rosuvastatin 🐶 Veterinary Use | 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 µM/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
S (Water solubility) 0.33 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Aug. 12, 2003 FDA IPR
Jan. 19, 2005 PMDA AstraZeneca 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
Rhabdomyolysis 1210.49 9.59 1006 181329 42945 63263742
Myalgia 916.28 9.59 1566 180769 144963 63161724
Maternal exposure during pregnancy 505.53 9.59 32 182303 220030 63086657
Pemphigus 456.43 9.59 16 182319 183710 63122977
Blood creatine phosphokinase increased 444.32 9.59 491 181844 29939 63276748
Sedation complication 421.59 9.59 336 181999 13486 63293201
Creatinine renal clearance decreased 419.27 9.59 359 181976 15949 63290738
Orthostatic hypotension 379.15 9.59 493 181842 35667 63271020
Systemic lupus erythematosus 378.23 9.59 71 182264 208847 63097840
Glossodynia 364.67 9.59 43 182292 178833 63127854
Hand deformity 330.88 9.59 36 182299 159421 63147266
Cognitive disorder 313.87 9.59 570 181765 55245 63251442
Anti-cyclic citrullinated peptide antibody positive 308.04 9.59 5 182330 116207 63190480
Blood calcium decreased 296.76 9.59 373 181962 26078 63280609
Contraindicated product administered 291.60 9.59 130 182205 217518 63089169
Wound 288.04 9.59 59 182276 163204 63143483
Exposure during pregnancy 276.94 9.59 55 182280 155492 63151195
Treatment failure 271.20 9.59 116 182219 198927 63107760
Sedation 242.29 9.59 415 181920 38394 63268293
Synovitis 242.05 9.59 117 182218 186801 63119886
Drug ineffective 240.36 9.59 1890 180445 1042875 62263812
Balance disorder 226.06 9.59 642 181693 83780 63222907
Duodenal ulcer perforation 222.23 9.59 6 182329 87203 63219484
Pericarditis 215.25 9.59 56 182279 131523 63175164
Myopathy 210.79 9.59 207 182128 10984 63295703
Low density lipoprotein increased 205.61 9.59 160 182175 6197 63300490
Arthropathy 186.89 9.59 240 182095 234552 63072135
Acute kidney injury 170.52 9.59 1317 181018 262098 63044589
Angina pectoris 170.09 9.59 308 182027 29770 63276917
Helicobacter infection 166.80 9.59 32 182303 92753 63213934
Folliculitis 161.99 9.59 10 182325 70307 63236380
Therapeutic product effect decreased 160.51 9.59 191 182144 192996 63113691
Product use issue 155.10 9.59 246 182089 220274 63086413
Constipation 149.62 9.59 1132 181203 223811 63082876
Infusion related reaction 146.64 9.59 303 182032 245218 63061469
Depressed level of consciousness 143.28 9.59 448 181887 61630 63245057
Muscle spasms 137.96 9.59 843 181492 155307 63151380
Dyslipidaemia 137.84 9.59 136 182199 7257 63299430
Impaired healing 137.60 9.59 61 182274 102481 63204206
Drug intolerance 132.57 9.59 449 181886 308212 62998475
Swelling 129.16 9.59 385 181950 274993 63031694
Blood pressure increased 125.96 9.59 847 181488 161215 63145472
Asthma 124.49 9.59 707 181628 126854 63179833
Off label use 120.12 9.59 1299 181036 673163 62633524
Discomfort 119.28 9.59 185 182150 167189 63139498
Fall 119.09 9.59 1681 180654 390653 62916034
Infection 118.92 9.59 305 182030 228868 63077819
Completed suicide 118.87 9.59 146 182189 145527 63161160
Sleep disorder due to general medical condition, insomnia type 118.57 9.59 8 182327 52209 63254478
High density lipoprotein decreased 117.83 9.59 75 182260 2095 63304592
Blister 115.83 9.59 121 182214 129693 63176994
Blood glucose increased 115.53 9.59 512 181823 83244 63223443
Alopecia 115.12 9.59 538 181797 336998 62969689
Muscle injury 110.35 9.59 26 182309 65319 63241368
Death 108.98 9.59 630 181705 373751 62932936
Immune-mediated myositis 108.53 9.59 60 182275 1283 63305404
Rheumatic fever 106.12 9.59 4 182331 43107 63263580
Blood triglycerides increased 104.86 9.59 153 182182 12335 63294352
Psoriasis 104.79 9.59 511 181824 86446 63220241
Irritable bowel syndrome 104.46 9.59 53 182282 82359 63224328
Hypotension 102.40 9.59 1215 181120 271389 63035298
Euglycaemic diabetic ketoacidosis 92.63 9.59 80 182255 3594 63303093
Full blood count abnormal 91.55 9.59 248 182087 31469 63275218
Reversible airways obstruction 91.01 9.59 60 182275 1782 63304905
Blood pressure systolic increased 89.74 9.59 320 182015 47077 63259610
Drug interaction 89.01 9.59 1028 181307 228103 63078584
Vital capacity decreased 87.11 9.59 57 182278 1671 63305016
Abdominal discomfort 87.02 9.59 552 181783 320333 62986354
General physical health deterioration 86.36 9.59 293 182042 201109 63105578
Pregnancy 85.56 9.59 5 182330 36831 63269856
Asthenia 83.86 9.59 1557 180778 382047 62924640
Obstructive airways disorder 78.91 9.59 180 182155 20519 63286168
Disease progression 77.96 9.59 146 182189 122612 63184075
Renal failure 77.49 9.59 591 181744 117061 63189626
Abortion spontaneous 77.31 9.59 20 182315 47175 63259512
Blood immunoglobulin E increased 75.86 9.59 73 182262 3776 63302911
Sputum culture positive 75.47 9.59 57 182278 2110 63304577
Hip arthroplasty 72.86 9.59 23 182312 47623 63259064
Muscular weakness 72.58 9.59 600 181735 121753 63184934
Hypersensitivity 72.58 9.59 517 181818 292168 63014519
Diabetic ketoacidosis 70.21 9.59 171 182164 20334 63286353
Device expulsion 69.62 9.59 9 182326 34913 63271774
Bronchiectasis 69.03 9.59 147 182188 15995 63290692
Myocardial infarction 68.72 9.59 507 181828 99386 63207301
Rheumatoid factor positive 67.36 9.59 86 182249 84320 63222367
Cough 67.34 9.59 1198 181137 291545 63015142
Arterial occlusive disease 66.78 9.59 84 182251 5874 63300813
Stomatitis 66.37 9.59 192 182143 138533 63168154
Intentional overdose 66.25 9.59 69 182266 74083 63232604
Bronchial secretion retention 65.13 9.59 58 182277 2715 63303972
Malignant mediastinal neoplasm 64.02 9.59 44 182291 1402 63305285
Cystitis 63.98 9.59 320 182015 54671 63252016
Drug abuse 63.09 9.59 69 182266 72449 63234238
Hypoglycaemia 61.93 9.59 338 181997 59727 63246960
Foetal exposure during pregnancy 59.64 9.59 10 182325 31952 63274735
Skin haemorrhage 57.86 9.59 104 182231 9990 63296697
Sinus congestion 57.70 9.59 147 182188 17976 63288711
Premature delivery 57.57 9.59 9 182326 30272 63276415
Nephritic syndrome 57.33 9.59 25 182310 311 63306376
Carotid artery thrombosis 56.98 9.59 54 182281 2740 63303947
Hepatic enzyme increased 56.89 9.59 344 181991 201984 63104703
Neurologic neglect syndrome 56.28 9.59 53 182282 2668 63304019
Chronic kidney disease 56.26 9.59 269 182066 45129 63261558
Pain in extremity 54.57 9.59 1291 181044 330195 62976492
Blood creatinine increased 53.82 9.59 434 181901 87410 63219277
Joint swelling 53.78 9.59 642 181693 327024 62979663
Condition aggravated 53.77 9.59 822 181513 401395 62905292
Hyper IgE syndrome 53.15 9.59 27 182308 483 63306204
Injury 53.06 9.59 80 182255 73167 63233520
Gangrene 51.38 9.59 75 182260 6048 63300639
Restrictive pulmonary disease 51.26 9.59 42 182293 1753 63304934
Product use in unapproved indication 51.11 9.59 303 182032 178777 63127910
Rash 51.09 9.59 1224 181111 559647 62747040
Neutropenia 51.07 9.59 294 182041 174711 63131976
Low density lipoprotein decreased 47.73 9.59 20 182315 224 63306463
Nasal oedema 46.40 9.59 37 182298 1485 63305202
Coma 45.95 9.59 71 182264 64293 63242394
Foetal acidosis 45.82 9.59 11 182324 11 63306676
Pancreatic neuroendocrine tumour 45.45 9.59 23 182312 408 63306279
Ischaemic stroke 43.65 9.59 132 182203 17825 63288862
Tubulointerstitial nephritis 43.49 9.59 141 182194 19762 63286925
Diabetes mellitus inadequate control 43.37 9.59 118 182217 15008 63291679
Dermatitis allergic 43.26 9.59 118 182217 15030 63291657
Cataract 42.95 9.59 296 182039 56757 63249930
Glycosylated haemoglobin increased 42.03 9.59 103 182232 12295 63294392
Diabetes mellitus 41.69 9.59 289 182046 55521 63251166
Pancytopenia 41.52 9.59 141 182194 96792 63209895
Respiratory tract infection 41.13 9.59 231 182104 41252 63265435
Liver disorder 40.69 9.59 279 182056 53408 63253279
Angina unstable 40.54 9.59 73 182262 7022 63299665
Hyperglycaemia 40.10 9.59 231 182104 41636 63265051
Coronary artery disease 39.50 9.59 191 182144 32186 63274501
Eosinophil count increased 39.42 9.59 93 182242 10835 63295852
Adjustment disorder 39.16 9.59 47 182288 3131 63303556
Pancreatitis 39.02 9.59 258 182077 48797 63257890
Drug tolerance decreased 38.74 9.59 3 182332 17470 63289217
Drug-induced liver injury 38.57 9.59 222 182113 40000 63266687
Adverse event 38.08 9.59 86 182249 67473 63239214
Muscle discomfort 37.96 9.59 16 182319 182 63306505
Ulnar tunnel syndrome 37.49 9.59 9 182326 9 63306678
Lactic acidosis 37.16 9.59 212 182123 38075 63268612
Affect lability 37.12 9.59 92 182243 11059 63295628
Therapy non-responder 37.06 9.59 104 182231 75797 63230890
Mobility decreased 36.95 9.59 520 181815 120639 63186048
Alanine aminotransferase increased 36.90 9.59 458 181877 103312 63203375
Paroxysmal extreme pain disorder 36.85 9.59 13 182322 87 63306600
Seizure 36.48 9.59 227 182108 132407 63174280
Degenerative bone disease 36.44 9.59 15 182320 160 63306527
Gastrointestinal disorder 36.41 9.59 224 182111 131015 63175672
Cerebrovascular accident 36.38 9.59 472 181863 107552 63199135
Blood test abnormal 36.23 9.59 113 182222 15516 63291171
Febrile neutropenia 36.17 9.59 196 182139 118253 63188434
Palpitations 36.01 9.59 488 181847 112282 63194405
Fibromyalgia 35.81 9.59 115 182220 80305 63226382
Blood calcium increased 35.29 9.59 81 182254 9269 63297418
Chromaturia 35.24 9.59 117 182218 16600 63290087
Intentional product use issue 35.11 9.59 219 182116 127673 63179014
Injection site reaction 35.06 9.59 72 182263 58452 63248235
Intentional self-injury 34.89 9.59 15 182320 25672 63281015
Lipids increased 34.17 9.59 28 182307 1169 63305518
Glomerular filtration rate decreased 33.80 9.59 100 182235 13341 63293346
Grip strength decreased 33.64 9.59 11 182324 22276 63284411
Weight decreased 33.23 9.59 1035 181300 275763 63030924
Upper-airway cough syndrome 32.66 9.59 89 182246 11329 63295358
Prescribed overdose 32.56 9.59 30 182305 34123 63272564
Hepatocellular injury 32.31 9.59 160 182175 27221 63279466
Hepatitis 32.09 9.59 210 182125 39578 63267109
Product substitution issue 32.00 9.59 110 182225 15886 63290801
Transaminases increased 31.98 9.59 176 182159 31191 63275496
Chronic respiratory disease 31.97 9.59 14 182321 176 63306511
Total lung capacity decreased 31.46 9.59 35 182300 2148 63304539
Myositis 31.43 9.59 77 182258 9189 63297498
Androgenetic alopecia 31.15 9.59 13 182322 144 63306543
Ill-defined disorder 31.03 9.59 125 182210 81630 63225057
Confabulation 30.63 9.59 16 182319 304 63306383
Confusional arousal 30.63 9.59 14 182321 196 63306491
Cytomegalovirus infection 30.49 9.59 11 182324 20941 63285746
Therapeutic product effect incomplete 30.41 9.59 222 182113 124834 63181853
Multiple allergies 30.36 9.59 98 182237 13704 63292983
Caesarean section 30.33 9.59 6 182329 17026 63289661
Pulmonary mass 30.28 9.59 137 182198 22459 63284228
Adverse drug reaction 30.18 9.59 122 182213 79592 63227095
Hemiplegia 30.07 9.59 76 182259 9247 63297440
Coronary artery occlusion 29.86 9.59 70 182265 8121 63298566
Post procedural hypothyroidism 29.75 9.59 15 182320 264 63306423
Sensory loss 29.49 9.59 80 182255 10158 63296529
Polymyositis 29.47 9.59 31 182304 1785 63304902
Generalised tonic-clonic seizure 29.47 9.59 24 182311 28992 63277695
Vertigo 28.97 9.59 281 182054 59606 63247081
Knee arthroplasty 28.95 9.59 71 182264 54135 63252552
Burning sensation 28.68 9.59 260 182075 54147 63252540
Multi-organ disorder 28.53 9.59 28 182307 1484 63305203
Cerebral infarction 28.46 9.59 140 182195 23753 63282934
Lower respiratory tract infection 27.95 9.59 244 182091 132063 63174624
Blood pressure systolic abnormal 27.61 9.59 93 182242 13293 63293394
Pyrexia 27.45 9.59 1089 181246 469389 62837298
Amblyopia 27.24 9.59 14 182321 257 63306430
Blood glucose abnormal 27.21 9.59 66 182269 7826 63298861
Suicide attempt 27.19 9.59 87 182248 60831 63245856
Necrotising myositis 27.17 9.59 18 182317 539 63306148
Polymyalgia rheumatica 26.96 9.59 43 182292 3748 63302939
Food interaction 26.90 9.59 21 182314 817 63305870
Respiratory tract congestion 26.87 9.59 112 182223 17720 63288967
Crush syndrome 26.67 9.59 11 182324 118 63306569
Device dislocation 26.43 9.59 21 182314 25684 63281003
Rhinorrhoea 26.20 9.59 296 182039 65281 63241406
Acute myocardial infarction 26.18 9.59 170 182165 31954 63274733
Personality disorder 26.10 9.59 54 182281 5757 63300930
Pertussis 25.91 9.59 19 182316 672 63306015
Thrombocytopenia 25.59 9.59 294 182041 150863 63155824
Myopathy toxic 25.55 9.59 17 182318 513 63306174
Respiratory arrest 25.28 9.59 34 182301 32611 63274076
Leukopenia 25.22 9.59 125 182210 77165 63229522
Chest discomfort 25.20 9.59 450 181885 109519 63197168
Chest pain 24.97 9.59 804 181531 215155 63091532
Blood pressure diastolic decreased 24.91 9.59 130 182205 22576 63284111
Hernia 24.74 9.59 86 182249 12488 63294199
Sepsis 24.70 9.59 301 182034 152822 63153865
Haemorrhagic diathesis 24.68 9.59 45 182290 4370 63302317
Facet joint syndrome 24.50 9.59 3 182332 12135 63294552
Microalbuminuria 24.48 9.59 15 182320 391 63306296
Blood pressure inadequately controlled 24.44 9.59 48 182287 4930 63301757
Gastrooesophageal reflux disease 24.32 9.59 398 181937 95241 63211446
Thyroid disorder 24.24 9.59 97 182238 15065 63291622
Endocrine ophthalmopathy 24.15 9.59 18 182317 653 63306034
Hyperlactacidaemia 24.05 9.59 35 182300 2814 63303873
Discontinued product administered 24.03 9.59 9 182326 73 63306614
Blood creatine increased 23.94 9.59 51 182284 5550 63301137
HIV infection 23.92 9.59 15 182320 408 63306279
Eyelid disorder 23.86 9.59 28 182307 1821 63304866
Transcription medication error 23.86 9.59 12 182323 210 63306477
Ulcer 23.65 9.59 24 182311 26083 63280604
Lung diffusion test decreased 23.51 9.59 18 182317 680 63306007
Toxic epidermal necrolysis 23.28 9.59 23 182312 25311 63281376
Blood pressure fluctuation 23.23 9.59 219 182116 46098 63260589
Creutzfeldt-Jakob disease 22.98 9.59 11 182324 172 63306515
Drug ineffective for unapproved indication 22.97 9.59 39 182296 34024 63272663
Goitre 22.90 9.59 52 182283 5909 63300778
Myoglobin blood increased 22.83 9.59 24 182311 1381 63305306
Hepatic enzyme abnormal 22.62 9.59 54 182281 6338 63300349
Sneezing 22.60 9.59 108 182227 18110 63288577
Toxic shock syndrome 22.59 9.59 19 182316 823 63305864
Parosmia 22.59 9.59 53 182282 6153 63300534
Hyperkeratosis 22.57 9.59 52 182283 5966 63300721
Atrial fibrillation 22.54 9.59 465 181870 116171 63190516
Listless 22.52 9.59 34 182301 2826 63303861
Bronchopulmonary aspergillosis allergic 22.44 9.59 30 182305 2228 63304459
Cardiac murmur 22.40 9.59 92 182243 14460 63292227
Coronary artery stenosis 22.39 9.59 45 182290 4699 63301988
Aspartate aminotransferase increased 22.34 9.59 374 181961 89903 63216784
Muscle disorder 22.11 9.59 46 182289 4923 63301764
Rheumatic disorder 22.06 9.59 35 182300 3037 63303650
Malaise 21.78 9.59 1429 180906 414525 62892162
Skin exfoliation 21.72 9.59 204 182131 42898 63263789
Respiratory failure 21.44 9.59 188 182147 101670 63205017
Blood creatine phosphokinase 21.38 9.59 6 182329 16 63306671
Sinonasal obstruction 21.32 9.59 12 182323 266 63306421
Sinus disorder 21.29 9.59 132 182203 24421 63282266
Rales 20.92 9.59 82 182253 12615 63294072
Catarrh 20.90 9.59 24 182311 1525 63305162
Lipids abnormal 20.73 9.59 12 182323 281 63306406
Hypereosinophilic syndrome 20.62 9.59 12 182323 284 63306403
Acute coronary syndrome 20.57 9.59 70 182265 10056 63296631
Rheumatoid nodule 20.32 9.59 12 182323 17143 63289544
Hypopnoea 20.28 9.59 38 182297 3768 63302919
Sleep disorder due to a general medical condition 20.28 9.59 5 182330 12183 63294504
Blood pressure abnormal 20.25 9.59 92 182243 15106 63291581
Dyspnoea exertional 20.09 9.59 263 182072 60039 63246648
Body temperature decreased 20.04 9.59 113 182222 20206 63286481
Albuminuria 20.03 9.59 11 182324 232 63306455
Premature baby 20.02 9.59 18 182317 20717 63285970
Blood creatine phosphokinase abnormal 19.99 9.59 11 182324 233 63306454
Drug specific antibody 19.98 9.59 29 182306 2326 63304361
Blood cholesterol abnormal 19.97 9.59 31 182304 2640 63304047
Anuria 19.83 9.59 80 182255 12471 63294216
Hepatic function abnormal 19.83 9.59 178 182157 36964 63269723
Motor dysfunction 19.80 9.59 72 182263 10689 63295998
Metabolic acidosis 19.65 9.59 207 182128 44862 63261825
Muscle contractions involuntary 19.64 9.59 29 182306 2363 63304324
Procollagen type I C-terminal propeptide increased 19.55 9.59 6 182329 24 63306663
Cardio-respiratory arrest 19.54 9.59 97 182238 59862 63246825
Lip dry 19.52 9.59 10 182325 15460 63291227
Red blood cell sedimentation rate abnormal 19.50 9.59 110 182225 19672 63287015
Arthritis 19.48 9.59 453 181882 115468 63191219
Blood immunoglobulin M increased 19.43 9.59 20 182315 1123 63305564
Metastases to bone 19.41 9.59 19 182316 21000 63285687
Reduced facial expression 19.35 9.59 26 182309 1940 63304747
Bone marrow failure 19.33 9.59 34 182301 29256 63277431
Blood immunoglobulin G increased 19.32 9.59 29 182306 2398 63304289
Pulmonary function test abnormal 19.25 9.59 25 182310 1805 63304882
Burns second degree 19.23 9.59 26 182309 1952 63304735
Transient ischaemic attack 19.18 9.59 179 182156 37574 63269113
Nightmare 19.10 9.59 107 182228 19087 63287600
Dizziness 19.04 9.59 1457 180878 428468 62878219
Tongue discomfort 19.02 9.59 28 182307 2275 63304412
Influenza 18.93 9.59 427 181908 108295 63198392
Endometriosis 18.89 9.59 45 182290 5275 63301412
Serum procollagen type I N-terminal propeptide increased 18.81 9.59 6 182329 28 63306659
Sputum culture 18.80 9.59 11 182324 263 63306424
Transplant rejection 18.78 9.59 4 182331 10776 63295911
Neutropenic sepsis 18.78 9.59 12 182323 16426 63290261
Swelling of eyelid 18.71 9.59 33 182302 3123 63303564
Infusion site streaking 18.71 9.59 14 182321 511 63306176
Poisoning 18.60 9.59 8 182327 13692 63292995
Degenerative aortic valve disease 18.51 9.59 9 182326 146 63306541
Device related infection 18.48 9.59 24 182311 23368 63283319
Blood parathyroid hormone decreased 18.41 9.59 3 182332 9788 63296899
Panniculitis 18.31 9.59 5 182330 11380 63295307
Pancreatitis acute 18.16 9.59 137 182198 27029 63279658
Malignant neoplasm progression 17.98 9.59 150 182185 81971 63224716
Renal impairment 17.98 9.59 355 181980 88000 63218687
Blood pressure diastolic abnormal 17.89 9.59 86 182249 14456 63292231
Infected dermal cyst 17.87 9.59 13 182322 454 63306233
Multiple sclerosis relapse 17.84 9.59 75 182260 48403 63258284
COVID-19 17.79 9.59 438 181897 112665 63194022
Multiple drug therapy 17.71 9.59 35 182300 3611 63303076
Mucosal inflammation 17.65 9.59 72 182263 46856 63259831
Skin necrosis 17.63 9.59 9 182326 13941 63292746
Urine albumin/creatinine ratio increased 17.58 9.59 11 182324 298 63306389
Chronic spontaneous urticaria 17.45 9.59 19 182316 1138 63305549
Lung opacity 17.35 9.59 32 182303 3136 63303551
Lipoprotein (a) increased 17.29 9.59 6 182329 38 63306649
Injection site erythema 17.29 9.59 154 182181 83020 63223667
Macular degeneration 17.29 9.59 27 182308 24349 63282338
Infrequent bowel movements 17.28 9.59 20 182315 1282 63305405
Bone erosion 17.12 9.59 98 182237 17619 63289068
Respiratory depression 17.11 9.59 9 182326 13706 63292981
Interstitial lung disease 17.01 9.59 261 182074 61647 63245040
Hyperlipasaemia 16.92 9.59 15 182320 698 63305989
Total cholesterol/HDL ratio abnormal 16.82 9.59 7 182328 77 63306610
Bursitis infective 16.78 9.59 20 182315 1323 63305364
Akathisia 16.76 9.59 3 182332 9143 63297544
Unwanted awareness during anaesthesia 16.68 9.59 11 182324 327 63306360
Therapy partial responder 16.55 9.59 5 182330 10653 63296034
Peripheral sensorimotor neuropathy 16.54 9.59 21 182314 1482 63305205
Lymphopenia 16.43 9.59 17 182318 18310 63288377
Head discomfort 16.26 9.59 79 182256 13336 63293351
Sopor 16.25 9.59 24 182311 22140 63284547
Status epilepticus 16.23 9.59 12 182323 15221 63291466
Haemorrhage subcutaneous 16.17 9.59 30 182305 2953 63303734
Poisoning deliberate 16.14 9.59 6 182329 11212 63295475
Apolipoprotein A-I decreased 16.10 9.59 5 182330 21 63306666
Malignant melanoma 16.08 9.59 70 182265 11286 63295401
Eye disorder 16.08 9.59 116 182219 22569 63284118
Premature labour 15.90 9.59 8 182327 12496 63294191
Stent placement 15.83 9.59 34 182301 3721 63302966
Arteriosclerosis 15.78 9.59 64 182271 10002 63296685
Breast cancer stage II 15.72 9.59 3 182332 8733 63297954
Hyperlipidaemia 15.60 9.59 103 182232 19468 63287219
Ligament pain 15.58 9.59 9 182326 210 63306477
Diffuse alopecia 15.52 9.59 16 182319 900 63305787
Needle issue 15.50 9.59 65 182270 10311 63296376
Blood immunoglobulin A decreased 15.45 9.59 19 182316 1298 63305389
Erythema multiforme 15.42 9.59 64 182271 10105 63296582
Eczema 15.36 9.59 151 182184 32140 63274547
Device issue 15.34 9.59 28 182307 23753 63282934
Sensorimotor disorder 15.21 9.59 12 182323 474 63306213
Hypertriglyceridaemia 15.20 9.59 46 182289 6213 63300474
Hyperplastic cholecystopathy 15.18 9.59 8 182327 155 63306532
Intensive care unit acquired weakness 15.11 9.59 15 182320 806 63305881
Musculoskeletal stiffness 15.09 9.59 409 181926 184209 63122478
Basophil count increased 14.93 9.59 16 182319 941 63305746
Eye haemorrhage 14.93 9.59 56 182279 8440 63298247
Gestational diabetes 14.86 9.59 3 182332 8393 63298294
Amylase increased 14.82 9.59 46 182289 6299 63300388
Mean cell volume increased 14.79 9.59 32 182303 3519 63303168
Night sweats 14.77 9.59 81 182254 48733 63257954
Psoriatic arthropathy 14.71 9.59 180 182155 91340 63215347
Pre-eclampsia 14.71 9.59 4 182331 9129 63297558
Musculoskeletal toxicity 14.66 9.59 6 182329 63 63306624
Rotator cuff syndrome 14.60 9.59 77 182258 13425 63293262
Foreign body 14.58 9.59 25 182310 2313 63304374
Dystonia 14.58 9.59 11 182324 13808 63292879
Neurotrophic keratopathy 14.57 9.59 3 182332 0 63306687
Decubitus ulcer 14.52 9.59 6 182329 10514 63296173
Coma acidotic 14.42 9.59 7 182328 113 63306574
Colitis microscopic 14.34 9.59 59 182276 9280 63297407
Hypocholesterolaemia 14.31 9.59 7 182328 115 63306572
Clitoris abscess 14.17 9.59 4 182331 11 63306676
Aspergillus infection 14.10 9.59 3 182332 8090 63298597
Occult blood 14.04 9.59 18 182317 1283 63305404
Dyspnoea 13.98 9.59 2133 180202 659180 62647507
Hyperphosphataemia 13.97 9.59 24 182311 2224 63304463
Liver injury 13.96 9.59 109 182226 60411 63246276
Cardiac neoplasm unspecified 13.95 9.59 6 182329 72 63306615
Steroid dependence 13.93 9.59 21 182314 1743 63304944
Neurotoxicity 13.87 9.59 17 182318 16973 63289714
Restless legs syndrome 13.86 9.59 96 182239 18435 63288252
Chronic sinusitis 13.83 9.59 10 182325 12833 63293854
Neutrophil count decreased 13.77 9.59 100 182235 56306 63250381
Muscle atrophy 13.75 9.59 48 182287 6985 63299702
Mixed liver injury 13.64 9.59 37 182298 4698 63301989
Hypercreatininaemia 13.52 9.59 12 182323 559 63306128
No adverse event 13.48 9.59 67 182268 41338 63265349
Blood growth hormone increased 13.43 9.59 11 182324 459 63306228
Sinus pain 13.38 9.59 30 182305 3380 63303307
Back pain 13.36 9.59 905 181430 263240 63043447
Mydriasis 13.29 9.59 9 182326 11947 63294740
Lichen planus 13.29 9.59 24 182311 2314 63304373
Hyperkalaemia 13.20 9.59 224 182111 53979 63252708
Hemiparesis 13.16 9.59 113 182222 23169 63283518
Cytokine release syndrome 13.14 9.59 13 182322 14301 63292386
Nephrolithiasis 13.11 9.59 181 182154 41803 63264884
Thrombotic microangiopathy 13.07 9.59 7 182328 10554 63296133
Erythema marginatum 13.03 9.59 4 182331 16 63306671
Hypomagnesaemia 13.00 9.59 133 182202 28604 63278083
Autoimmune myositis 12.99 9.59 7 182328 142 63306545
Rheumatoid arthritis 12.99 9.59 596 181739 253223 63053464
Blood ketone body increased 12.98 9.59 9 182326 291 63306396
Sputum retention 12.98 9.59 12 182323 590 63306097
Carotid artery occlusion 12.84 9.59 36 182299 4658 63302029
Polyglandular autoimmune syndrome type II 12.80 9.59 5 182330 46 63306641
Sleep apnoea syndrome 12.79 9.59 134 182201 28999 63277688
Eating disorder 12.77 9.59 96 182239 18920 63287767
Cystitis noninfective 12.63 9.59 15 182320 988 63305699
Haemorrhagic stroke 12.62 9.59 41 182294 5751 63300936
Excessive cerumen production 12.53 9.59 10 182325 402 63306285
Injection site hypersensitivity 12.53 9.59 22 182313 2075 63304612
Cardiac valve fibroelastoma 12.50 9.59 3 182332 3 63306684
Gastrointestinal ulcer perforation 12.50 9.59 3 182332 3 63306684
Diabetic nephropathy 12.48 9.59 18 182317 1436 63305251
Pulmonary embolism 12.47 9.59 248 182087 116436 63190251
Low density lipoprotein abnormal 12.43 9.59 8 182327 228 63306459
Cerebral haemorrhage 12.40 9.59 139 182196 30590 63276097
Abortion induced 12.37 9.59 7 182328 10235 63296452
Urticaria 12.36 9.59 372 181963 165430 63141257
Hyperparathyroidism secondary 12.35 9.59 18 182317 1449 63305238
Heart rate increased 12.25 9.59 356 181979 93882 63212805
X-ray abnormal 12.25 9.59 4 182331 8106 63298581
Cardiac failure chronic 12.20 9.59 34 182301 4384 63302303
Eyelid oedema 12.20 9.59 61 182274 10418 63296269
Vitamin B12 decreased 12.19 9.59 30 182305 3590 63303097
Acute myeloid leukaemia 12.15 9.59 19 182316 17128 63289559
Urine ketone body present 12.12 9.59 24 182311 2479 63304208
Aortic valve calcification 12.12 9.59 11 182324 528 63306159
Dysgeusia 12.10 9.59 195 182140 46515 63260172
Brain injury 12.02 9.59 46 182289 6997 63299690
Trimethylaminuria 12.02 9.59 7 182328 166 63306521
Gamma-glutamyltransferase increased 12.00 9.59 150 182185 33881 63272806
Croup infectious 11.98 9.59 11 182324 536 63306151
Oedema peripheral 11.94 9.59 662 181673 188849 63117838
Complication associated with device 11.86 9.59 19 182316 16959 63289728
Pulmonary haemorrhage 11.84 9.59 3 182332 7178 63299509
Bronchopulmonary aspergillosis 11.79 9.59 5 182330 8630 63298057
Cardiac flutter 11.79 9.59 32 182303 4064 63302623
Skin discolouration 11.78 9.59 163 182172 37665 63269022
Pemphigoid 11.75 9.59 47 182288 7297 63299390
Low birth weight baby 11.71 9.59 3 182332 7126 63299561
Circulatory collapse 11.51 9.59 29 182306 21909 63284778
Drug resistance 11.50 9.59 31 182304 22902 63283785
Type 2 diabetes mellitus 11.48 9.59 252 182083 63616 63243071
Photosensitivity reaction 11.40 9.59 78 182257 14916 63291771
Joint dislocation 11.37 9.59 23 182312 18777 63287910
Drug withdrawal syndrome 11.34 9.59 40 182295 27154 63279533
Cardiac disorder 11.30 9.59 207 182128 50609 63256078
Ingrowing nail 11.29 9.59 23 182312 2426 63304261
Sputum discoloured 11.25 9.59 83 182252 16264 63290423
Obesity 11.23 9.59 46 182289 29906 63276781
Skin laceration 11.20 9.59 107 182228 22601 63284086
Pruritus genital 11.15 9.59 24 182311 2630 63304057
Giant cell arteritis 11.14 9.59 22 182313 2269 63304418
Cardiac failure 11.11 9.59 335 182000 88807 63217880
Peripheral venous disease 11.11 9.59 17 182318 15460 63291227
Hepatic steatosis 11.10 9.59 129 182206 28640 63278047
Atrial tachycardia 11.10 9.59 32 182303 4208 63302479
Blood triglycerides decreased 11.07 9.59 5 182330 68 63306619
Urinary casts present 11.07 9.59 5 182330 68 63306619
Cataract operation 11.07 9.59 38 182297 5484 63301203
Nasal ulcer 11.05 9.59 22 182313 2282 63304405
Haemoglobin increased 11.01 9.59 29 182306 3617 63303070
Overdose 11.01 9.59 249 182086 114829 63191858
Middle insomnia 10.98 9.59 68 182267 12575 63294112
Campylobacter test positive 10.95 9.59 4 182331 30 63306657
Adrenal gland cancer 10.94 9.59 5 182330 70 63306617
Endometrial disorder 10.91 9.59 12 182323 727 63305960
Mouth injury 10.86 9.59 14 182321 1003 63305684
Monocyte count decreased 10.86 9.59 21 182314 2132 63304555
Maternal condition affecting foetus 10.83 9.59 7 182328 201 63306486
Encephalitis 10.82 9.59 6 182329 8874 63297813
Peripheral vascular disorder 10.79 9.59 40 182295 5995 63300692
Micturition disorder 10.72 9.59 23 182312 2515 63304172
Lymphangiectasia 10.69 9.59 5 182330 74 63306613
Spinal instability 10.66 9.59 6 182329 133 63306554
Tendon pain 10.61 9.59 27 182308 3299 63303388
Gingival pain 10.57 9.59 49 182286 8113 63298574
Mean cell haemoglobin increased 10.56 9.59 25 182310 2918 63303769
Haemophagocytic lymphohistiocytosis 10.53 9.59 9 182326 10618 63296069
Pseudophaeochromocytoma 10.51 9.59 5 182330 77 63306610
Somnolence 10.51 9.59 413 181922 178272 63128415
Total bile acids increased 10.50 9.59 6 182329 137 63306550
Tinnitus 10.48 9.59 152 182183 35476 63271211
Joint abscess 10.44 9.59 9 182326 403 63306284
Ventricular fibrillation 10.41 9.59 64 182271 11803 63294884
Febrile bone marrow aplasia 10.40 9.59 4 182331 7321 63299366
Lipase increased 10.39 9.59 56 182279 9844 63296843
Pulseless electrical activity 10.38 9.59 46 182289 7475 63299212
Vascular pseudoaneurysm 10.36 9.59 17 182318 1517 63305170
Vaginal odour 10.35 9.59 10 182325 520 63306167
Inflammation 10.33 9.59 170 182165 82103 63224584
Peripheral arterial occlusive disease 10.32 9.59 31 182304 4170 63302517
BRAF V600E mutation positive 10.32 9.59 4 182331 36 63306651
Neonatal asphyxia 10.30 9.59 8 182327 309 63306378
Aortic disorder 10.29 9.59 12 182323 775 63305912
Autoimmune nephritis 10.26 9.59 9 182326 413 63306274
Coeliac disease 10.24 9.59 13 182322 12784 63293903
Obstructive pancreatitis 10.24 9.59 9 182326 414 63306273
Mental disorder 10.23 9.59 39 182296 25880 63280807
Pollakiuria 10.22 9.59 124 182211 27813 63278874
Forced vital capacity decreased 10.21 9.59 14 182321 1065 63305622
Procedural pain 10.20 9.59 30 182305 21539 63285148
Diverticulitis 10.19 9.59 165 182170 39392 63267295
Agitation 10.19 9.59 116 182219 59641 63247046
Tri-iodothyronine free decreased 10.14 9.59 8 182327 316 63306371
Idiopathic angioedema 10.13 9.59 4 182331 38 63306649
Blood creatine phosphokinase MM increased 10.13 9.59 4 182331 38 63306649
Blood cholesterol decreased 10.09 9.59 13 182322 931 63305756
Nasal discharge discolouration 10.08 9.59 21 182314 2250 63304437
Atelectasis 10.07 9.59 30 182305 21453 63285234
Sinus tachycardia 9.92 9.59 36 182299 24232 63282455
Vascular encephalopathy 9.92 9.59 9 182326 432 63306255
Carotid artery stenosis 9.86 9.59 35 182300 5135 63301552
Hepatitis acute 9.86 9.59 52 182283 9068 63297619
Interstitial granulomatous dermatitis 9.77 9.59 4 182331 42 63306645
Urea urine increased 9.77 9.59 3 182332 12 63306675
Gastrointestinal toxicity 9.77 9.59 5 182330 7736 63298951
Renal tubular necrosis 9.76 9.59 63 182272 11815 63294872
Hypercalcaemia 9.70 9.59 45 182290 28277 63278410
Impaired fasting glucose 9.68 9.59 7 182328 242 63306445
Duplicate therapy error 9.67 9.59 5 182330 93 63306594
Blood urea increased 9.61 9.59 117 182218 26262 63280425

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 1263.02 10.74 1711 154593 82399 34718228
Rhabdomyolysis 1047.73 10.74 1403 154901 66760 34733867
Blood creatine phosphokinase increased 507.09 10.74 799 155505 44058 34756569
Toxicity to various agents 357.31 10.74 228 156076 200134 34600493
Myopathy 276.06 10.74 298 156006 11256 34789371
Drug abuse 275.92 10.74 54 156250 99042 34701585
Death 228.10 10.74 962 155342 397087 34403540
Completed suicide 205.14 10.74 91 156213 98077 34702550
High density lipoprotein decreased 189.79 10.74 141 156163 3219 34797408
Low density lipoprotein increased 169.33 10.74 148 156156 4288 34796339
Low density lipoprotein decreased 139.71 10.74 78 156226 1065 34799562
Neutropenia 138.55 10.74 310 155994 156468 34644159
Blood triglycerides increased 134.00 10.74 233 156071 13926 34786701
Foetal exposure during pregnancy 132.09 10.74 10 156294 38091 34762536
Rheumatoid factor negative 131.19 10.74 69 156235 830 34799797
Asthma 122.10 10.74 444 155860 42212 34758415
Off label use 119.30 10.74 1251 155053 418273 34382354
Full blood count abnormal 117.84 10.74 259 156045 18409 34782218
Pyrexia 117.13 10.74 941 155363 332072 34468555
Angina pectoris 114.18 10.74 354 155950 31009 34769618
Coronary artery disease 112.41 10.74 471 155833 47834 34752793
Tendon rupture 103.89 10.74 142 156162 6870 34793757
Pneumonia 101.08 10.74 1086 155218 361541 34439086
Chest discomfort 99.54 10.74 495 155809 54035 34746592
Overdose 94.22 10.74 164 156140 90895 34709732
Muscle spasms 90.54 10.74 610 155694 74391 34726236
Myocardial infarction 89.72 10.74 881 155423 120204 34680423
Disease progression 89.57 10.74 221 156083 107856 34692771
Sepsis 89.19 10.74 412 155892 166149 34634478
Intentional overdose 88.81 10.74 42 156262 43632 34756995
Acute kidney injury 87.53 10.74 1878 154426 303110 34497517
Mucosal inflammation 78.75 10.74 37 156267 38585 34762042
Cardiac failure 77.66 10.74 684 155620 90564 34710063
