastatin calcium HUMAN PRESCRIPTION DRUG LABEL 1 0781-5403 TABLET, FILM COATED 40 mg ORAL ANDA 26 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6778 TABLET, COATED 5 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6779 TABLET, COATED 10 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6780 TABLET, COATED 20 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6781 TABLET, COATED 40 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-179 TABLET, COATED 5 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-180 TABLET, COATED 10 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-181 TABLET, COATED 20 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-182 TABLET, COATED 40 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 16714-988 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 16714-989 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 16714-990 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 16714-991 TABLET, FILM COATED 40 mg ORAL ANDA 29 sections
Rosuvastatin HUMAN PRESCRIPTION DRUG LABEL 1 16729-284 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
Rosuvastatin HUMAN PRESCRIPTION DRUG LABEL 1 16729-285 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Rosuvastatin HUMAN PRESCRIPTION DRUG LABEL 1 16729-286 TABLET, FILM COATED 20 mg ORAL ANDA 30 sections
Rosuvastatin HUMAN PRESCRIPTION DRUG LABEL 1 16729-287 TABLET, FILM COATED 40 mg ORAL ANDA 30 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 21695-287 TABLET, FILM COATED 10 mg ORAL NDA 17 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 21695-288 TABLET, FILM COATED 20 mg ORAL NDA 17 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 21695-659 TABLET, FILM COATED 40 mg ORAL NDA 17 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 21695-759 TABLET, FILM COATED 5 mg ORAL NDA 17 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 27808-155 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 27808-156 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections