ezetimibe 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antihyperlipidaemics, acyl CoA: cholesterol acyltransferase (ACAT) inhibitors 1125 163222-33-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • SCH58235
  • SCH-58235
  • ezetimib
  • ezetimibe
  • ezedoc
  • ezentia
  • ezetrol
  • zetia
An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.
  • Molecular weight: 409.43
  • Formula: C24H21F2NO3
  • CLOGP: 3.96
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 60.77
  • ALOGS: -4.68
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.35 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.047 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.089 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 58.884 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 28.119 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 1.160 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 2.060 % High 1
herg hERG pIC50 4.858 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 35.810 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 97.949 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 1.110 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAPK10,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PRKDC,TGFBR1 17
kinase-selectivity-class ACVR2B,AXL,GRK2 3
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.710 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 4.786 High 1
mh-clint Mouse hepatocyte intrinsic clearance 96.383 High 1
mppb Mouse plasma protein binding (% unbound) 1.260 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 19.724 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 2.370 % High 1
rat-kpuu-brain Rat brain Kpuu 0.133 % High 1
rh-clint Rat hepatocyte intrinsic clearance 209.411 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 10.540 % High 1
rppb Rat plasma protein binding (% unbound) 0.890 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 15.453 uM High 1

Approvals:

DateAgencyCompanyOrphan
Oct. 25, 2002 FDA MSD INTL GMBH
April 18, 2007 PMDA Schering-Plough K.K

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
Myalgia 1843.72 10.21 1476 89918 173649 90363404
Rhabdomyolysis 794.16 10.21 546 90848 50710 90486343
Blood creatine phosphokinase increased 523.48 10.21 361 91033 33662 90503391
Angina pectoris 368.65 10.21 310 91084 38850 90498203
Low density lipoprotein increased 333.52 10.21 163 91231 7922 90529131
Pemphigus 300.16 10.21 6 91388 326858 90210195
Arterial occlusive disease 298.82 10.21 175 91219 12271 90524782
Hand deformity 282.54 10.21 3 91391 296359 90240694
Gangrene 275.23 10.21 168 91226 12708 90524345
Carotid artery thrombosis 259.09 10.21 143 91251 8949 90528104
Neurologic neglect syndrome 257.22 10.21 141 91253 8706 90528347
Maternal exposure during pregnancy 239.91 10.21 38 91356 360025 90177028
Synovitis 235.76 10.21 28 91366 329724 90207329
Adjustment disorder 235.24 10.21 137 91257 9505 90527548
Glossodynia 228.38 10.21 28 91366 321751 90215302
Pericarditis 226.50 10.21 11 91383 270140 90266913
Wound 226.10 10.21 22 91372 302958 90234095
Contraindicated product administered 222.03 10.21 30 91364 320109 90216944
Personality disorder 215.16 10.21 142 91252 12302 90524751
Sinus congestion 211.73 10.21 194 91200 27230 90509823
Sensory loss 210.26 10.21 162 91232 17913 90519140
Systemic lupus erythematosus 210.23 10.21 53 91341 361843 90175210
Infusion related reaction 206.56 10.21 81 91313 416699 90120354
Duodenal ulcer perforation 203.33 10.21 4 91390 221284 90315769
Hemiplegia 194.92 10.21 148 91246 16012 90521041
Skin haemorrhage 194.50 10.21 166 91228 21214 90515839
Coronary artery disease 194.35 10.21 203 91191 33420 90503633
Helicobacter infection 187.73 10.21 10 91384 226840 90310213
Folliculitis 186.54 10.21 4 91390 204349 90332704
Muscle spasms 186.21 10.21 618 90776 251265 90285788
Sneezing 182.87 10.21 186 91208 29683 90507370
Muscular weakness 180.27 10.21 537 90857 206129 90330924
Cerebrovascular accident 177.76 10.21 388 91006 123145 90413908
Motor dysfunction 176.35 10.21 150 91244 19080 90517973
Affect lability 176.18 10.21 146 91248 17917 90519136
Palpitations 172.91 10.21 408 90986 136320 90400733
Coordination abnormal 170.58 10.21 154 91240 21202 90515851
Myopathy 165.69 10.21 125 91269 13393 90523660
Off label use 163.84 10.21 568 90826 1101684 89435369
Sinus disorder 152.63 10.21 181 91213 34266 90502787
Hemiparesis 152.36 10.21 174 91220 31645 90505408
Muscle injury 148.65 10.21 7 91387 176647 90360406
Eating disorder 147.25 10.21 161 91233 27912 90509141
Myocardial infarction 146.96 10.21 328 91066 105644 90431409
Respiratory tract congestion 146.92 10.21 159 91235 27251 90509802
Cataract 146.78 10.21 262 91132 71830 90465223
Product use issue 133.42 10.21 84 91310 329835 90207218
Chest discomfort 130.65 10.21 370 91024 137995 90399058
Therapeutic product effect decreased 129.32 10.21 59 91335 277512 90259541
Irritable bowel syndrome 125.07 10.21 28 91366 207420 90329633
Influenza like illness 121.43 10.21 258 91136 80353 90456700
Skin exfoliation 119.70 10.21 232 91162 67681 90469372
Aphasia 118.84 10.21 179 91215 42633 90494420
Impaired healing 118.44 10.21 44 91350 234155 90302898
Psoriatic arthropathy 115.30 10.21 43 91351 228292 90308761
Drug ineffective 114.70 10.21 873 90521 1383425 89153628
Liver function test abnormal 114.21 10.21 193 91201 50652 90486401
Exposure during pregnancy 113.69 10.21 49 91345 238361 90298692
Treatment failure 112.75 10.21 85 91309 303843 90233210
Acute kidney injury 111.64 10.21 626 90768 319761 90217292
Infection 110.83 10.21 121 91273 361973 90175080
Pancreatitis acute 107.83 10.21 147 91247 31968 90505085
Swelling 107.58 10.21 160 91234 418898 90118155
C-reactive protein abnormal 107.36 10.21 5 91389 127424 90409629
Blood pressure increased 106.21 10.21 437 90957 196780 90340273
Rhinorrhoea 104.57 10.21 257 91137 88059 90448994
Fibromyalgia 103.88 10.21 39 91355 206230 90330823
Flatulence 102.31 10.21 164 91230 41203 90495850
Fall 102.05 10.21 832 90562 480978 90056075
Dysarthria 102.03 10.21 191 91203 54291 90482762
Pain in extremity 100.87 10.21 788 90606 449741 90087312
Coronary artery occlusion 100.20 10.21 77 91317 8477 90528576
Discomfort 97.61 10.21 80 91314 274255 90262798
Blister 96.26 10.21 70 91324 254928 90282125
Amyloid arthropathy 94.54 10.21 42 91352 1638 90535415
Immune-mediated myositis 94.46 10.21 47 91347 2374 90534679
Muscle spasticity 94.24 10.21 145 91249 35177 90501876
Stomatitis 94.19 10.21 83 91311 274615 90262438
Muscle rupture 93.90 10.21 51 91343 3090 90533963
Alopecia 93.75 10.21 227 91167 494844 90042209
Vascular stent stenosis 91.85 10.21 32 91362 644 90536409
Intentional product use issue 89.34 10.21 54 91340 216838 90320215
Dyslipidaemia 88.92 10.21 77 91317 10030 90527023
Pulmonary pain 87.54 10.21 58 91336 5056 90531997
Dysphagia 86.89 10.21 280 91114 111998 90425055
Facet joint syndrome 85.78 10.21 3 91391 98386 90438667
Joint swelling 84.49 10.21 245 91149 503055 90033998
Lip dry 81.79 10.21 5 91389 100950 90436103
Hyper IgE syndrome 80.72 10.21 27 91367 478 90536575
Crush syndrome 80.57 10.21 24 91370 285 90536768
Mobility decreased 78.67 10.21 82 91312 250652 90286401
Arthropathy 75.73 10.21 160 91234 366082 90170971
Injury 74.69 10.21 54 91340 197295 90339758
Joint range of motion decreased 74.66 10.21 22 91372 135621 90401432
Cystitis 74.61 10.21 190 91204 66528 90470525
Blood triglycerides increased 72.30 10.21 79 91315 13682 90523371
Toxicity to various agents 71.79 10.21 112 91282 287734 90249319
Wound infection 71.30 10.21 11 91383 106391 90430662
Wheezing 69.07 10.21 83 91311 237997 90299056
Muscle discomfort 68.28 10.21 21 91373 280 90536773
Grip strength decreased 68.27 10.21 7 91387 92569 90444484
Ill-defined disorder 68.15 10.21 52 91342 184839 90352214
Blood glucose increased 66.11 10.21 229 91165 95017 90442036
High density lipoprotein decreased 65.54 10.21 38 91356 2613 90534440
Asthenia 63.89 10.21 820 90574 532931 90004122
Acute coronary syndrome 63.75 10.21 66 91328 10747 90526306
Liver injury 62.83 10.21 48 91346 170519 90366534
Peripheral venous disease 60.22 10.21 7 91387 83914 90453139
Lung disorder 59.38 10.21 39 91355 149844 90387209
Hypersensitivity 57.73 10.21 249 91145 454428 90082625
Nausea 57.34 10.21 1494 89900 1108822 89428231
Influenza 55.14 10.21 282 91112 138982 90398071
Lipoprotein (a) increased 54.69 10.21 13 91381 58 90536995
Inhibitory drug interaction 54.45 10.21 36 91358 3127 90533926
Coronary artery stenosis 54.36 10.21 44 91350 5222 90531831
Carotid arteriosclerosis 54.15 10.21 26 91368 1214 90535839
Hyperlipidaemia 54.14 10.21 89 91305 22827 90514226
Body tinea 53.66 10.21 31 91363 2117 90534936
Neutropenia 52.80 10.21 91 91303 224813 90312240
Acute myocardial infarction 51.75 10.21 111 91283 34779 90502274
Autoimmune disorder 51.26 10.21 8 91386 76736 90460317
Truncus arteriosus persistent 50.73 10.21 18 91376 383 90536670
Lower respiratory tract infection 50.54 10.21 111 91283 250548 90286505
Type 2 diabetes mellitus 49.78 10.21 80 91314 203164 90333889
Glucose tolerance impaired 49.36 10.21 50 91344 7935 90529118
Cough 48.90 10.21 578 90816 368384 90168669
Pancreatitis 48.55 10.21 168 91226 69658 90467395
Antinuclear antibody negative 48.55 10.21 16 91378 270 90536783
Cone-rod dystrophy 48.51 10.21 9 91385 6 90537047
Alanine aminotransferase increased 48.51 10.21 242 91152 118096 90418957
Restrictive pulmonary disease 48.38 10.21 30 91364 2332 90534721
Prescribed overdose 48.23 10.21 19 91375 97606 90439447
C-reactive protein increased 47.70 10.21 68 91326 181321 90355732
Coombs positive haemolytic anaemia 47.21 10.21 18 91376 472 90536581
Febrile neutropenia 47.20 10.21 54 91340 158295 90378758
Cardiac failure congestive 46.40 10.21 210 91184 98484 90438569
Dizziness 46.36 10.21 843 90551 588441 89948612
Polymyositis 45.46 10.21 28 91366 2151 90534902
Pulmonary fibrosis 45.33 10.21 26 91368 107477 90429576
Arthritis 44.99 10.21 306 91088 167009 90370044
Pregnancy 44.96 10.21 5 91389 62042 90475011
Bursitis 44.83 10.21 40 91354 131614 90405439
Aspartate aminotransferase increased 43.97 10.21 213 91181 102724 90434329
Congenital cardiovascular anomaly 43.38 10.21 17 91377 481 90536572
Myopathy toxic 43.28 10.21 18 91376 596 90536457
C3 glomerulopathy 42.93 10.21 13 91381 164 90536889
Drug interaction 42.03 10.21 445 90949 276008 90261045
Rhinalgia 41.75 10.21 28 91366 2490 90534563
Back pain 41.63 10.21 496 90898 316679 90220374
Completed suicide 41.59 10.21 51 91343 145007 90392046
Skin disorder 41.52 10.21 105 91289 36601 90500452
Hepatic enzyme increased 41.34 10.21 205 91189 360531 90176522
Necrotising myositis 41.14 10.21 19 91375 812 90536241
Death 40.35 10.21 282 91112 456269 90080784
Condition aggravated 40.30 10.21 395 90999 595150 89941903
Musculoskeletal stiffness 39.71 10.21 159 91235 296373 90240680
Disease progression 38.96 10.21 61 91333 156554 90380499
Infection susceptibility increased 38.83 10.21 32 91362 3894 90533159
Euglycaemic diabetic ketoacidosis 38.65 10.21 39 91355 6162 90530891
Urine protein/creatinine ratio increased 37.58 10.21 19 91375 993 90536060
Epilepsy 37.43 10.21 18 91376 82188 90454865
Night sweats 37.21 10.21 45 91349 128721 90408332
Therapy non-responder 37.19 10.21 50 91344 136654 90400399
Arterial stenosis 36.87 10.21 17 91377 724 90536329
International normalised ratio increased 36.58 10.21 118 91276 47198 90489855
Milk-alkali syndrome 36.21 10.21 20 91374 1253 90535800
Chromaturia 35.58 10.21 67 91327 19120 90517933
Myelosuppression 34.87 10.21 6 91388 53585 90483468
Hypoglycaemia 34.62 10.21 151 91243 69697 90467356
Blepharospasm 34.38 10.21 7 91387 55438 90481615
Endocarditis enterococcal 34.19 10.21 12 91382 247 90536806
Hepatic steatosis 34.06 10.21 98 91296 36847 90500206
Musculoskeletal discomfort 33.71 10.21 69 91325 20922 90516131
Prescribed underdose 33.29 10.21 17 91377 75002 90462051
Cardiac septal defect 32.89 10.21 16 91378 769 90536284
Road traffic accident 32.84 10.21 36 91358 107590 90429463
Peripheral swelling 32.76 10.21 263 91131 412843 90124210
Scleroedema 32.75 10.21 10 91384 130 90536923
Hip arthroplasty 32.74 10.21 18 91376 76190 90460863
Psoriasis 32.71 10.21 258 91136 147496 90389557
Myoglobin blood increased 32.52 10.21 20 91374 1532 90535521
Arteriosclerosis 32.45 10.21 47 91347 10806 90526247
Gastritis haemorrhagic 32.23 10.21 21 91373 1779 90535274
Cardiac myxoma 31.75 10.21 12 91382 307 90536746
General physical health deterioration 31.52 10.21 219 91175 354896 90182157
Toxic shock syndrome 31.34 10.21 17 91377 1027 90536026
Endocrine ophthalmopathy 30.89 10.21 17 91377 1057 90535996
Angina unstable 30.75 10.21 37 91357 7106 90529947
Product use in unapproved indication 30.51 10.21 206 91188 336030 90201023
Sensorimotor disorder 30.47 10.21 15 91379 740 90536313
Vulvovaginal pruritus 30.33 10.21 28 91366 3965 90533088
Respiratory disorder 29.81 10.21 14 91380 64802 90472251
Muscle disorder 29.73 10.21 32 91362 5447 90531606
Drug ineffective for unapproved indication 29.73 10.21 15 91379 66629 90470424
Malaise 29.64 10.21 787 90607 585199 89951854
Vulvovaginal burning sensation 29.61 10.21 23 91371 2572 90534481
Nasal discomfort 29.40 10.21 32 91362 5516 90531537
Mitral valve replacement 29.38 10.21 13 91381 502 90536551
Nasal dryness 29.24 10.21 32 91362 5551 90531502
Aortic stenosis 29.23 10.21 34 91360 6302 90530751
Renal impairment 29.04 10.21 194 91200 105227 90431826
Lupus-like syndrome 28.61 10.21 7 91387 48839 90488214
Poor quality sleep 28.30 10.21 71 91323 24622 90512431
Intervertebral disc degeneration 28.00 10.21 57 91337 17217 90519836
Low density lipoprotein abnormal 27.88 10.21 11 91383 317 90536736
Delirium 27.55 10.21 39 91355 104320 90432733
Oral herpes 27.19 10.21 85 91309 33439 90503614
Carotid artery stenosis 26.94 10.21 30 91364 5304 90531749
Transient ischaemic attack 26.71 10.21 100 91294 43076 90493977
Heart disease congenital 26.54 10.21 18 91376 1631 90535422
Herpes simplex reactivation 26.24 10.21 15 91379 1004 90536049
Sedation 26.16 10.21 8 91386 48163 90488890
Onychomadesis 26.16 10.21 7 91387 45991 90491062
Low density lipoprotein decreased 26.13 10.21 10 91384 265 90536788
Purpura 25.43 10.21 50 91344 14728 90522325
Lower limb fracture 25.32 10.21 29 91365 84984 90452069
Restless legs syndrome 25.12 10.21 64 91330 22406 90514647
Peripheral arterial occlusive disease 25.10 10.21 27 91367 4594 90532459
Coma acidotic 25.02 10.21 8 91386 122 90536931
Inflammation 25.02 10.21 94 91300 178498 90358555
Lipids increased 24.98 10.21 16 91378 1316 90535737
Coeliac disease 24.97 10.21 7 91387 44603 90492450
Vision blurred 24.63 10.21 193 91201 110100 90426953
Aortic valve replacement 24.52 10.21 14 91380 935 90536118
Pancytopenia 24.43 10.21 53 91341 120210 90416843
Microscopic polyangiitis 24.12 10.21 9 91385 222 90536831
Eyelid disorder 24.00 10.21 19 91375 2184 90534869
Polycystic ovaries 23.87 10.21 29 91365 5625 90531428
Device expulsion 23.67 10.21 6 91388 40880 90496173
Cerebrovascular arteriovenous malformation 23.66 10.21 7 91387 81 90536972
Sleep apnoea syndrome 23.49 10.21 78 91316 31669 90505384
Blood pressure systolic abnormal 23.38 10.21 57 91337 19421 90517632
Hip fracture 23.35 10.21 80 91314 32997 90504056
Paranasal sinus discomfort 23.26 10.21 30 91364 6180 90530873
Suicide attempt 23.24 10.21 25 91369 75374 90461679
Tubulointerstitial nephritis 23.14 10.21 67 91327 25276 90511777
Muscle atrophy 23.13 10.21 35 91359 8366 90528687
Respiratory syncytial virus test positive 23.11 10.21 14 91380 1044 90536009
Taste disorder 23.06 10.21 17 91377 61529 90475524
Finger deformity 22.97 10.21 3 91391 32894 90504159
Myocardial ischaemia 22.89 10.21 46 91348 13768 90523285
Apolipoprotein B increased 22.84 10.21 5 91389 14 90537039
Nasal ulcer 22.83 10.21 20 91374 2646 90534407
Impaired work ability 22.60 10.21 56 91338 19270 90517783
Hypercholesterolaemia 22.60 10.21 42 91352 100850 90436203
Migraine 22.48 10.21 107 91287 190285 90346768
Sleep disorder 22.40 10.21 113 91281 197917 90339136
Reaction to colouring 22.38 10.21 6 91388 47 90537006
Drug tolerance decreased 22.27 10.21 3 91391 32127 90504926
Encephalopathy 21.40 10.21 10 91384 46434 90490619
Hypoaesthesia 21.38 10.21 208 91186 314002 90223051
Glycosylated haemoglobin increased 21.36 10.21 48 91346 15514 90521539
Non-high-density lipoprotein cholesterol increased 21.23 10.21 8 91386 203 90536850
Vascular purpura 21.14 10.21 16 91378 1722 90535331
Renovascular hypertension 21.09 10.21 5 91389 22 90537031
Intentional overdose 21.08 10.21 39 91355 93795 90443258
Impaired quality of life 20.95 10.21 61 91333 23083 90513970
Abdominal discomfort 20.89 10.21 347 91047 476981 90060072
Complex regional pain syndrome 20.89 10.21 19 91375 2640 90534413
Copper metabolism disorder 20.83 10.21 4 91390 4 90537049
Cardiac failure chronic 20.72 10.21 27 91367 5619 90531434
Therapeutic product effect incomplete 20.61 10.21 113 91281 193783 90343270
Ear infection 20.56 10.21 24 91370 69751 90467302
Urinary tract infection 20.49 10.21 427 90967 305205 90231848
Drug hypersensitivity 20.30 10.21 337 91057 463272 90073781
Foetal exposure during pregnancy 20.20 10.21 9 91385 42966 90494087
Faeces discoloured 20.08 10.21 57 91337 21263 90515790
Hyperkalaemia 20.01 10.21 123 91271 64841 90472212
Gout 19.88 10.21 49 91345 16810 90520243
Palmar erythema 19.79 10.21 16 91378 1895 90535158
Aortic arteriosclerosis 19.73 10.21 31 91363 7653 90529400
Coronary artery thrombosis 19.66 10.21 13 91381 1129 90535924
Carotid artery disease 19.59 10.21 15 91379 1642 90535411
Biliary fibrosis 19.56 10.21 4 91390 7 90537046
Blood glucose decreased 19.55 10.21 60 91334 23369 90513684
Sciatica 19.52 10.21 46 91348 101336 90435717
Atrial fibrillation 19.32 10.21 213 91181 133398 90403655
Abnormal dreams 19.27 10.21 38 91356 11219 90525834
Oedema 19.02 10.21 121 91273 200174 90336879
Pyrexia 18.98 10.21 514 90880 659971 89877082
Gastric disorder 18.75 10.21 75 91319 33309 90503744
Platelet count decreased 18.60 10.21 73 91321 136896 90400157
Diabetic neuropathy 18.57 10.21 23 91371 4551 90532502
Cholestasis 18.39 10.21 79 91315 36220 90500833
Swelling of eyelid 18.36 10.21 25 91369 5429 90531624
Chronic spontaneous urticaria 18.35 10.21 15 91379 1805 90535248
Spleen congestion 18.06 10.21 6 91388 104 90536949
Lipids abnormal 18.01 10.21 8 91386 312 90536741
Gastrooesophageal reflux disease 17.94 10.21 251 91143 166086 90370967
Urticaria 17.68 10.21 216 91178 312518 90224535
Total cholesterol/HDL ratio decreased 17.60 10.21 4 91390 14 90537039
Hospitalisation 17.57 10.21 68 91326 128032 90409021
Oesophageal irritation 17.52 10.21 8 91386 333 90536720
Antiphospholipid syndrome 17.38 10.21 16 91378 2258 90534795
Ischaemic cardiomyopathy 17.33 10.21 17 91377 2596 90534457
Back injury 17.31 10.21 13 91381 46609 90490444
Autoimmune myositis 17.26 10.21 8 91386 345 90536708
Anxiety disorder 17.23 10.21 23 91371 4899 90532154
Chest pain 17.20 10.21 433 90961 319212 90217841
Arteriosclerosis coronary artery 17.15 10.21 33 91361 9570 90527483
Spontaneous haematoma 17.13 10.21 12 91382 1146 90535907
Language disorder 17.12 10.21 17 91377 2635 90534418
Polymyalgia rheumatica 17.03 10.21 23 91371 4954 90532099
Osteoarthropathy 16.94 10.21 8 91386 360 90536693
Photopsia 16.86 10.21 23 91371 5001 90532052
Swollen tongue 16.76 10.21 91 91303 45865 90491188
Cardiac valve disease 16.75 10.21 22 91372 4613 90532440
Nail disorder 16.68 10.21 21 91373 59046 90478007
Heliotrope rash 16.66 10.21 7 91387 238 90536815
Hyperhidrosis 16.48 10.21 210 91184 136095 90400958
Hyperparathyroidism secondary 16.41 10.21 14 91380 1787 90535266
Lichen planus 16.39 10.21 17 91377 2774 90534279
Transferrin decreased 16.34 10.21 8 91386 390 90536663
Frequent bowel movements 16.33 10.21 20 91374 56915 90480138
Mononeuropathy multiplex 16.23 10.21 8 91386 396 90536657
Anxiety 16.19 10.21 418 90976 309354 90227699
Product administration error 16.18 10.21 61 91333 26362 90510691
Immunodeficiency 16.12 10.21 12 91382 43222 90493831
Reaction to excipient 16.02 10.21 14 91380 1846 90535207
Anembryonic gestation 16.02 10.21 9 91385 583 90536470
Palatal swelling 16.01 10.21 6 91388 150 90536903
Exostosis 15.95 10.21 18 91376 53116 90483937
Gastric ulcer haemorrhage 15.88 10.21 23 91371 5288 90531765
Skin laceration 15.85 10.21 60 91334 25975 90511078
Blood uric acid abnormal 15.79 10.21 6 91388 156 90536897
Glomerular filtration rate decreased 15.69 10.21 45 91349 16887 90520166
Gastrointestinal haemorrhage 15.48 10.21 149 91245 90099 90446954
Blood lactic acid increased 15.47 10.21 30 91364 8748 90528305
Iron binding capacity total decreased 15.15 10.21 8 91386 458 90536595
Aphthous ulcer 15.11 10.21 45 91349 17242 90519811
Helicobacter gastritis 15.05 10.21 13 91381 1687 90535366
Bone density decreased 15.02 10.21 45 91349 17300 90519753
Poikiloderma 14.90 10.21 7 91387 311 90536742
General physical condition 14.85 10.21 4 91390 32 90537021
Obstructive pancreatitis 14.84 10.21 9 91385 672 90536381
Hepatic cyst 14.83 10.21 25 91369 6543 90530510
Gingival oedema 14.77 10.21 5 91389 92 90536961
Sleep disorder due to a general medical condition 14.74 10.21 14 91380 44724 90492329
Bradycardia 14.66 10.21 139 91255 83708 90453345
Cognitive disorder 14.59 10.21 30 91364 69377 90467676
Acute on chronic liver failure 14.46 10.21 7 91387 333 90536720
Lip swelling 14.45 10.21 77 91317 38533 90498520
Adverse reaction 14.32 10.21 6 91388 29706 90507347
Blood creatine phosphokinase MM increased 14.23 10.21 4 91390 38 90537015
Vertebral lateral recess stenosis 14.23 10.21 7 91387 345 90536708
Acquired epidermolysis bullosa 14.14 10.21 4 91390 39 90537014
Haematoma muscle 14.10 10.21 13 91381 1837 90535216
Nephrogenic systemic fibrosis 14.08 10.21 19 91375 4089 90532964
Muscle fatigue 14.01 10.21 16 91378 2908 90534145
Osteoarthritis 13.97 10.21 128 91266 195602 90341451
Nasal cyst 13.87 10.21 4 91390 42 90537011
Hot flush 13.78 10.21 105 91289 59383 90477670
Hypoglycaemic seizure 13.77 10.21 8 91386 552 90536501
Ligamentum flavum hypertrophy 13.77 10.21 7 91387 370 90536683
Gait disturbance 13.75 10.21 352 91042 260144 90276909
Stent placement 13.74 10.21 19 91375 4184 90532869
Product quality issue 13.72 10.21 38 91356 79287 90457766
Headache 13.68 10.21 1028 90366 861718 89675335
Increased appetite 13.66 10.21 34 91360 11731 90525322
Abortion spontaneous 13.49 10.21 21 91373 54035 90483018
Cerebellar syndrome 13.41 10.21 18 91376 3854 90533199
Myositis 13.39 10.21 54 91340 24074 90512979
Drug resistance 13.36 10.21 7 91387 30442 90506611
Mean cell haemoglobin increased 13.29 10.21 18 91376 3887 90533166
Therapy cessation 13.26 10.21 72 91322 36289 90500764
Malignant neoplasm progression 13.24 10.21 59 91335 106811 90430242
Cholangitis 13.22 10.21 25 91369 7157 90529896
Cystitis noninfective 13.21 10.21 11 91383 1358 90535695
Autoimmune hepatitis 13.18 10.21 31 91363 10320 90526733
Liver function test increased 12.99 10.21 43 91351 84812 90452241
Aneurysm 12.88 10.21 17 91377 3583 90533470
Hyperchylomicronaemia 12.83 10.21 4 91390 56 90536997
Radius fracture 12.80 10.21 18 91376 4026 90533027
Arcus lipoides 12.69 10.21 3 91391 13 90537040
Renal failure 12.67 10.21 194 91200 130813 90406240
Tremor 12.65 10.21 221 91173 152952 90384101
Paranoia 12.64 10.21 35 91359 12873 90524180
Injection site extravasation 12.58 10.21 28 91366 8991 90528062
Throat tightness 12.57 10.21 61 91333 29423 90507630
Toe operation 12.57 10.21 10 91384 1158 90535895
Red blood cell sedimentation rate increased 12.55 10.21 42 91352 82553 90454500
Food allergy 12.51 10.21 5 91389 25473 90511580
Blood cholesterol abnormal 12.49 10.21 15 91379 2875 90534178
Hallucination, auditory 12.49 10.21 40 91354 15935 90521118
Catheter site thrombosis 12.43 10.21 7 91387 455 90536598
Laryngitis 12.39 10.21 20 91374 50733 90486320
Vascular stent occlusion 12.39 10.21 4 91390 63 90536990
Product substitution issue 12.23 10.21 43 91351 17965 90519088
Aortic valve stenosis 12.15 10.21 18 91376 4222 90532831
Haematochezia 12.12 10.21 117 91277 70796 90466257
Xanthoma 12.00 10.21 4 91390 70 90536983
Septic shock 11.98 10.21 44 91350 84116 90452937
Feeling abnormal 11.97 10.21 236 91158 166999 90370054
Bone marrow failure 11.94 10.21 9 91385 32212 90504841
Abscess 11.89 10.21 44 91350 18847 90518206
Low density lipoprotein 11.88 10.21 3 91391 18 90537035
Renal pain 11.87 10.21 25 91369 7734 90529319
Small intestinal haemorrhage 11.86 10.21 13 91381 2258 90534795
Vascular access site pain 11.84 10.21 7 91387 499 90536554
Neutrophil count decreased 11.83 10.21 35 91359 71497 90465556
Sepsis 11.81 10.21 120 91274 179694 90357359
Duodenitis 11.76 10.21 18 91376 4345 90532708
Pancreatic neoplasm 11.66 10.21 9 91385 997 90536056
Peritonitis 11.66 10.21 45 91349 19660 90517393
Joint space narrowing 11.66 10.21 8 91386 739 90536314
Xanthelasma 11.60 10.21 4 91390 78 90536975
Paresis 11.59 10.21 14 91380 2700 90534353
Electrocardiogram Q wave abnormal 11.53 10.21 5 91389 184 90536869
Eye infection 11.43 10.21 36 91358 14218 90522835
Blood pressure systolic increased 11.36 10.21 99 91295 58246 90478807
Hypothyroidism 11.33 10.21 92 91302 53035 90484018
Renal disorder 11.23 10.21 71 91323 37788 90499265
Syncope 11.17 10.21 192 91202 132471 90404582
Hepatic cirrhosis 11.16 10.21 30 91364 63223 90473830
Liver disorder 11.13 10.21 74 91320 121195 90415858
Coronary arterial stent insertion 11.08 10.21 14 91380 2826 90534227
Skin induration 11.05 10.21 15 91379 3247 90533806
Vaginal discharge 11.00 10.21 3 91391 19461 90517592
Hyperphosphataemia 10.99 10.21 16 91378 3695 90533358
MELAS syndrome 10.89 10.21 5 91389 211 90536842
Memory impairment 10.85 10.21 137 91257 197107 90339946
Normal newborn 10.81 10.21 5 91389 23357 90513696
Chronic obstructive pulmonary disease 10.81 10.21 118 91276 73711 90463342
Granuloma annulare 10.78 10.21 8 91386 836 90536217
Hypotrichosis 10.69 10.21 5 91389 220 90536833
Multiple sclerosis relapse 10.66 10.21 23 91371 52282 90484771
Right atrial enlargement 10.65 10.21 5 91389 222 90536831
Mitral valve incompetence 10.63 10.21 48 91346 22476 90514577
Abdominal distension 10.63 10.21 188 91206 130413 90406640
Ascites 10.58 10.21 20 91374 47720 90489333
Myoglobinuria 10.46 10.21 6 91388 404 90536649
Hypertriglyceridaemia 10.46 10.21 24 91370 7865 90529188
Pancreatic cyst 10.43 10.21 12 91382 2198 90534855
Seizure 10.38 10.21 101 91293 152528 90384525
Disease risk factor 10.36 10.21 5 91389 236 90536817
Eye irritation 10.25 10.21 64 91330 33914 90503139
Pustular psoriasis 10.22 10.21 3 91391 18553 90518500

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 1629.99 11.04 1348 73586 94732 42451669
Rhabdomyolysis 724.40 11.04 785 74149 77234 42469167
Blood creatine phosphokinase increased 671.23 11.04 606 74328 47732 42498669
Myopathy 401.10 11.04 268 74666 13493 42532908
Low density lipoprotein increased 291.54 11.04 156 74778 5199 42541202
Myocardial infarction 221.33 11.04 595 74339 123414 42422987
Angina pectoris 199.54 11.04 267 74667 32629 42513772
Off label use 183.68 11.04 548 74386 637787 41908614
Muscular weakness 166.69 11.04 418 74516 83080 42463321
Muscle spasms 143.57 11.04 403 74531 85641 42460760
Coronary artery disease 140.30 11.04 299 74635 53421 42492980
High density lipoprotein decreased 125.96 11.04 81 74853 3816 42542585
Death 114.24 11.04 435 74499 470750 42075651
Neutropenia 113.50 11.04 110 74824 199321 42347080
Low density lipoprotein decreased 112.63 11.04 52 74882 1252 42545149
Myositis 104.76 11.04 130 74804 14736 42531665
Dizziness 102.98 11.04 770 74164 248484 42297917
Toxicity to various agents 100.22 11.04 155 74779 228981 42317420
Blood triglycerides increased 99.40 11.04 131 74803 15765 42530636
Muscle discomfort 96.20 11.04 29 74905 194 42546207
Low density lipoprotein abnormal 90.03 11.04 32 74902 379 42546022
Angina unstable 86.98 11.04 104 74830 11344 42535057
Drug interaction 85.64 11.04 779 74155 266220 42280181
Immune-mediated myositis 85.17 11.04 63 74871 3730 42542671
Hepatic enzyme increased 84.86 11.04 223 74711 45561 42500840
Drug abuse 65.29 11.04 53 74881 104718 42441683
Blood cholesterol increased 64.27 11.04 144 74790 26597 42519804
Pancreatitis 63.79 11.04 194 74740 43074 42503327
Malignant neoplasm progression 62.52 11.04 59 74875 108341 42438060
Febrile neutropenia 61.61 11.04 148 74786 185555 42360846
Venous pressure jugular increased 61.16 11.04 29 74905 743 42545658
Pancreatitis acute 59.68 11.04 161 74773 33403 42512998
Sepsis 59.15 11.04 168 74766 199166 42347235
Acute kidney injury 55.13 11.04 929 74005 366408 42179993
Disease progression 54.68 11.04 106 74828 143550 42402851
Erectile dysfunction 54.19 11.04 129 74805 24784 42521617
Asthenia 53.62 11.04 740 74194 280053 42266348
Coronary artery occlusion 52.97 11.04 80 74854 10917 42535484
Acute myocardial infarction 52.44 11.04 222 74712 57943 42488458
Pneumonia 52.15 11.04 483 74451 421666 42124735
Muscle rupture 51.38 11.04 39 74895 2401 42544000
Chest pain 50.82 11.04 419 74515 139111 42407290
Product use in unapproved indication 50.74 11.04 161 74773 184295 42362106
Pyrexia 50.33 11.04 447 74487 393595 42152806
Treatment failure 49.59 11.04 24 74910 62600 42483801
Necrotising myositis 47.82 11.04 28 74906 1113 42545288
Hyperthyroidism 47.24 11.04 88 74846 14253 42532148
Coronary artery stenosis 46.48 11.04 73 74861 10306 42536095
Drug ineffective for unapproved indication 46.25 11.04 12 74922 46151 42500250
Dyslipidaemia 46.06 11.04 69 74865 9349 42537052
Foetal exposure during pregnancy 44.26 11.04 14 74920 47297 42499104
Infection 44.12 11.04 81 74853 111987 42434414
Type V hyperlipidaemia 44.08 11.04 25 74909 935 42545466
Liver function test abnormal 43.83 11.04 141 74793 32250 42514151
Muscle disorder 43.60 11.04 39 74895 3025 42543376
Dyspnoea exertional 42.59 11.04 188 74746 49960 42496441
Radiation inflammation 42.04 11.04 25 74909 1023 42545378
Septic shock 41.95 11.04 60 74874 91612 42454789
Myelosuppression 41.54 11.04 10 74924 40451 42505950
Amyotrophic lateral sclerosis 40.67 11.04 25 74909 1087 42545314
Blood cholesterol decreased 40.65 11.04 25 74909 1088 42545313
Pulmonary pain 39.51 11.04 28 74906 1550 42544851
Suicide attempt 39.12 11.04 16 74918 46084 42500317
Cytokine release syndrome 38.53 11.04 15 74919 44512 42501889
Drug resistance 38.17 11.04 7 74927 34241 42512160
Alanine aminotransferase increased 38.01 11.04 276 74658 88130 42458271
Aspartate aminotransferase increased 37.36 11.04 248 74686 76915 42469486
Chromaturia 37.19 11.04 85 74849 15904 42530497
Intentional product use issue 37.01 11.04 43 74891 71790 42474611
Hyperuricaemia 36.40 11.04 62 74872 9362 42537039
Left atrial dilatation 35.02 11.04 31 74903 2371 42544030
Completed suicide 34.29 11.04 74 74860 96391 42450010
Oedema peripheral 34.28 11.04 378 74556 135698 42410703
Total cholesterol/HDL ratio increased 34.16 11.04 13 74921 189 42546212
Restrictive pulmonary disease 33.70 11.04 24 74910 1339 42545062
Inspiratory capacity abnormal 33.64 11.04 11 74923 99 42546302
Muscle atrophy 33.61 11.04 56 74878 8305 42538096
Left ventricular dysfunction 33.50 11.04 67 74867 11434 42534967
Autoimmune hepatitis 32.96 11.04 45 74889 5600 42540801
Lipoprotein (a) increased 32.96 11.04 15 74919 349 42546052
Pulmonary embolism 32.44 11.04 105 74829 119507 42426894
Sedation 32.35 11.04 7 74927 30468 42515933
Drug dependence 32.31 11.04 6 74928 29088 42517313
Crush syndrome 32.30 11.04 10 74924 74 42546327
Ischaemic cardiomyopathy 32.20 11.04 48 74886 6474 42539927
Urticarial dermatitis 32.07 11.04 6 74928 0 42546401
Ascites 31.33 11.04 32 74902 56646 42489755
Cutaneous lupus erythematosus 30.89 11.04 19 74915 827 42545574
Pain in extremity 30.76 11.04 402 74532 150202 42396199
Erythromelalgia 30.69 11.04 9 74925 54 42546347
Bone marrow failure 30.59 11.04 10 74924 33083 42513318
Cardiac failure congestive 30.57 11.04 256 74678 85346 42461055
Vascular stent stenosis 30.14 11.04 21 74913 1131 42545270
Arthralgia 29.92 11.04 517 74417 204721 42341680
Premature baby 29.89 11.04 3 74931 23150 42523251
Haematocrit increased 29.47 11.04 29 74905 2538 42543863
Leukopenia 29.43 11.04 54 74880 74692 42471709
Acquired haemophilia 29.30 11.04 24 74910 1651 42544750
Glycogen storage disease type V 29.19 11.04 8 74926 36 42546365
Stent placement 28.72 11.04 41 74893 5319 42541082
Multiple organ dysfunction syndrome 28.58 11.04 82 74852 96953 42449448
Intentional overdose 28.50 11.04 29 74905 51427 42494974
Myocardial ischaemia 28.41 11.04 82 74852 17680 42528721
Exercise lack of 28.17 11.04 10 74924 118 42546283
Atrial fibrillation 27.83 11.04 371 74563 139222 42407179
Neutrophil count decreased 27.56 11.04 43 74891 63372 42483029
Hospitalisation 27.26 11.04 56 74878 74274 42472127
Mean cell haemoglobin concentration abnormal 27.14 11.04 8 74926 49 42546352
Tendon rupture 27.12 11.04 50 74884 8033 42538368
Diaphragmatic disorder 26.52 11.04 20 74914 1219 42545182
Pancytopenia 26.27 11.04 112 74822 117631 42428770
Prohormone brain natriuretic peptide increased 26.25 11.04 9 74925 95 42546306
Glycosylated haemoglobin increased 26.05 11.04 65 74869 12859 42533542
Arteriosclerosis 25.88 11.04 80 74854 17909 42528492
Respiratory failure 25.55 11.04 127 74807 128005 42418396
Renal impairment 25.41 11.04 301 74633 109927 42436474
Mucosal dryness 25.16 11.04 22 74912 1656 42544745
Xanthoma 25.06 11.04 9 74925 110 42546291
Autoimmune myositis 24.74 11.04 15 74919 636 42545765
Cytomegalovirus infection 24.64 11.04 13 74921 32293 42514108
C-reactive protein increased 24.07 11.04 47 74887 63513 42482888
Troponin increased 24.01 11.04 81 74853 18981 42527420
Platelet count decreased 23.98 11.04 144 74790 138437 42407964
Myasthenic syndrome 23.93 11.04 16 74918 805 42545596
Miller Fisher syndrome 23.45 11.04 9 74925 134 42546267
Toxic epidermal necrolysis 23.16 11.04 9 74925 26741 42519660
Incorrect route of product administration 23.08 11.04 7 74927 24298 42522103
Thrombocytopenia 22.84 11.04 219 74715 190060 42356341
Therapy partial responder 22.51 11.04 4 74930 20017 42526384
Hypovolaemia 22.35 11.04 57 74877 11428 42534973
Spinal osteoarthritis 22.25 11.04 48 74886 8638 42537763
Serotonin syndrome 21.88 11.04 9 74925 25836 42520565
Allergy to animal 21.75 11.04 13 74921 537 42545864
White blood cell count decreased 21.68 11.04 110 74824 110286 42436115
Bronchopulmonary aspergillosis 21.59 11.04 4 74930 19425 42526976
Lymphocyte count decreased 21.49 11.04 11 74923 27798 42518603
Drug intolerance 21.43 11.04 226 74708 80198 42466203
Acute coronary syndrome 21.29 11.04 66 74868 14799 42531602
Mucosal inflammation 20.96 11.04 34 74900 49340 42497061
Phaeochromocytoma malignant 20.94 11.04 7 74927 68 42546333
Candida infection 20.93 11.04 6 74928 21604 42524797
Coma 20.80 11.04 39 74895 53515 42492886
Overdose 20.60 11.04 105 74829 105159 42441242
Dyspnoea at rest 20.59 11.04 31 74903 4218 42542183
Heart valve stenosis 20.58 11.04 7 74927 72 42546329
Neurotoxicity 20.40 11.04 8 74926 23643 42522758
Polymyositis 20.30 11.04 20 74914 1753 42544648
Pericardial haemorrhage 20.16 11.04 28 74906 3541 42542860
BRASH syndrome 19.81 11.04 20 74914 1805 42544596
Food aversion 19.79 11.04 12 74922 509 42545892
Self esteem decreased 19.77 11.04 12 74922 510 42545891
Orthostatic hypotension 19.76 11.04 106 74828 30464 42515937
Syncope 19.72 11.04 264 74670 99142 42447259
Exercise tolerance decreased 19.70 11.04 37 74897 6029 42540372
Drug ineffective 19.51 11.04 908 74026 629289 41917112
Feeling abnormal 18.54 11.04 196 74738 69590 42476811
Drug effect less than expected 18.49 11.04 28 74906 3829 42542572
Muscle fatigue 18.48 11.04 19 74915 1752 42544649
Back pain 18.47 11.04 351 74583 141425 42404976
Product use issue 18.37 11.04 71 74863 76680 42469721
Muscle necrosis 18.34 11.04 15 74919 1030 42545371
Haemorrhagic transformation stroke 18.30 11.04 19 74915 1772 42544629
Hypophosphataemia 18.21 11.04 7 74927 20938 42525463
Flatulence 18.19 11.04 90 74844 25062 42521339
Aldolase increased 18.16 11.04 6 74928 56 42546345
Testicular swelling 18.13 11.04 20 74914 1999 42544402
Lipase increased 18.09 11.04 50 74884 10516 42535885
Accidental overdose 18.05 11.04 14 74920 28316 42518085
Potentiating drug interaction 18.03 11.04 37 74897 6431 42539970
Paraesthesia 17.99 11.04 203 74731 73256 42473145
Heliotrope rash 17.98 11.04 5 74929 24 42546377
Hyperkalaemia 17.78 11.04 218 74716 80240 42466161
Dyspepsia 17.70 11.04 129 74805 41223 42505178
Cardio-respiratory arrest 17.66 11.04 49 74885 58587 42487814
Somnolence 17.52 11.04 161 74773 140944 42405457
Blood creatine phosphokinase abnormal 17.49 11.04 10 74924 380 42546021
Cardiac disorder 17.28 11.04 146 74788 48786 42497615
ECG signs of myocardial ischaemia 17.16 11.04 8 74926 197 42546204
Type IIa hyperlipidaemia 16.57 11.04 9 74925 309 42546092
Hypercholesterolaemia 16.54 11.04 55 74879 12794 42533607
Neoplasm progression 16.45 11.04 16 74918 28984 42517417
Anion gap abnormal 16.43 11.04 10 74924 427 42545974
Agitation 16.37 11.04 58 74876 64256 42482145
Loss of personal independence in daily activities 16.25 11.04 40 74894 49776 42496625
Fatigue 16.23 11.04 928 74006 434713 42111688
Tendon injury 16.21 11.04 14 74920 1036 42545365
Melaena 16.08 11.04 120 74814 38626 42507775
Haemoglobin increased 15.97 11.04 31 74903 5175 42541226
Ventricular tachycardia 15.85 11.04 99 74835 30061 42516340
Genital pain 15.84 11.04 13 74921 897 42545504
Sclerodactylia 15.81 11.04 5 74929 40 42546361
Laryngeal discomfort 15.77 11.04 8 74926 238 42546163
Irritable bowel syndrome 15.76 11.04 29 74905 4652 42541749
Respiratory arrest 15.76 11.04 16 74918 28408 42517993
Psychotic disorder 15.57 11.04 17 74917 29191 42517210
Hypotony of eye 15.39 11.04 8 74926 251 42546150
Dyspnoea 15.37 11.04 937 73997 441684 42104717
Cerebrovascular accident 15.32 11.04 248 74686 96912 42449489
Cardiovascular disorder 15.28 11.04 55 74879 13310 42533091
Stomatitis 15.20 11.04 42 74892 50287 42496114
Serum ferritin abnormal 14.91 11.04 8 74926 268 42546133
Aggression 14.77 11.04 35 74899 44128 42502273
Dissociation 14.68 11.04 25 74909 3773 42542628
Blood creatine phosphokinase 14.65 11.04 6 74928 107 42546294
Influenza like illness 14.60 11.04 101 74833 31739 42514662
Drug withdrawal syndrome 14.57 11.04 10 74924 21539 42524862
Anuria 14.52 11.04 49 74885 11483 42534918
Faeces pale 14.51 11.04 16 74918 1598 42544803
Electrocardiogram abnormal 14.49 11.04 45 74889 10100 42536301
Neuroleptic malignant syndrome 14.47 11.04 10 74924 21462 42524939
Gastrointestinal pain 14.42 11.04 27 74907 4388 42542013
Duplicate therapy error 14.38 11.04 8 74926 288 42546113
Pancreatic carcinoma 14.35 11.04 43 74891 9463 42536938
Delirium 14.30 11.04 46 74888 52473 42493928
Tumour lysis syndrome 14.14 11.04 11 74923 22220 42524181
Muscle injury 14.05 11.04 16 74918 1656 42544745
Genital ulceration 14 11.04 12 74922 879 42545522
Coronary artery bypass 13.98 11.04 28 74906 4782 42541619
Lichenoid keratosis 13.97 11.04 25 74909 3925 42542476
Apolipoprotein increased 13.96 11.04 3 74931 3 42546398
Inappropriate schedule of product administration 13.91 11.04 105 74829 95797 42450604
Transaminases abnormal 13.89 11.04 8 74926 308 42546093
High density lipoprotein abnormal 13.86 11.04 5 74929 62 42546339
Electrocardiogram QT prolonged 13.76 11.04 41 74893 47904 42498497
Posterior reversible encephalopathy syndrome 13.49 11.04 3 74931 12818 42533583
Dystonia 13.45 11.04 3 74931 12787 42533614
Total cholesterol/HDL ratio decreased 13.44 11.04 5 74929 68 42546333
Peripheral arterial occlusive disease 13.37 11.04 34 74900 6804 42539597
Abdominal discomfort 13.36 11.04 196 74738 75059 42471342
Pneumothorax 13.34 11.04 13 74921 23530 42522871
Hepatic function abnormal 13.31 11.04 144 74790 51423 42494978
Adrenal insufficiency 13.18 11.04 67 74867 18857 42527544
Tachycardia 13.13 11.04 114 74820 100973 42445428
Aortic bruit 13.08 11.04 7 74927 233 42546168
Pancreatic neoplasm 13.08 11.04 12 74922 962 42545439
Euglycaemic diabetic ketoacidosis 13.06 11.04 30 74904 5630 42540771
Thrombosis 13.03 11.04 69 74865 68442 42477959
Arteriosclerosis coronary artery 12.92 11.04 66 74868 18611 42527790
Glomerular filtration rate decreased 12.90 11.04 60 74874 16291 42530110
Ureteric cancer recurrent 12.87 11.04 4 74930 30 42546371
Red blood cell count abnormal 12.84 11.04 11 74923 805 42545596
Injury 12.84 11.04 75 74859 22241 42524160
Lipoprotein increased 12.75 11.04 3 74931 6 42546395
Aortic embolus 12.75 11.04 3 74931 6 42546395
Carotid artery stenosis 12.75 11.04 29 74905 5407 42540994
Plasma cell myeloma 12.72 11.04 42 74892 47536 42498865
Delusion 12.68 11.04 5 74929 14729 42531672
Iron binding capacity total increased 12.65 11.04 4 74930 32 42546369
Vein disorder 12.64 11.04 17 74917 2085 42544316
Aspergillus infection 12.64 11.04 6 74928 15831 42530570
Hepatitis cholestatic 12.60 11.04 42 74892 9782 42536619
Ventricular fibrillation 12.54 11.04 21 74913 30102 42516299
Blood creatinine increased 12.54 11.04 267 74667 109736 42436665
Intentional product misuse 12.53 11.04 61 74873 61839 42484562
Systemic infection 12.47 11.04 28 74906 5177 42541224
Abnormal behaviour 12.40 11.04 17 74917 26434 42519967
Gait disturbance 12.20 11.04 241 74693 97759 42448642
Microalbuminuria 12.19 11.04 11 74923 863 42545538
Hepatic failure 12.11 11.04 31 74903 38069 42508332
Bacterial infection 12.02 11.04 19 74915 27860 42518541
Cytopenia 11.99 11.04 8 74926 17489 42528912
Muscle strength abnormal 11.98 11.04 7 74927 277 42546124
Blood glucose increased 11.95 11.04 189 74745 73510 42472891
Hyperphosphataemia 11.89 11.04 4 74930 13000 42533401
Bacteraemia 11.84 11.04 16 74918 25024 42521377
Hypotension 11.83 11.04 560 74374 257071 42289330
Hypercapnic coma 11.78 11.04 6 74928 180 42546221
Urogenital haemorrhage 11.77 11.04 10 74924 724 42545677
Dermatitis atopic 11.68 11.04 48 74886 12356 42534045
Knee arthroplasty 11.67 11.04 38 74896 8743 42537658
Acute phosphate nephropathy 11.65 11.04 3 74931 10 42546391
Progressive multifocal leukoencephalopathy 11.55 11.04 3 74931 11533 42534868
Arrhythmia 11.55 11.04 115 74819 40202 42506199
Pancreatitis necrotising 11.53 11.04 22 74912 3627 42542774
Blood pressure increased 11.49 11.04 247 74687 101681 42444720
Condition aggravated 11.48 11.04 360 74574 260394 42286007
Nasal neoplasm 11.37 11.04 5 74929 107 42546294
Impetigo 11.36 11.04 13 74921 1353 42545048
Escherichia infection 11.34 11.04 3 74931 11393 42535008
Polymyalgia rheumatica 11.33 11.04 17 74917 2306 42544095
Weight decreased 11.32 11.04 460 74474 207488 42338913
Pseudomonas infection 11.30 11.04 7 74927 15916 42530485
Cholestatic liver injury 11.28 11.04 22 74912 3687 42542714
COVID-19 11.27 11.04 140 74794 115808 42430593
Tricuspid valve incompetence 11.26 11.04 44 74890 11069 42535332
Dyskinesia oesophageal 11.13 11.04 4 74930 49 42546352
Therapeutic drug monitoring analysis incorrectly performed 11.11 11.04 7 74927 318 42546083
Diabetes mellitus inadequate control 11.08 11.04 55 74879 15335 42531066
Hand fracture 11.07 11.04 19 74915 2887 42543514
Burning sensation 11.06 11.04 69 74865 20944 42525457

FDA Adverse Event Reporting System (Geriatric)

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 2676.34 10.23 2221 136724 220160 110230194
Rhabdomyolysis 1374.36 10.23 1168 137777 119233 110331121
Blood creatine phosphokinase increased 952.46 10.23 766 138179 72311 110378043
Angina pectoris 487.67 10.23 490 138455 61805 110388549
Myopathy 483.07 10.23 332 138613 24628 110425726
Low density lipoprotein increased 409.18 10.23 220 138725 10446 110439908
Myocardial infarction 330.25 10.23 739 138206 191344 110259010
Off label use 293.41 10.23 941 138004 1499244 108951110
Muscular weakness 288.90 10.23 824 138121 247644 110202710
Coronary artery disease 276.37 10.23 393 138552 71297 110379057
Arterial occlusive disease 255.39 10.23 186 138759 15122 110435232
Hand deformity 253.88 10.23 4 138941 218502 110231852
Carotid artery thrombosis 234.66 10.23 148 138797 9490 110440864
Neurologic neglect syndrome 231.96 10.23 145 138800 9153 110441201
Synovitis 220.76 10.23 39 138906 274053 110176301
Gangrene 216.34 10.23 173 138772 16168 110434186
Pemphigus 211.49 10.23 15 138930 214555 110235799
Acute kidney injury 210.41 10.23 1442 137503 633988 109816366
Maternal exposure during pregnancy 208.05 10.23 35 138910 254848 110195506
Pericarditis 205.74 10.23 19 138926 219095 110231259
Adjustment disorder 200.42 10.23 140 138805 10655 110439699
Muscle spasms 195.57 10.23 779 138166 277378 110172976
Personality disorder 191.83 10.23 146 138799 12691 110437663
Systemic lupus erythematosus 188.59 10.23 44 138901 254294 110196060
Folliculitis 183.44 10.23 6 138939 167647 110282707
Immune-mediated myositis 181.39 10.23 107 138838 6079 110444275
Sensory loss 179.37 10.23 175 138770 21282 110429072
Contraindicated product administered 178.13 10.23 46 138899 248221 110202133
Sinus congestion 177.44 10.23 205 138740 30254 110420100
Duodenal ulcer perforation 176.34 10.23 12 138933 177688 110272666
Infusion related reaction 175.94 10.23 133 138812 381029 110069325
Drug interaction 174.35 10.23 1150 137795 499033 109951321
Glossodynia 169.43 10.23 36 138909 221968 110228386
Helicobacter infection 167.50 10.23 17 138928 181860 110268494
Skin haemorrhage 165.02 10.23 179 138766 24648 110425706
Sneezing 156.45 10.23 197 138748 31787 110418567
Hemiplegia 156.24 10.23 167 138778 22615 110427739
Affect lability 153.92 10.23 151 138794 18486 110431868
Infection 145.73 10.23 144 138801 362056 110088298
Cerebrovascular accident 142.34 10.23 526 138419 180758 110269596
Treatment failure 142.27 10.23 86 138859 277148 110173206
Pancreatitis acute 139.05 10.23 262 138683 60012 110390342
Coordination abnormal 138.97 10.23 165 138780 25063 110425291
Palpitations 138.71 10.23 478 138467 158734 110291620
Motor dysfunction 138.38 10.23 162 138783 24244 110426110
High density lipoprotein decreased 136.98 10.23 87 138858 5646 110444708
Therapeutic product effect decreased 136.68 10.23 68 138877 244248 110206106
Toxicity to various agents 132.03 10.23 252 138693 480303 109970051
Low density lipoprotein decreased 131.86 10.23 54 138891 1368 110448986
Wound 128.52 10.23 67 138878 234370 110215984
Angina unstable 126.23 10.23 128 138817 16304 110434050
Fibromyalgia 125.81 10.23 30 138915 170879 110279475
Pulmonary pain 124.80 10.23 85 138860 6208 110444146
Acute myocardial infarction 123.83 10.23 304 138641 83473 110366881
Muscle rupture 122.59 10.23 74 138871 4386 110445968
Stomatitis 122.48 10.23 96 138849 270146 110180208
Sinus disorder 121.09 10.23 176 138769 32552 110417802
Neutropenia 120.88 10.23 177 138768 374443 110075911
Muscle discomfort 120.52 10.23 38 138907 436 110449918
Muscle injury 117.87 10.23 18 138927 140789 110309565
Influenza like illness 117.33 10.23 308 138637 88104 110362250
Intentional product use issue 116.27 10.23 85 138860 247821 110202533
Drug ineffective 115.26 10.23 1290 137655 1519250 108931104
Sleep disorder due to general medical condition, insomnia type 114.78 10.23 4 138941 105639 110344715
Chest discomfort 114.24 10.23 477 138468 173371 110276983
Eating disorder 112.80 10.23 165 138780 30693 110419661
Product use issue 112.01 10.23 136 138809 311559 110138795
Dizziness 111.77 10.23 1354 137591 696839 109753515
Respiratory tract congestion 109.91 10.23 163 138782 30694 110419660
Cataract 109.69 10.23 281 138664 79204 110371150
Asthenia 108.90 10.23 1333 137612 687666 109762688
Myositis 108.88 10.23 163 138782 30953 110419401
Blood triglycerides increased 108.58 10.23 142 138803 23784 110426570
Liver function test abnormal 108.12 10.23 256 138689 68694 110381660
Facet joint syndrome 107.60 10.23 3 138942 96825 110353529
Flatulence 107.27 10.23 216 138729 51933 110398421
Swelling 106.40 10.23 173 138772 350868 110099486
Crush syndrome 106.01 10.23 33 138912 362 110449992
Dyslipidaemia 105.91 10.23 115 138830 15850 110434504
Coronary artery occlusion 105.32 10.23 114 138831 15658 110434696
Lip dry 104.67 10.23 5 138940 100078 110350276
Psoriatic arthropathy 103.81 10.23 59 138886 196702 110253652
Blood pressure increased 100.97 10.23 612 138333 257761 110192593
Exposure during pregnancy 100.79 10.23 42 138903 167382 110282972
Alopecia 100.37 10.23 191 138754 364562 110085792
Irritable bowel syndrome 99.17 10.23 41 138904 164174 110286180
Impaired healing 98.17 10.23 63 138882 196654 110253700
Hemiparesis 97.75 10.23 188 138757 43715 110406639
Product use in unapproved indication 96.64 10.23 267 138678 447110 110003244
Restrictive pulmonary disease 86.82 10.23 53 138892 3206 110447148
Skin exfoliation 85.98 10.23 274 138671 87377 110362977
Joint swelling 85.78 10.23 278 138667 442567 110007787
Amyloid arthropathy 85.72 10.23 42 138903 1638 110448716
Aphasia 84.97 10.23 212 138733 58785 110391569
Vascular stent stenosis 83.37 10.23 40 138905 1489 110448865
Necrotising myositis 81.59 10.23 43 138902 1959 110448395
Blister 80.83 10.23 100 138845 227276 110223078
Coronary artery stenosis 80.80 10.23 93 138852 13665 110436689
Muscle spasticity 80.21 10.23 154 138791 35761 110414593
Drug ineffective for unapproved indication 79.83 10.23 16 138929 102822 110347532
Death 76.94 10.23 538 138407 698331 109752023
Low density lipoprotein abnormal 75.61 10.23 28 138917 537 110449817
Erectile dysfunction 74.85 10.23 104 138841 18452 110431902
Alanine aminotransferase increased 74.77 10.23 440 138505 183333 110267021
Peripheral venous disease 74.55 10.23 9 138936 84108 110366246
Aspartate aminotransferase increased 74.40 10.23 397 138548 159539 110290815
Rhinorrhoea 74.03 10.23 290 138655 102376 110347978
Lipoprotein (a) increased 72.43 10.23 19 138926 105 110450249
Completed suicide 71.05 10.23 122 138823 242259 110208095
Cardiac failure congestive 71.05 10.23 376 138569 150624 110299730
Hypersensitivity 70.57 10.23 265 138680 403733 110046621
C-reactive protein increased 70.20 10.23 103 138842 217816 110232538
Grip strength decreased 70.02 10.23 9 138936 80165 110370189
Joint range of motion decreased 69.49 10.23 33 138912 121799 110328555
Pain in extremity 69.43 10.23 925 138020 486193 109964161
Febrile neutropenia 68.40 10.23 189 138756 316578 110133776
Ill-defined disorder 68.20 10.23 58 138887 156795 110293559
Hyper IgE syndrome 67.06 10.23 27 138918 654 110449700
Renal impairment 65.90 10.23 434 138511 188011 110262343
Bursitis 65.64 10.23 41 138904 129877 110320477
Mobility decreased 65.56 10.23 124 138821 237298 110213056
Myelosuppression 62.98 10.23 20 138925 94320 110356034
Dysarthria 62.59 10.23 240 138705 83881 110366473
Disease progression 61.80 10.23 134 138811 243900 110206454
Dysphagia 60.06 10.23 364 138581 153236 110297118
Chromaturia 59.65 10.23 121 138824 29239 110421115
Polymyositis 59.46 10.23 44 138901 3664 110446690
Sedation 58.10 10.23 9 138936 69674 110380680
Atrial fibrillation 57.66 10.23 489 138456 229153 110221201
Lung disorder 56.15 10.23 87 138858 179960 110270394
Arthropathy 55.98 10.23 180 138765 287342 110163012
Suicide attempt 55.97 10.23 30 138915 103364 110346990
Fall 55.75 10.23 1066 137879 602416 109847938
Venous pressure jugular increased 54.99 10.23 29 138916 1323 110449031
Dyspnoea exertional 54.45 10.23 267 138678 103793 110346561
Muscle atrophy 53.04 10.23 74 138871 13180 110437174
Euglycaemic diabetic ketoacidosis 52.76 10.23 69 138876 11554 110438800
Acute coronary syndrome 52.71 10.23 100 138845 23012 110427342
Wound infection 52.20 10.23 28 138917 96437 110353917
Cystitis 52.11 10.23 192 138753 65844 110384510
Ischaemic cardiomyopathy 51.91 10.23 57 138888 7954 110442400
International normalised ratio increased 51.53 10.23 231 138714 86541 110363813
Cone-rod dystrophy 51.51 10.23 10 138935 7 110450347
Lower respiratory tract infection 51.03 10.23 147 138798 242959 110207395
Drug hypersensitivity 50.17 10.23 349 138596 453741 109996613
Radiation inflammation 49.91 10.23 25 138920 1023 110449331
Wheezing 49.53 10.23 160 138785 255070 110195284
Hyperuricaemia 49.24 10.23 75 138870 14456 110435898
Lower limb fracture 48.50 10.23 17 138928 75331 110375023
Discomfort 47.16 10.23 127 138818 214580 110235774
Type V hyperlipidaemia 47.07 10.23 27 138918 1455 110448899
Autoimmune hepatitis 46.80 10.23 74 138871 14730 110435624
Night sweats 46.48 10.23 60 138885 133923 110316431
Pregnancy 46.41 10.23 5 138940 51062 110399292
Epilepsy 46.13 10.23 35 138910 100174 110350180
Amyotrophic lateral sclerosis 45.69 10.23 30 138915 2061 110448293
Body tinea 45.38 10.23 30 138915 2085 110448269
Chest pain 45.30 10.23 694 138251 375681 110074673
Hyperkalaemia 45.21 10.23 309 138636 135487 110314867
Autoimmune myositis 45.10 10.23 23 138922 978 110449376
Injury 44.32 10.23 98 138847 177167 110273187
Syncope 44.02 10.23 418 138527 202118 110248236
Blepharospasm 43.70 10.23 8 138937 54843 110395511
Intentional overdose 43.28 10.23 62 138883 132439 110317915
Malignant neoplasm progression 43.24 10.23 97 138848 174470 110275884
Total cholesterol/HDL ratio increased 42.56 10.23 17 138928 403 110449951
Inspiratory capacity abnormal 41.39 10.23 12 138933 101 110450253
Delirium 41.38 10.23 66 138879 134959 110315395
Pancreatitis 41.34 10.23 229 138716 93304 110357050
Back pain 41.21 10.23 675 138270 370321 110080033
Glycosylated haemoglobin increased 40.66 10.23 91 138854 23528 110426826
Blood glucose increased 40.32 10.23 295 138650 132201 110318153
Hyperthyroidism 39.89 10.23 103 138842 29158 110421196
Xanthoma 39.81 10.23 14 138931 230 110450124
Carotid arteriosclerosis 39.69 10.23 32 138913 3025 110447329
Myopathy toxic 39.06 10.23 23 138922 1302 110449052
Muscle disorder 39.01 10.23 45 138900 6627 110443727
Myocardial ischaemia 38.54 10.23 96 138849 26588 110423766
Sleep disorder 38.20 10.23 125 138820 198519 110251835
Myoglobin blood increased 38.17 10.23 36 138909 4196 110446158
Onychomadesis 37.83 10.23 6 138939 45657 110404697
Carotid artery stenosis 37.49 10.23 52 138893 9211 110441143
Skin disorder 37.47 10.23 129 138816 42784 110407570
Cough 37.44 10.23 800 138145 460841 109989513
Troponin increased 36.76 10.23 101 138844 29665 110420689
Blood cholesterol decreased 36.47 10.23 29 138916 2687 110447667
Sepsis 36.42 10.23 251 138694 327095 110123259
Drug resistance 35.80 10.23 13 138932 56361 110393993
Left atrial dilatation 35.44 10.23 32 138913 3528 110446826
Infection susceptibility increased 35.14 10.23 35 138910 4363 110445991
Coeliac disease 35.06 10.23 6 138939 43181 110407173
Prescribed overdose 34.97 10.23 35 138910 87546 110362808
Urticarial dermatitis 34.09 10.23 6 138939 0 110450354
Pyrexia 33.76 10.23 865 138080 897400 109552954
Migraine 33.71 10.23 107 138838 171545 110278809
Tendon rupture 33.46 10.23 62 138883 14016 110436338
Inhibitory drug interaction 33.45 10.23 36 138909 4911 110445443
Condition aggravated 33.40 10.23 687 138258 734149 109716205
Faeces discoloured 33.16 10.23 106 138839 33842 110416512
Cytokine release syndrome 33.07 10.23 24 138921 70282 110380072
Pulmonary fibrosis 33.07 10.23 48 138897 101994 110348360
Cardiac myxoma 33.06 10.23 12 138933 217 110450137
Autoimmune disorder 32.61 10.23 21 138924 65462 110384892
Bone marrow failure 32.48 10.23 16 138929 57832 110392522
Psoriasis 32.46 10.23 293 138652 139700 110310654
Road traffic accident 32.43 10.23 53 138892 107345 110343009
Hyperlipidaemia 32.39 10.23 109 138836 35739 110414615
Liver injury 32.25 10.23 90 138855 150323 110300031
Glucose tolerance impaired 32.25 10.23 50 138895 9787 110440567
ECG signs of myocardial ischaemia 32.17 10.23 14 138931 414 110449940
Hepatic function abnormal 32.01 10.23 207 138738 89088 110361266
Drug abuse 31.84 10.23 115 138830 177296 110273058
Arthritis 31.65 10.23 336 138609 167250 110283104
Therapy non-responder 31.64 10.23 97 138848 157210 110293144
Melaena 31.50 10.23 170 138775 68587 110381767
Sciatica 31.41 10.23 42 138903 92357 110357997
Inflammation 31.01 10.23 131 138814 193107 110257247
Hospitalisation 30.75 10.23 85 138860 142408 110307946
Cytomegalovirus infection 30.65 10.23 15 138930 54429 110395925
Hepatic steatosis 30.51 10.23 132 138813 48699 110401655
Septic shock 30.37 10.23 99 138846 157429 110292925
Muscle necrosis 30.35 10.23 22 138923 1775 110448579
Lupus-like syndrome 30.32 10.23 7 138938 40785 110409569
Cholestasis 29.88 10.23 160 138785 64358 110385996
Type 2 diabetes mellitus 29.78 10.23 118 138827 177114 110273240
Glomerular filtration rate decreased 29.75 10.23 92 138853 28864 110421490
Pancytopenia 29.54 10.23 149 138796 209464 110240890
Acquired haemophilia 28.89 10.23 25 138920 2606 110447748
Scleroedema 28.85 10.23 10 138935 157 110450197
Neutrophil count decreased 28.50 10.23 69 138876 120872 110329482
Renal failure 28.48 10.23 421 138524 226153 110224201
Prescribed underdose 28.44 10.23 24 138921 65150 110385204
Peripheral swelling 28.34 10.23 348 138597 403686 110046668
Left ventricular dysfunction 28.30 10.23 79 138866 23414 110426940
Haematocrit increased 28.25 10.23 33 138912 4926 110445428
Finger deformity 28.22 10.23 4 138941 33088 110417266
Nausea 27.69 10.23 1853 137092 1233837 109216517
Aortic valve replacement 27.67 10.23 20 138925 1606 110448748
Vulvovaginal pruritus 27.52 10.23 27 138918 3304 110447050
Ear infection 27.50 10.23 23 138922 62709 110387645
Taste disorder 27.42 10.23 25 138920 65362 110384992
Endocarditis enterococcal 27.26 10.23 12 138933 365 110449989
Diaphragmatic disorder 27.19 10.23 21 138924 1865 110448489
Blood creatinine increased 27.11 10.23 350 138595 182539 110267815
Stent placement 26.90 10.23 39 138906 7195 110443159
Nasal dryness 26.10 10.23 34 138911 5672 110444682
Onychomycosis 26.01 10.23 8 138937 38523 110411831
Arteriosclerosis coronary artery 25.98 10.23 80 138865 25038 110425316
Endocrine ophthalmopathy 25.94 10.23 18 138927 1355 110448999
Arteriosclerosis 25.73 10.23 79 138866 24688 110425666
Nail disorder 25.70 10.23 21 138924 57914 110392440
Rhinalgia 25.53 10.23 28 138917 3901 110446453
Vulvovaginal burning sensation 25.47 10.23 21 138924 2048 110448306
Pericardial haemorrhage 25.30 10.23 32 138913 5185 110445169
Heliotrope rash 25.16 10.23 10 138935 234 110450120
Platelet count decreased 24.98 10.23 178 138767 230265 110220089
Hypoglycaemia 24.91 10.23 239 138706 115865 110334489
Testicular swelling 24.90 10.23 19 138926 1657 110448697
Influenza 24.81 10.23 323 138622 168778 110281576
Electrocardiogram abnormal 24.63 10.23 65 138880 18644 110431710
Purpura 24.60 10.23 77 138868 24311 110426043
Toxic shock syndrome 24.29 10.23 18 138927 1502 110448852
Mitral valve replacement 24.25 10.23 13 138932 613 110449741
Lipids increased 24.24 10.23 20 138925 1953 110448401
Heart valve stenosis 24.14 10.23 9 138936 176 110450178
Milk-alkali syndrome 23.96 10.23 20 138925 1985 110448369
Hip arthroplasty 23.81 10.23 21 138924 55792 110394562
Anuria 23.77 10.23 76 138869 24265 110426089
Thrombotic microangiopathy 23.77 10.23 4 138941 29145 110421209
Total cholesterol/HDL ratio decreased 23.73 10.23 7 138938 63 110450291
Hypotension 23.69 10.23 842 138103 523007 109927347
Potentiating drug interaction 23.67 10.23 48 138897 11595 110438759
Haemorrhagic stroke 23.59 10.23 53 138892 13736 110436618
Device expulsion 23.57 10.23 5 138940 30886 110419468
Encephalopathy 23.55 10.23 41 138904 81014 110369340
Fatigue 23.54 10.23 1802 137143 1214156 109236198
Toxic epidermal necrolysis 23.42 10.23 22 138923 56705 110393649
Phaeochromocytoma malignant 23.25 10.23 7 138938 68 110450286
Musculoskeletal stiffness 23.19 10.23 232 138713 279590 110170764
Prohormone brain natriuretic peptide increased 23.16 10.23 11 138934 400 110449954
Polymyalgia rheumatica 22.90 10.23 34 138911 6408 110443946
Glycogen storage disease type V 22.90 10.23 6 138939 33 110450321
Obstructive pancreatitis 22.82 10.23 16 138929 1225 110449129
Polycystic ovaries 22.59 10.23 29 138916 4767 110445587
Haematuria 22.55 10.23 180 138765 82825 110367529
Product quality issue 22.55 10.23 39 138906 77260 110373094
Exostosis 22.53 10.23 15 138930 45941 110404413
Nasal discomfort 22.51 10.23 33 138912 6148 110444206
Myasthenic syndrome 22.41 10.23 16 138929 1260 110449094
Carotid artery disease 22.17 10.23 20 138925 2203 110448151
Gait disturbance 22.16 10.23 481 138464 277727 110172627
Coma acidotic 22.02 10.23 8 138937 145 110450209
Oedema peripheral 21.82 10.23 554 138391 328106 110122248
Muscle fatigue 21.72 10.23 26 138919 3981 110446373
Red blood cell sedimentation rate increased 21.51 10.23 41 138904 78261 110372093
Neutropenic sepsis 21.46 10.23 6 138939 30740 110419614
Walking aid user 21.45 10.23 3 138942 25072 110425282
Nasal ulcer 21.43 10.23 21 138924 2566 110447788
Immunodeficiency 21.41 10.23 11 138934 38827 110411527
Sleep apnoea syndrome 21.31 10.23 104 138841 40343 110410011
Sensorimotor disorder 21.29 10.23 15 138930 1157 110449197
Therapy cessation 21.29 10.23 112 138833 44745 110405609
Hepatic cytolysis 21.21 10.23 130 138815 54923 110395431
Bradycardia 21.14 10.23 293 138652 155224 110295130
Presyncope 21.14 10.23 119 138826 48768 110401586
Transient ischaemic attack 20.94 10.23 145 138800 63837 110386517
Respiratory disorder 20.84 10.23 36 138909 71346 110379008
Leukopenia 20.83 10.23 106 138839 148685 110301669
Eyelid disorder 20.82 10.23 20 138925 2385 110447969
Cholestatic liver injury 20.78 10.23 35 138910 7341 110443013
Musculoskeletal discomfort 20.76 10.23 71 138874 23467 110426887
Systemic infection 20.58 10.23 41 138904 9778 110440576
Status epilepticus 20.53 10.23 7 138938 31564 110418790
Tendon injury 20.51 10.23 20 138925 2429 110447925
Mucosal dryness 20.43 10.23 26 138919 4237 110446117
Neurotoxicity 20.39 10.23 14 138931 42193 110408161
Cardiac failure chronic 20.27 10.23 50 138895 13761 110436593
Cerebrovascular arteriovenous malformation 20.25 10.23 7 138938 109 110450245
Intervertebral disc degeneration 20.03 10.23 59 138886 18026 110432328
Copper metabolism disorder 19.96 10.23 4 138941 4 110450350
Chronic kidney disease 19.95 10.23 164 138781 76127 110374227
Gastric disorder 19.95 10.23 89 138856 33268 110417086
Osteoarthritis 19.82 10.23 141 138804 182482 110267872
Peripheral arterial occlusive disease 19.75 10.23 39 138906 9241 110441113
Hypoaesthesia 19.69 10.23 277 138668 313946 110136408
Vascular purpura 19.68 10.23 24 138921 3747 110446607
Mucosal inflammation 19.53 10.23 59 138886 96082 110354272
Dry mouth 19.52 10.23 159 138786 199789 110250565
Mean cell haemoglobin concentration abnormal 19.45 10.23 8 138937 205 110450149
Language disorder 19.34 10.23 24 138921 3814 110446540
Pancreatic neoplasm 19.32 10.23 17 138928 1812 110448542
Laryngitis 19.28 10.23 15 138930 42396 110407958
Cerebellar syndrome 19.23 10.23 31 138914 6271 110444083
Reaction to colouring 19.18 10.23 6 138939 67 110450287
Arterial stenosis 19.04 10.23 16 138929 1603 110448751
Diabetes mellitus inadequate control 18.99 10.23 81 138864 29694 110420660
Cardiac disorder 18.89 10.23 162 138783 76118 110374236
Paranasal sinus discomfort 18.86 10.23 31 138914 6374 110443980
Hypovolaemia 18.79 10.23 65 138880 21609 110428745
Feeling abnormal 18.65 10.23 325 138620 180386 110269968
Faeces pale 18.56 10.23 22 138923 3335 110447019
Miller Fisher syndrome 18.44 10.23 9 138936 348 110450006
Arrhythmia 18.43 10.23 150 138795 69425 110380929
Ligament rupture 18.39 10.23 24 138921 4011 110446343
Antinuclear antibody negative 18.36 10.23 7 138938 146 110450208
Anion gap abnormal 18.28 10.23 12 138933 824 110449530
Labelled drug-drug interaction medication error 18.14 10.23 79 138866 29223 110421131
Diabetic neuropathy 18.13 10.23 32 138913 6967 110443387
Ascites 18.11 10.23 58 138887 92750 110357604
Hepatic cirrhosis 18.06 10.23 36 138909 67590 110382764
Exercise tolerance decreased 18.04 10.23 44 138901 12023 110438331
Somnolence 18.01 10.23 264 138681 297185 110153169
Lipase increased 17.96 10.23 58 138887 18614 110431740
Miosis 17.96 10.23 3 138942 21980 110428374
Multiple sclerosis relapse 17.94 10.23 22 138923 50218 110400136
Lipids abnormal 17.89 10.23 11 138934 674 110449680
Cutaneous lupus erythematosus 17.88 10.23 22 138923 3466 110446888
Exercise lack of 17.85 10.23 10 138935 515 110449839
Back injury 17.74 10.23 20 138925 47379 110402975
Aortic bruit 17.62 10.23 8 138937 262 110450092
Blood creatine phosphokinase abnormal 17.54 10.23 11 138934 698 110449656
Lactic acidosis 17.47 10.23 186 138759 92625 110357729
Cardiac valve disease 17.47 10.23 30 138915 6391 110443963
General physical condition 17.47 10.23 5 138940 40 110450314
Apolipoprotein B increased 17.45 10.23 4 138941 11 110450343
Hepatitis cholestatic 17.30 10.23 55 138890 17511 110432843
Urticaria 17.28 10.23 289 138656 318568 110131786
Amaurosis fugax 17.24 10.23 18 138927 2372 110447982
Biliary fibrosis 16.95 10.23 4 138941 13 110450341
Pancreatic carcinoma 16.93 10.23 49 138896 14823 110435531
Poisoning deliberate 16.84 10.23 6 138939 26325 110424029
Anembryonic gestation 16.78 10.23 9 138936 425 110449929
Lymphocyte count decreased 16.59 10.23 29 138916 57214 110393140
Cutaneous vasculitis 16.53 10.23 44 138901 12685 110437669
Drug tolerance decreased 16.42 10.23 7 138938 27533 110422821
Dystonia 16.30 10.23 6 138939 25799 110424555
Myoglobinuria 16.25 10.23 13 138932 1215 110449139
Eye irritation 16.20 10.23 84 138861 33368 110416986
Ventricular tachycardia 16.16 10.23 113 138832 49896 110400458
Aspergillus infection 16.11 10.23 6 138939 25610 110424744
Respiratory syncytial virus test positive 16.01 10.23 14 138931 1480 110448874
Delusion 15.92 10.23 5 138940 23750 110426604
Neoplasm progression 15.90 10.23 36 138909 64559 110385795
Helicobacter gastritis 15.90 10.23 18 138927 2598 110447756
Blood creatine phosphokinase 15.80 10.23 8 138937 335 110450019
Normal newborn 15.80 10.23 4 138941 21892 110428462
Bacteraemia 15.74 10.23 18 138927 42372 110407982
Gynaecomastia 15.71 10.23 36 138909 9454 110440900
Product substitution issue 15.70 10.23 64 138881 22997 110427357
White blood cell count decreased 15.53 10.23 199 138746 229191 110221163
Incorrect route of product administration 15.53 10.23 36 138909 64025 110386329
Type IIa hyperlipidaemia 15.39 10.23 9 138936 503 110449851
Microscopic polyangiitis 15.37 10.23 9 138936 504 110449850
Haemorrhagic transformation stroke 15.32 10.23 19 138926 3018 110447336
Gastrooesophageal reflux disease 15.24 10.23 314 138631 179662 110270692
Dermatitis atopic 15.16 10.23 68 138877 25473 110424881
Hepatic enzyme increased 15.14 10.23 298 138647 320594 110129760
International normalised ratio abnormal 15.11 10.23 28 138917 6329 110444025
Lichen planus 15.10 10.23 20 138925 3390 110446964
Vertebral foraminal stenosis 14.98 10.23 13 138932 1360 110448994
Haematotoxicity 14.93 10.23 4 138941 21078 110429276
Weight decreased 14.90 10.23 725 138220 467332 109983022
Coronary artery bypass 14.85 10.23 27 138918 6015 110444339
Therapeutic product effect incomplete 14.84 10.23 195 138750 223610 110226744
Loss of personal independence in daily activities 14.78 10.23 119 138826 149901 110300453
Genital pain 14.76 10.23 13 138932 1387 110448967
Diabetes mellitus 14.64 10.23 190 138755 99191 110351163
Therapy partial responder 14.58 10.23 15 138930 37046 110413308
Spontaneous haematoma 14.56 10.23 15 138930 1946 110448408
Injection site reaction 14.52 10.23 60 138885 89010 110361344
Urogenital haemorrhage 14.48 10.23 11 138934 953 110449401
Graft versus host disease 14.44 10.23 3 138942 18803 110431551
Cerebral infarction 14.40 10.23 113 138832 51725 110398629
Chronic spontaneous urticaria 14.36 10.23 15 138930 1978 110448376
Gastric ulcer haemorrhage 14.24 10.23 36 138909 10058 110440296
Anxiety 14.21 10.23 549 138396 344529 110105825
Small fibre neuropathy 14.09 10.23 11 138934 992 110449362
Injection site extravasation 14.07 10.23 36 138909 10133 110440221
Palmar erythema 14.06 10.23 16 138929 2322 110448032
Pallor 14.02 10.23 120 138825 56347 110394007
Overdose 13.97 10.23 208 138737 233586 110216768
Duplicate therapy error 13.95 10.23 8 138937 431 110449923
Cytomegalovirus infection reactivation 13.92 10.23 3 138942 18330 110432024
Erythromelalgia 13.88 10.23 8 138937 435 110449919
Gout 13.87 10.23 86 138859 36480 110413874
Tumour lysis syndrome 13.86 10.23 11 138934 30790 110419564
Renal pain 13.84 10.23 35 138910 9782 110440572
Blood uric acid abnormal 13.83 10.23 8 138937 438 110449916
FEV1/FVC ratio decreased 13.78 10.23 7 138938 295 110450059
Hypoparathyroidism 13.77 10.23 13 138932 1517 110448837
Frequent bowel movements 13.66 10.23 45 138900 71345 110379009
Pemphigoid 13.66 10.23 55 138890 19652 110430702
Renovascular hypertension 13.64 10.23 5 138940 93 110450261
Blood cholesterol abnormal 13.64 10.23 20 138925 3726 110446628
Hip fracture 13.54 10.23 83 138862 35068 110415286
Serum ferritin abnormal 13.46 10.23 8 138937 461 110449893
Device difficult to use 13.45 10.23 53 138892 18752 110431602
Gastrointestinal haemorrhage 13.44 10.23 287 138658 165231 110285123
Nasal cyst 13.37 10.23 4 138941 38 110450316
Hypotony of eye 13.36 10.23 8 138937 467 110449887
Tuberculosis 13.31 10.23 3 138942 17771 110432583
Haemoglobin increased 13.30 10.23 33 138912 9114 110441240
Metastases to central nervous system 13.29 10.23 6 138939 22811 110427543
Acquired epidermolysis bullosa 13.26 10.23 5 138940 101 110450253
Oral herpes 13.15 10.23 84 138861 35996 110414358
Lower gastrointestinal haemorrhage 13.14 10.23 52 138893 18434 110431920
Blood creatine phosphokinase MM increased 13.09 10.23 4 138941 41 110450313
Dyspnoea at rest 13.09 10.23 31 138914 8315 110442039
Photopsia 13.09 10.23 26 138919 6188 110444166
Maternal exposure timing unspecified 13.08 10.23 5 138940 21008 110429346
Gait inability 13.05 10.23 109 138836 136267 110314087
Thrombocytopenia 13.04 10.23 336 138609 348549 110101805
Generalised tonic-clonic seizure 13.04 10.23 31 138914 54649 110395705
Posterior reversible encephalopathy syndrome 12.99 10.23 14 138931 33847 110416507
Urinary tract disorder 12.97 10.23 25 138920 5819 110444535
Aortic stenosis 12.96 10.23 41 138904 13018 110437336
Aortic valve calcification 12.95 10.23 10 138935 888 110449466
Vision blurred 12.94 10.23 231 138714 128791 110321563
Nephrogenic systemic fibrosis 12.85 10.23 24 138921 5459 110444895
Coronary artery thrombosis 12.81 10.23 18 138927 3226 110447128
Vertebral lateral recess stenosis 12.78 10.23 7 138938 345 110450009
Intentional self-injury 12.73 10.23 17 138928 37412 110412942
Colitis ulcerative 12.68 10.23 52 138893 77311 110373043
Accidental overdose 12.67 10.23 29 138916 51805 110398549
Liver disorder 12.59 10.23 116 138829 142127 110308227
Product administration error 12.56 10.23 85 138860 37132 110413222
Hyperparathyroidism secondary 12.56 10.23 18 138927 3286 110447068
Suspected suicide attempt 12.56 10.23 7 138938 357 110449997
Aldolase increased 12.46 10.23 6 138939 225 110450129
Cognitive disorder 12.44 10.23 62 138883 87449 110362905
Liver function test increased 12.44 10.23 63 138882 88485 110361869
Pulmonary embolism 12.41 10.23 192 138753 214282 110236072
Agitation 12.40 10.23 87 138858 112964 110337390
Pneumonia 12.40 10.23 941 138004 875773 109574581
Mitral valve incompetence 12.40 10.23 78 138867 33251 110417103
Ligamentum flavum hypertrophy 12.36 10.23 7 138938 368 110449986
Paresis 12.36 10.23 22 138923 4822 110445532
Cardiac aneurysm 12.33 10.23 13 138932 1732 110448622
Transferrin decreased 12.31 10.23 8 138937 540 110449814
BRASH syndrome 12.31 10.23 19 138926 3704 110446650
Osteoarthropathy 12.29 10.23 7 138938 372 110449982
Blood loss anaemia 12.25 10.23 50 138895 17975 110432379
Hypoglycaemic seizure 12.25 10.23 10 138935 962 110449392
Product confusion 12.25 10.23 6 138939 234 110450120
Urinary occult blood 12.23 10.23 4 138941 52 110450302
Lip swelling 12.23 10.23 107 138838 50560 110399794
Drug dependence 12.21 10.23 28 138917 49992 110400362
Product prescribing error 12.18 10.23 108 138837 51223 110399131
Haemophagocytic lymphohistiocytosis 12.16 10.23 13 138932 31546 110418808
Duodenitis 12.15 10.23 32 138913 9164 110441190
Hypogammaglobulinaemia 12.13 10.23 5 138940 20071 110430283
Orthostatic hypotension 12.11 10.23 132 138813 66117 110384237
Cytopenia 12.06 10.23 12 138933 30104 110420250
Ear pain 12.05 10.23 31 138914 53195 110397159
Palatal swelling 11.99 10.23 6 138939 245 110450109
Bronchiectasis 11.99 10.23 17 138928 36476 110413878
Dyskinesia oesophageal 11.96 10.23 4 138941 56 110450298
Vertigo 11.94 10.23 164 138781 86706 110363648