Coronary artery occlusion 77.16 10.74 159 156145 10803 34789824
Blood pressure systolic increased 77.08 10.74 252 156052 22700 34777927
Conjunctivitis allergic 74.97 10.74 53 156251 1117 34799510
Seizure 73.81 10.74 232 156072 104625 34696002
Muscular weakness 73.04 10.74 567 155737 72330 34728297
Chromaturia 72.65 10.74 184 156120 14336 34786291
Febrile neutropenia 71.76 10.74 341 155963 136508 34664119
Productive cough 70.95 10.74 346 155958 37467 34763160
Acute myocardial infarction 69.73 10.74 445 155859 53274 34747353
Wheezing 69.38 10.74 367 155937 41035 34759592
Leukopenia 68.90 10.74 109 156195 62747 34737880
Gait spastic 68.73 10.74 49 156255 1047 34799580
Multiple organ dysfunction syndrome 67.05 10.74 152 156152 76414 34724213
Blood cholesterol increased 66.70 10.74 223 156081 20320 34780307
Pancytopenia 65.94 10.74 212 156092 94945 34705682
Arthralgia 65.11 10.74 1095 155209 168946 34631681
Cardiac failure chronic 64.79 10.74 122 156182 7757 34792870
Rales 64.51 10.74 139 156165 9744 34790883
Myoglobin blood increased 63.64 10.74 73 156231 2950 34797677
Ascites 63.08 10.74 69 156235 46502 34754125
Obstructive airways disorder 62.14 10.74 181 156123 15313 34785314
Bone erosion 62.05 10.74 83 156221 3932 34796695
Septic shock 61.77 10.74 144 156160 71690 34728937
Congenital hiatus hernia 60.58 10.74 41 156263 803 34799824
Fractional exhaled nitric oxide increased 60.20 10.74 45 156259 1037 34799590
Mycotic allergy 59.73 10.74 36 156268 572 34800055
Diastolic dysfunction 58.30 10.74 102 156202 6125 34794502
Thrombocytopenia 57.76 10.74 435 155869 155812 34644815
White blood cell count decreased 57.23 10.74 226 156078 95219 34705408
Computerised tomogram coronary artery abnormal 57.20 10.74 25 156279 192 34800435
Loss of personal independence in daily activities 56.89 10.74 296 156008 32883 34767744
Vascular stent stenosis 56.70 10.74 45 156259 1136 34799491
Spirometry abnormal 56.38 10.74 37 156267 687 34799940
Erectile dysfunction 55.84 10.74 211 156093 20426 34780201
Red blood cell sedimentation rate abnormal 55.17 10.74 74 156230 3515 34797112
Exercise tolerance decreased 55.10 10.74 90 156214 5108 34795519
Malignant neoplasm progression 55.03 10.74 205 156099 87841 34712786
Sleep disorder due to a general medical condition 54.81 10.74 90 156214 5131 34795496
Hypercholesterolaemia 54.65 10.74 121 156183 8641 34791986
Pain in extremity 54.51 10.74 831 155473 125682 34674945
Diabetes mellitus 54.02 10.74 377 155927 46496 34754131
Suicide attempt 52.93 10.74 58 156246 39058 34761569
Drug dependence 52.86 10.74 21 156283 24196 34776431
Muscle rupture 52.66 10.74 58 156246 2240 34798387
Mite allergy 52.54 10.74 35 156269 667 34799960
Bone marrow failure 52.38 10.74 33 156271 29220 34771407
Stenosis 51.95 10.74 47 156257 1426 34799201
Coronary artery stenosis 51.42 10.74 125 156179 9491 34791136
Blood pressure increased 51.26 10.74 611 155693 87491 34713136
Cytomegalovirus infection 50.33 10.74 27 156277 26108 34774519
Hepatojugular reflux 49.96 10.74 32 156272 569 34800058
Needle fatigue 49.82 10.74 37 156267 844 34799783
Plantar fasciitis 49.52 10.74 54 156250 2062 34798565
Arteriosclerosis coronary artery 49.26 10.74 145 156159 12340 34788287
Angina unstable 48.54 10.74 138 156166 11515 34789112
Immune-mediated myositis 48.48 10.74 53 156251 2030 34798597
5-hydroxyindolacetic acid in urine increased 47.07 10.74 23 156281 234 34800393
Ventricular hypokinesia 46.94 10.74 87 156217 5465 34795162
Intentional self-injury 46.65 10.74 4 156300 13767 34786860
Atrial fibrillation 45.64 10.74 785 155519 121608 34679019
Electrocardiogram Q wave abnormal 45.18 10.74 27 156277 422 34800205
Ejection fraction decreased 44.71 10.74 187 156117 18967 34781660
Premature baby 44.57 10.74 16 156288 19617 34781010
Dust allergy 44.53 10.74 35 156269 871 34799756
Relapsing-remitting multiple sclerosis 44.08 10.74 37 156267 1013 34799614
Dyspnoea exertional 44.08 10.74 338 155966 42941 34757686
Orbital myositis 43.85 10.74 18 156286 116 34800511
Asthenia 43.41 10.74 1418 154886 243833 34556794
Ill-defined disorder 43.40 10.74 149 156155 13760 34786867
Infection 43.37 10.74 234 156070 90681 34709946
Psychotic disorder 43.21 10.74 28 156276 24424 34776203
Muscle necrosis 43.06 10.74 34 156270 852 34799775
Blood mercury abnormal 43.03 10.74 21 156283 213 34800414
Micturition urgency 42.85 10.74 92 156212 6433 34794194
Middle insomnia 42.50 10.74 94 156210 6708 34793919
Drug ineffective 41.50 10.74 1647 154657 455104 34345523
Euglycaemic diabetic ketoacidosis 41.45 10.74 61 156243 3161 34797466
Vomiting 41.23 10.74 820 155484 246801 34553826
Somnolence 41.20 10.74 309 155995 110807 34689820
Brain natriuretic peptide increased 40.91 10.74 83 156221 5576 34795051
Chest pain 40.61 10.74 794 155510 125968 34674659
Acute coronary syndrome 40.44 10.74 143 156161 13402 34787225
Respiratory failure 40.22 10.74 302 156002 108270 34692357
Dermatomyositis 39.59 10.74 38 156266 1245 34799382
Rhinitis perennial 39.11 10.74 22 156282 305 34800322
Eosinophilia 38.94 10.74 225 156079 25997 34774630
Arteriosclerosis 38.92 10.74 130 156174 11838 34788789
Coma 38.91 10.74 92 156212 45586 34755041
Hepatic enzyme increased 37.48 10.74 301 156003 38779 34761848
Occult blood 37.30 10.74 31 156273 837 34799790
Tricuspid valve incompetence 37.22 10.74 112 156192 9648 34790979
Muscle disorder 37.21 10.74 52 156252 2569 34798058
Lung diffusion test decreased 37.19 10.74 27 156277 594 34800033
Amyotrophic lateral sclerosis 36.93 10.74 33 156271 985 34799642
Gait disturbance 36.93 10.74 560 155744 84580 34716047
Malignant melanoma in situ 36.84 10.74 42 156262 1686 34798941
Diabetic ketoacidosis 36.72 10.74 169 156135 17863 34782764
Drug resistance 36.69 10.74 37 156267 25890 34774737
Fractured coccyx 36.49 10.74 17 156287 154 34800473
Diabetes mellitus inadequate control 35.87 10.74 137 156167 13327 34787300
Reversible airways obstruction 35.69 10.74 24 156280 465 34800162
Mental status changes 35.48 10.74 73 156231 38010 34762617
Low cardiac output syndrome 35.43 10.74 26 156278 582 34800045
Haemorrhagic stroke 34.96 10.74 85 156219 6454 34794173
Sensation of foreign body 34.81 10.74 52 156252 2731 34797896
Drug withdrawal syndrome 34.66 10.74 23 156281 19811 34780816
Product use in unapproved indication 34.55 10.74 347 155957 117152 34683475
Respiratory distress 34.40 10.74 67 156237 35598 34765029
Carotid arteriosclerosis 34.37 10.74 42 156262 1816 34798811
Agitation 34.33 10.74 136 156168 57263 34743364
Hypertonic bladder 34.26 10.74 42 156262 1822 34798805
Haemophagocytic lymphohistiocytosis 34.17 10.74 8 156296 12965 34787662
General physical health deterioration 34.01 10.74 388 155916 127881 34672746
Dizziness 34.00 10.74 1245 155059 217276 34583351
Blood pressure inadequately controlled 33.99 10.74 50 156254 2590 34798037
Glycosylated haemoglobin increased 33.98 10.74 120 156184 11240 34789387
Myositis 33.97 10.74 125 156179 11945 34788682
Dyslipidaemia 33.48 10.74 91 156213 7397 34793230
Helicobacter gastritis 33.30 10.74 34 156270 1202 34799425
Troponin increased 32.95 10.74 119 156185 11270 34789357
Encephalopathy 32.65 10.74 68 156236 35251 34765376
Respiratory depression 32.44 10.74 16 156288 16229 34784398
Neuroleptic malignant syndrome 32.43 10.74 20 156284 17914 34782713
Hepatic neoplasm 32.30 10.74 42 156262 1935 34798692
Muscle discomfort 32.20 10.74 14 156290 106 34800521
Presyncope 31.95 10.74 169 156135 18890 34781737
Neutrophil count decreased 31.25 10.74 120 156184 50984 34749643
Cardio-respiratory arrest 30.55 10.74 135 156169 55138 34745489
Blood thyroid stimulating hormone abnormal 30.54 10.74 20 156284 370 34800257
Interstitial lung disease 30.50 10.74 435 155869 64847 34735780
N-terminal prohormone brain natriuretic peptide abnormal 30.38 10.74 16 156288 193 34800434
Respiratory arrest 30.37 10.74 49 156255 27994 34772633
Type 2 diabetes mellitus 30.27 10.74 147 156157 15885 34784742
Normochromic normocytic anaemia 29.95 10.74 62 156242 4225 34796402
Neutropenic sepsis 29.94 10.74 12 156292 13755 34786872
Skin laceration 29.88 10.74 123 156181 12386 34788241
Carotid artery stenosis 29.83 10.74 68 156236 4951 34795676
Supine hypertension 29.56 10.74 19 156285 340 34800287
Bundle branch block left 29.11 10.74 75 156229 5904 34794723
Discomfort 29.10 10.74 164 156140 18774 34781853
Pathogen resistance 28.96 10.74 4 156300 9478 34791149
Mitral valve incompetence 28.93 10.74 138 156166 14805 34785822
Platelet count decreased 28.74 10.74 370 155934 119347 34681280
Plasmapheresis 28.50 10.74 18 156286 312 34800315
Left ventricular dysfunction 28.47 10.74 104 156200 9903 34790724
Toxic epidermal necrolysis 28.29 10.74 33 156271 21613 34779014
Product substitution issue 27.95 10.74 104 156200 9991 34790636
Pericardial disease 27.94 10.74 20 156284 430 34800197
Depressed level of consciousness 27.90 10.74 98 156206 42743 34757884
Pulmonary valve disease 27.86 10.74 18 156286 325 34800302
Candida infection 27.78 10.74 23 156281 17692 34782935
Dyspnoea 27.62 10.74 1997 154307 374785 34425842
Aggression 27.53 10.74 86 156218 38878 34761749
Guillain-Barre syndrome 27.24 10.74 74 156230 6013 34794614
Thrombotic microangiopathy 27.13 10.74 7 156297 10623 34790004
Hyperthyroidism 26.92 10.74 106 156198 10460 34790167
Staphylococcal infection 26.32 10.74 68 156236 32692 34767935
Poisoning 26.04 10.74 11 156293 12215 34788412
Nipple inflammation 25.98 10.74 10 156294 53 34800574
Left ventricular enlargement 25.95 10.74 23 156281 679 34799948
Lipoprotein (a) increased 25.82 10.74 10 156294 54 34800573
Abnormal behaviour 25.77 10.74 45 156259 24924 34775703
Tumour lysis syndrome 25.71 10.74 23 156281 17036 34783591
Cough 25.45 10.74 864 155440 149276 34651351
Coronary artery restenosis 25.27 10.74 27 156277 1007 34799620
Device related infection 25.08 10.74 24 156280 17213 34783414
Cardiac arrest 25.04 10.74 292 156012 95867 34704760
Low density lipoprotein abnormal 24.99 10.74 17 156287 336 34800291
Neoplasm progression 24.96 10.74 41 156263 23259 34777368
Miosis 24.87 10.74 6 156298 9529 34791098
Inspiratory capacity abnormal 24.74 10.74 12 156292 120 34800507
Posterior reversible encephalopathy syndrome 24.56 10.74 7 156297 9947 34790680
Blood glucose increased 24.50 10.74 427 155877 66291 34734336
Blood pressure fluctuation 24.49 10.74 195 156109 25054 34775573
Crush syndrome 24.42 10.74 10 156294 64 34800563
Cardiac discomfort 24.41 10.74 21 156283 595 34800032
Breast pain 24.37 10.74 31 156273 1397 34799230
Anaemia 24.31 10.74 827 155477 232508 34568119
Brain natriuretic peptide abnormal 24.26 10.74 17 156287 353 34800274
Pancreatitis 24.06 10.74 273 156031 38618 34762009
Musculoskeletal discomfort 23.93 10.74 85 156219 7983 34792644
Autoimmune myositis 23.91 10.74 12 156292 130 34800497
Immune reconstitution inflammatory syndrome 23.88 10.74 5 156299 8754 34791873
Autoimmune hepatitis 23.65 10.74 57 156247 4303 34796324
Nodular rash 23.58 10.74 11 156293 100 34800527
Hospitalisation 23.14 10.74 154 156150 56748 34743879
Transient ischaemic attack 22.94 10.74 206 156098 27407 34773220
Blood cholesterol decreased 22.92 10.74 26 156278 1038 34799589
Growth hormone deficiency 22.83 10.74 15 156289 279 34800348
Stomatitis 22.79 10.74 105 156199 42409 34758218
Chronic kidney disease 22.72 10.74 283 156021 40927 34759700
Monoparesis 22.71 10.74 39 156265 2307 34798320
Lipoma 22.67 10.74 33 156271 1693 34798934
Head titubation 22.66 10.74 17 156287 394 34800233
Breath sounds abnormal 22.60 10.74 75 156229 6806 34793821
Ventricular extrasystoles 22.60 10.74 110 156194 11898 34788729
Aortic aneurysm 22.37 10.74 74 156230 6705 34793922
Acute respiratory distress syndrome 22.36 10.74 52 156252 25917 34774710
Bronchiectasis 22.33 10.74 95 156209 9706 34790921
Hepatitis C 22.33 10.74 8 156296 9822 34790805
Melanoderma 22.21 10.74 12 156292 153 34800474
Enterococcal infection 22.14 10.74 7 156297 9299 34791328
Pollakiuria 21.93 10.74 157 156147 19517 34781110
Hepatic encephalopathy 21.89 10.74 20 156284 14665 34785962
Blood triglycerides abnormal 21.85 10.74 14 156290 249 34800378
Bronchopulmonary aspergillosis 21.81 10.74 20 156284 14639 34785988
Meningitis aseptic 21.79 10.74 46 156258 3178 34797449
Seronegative arthritis 21.72 10.74 25 156279 1014 34799613
Pulmonary arterial pressure abnormal 21.71 10.74 13 156291 204 34800423
Physical examination abnormal 21.68 10.74 15 156289 305 34800322
Total cholesterol/HDL ratio increased 21.61 10.74 12 156292 162 34800465
Substance abuse 21.59 10.74 4 156300 7637 34792990
Body temperature decreased 21.45 10.74 115 156189 12919 34787708
Fatigue 21.38 10.74 1929 154375 368724 34431903
Loss of control of legs 21.29 10.74 21 156283 712 34799915
Cytokine release syndrome 21.18 10.74 44 156260 22833 34777794
Muscle spasticity 20.99 10.74 66 156238 5822 34794805
Pulmonary function test abnormal 20.95 10.74 40 156264 2570 34798057
Chronic obstructive pulmonary disease 20.90 10.74 321 155983 48597 34752030
Colitis ulcerative 20.89 10.74 136 156168 16384 34784243
Pneumocystis jirovecii pneumonia 20.82 10.74 35 156269 19675 34780952
Diabetic neuropathy 20.80 10.74 53 156251 4144 34796483
Cytomegalovirus viraemia 20.76 10.74 4 156300 7426 34793201
Inappropriate antidiuretic hormone secretion 20.69 10.74 16 156288 12737 34787890
Diabetic metabolic decompensation 20.68 10.74 32 156272 1734 34798893
Atrial septal defect 20.61 10.74 4 156300 7388 34793239
Carcinoid tumour 20.60 10.74 13 156291 225 34800402
Chronic cutaneous lupus erythematosus 20.53 10.74 10 156294 101 34800526
No adverse event 20.48 10.74 45 156259 22882 34777745
Muscle injury 20.42 10.74 29 156275 1454 34799173
Oesophageal carcinoma 20.42 10.74 8 156296 9296 34791331
Intentional product misuse 20.32 10.74 120 156184 45491 34755136
Haematocrit increased 20.28 10.74 35 156269 2078 34798549
Aplastic anaemia 20.28 10.74 9 156295 9707 34790920
Glomerular filtration rate 20.19 10.74 10 156294 105 34800522
Blood cholesterol abnormal 20.14 10.74 32 156272 1774 34798853
Movement disorder 20.12 10.74 108 156196 12140 34788487
Incorrect route of product administration 20.09 10.74 22 156282 14823 34785804
Haematuria 20.05 10.74 325 155979 49741 34750886
Food aversion 19.86 10.74 16 156288 413 34800214
N-terminal prohormone brain natriuretic peptide increased 19.84 10.74 40 156264 2675 34797952
Anastomotic infection 19.71 10.74 10 156294 111 34800516
Dysphagia 19.68 10.74 181 156123 62200 34738427
Lipids increased 19.67 10.74 24 156280 1036 34799591
Aortic stenosis 19.52 10.74 53 156251 4305 34796322
Akathisia 19.47 10.74 6 156298 8103 34792524
Right atrial enlargement 19.41 10.74 13 156291 250 34800377
Polymyositis 19.40 10.74 28 156276 1425 34799202
Transplant rejection 19.35 10.74 11 156293 10300 34790327
Ventricular hyperkinesia 19.20 10.74 12 156292 204 34800423
Transaminases abnormal 19.19 10.74 13 156291 255 34800372
Aortic valve incompetence 19.08 10.74 64 156240 5840 34794787
Secretion discharge 19.07 10.74 64 156240 5841 34794786
Drug interaction 19.05 10.74 1212 155092 224734 34575893
Palpitations 18.89 10.74 267 156037 39719 34760908
Mitral valve thickening 18.89 10.74 15 156289 379 34800248
Mean platelet volume increased 18.87 10.74 17 156287 513 34800114
Ventricular arrhythmia 18.83 10.74 61 156243 5467 34795160
Adjustment disorder 18.82 10.74 25 156279 1176 34799451
Prinzmetal angina 18.79 10.74 23 156281 996 34799631
Dyspnoea at rest 18.62 10.74 48 156256 3780 34796847
Drug-induced liver injury 18.56 10.74 204 156100 28628 34771999
Withdrawal syndrome 18.52 10.74 17 156287 12438 34788189
Therapy non-responder 18.52 10.74 101 156203 39045 34761582
Meningitis eosinophilic 18.50 10.74 6 156298 17 34800610
Cerebral haemorrhage 18.44 10.74 238 156066 34699 34765928
Product use issue 18.43 10.74 187 156117 63029 34737598
Electrocardiogram abnormal 18.34 10.74 86 156218 9161 34791466
Blood thyroid stimulating hormone increased 18.32 10.74 51 156253 4204 34796423
Musculoskeletal stiffness 18.32 10.74 302 156002 46378 34754249
Peritonitis 18.28 10.74 28 156276 16337 34784290
Platelet distribution width increased 18.07 10.74 10 156294 134 34800493
Mania 18.06 10.74 10 156294 9501 34791126
Unresponsive to stimuli 17.99 10.74 63 156241 27506 34773121