Biopsy kidney 11.92 10.23 6 138939 248 110450106
Muscle strength abnormal 11.86 10.23 7 138938 398 110449956
Swollen tongue 11.85 10.23 122 138823 60240 110390114
Coma 11.84 10.23 93 138852 117776 110332578
Myasthenia gravis 11.83 10.23 56 138889 21455 110428899
Small intestinal haemorrhage 11.82 10.23 21 138924 4597 110445757
Loss of libido 11.81 10.23 17 138928 3116 110447238
Ventricular extrasystoles 11.77 10.23 58 138887 22583 110427771
Tubulointerstitial nephritis 11.76 10.23 112 138833 54172 110396182
Gastritis 11.74 10.23 111 138834 53588 110396766
Left ventricular hypertrophy 11.73 10.23 40 138905 13204 110437150
Mouth ulceration 11.71 10.23 27 138918 48111 110402243
Lichenoid keratosis 11.66 10.23 25 138920 6277 110444077
Melanaemia 11.65 10.23 4 138941 61 110450293
Lipoma excision 11.65 10.23 5 138940 143 110450211
Gastrointestinal pain 11.55 10.23 37 138908 11823 110438531
Hyperchylomicronaemia 11.53 10.23 4 138941 63 110450291
Breath sounds abnormal 11.53 10.23 9 138936 25395 110424959
Serotonin syndrome 11.52 10.23 37 138908 59116 110391238
Cytomegalovirus viraemia 11.44 10.23 4 138941 17760 110432594
Biliary obstruction 11.40 10.23 23 138922 5535 110444819
Acute on chronic liver failure 11.38 10.23 7 138938 429 110449925
Self esteem decreased 11.36 10.23 10 138935 1067 110449287
Allergy to animal 11.33 10.23 13 138932 1903 110448451
Sleep disorder due to a general medical condition 11.30 10.23 31 138914 52081 110398273
Peripheral artery occlusion 11.30 10.23 16 138929 2889 110447465
Joint space narrowing 11.28 10.23 9 138936 838 110449516
Memory impairment 11.16 10.23 177 138768 196767 110253587
Genital ulceration 11.01 10.23 13 138932 1962 110448392
Respiratory arrest 10.98 10.23 37 138908 58262 110392092
Tricuspid valve incompetence 10.91 10.23 59 138886 23814 110426540
Oesophageal irritation 10.89 10.23 6 138939 299 110450055
Staphylococcal infection 10.86 10.23 48 138897 69896 110380458
Peyronie's disease 10.83 10.23 3 138942 21 110450333
Abdominal pain lower 10.76 10.23 82 138863 37201 110413153
Cystitis noninfective 10.75 10.23 12 138933 1706 110448648
Bronchopulmonary aspergillosis 10.74 10.23 13 138932 29850 110420504
Adverse drug reaction 10.73 10.23 83 138862 105476 110344878
Macular degeneration 10.71 10.23 7 138938 21652 110428702
Bronchomalacia 10.69 10.23 6 138939 310 110450044
Restless legs syndrome 10.68 10.23 60 138885 24566 110425788
Drug-induced liver injury 10.67 10.23 211 138734 119856 110330498
Cardiac failure 10.65 10.23 310 138635 187316 110263038
Productive cough 10.65 10.23 92 138853 114213 110336141
Osteoporosis 10.61 10.23 65 138880 87087 110363267
Proctitis 10.59 10.23 4 138941 16923 110433431
Clostridium difficile infection 10.58 10.23 32 138913 52097 110398257
Dysuria 10.55 10.23 119 138826 60112 110390242
Food allergy 10.49 10.23 6 138939 19942 110430412
Acute myeloid leukaemia 10.42 10.23 20 138925 38090 110412264
Subdural haematoma 10.42 10.23 80 138865 36374 110413980
Diplopia 10.39 10.23 89 138856 41805 110408549
Arcus lipoides 10.37 10.23 3 138942 25 110450329
Nasal neoplasm 10.33 10.23 5 138940 190 110450164
Hypercapnic coma 10.32 10.23 7 138938 508 110449846
Ketoacidosis 10.31 10.23 32 138913 10055 110440299
Quadriparesis 10.28 10.23 20 138925 4687 110445667
Erythema 10.28 10.23 283 138662 291164 110159190
Ear haemorrhage 10.28 10.23 14 138931 2437 110447917
Urticaria pigmentosa 10.27 10.23 3 138942 26 110450328

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AX09 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Other lipid modifying agents
ATC C10BA02 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA05 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA06 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA10 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA11 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA12 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA13 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA15 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
FDA PE N0000008553 Decreased Cholesterol Absorption
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000175911 Dietary Cholesterol Absorption Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35679 antilipemic drug
CHEBI has role CHEBI:35821 anticholesteremic drug

Related Drugs by ATC class:

C10AX Other lipid modifying agents 15 drugs
alipogene tiparvovecalirocumabbempedoic aciddextrothyroxineevinacumabevolocumabinclisiranlerodalcibep-ligalomitapidemeglutolmipomersenpolicosanol show all 15 →
C10BA Combinations of various lipid modifying agents 9 drugs
atorvastatinbempedoic acidfenofibratelovastatinnicotinic acidpitavastatinpravastatinrosuvastatinsimvastatin

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Hyperlipidemia indication 55822004 DOID:1168
Familial hypercholesterolemia - homozygous indication 238078005
Familial hypercholesterolemia - heterozygous indication 238079002
Sitosterolemia indication 238104009 DOID:0090019
Mixed hyperlipidemia indication 267434003
Alopecia areata off-label use 68225006 DOID:986
Alcoholism contraindication 7200002
Acute nephropathy contraindication 58574008
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
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
SLCO1B1 Gene Variant for OATP1B1 Transporter Affecting Hepatic Clearance contraindication
Myopathy related to SLCO1B1 Gene Variant contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.48 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG ZETIA ORGANON N021445 Oct. 25, 2002 RX TABLET ORAL 7612058 Oct. 30, 2025 REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
10MG ZETIA ORGANON N021445 Oct. 25, 2002 RX TABLET ORAL 7612058 Oct. 30, 2025 TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE
10MG;EQ 10MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 10MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 10912751 March 14, 2036 A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING A FIXED-DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 10912751 March 14, 2036 A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 11744816 March 14, 2036 A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 11744816 March 14, 2036 A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 11926584 June 19, 2040 A METHOD OF LOWERING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN A HUMAN PATIENT IN NEED THEREOF COMPRISING ADMINISTRATION OF BEMPEDOIC ACID ALONE OR IN COMBINATION WITH OTHER LIPID LOWERING THERAPIES
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 12404227 June 19, 2040 A METHOD OF TREATING PRIMARY HYPERLIPIDEMIA USING BEMPEDOIC ACID

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL March 22, 2027 EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, ALONE OR IN COMBINATION WITH OTHER LDL-C LOWERING THERAPIES, TO REDUCE LDL-C IN ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL March 22, 2027 TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND CORONARY REVASCULARIZATION IN ADULTS WHO ARE UNABLE TO TAKE RECOMMENDED STATIN THERAPY (INCLUDING THOSE NOT TAKING A STATIN) WITH ESTABLISHED CARDIOVASCULAR DISEASE (CVD), OR AT HIGH RISK FOR A CVD EVENT BUT WITHOUT ESTABLISHED CVD

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Niemann-Pick C1-like protein 1 Membrane other ANTAGONIST Kd 6.66 IUPHAR CHEMBL
Sodium/bile acid cotransporter Transporter Ki 4.60 CHEMBL
Niemann-Pick C1-like protein 1 Membrane other Ki 6.70 CHEMBL

External reference:

IDSource
4021366 VUID
N0000148785 NUI
D01966 KEGG_DRUG
4021366 VANDF
C1142985 UMLSCUI
CHEBI:49040 CHEBI
CHEMBL1138 ChEMBL_ID
D000069438 MESH_DESCRIPTOR_UI
DB00973 DRUGBANK_ID
150311 PUBCHEM_CID
6816 IUPHAR_LIGAND_ID
8010 INN_ID
EOR26LQQ24 UNII
341248 RXNORM
17026 MMSL
229065 MMSL
45364 MMSL
d04824 MMSL
009817 NDDF
408041006 SNOMEDCT_US
409149001 SNOMEDCT_US
H56 PDB_CHEM_ID
EOR26LQQ24 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0591-3713 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0781-5690 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0904-7103 TABLET 10 mg ORAL ANDA 25 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 10135-787 TABLET 10 mg ORAL ANDA 23 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 10135-787 TABLET 10 mg ORAL ANDA 23 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-778 TABLET 10 mg ORAL ANDA 26 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-779 TABLET 10 mg ORAL ANDA 26 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-780 TABLET 10 mg ORAL ANDA 26 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-781 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe Human Prescription Drug Label 1 16714-813 TABLET 10 mg ORAL ANDA 27 sections
EZETIMIBE HUMAN PRESCRIPTION DRUG LABEL 1 16729-433 TABLET 10 mg ORAL ANDA 29 sections
EZETIMIBE HUMAN PRESCRIPTION DRUG LABEL 1 16729-433 TABLET 10 mg ORAL ANDA 29 sections
VYTORIN HUMAN PRESCRIPTION DRUG LABEL 2 21695-325 TABLET 10 mg ORAL NDA 28 sections
VYTORIN HUMAN PRESCRIPTION DRUG LABEL 2 21695-339 TABLET 10 mg ORAL NDA 28 sections
Zetia HUMAN PRESCRIPTION DRUG LABEL 1 21695-778 TABLET 10 mg ORAL NDA 29 sections
VYTORIN HUMAN PRESCRIPTION DRUG LABEL 2 21695-827 TABLET 10 mg ORAL NDA 28 sections
EZETIMIBE HUMAN PRESCRIPTION DRUG LABEL 1 31722-628 TABLET 10 mg ORAL ANDA 25 sections
Ezetimibe Human Prescription Drug Label 1 33342-373 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-742 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-743 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-744 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-745 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 50090-3087 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe Human Prescription Drug Label 1 50090-3422 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe Human Prescription Drug Label 1 50090-3657 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 50090-3984 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe and Simvastatin Human Prescription Drug Label 2 50090-4772 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe Human Prescription Drug Label 1 50090-6630 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe Human Prescription Drug Label 1 50090-6631 TABLET 10 mg ORAL ANDA 27 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 50090-7047 TABLET 10 mg ORAL ANDA 28 sections