Oxygen saturation increased 17.99 10.74 13 156291 284 34800343
Mycobacterium test positive 17.98 10.74 15 156289 407 34800220
Pulmonary haemorrhage 17.93 10.74 12 156292 10292 34790335
Delusion 17.91 10.74 18 156286 12617 34788010
Left ventricular hypertrophy 17.91 10.74 78 156226 8052 34792575
Hyponatraemia 17.88 10.74 261 156043 82430 34718197
Psoriasis 17.87 10.74 258 156046 38554 34762073
Haemolysis 17.69 10.74 7 156297 8087 34792540
Degenerative bone disease 17.61 10.74 8 156296 68 34800559
Oropharyngeal discomfort 17.57 10.74 42 156262 3154 34797473
Systolic dysfunction 17.57 10.74 38 156266 2670 34797957
Decreased ventricular preload 17.56 10.74 6 156298 21 34800606
Electrocardiogram QRS complex abnormal 17.49 10.74 14 156290 358 34800269
Hepatic function abnormal 17.40 10.74 287 156017 44076 34756551
Muscle rigidity 17.32 10.74 13 156291 10505 34790122
Body temperature increased 17.29 10.74 32 156272 17336 34783291
Cardiac disorder 17.29 10.74 280 156024 42846 34757781
Paraesthesia 17.28 10.74 392 155912 63780 34736847
Atrial enlargement 17.23 10.74 18 156286 654 34799973
Lymphomatoid papulosis 17.20 10.74 11 156293 195 34800432
Serotonin syndrome 17.09 10.74 40 156264 19893 34780734
Hypochromasia 17.08 10.74 13 156291 308 34800319
Muscle atrophy 17.05 10.74 72 156232 7332 34793295
Myelosuppression 17.05 10.74 38 156266 19227 34781400
Nipple disorder 17.01 10.74 11 156293 199 34800428
Impaired quality of life 17.00 10.74 61 156243 5757 34794870
Plasma cell myeloma 16.98 10.74 114 156190 41923 34758704
Gynaecomastia 16.88 10.74 90 156214 10090 34790537
Haemoglobin increased 16.84 10.74 43 156261 3366 34797261
Tachycardia 16.82 10.74 272 156032 84500 34716127
Poisoning deliberate 16.80 10.74 7 156297 7837 34792790
Coagulopathy 16.73 10.74 40 156264 19749 34780878
Vascular stent thrombosis 16.60 10.74 39 156265 2896 34797731
Sedation 16.57 10.74 44 156260 20962 34779665
Blood pressure diastolic abnormal 16.26 10.74 53 156251 4765 34795862
Pneumonia aspiration 16.25 10.74 115 156189 41788 34758839
Progressive multifocal leukoencephalopathy 16.16 10.74 12 156292 9752 34790875
Pruritus 16.15 10.74 783 155521 141198 34659429
Osteonecrosis of jaw 16.07 10.74 35 156269 17854 34782773
Sinus pain 16.06 10.74 18 156286 709 34799918
Histamine level increased 15.99 10.74 7 156297 54 34800573
Cytopenia 15.99 10.74 20 156284 12703 34787924
Cardiotoxicity 15.87 10.74 3 156301 5645 34794982
Intermittent claudication 15.82 10.74 33 156271 2261 34798366
Acute hepatic failure 15.80 10.74 24 156280 14050 34786577
Cerebral infarction 15.77 10.74 190 156114 27265 34773362
Paraplegia 15.73 10.74 38 156266 2873 34797754
Walking disability 15.69 10.74 20 156284 903 34799724
Status epilepticus 15.67 10.74 20 156284 12594 34788033
Ischaemic stroke 15.60 10.74 137 156167 18113 34782514
Low birth weight baby 15.46 10.74 8 156296 7897 34792730
Arterial spasm 15.37 10.74 8 156296 94 34800533
Nervous system disorder 15.20 10.74 26 156278 14517 34786110
Syncope 15.15 10.74 525 155779 90926 34709701
Cardiovascular somatic symptom disorder 15.11 10.74 6 156298 35 34800592
Forced vital capacity decreased 15.10 10.74 18 156286 758 34799869
Helicobacter test false negative 15.07 10.74 7 156297 63 34800564
Mucormycosis 15.00 10.74 4 156300 5938 34794689
Joint destruction 14.98 10.74 13 156291 373 34800254
AST/ALT ratio abnormal 14.97 10.74 5 156299 16 34800611
Angiocardiogram 14.95 10.74 10 156294 192 34800435
Drug ineffective for unapproved indication 14.94 10.74 55 156249 23660 34776967
Aldolase increased 14.88 10.74 7 156297 65 34800562
Aspergillus infection 14.64 10.74 20 156284 12234 34788393
Hepatitis E antibody positive 14.62 10.74 11 156293 256 34800371
Prostatic haemorrhage 14.62 10.74 11 156293 256 34800371
Retroperitoneal fibrosis 14.52 10.74 13 156291 389 34800238
Dysphonia 14.39 10.74 164 156140 23219 34777408
Blood creatine phosphokinase 14.34 10.74 8 156296 109 34800518
Very low density lipoprotein increased 14.32 10.74 5 156299 19 34800608
Ureteric cancer 14.30 10.74 10 156294 207 34800420
Bacteraemia 14.30 10.74 43 156261 19674 34780953
Pancreatitis acute 14.14 10.74 190 156114 27951 34772676
Blood pressure diastolic increased 14.11 10.74 52 156252 4973 34795654
Base excess decreased 14.09 10.74 10 156294 212 34800415
Supraventricular extrasystoles 14.08 10.74 41 156263 3467 34797160
Sclerodactylia 14.08 10.74 6 156298 43 34800584
Condition aggravated 14.07 10.74 709 155595 191487 34609140
Bacterial infection 14.03 10.74 35 156269 17028 34783599
Cystitis haemorrhagic 14.00 10.74 4 156300 5675 34794952
Haemoglobin decreased 14.00 10.74 422 155882 120350 34680277
Tongue oedema 13.98 10.74 37 156267 2960 34797667
Hemiplegia 13.94 10.74 65 156239 6907 34793720
Prohormone brain natriuretic peptide increased 13.93 10.74 7 156297 76 34800551
Blood pressure systolic abnormal 13.84 10.74 44 156260 3904 34796723
Escherichia infection 13.82 10.74 10 156294 8235 34792392
Weight decreased 13.82 10.74 940 155364 175361 34625266
Extrasystoles 13.76 10.74 43 156261 3780 34796847
Impatience 13.72 10.74 12 156292 348 34800279
Hallucination, auditory 13.69 10.74 20 156284 11897 34788730
Gastrooesophageal reflux disease 13.66 10.74 242 156062 37682 34762945
Diabetic foot 13.60 10.74 35 156269 2753 34797874
Obsessive-compulsive disorder 13.57 10.74 4 156300 5560 34795067
Lethargy 13.55 10.74 118 156186 41004 34759623
Hepatitis E virus test positive 13.52 10.74 11 156293 288 34800339
Oedema genital 13.46 10.74 14 156290 506 34800121
Neutrophil count increased 13.46 10.74 36 156268 17110 34783517
Epilepsy 13.44 10.74 50 156254 21445 34779182
Ileus 13.44 10.74 34 156270 16465 34784162
Impaired work ability 13.41 10.74 64 156240 6866 34793761
Tongue dry 13.39 10.74 10 156294 230 34800397
Expired product administered 13.37 10.74 39 156265 3302 34797325
Exostosis 13.36 10.74 49 156255 4674 34795953
Carnitine palmitoyltransferase deficiency 13.30 10.74 4 156300 8 34800619
Mesenteric artery thrombosis 13.29 10.74 13 156291 436 34800191
Fistula 13.26 10.74 7 156297 6833 34793794
Stevens-Johnson syndrome 13.26 10.74 41 156263 18598 34782029
Oral candidiasis 13.26 10.74 21 156283 12089 34788538
Blood triglycerides 13.24 10.74 3 156301 0 34800627
Joint swelling 13.18 10.74 356 155948 59534 34741093
Hallucination 13.15 10.74 157 156147 51341 34749286
High density lipoprotein abnormal 13.11 10.74 6 156298 52 34800575
Therapeutic product effect incomplete 13.06 10.74 307 155997 50234 34750393
Heart rate decreased 13.06 10.74 207 156097 31538 34769089
Malnutrition 13.03 10.74 23 156281 12686 34787941
Behaviour disorder 12.98 10.74 3 156301 4907 34795720
Musculoskeletal toxicity 12.96 10.74 8 156296 133 34800494
Electrocardiogram QRS complex prolonged 12.92 10.74 3 156301 4891 34795736
Treatment failure 12.85 10.74 140 156164 46557 34754070
Lipase increased 12.83 10.74 79 156225 9337 34791290
Hypertension 12.81 10.74 739 155565 135704 34664923
Drug intolerance 12.80 10.74 353 155951 59217 34741410
Generalised tonic-clonic seizure 12.76 10.74 50 156254 21124 34779503
Kidney transplant rejection 12.69 10.74 9 156295 7488 34793139
Oxygen consumption decreased 12.65 10.74 10 156294 251 34800376
Eczema 12.59 10.74 132 156172 18304 34782323
Neuropathy peripheral 12.55 10.74 280 156024 82983 34717644
Skin toxicity 12.50 10.74 3 156301 4781 34795846
Appendicitis 12.46 10.74 30 156274 14777 34785850
Blood pressure ambulatory increased 12.37 10.74 6 156298 60 34800567
Lipids abnormal 12.33 10.74 12 156292 400 34800227
Peripheral swelling 12.33 10.74 438 155866 76103 34724524
Hypogammaglobulinaemia 12.20 10.74 10 156294 7730 34792897
Stent placement 12.18 10.74 50 156254 5028 34795599
Heliotrope rash 12.17 10.74 4 156300 12 34800615
Cardiac autonomic neuropathy 12.12 10.74 6 156298 63 34800564
Left ventricular dilatation 12.07 10.74 16 156288 751 34799876
Albuminuria 12.06 10.74 12 156292 411 34800216
Myocardial ischaemia 12.06 10.74 125 156179 17283 34783344
Dyspepsia 12.05 10.74 231 156073 36501 34764126
Tendonitis 12.02 10.74 76 156228 9064 34791563
Acute respiratory failure 11.93 10.74 85 156219 30843 34769784
Eosinophilic granulomatosis with polyangiitis 11.90 10.74 27 156277 1960 34798667
Steroid dependence 11.87 10.74 23 156281 1494 34799133
Epstein-Barr virus infection 11.84 10.74 10 156294 7618 34793009
Nodule 11.80 10.74 61 156243 6758 34793869
Myoglobinuria 11.73 10.74 16 156288 772 34799855
Glomerular filtration rate increased 11.64 10.74 12 156292 429 34800198
Infusion related reaction 11.62 10.74 167 156137 52890 34747737
Angiogram 11.62 10.74 9 156295 219 34800408
Hypoaesthesia 11.53 10.74 358 155946 61086 34739541
Abscess of salivary gland 11.49 10.74 4 156300 15 34800612
Emotional distress 11.46 10.74 32 156272 14994 34785633
Left atrial enlargement 11.45 10.74 17 156287 888 34799739
Defect conduction intraventricular 11.44 10.74 11 156293 361 34800266
Conjunctivitis 11.43 10.74 16 156288 9689 34790938
Streptococcal infection 11.33 10.74 4 156300 4957 34795670
Chemical burns of eye 11.29 10.74 4 156300 16 34800611
High density lipoprotein increased 11.27 10.74 11 156293 368 34800259
Blood creatinine increased 11.26 10.74 526 155778 94450 34706177
Pericardial fibrosis 11.25 10.74 7 156297 118 34800509
Blood urine present 11.24 10.74 85 156219 10749 34789878
Palmar-plantar erythrodysaesthesia syndrome 11.22 10.74 38 156266 16757 34783870
Gait inability 11.20 10.74 142 156162 20616 34780011
Peripheral arterial occlusive disease 11.19 10.74 54 156250 5820 34794807
Mandibular mass 11.18 10.74 3 156301 3 34800624
Hepatocellular injury 11.18 10.74 150 156154 22061 34778566
Klebsiella infection 11.15 10.74 13 156291 8518 34792109
Eosinophil count increased 11.10 10.74 71 156233 8501 34792126
Acute myeloid leukaemia 11.10 10.74 43 156261 18227 34782400
Parkinsonism 11.08 10.74 12 156292 8126 34792501
Oedema peripheral 11.06 10.74 648 155656 119164 34681463
Bradycardia 11.04 10.74 427 155877 74991 34725636
Throat irritation 10.96 10.74 83 156221 10502 34790125
Hypercreatinaemia 10.94 10.74 8 156296 178 34800449
Product residue present 10.93 10.74 32 156272 2714 34797913
Blood chloride increased 10.93 10.74 33 156271 2848 34797779
Device dislocation 10.88 10.74 56 156248 6193 34794434
Liver injury 10.86 10.74 108 156196 14770 34785857
Anaemia macrocytic 10.86 10.74 34 156270 2992 34797635
Hypoalbuminaemia 10.78 10.74 24 156280 12150 34788477
Mobility decreased 10.76 10.74 192 156112 29936 34770691

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
Rhabdomyolysis 2034.66 9.81 2171 285748 100960 79355509
Myalgia 1752.09 9.81 2709 285210 182932 79273537
Blood creatine phosphokinase increased 842.45 9.81 1114 286805 64976 79391493
Myopathy 449.84 9.81 458 287461 20105 79436364
Maternal exposure during pregnancy 390.85 9.81 26 287893 136512 79319957
Sedation complication 362.94 9.81 360 287559 15309 79441160
Creatinine renal clearance decreased 353.04 9.81 388 287531 18614 79437855
Completed suicide 348.92 9.81 229 287690 245538 79210931
Orthostatic hypotension 297.54 9.81 639 287280 55525 79400944
Drug abuse 286.89 9.81 114 287805 162577 79293892
Acute kidney injury 274.36 9.81 2973 284946 516431 78940038
Pemphigus 260.26 9.81 28 287891 99554 79356915
Hand deformity 248.11 9.81 39 287880 103880 79352589
Low density lipoprotein increased 241.39 9.81 220 287699 8402 79448067
Glossodynia 239.56 9.81 42 287877 103295 79353174
Anti-cyclic citrullinated peptide antibody positive 234.52 9.81 17 287902 83126 79373343
Full blood count abnormal 233.62 9.81 477 287442 39997 79416472
Angina pectoris 229.92 9.81 549 287370 51183 79405286
Systemic lupus erythematosus 226.88 9.81 77 287842 121072 79335397
Exposure during pregnancy 224.02 9.81 46 287873 101086 79355383
Toxicity to various agents 214.88 9.81 790 287129 420750 79035719
Synovitis 211.73 9.81 142 287777 150592 79305877
Blood calcium decreased 201.69 9.81 390 287529 31429 79425040
Balance disorder 200.51 9.81 797 287122 98060 79358409
Off label use 192.40 9.81 2224 285695 904991 78551478
High density lipoprotein decreased 188.63 9.81 147 287772 4508 79451961
Duodenal ulcer perforation 188.29 9.81 13 287906 66198 79390271
Cognitive disorder 186.15 9.81 616 287303 69310 79387159
Wound 179.15 9.81 98 287821 116081 79340388
Blood triglycerides increased 175.87 9.81 291 287628 20749 79435720
Death 175.06 9.81 1262 286657 565252 78891217
Drug ineffective 161.62 9.81 2841 285078 1078072 78378397
Treatment failure 159.38 9.81 230 287689 170256 79286213
Asthma 156.35 9.81 927 286992 134168 79322301
Contraindicated product administered 153.80 9.81 206 287713 157332 79299137
Intentional overdose 152.61 9.81 97 287822 105863 79350606
Therapeutic product effect decreased 151.28 9.81 223 287696 163640 79292829
Neutropenia 149.90 9.81 534 287385 287176 79169293
Immune-mediated myositis 148.16 9.81 113 287806 3354 79453115
Helicobacter infection 147.70 9.81 35 287884 69669 79386800
Blood pressure systolic increased 145.54 9.81 552 287367 66434 79390035
Pericarditis 143.95 9.81 100 287819 104136 79352333
Folliculitis 143.60 9.81 16 287903 55364 79401105
Blood pressure increased 141.99 9.81 1273 286646 210087 79246382
Low density lipoprotein decreased 141.96 9.81 75 287844 1146 79455323
Infection 141.54 9.81 426 287493 241286 79215183
Muscle spasms 138.94 9.81 1093 286826 173637 79282832
Dyslipidaemia 137.30 9.81 189 287730 11444 79445025
Infusion related reaction 134.65 9.81 406 287513 229831 79226638
Myocardial infarction 133.56 9.81 1128 286791 183001 79273468
Alopecia 132.43 9.81 412 287507 230943 79225526
Asthenia 128.38 9.81 2575 285344 509114 78947355
Sedation 128.28 9.81 446 287473 51449 79405020
Euglycaemic diabetic ketoacidosis 125.82 9.81 139 287780 6705 79449764
Reversible airways obstruction 118.19 9.81 82 287837 2094 79454375
Acute myocardial infarction 116.55 9.81 569 287350 76467 79380002
Impaired healing 114.66 9.81 89 287830 87566 79368903
Sleep disorder due to general medical condition, insomnia type 114.42 9.81 12 287907 43544 79412925
Product use issue 114.26 9.81 382 287537 209440 79247029
Coronary artery disease 114.08 9.81 504 287415 64970 79391499
Muscular weakness 111.48 9.81 975 286944 159754 79296715
Disease progression 111.47 9.81 320 287599 184042 79272427
Blood glucose increased 110.73 9.81 753 287166 114222 79342247
Diabetic ketoacidosis 104.92 9.81 316 287603 33806 79422663
Arthropathy 103.03 9.81 313 287606 176798 79279671
Cardiac failure 102.09 9.81 929 286990 153913 79302556
Rheumatoid factor negative 100.65 9.81 59 287860 1114 79455355
Obstructive airways disorder 100.20 9.81 295 287624 31164 79425305
Irritable bowel syndrome 99.63 9.81 50 287869 62191 79394278
Blister 94.16 9.81 180 287739 119296 79337173
Pyrexia 93.16 9.81 1809 286110 676900 78779569
Stomatitis 91.46 9.81 251 287668 146506 79309963
Chromaturia 91.32 9.81 251 287668 25495 79430974
Coronary artery occlusion 87.77 9.81 180 287739 15135 79441334
Drug interaction 86.89 9.81 2036 285883 413147 79043322
Constipation 86.35 9.81 1469 286450 281581 79174888
Conjunctivitis allergic 84.58 9.81 61 287858 1659 79454810
Product use in unapproved indication 83.40 9.81 545 287374 249814 79206655
Rales 83.23 9.81 207 287712 19794 79436675
Diabetes mellitus 83.12 9.81 526 287393 77864 79378605
General physical health deterioration 82.93 9.81 617 287302 274621 79181848
Rheumatic fever 82.88 9.81 5 287914 28520 79427949
Coma 82.53 9.81 148 287771 100501 79355968
Cardiac failure chronic 82.51 9.81 146 287773 10989 79445480
Pancytopenia 80.78 9.81 316 287603 165429 79291040
Pregnancy 80.21 9.81 4 287915 26847 79429622
Swelling 79.34 9.81 458 287461 216253 79240216
Seizure 79.24 9.81 381 287538 188453 79268016
Diabetes mellitus inadequate control 77.72 9.81 228 287691 24036 79432433
Overdose 77.68 9.81 371 287548 183835 79272634
Sepsis 77.39 9.81 612 287307 268816 79187653
Febrile neutropenia 76.36 9.81 504 287415 230495 79225974
Chronic kidney disease 75.24 9.81 452 287467 65702 79390767
Erectile dysfunction 74.39 9.81 164 287755 14500 79441969
Chest discomfort 73.83 9.81 793 287126 137251 79319218
Condition aggravated 73.20 9.81 1321 286598 499803 78956666
Angina unstable 72.98 9.81 175 287744 16352 79440117
Cough 72.86 9.81 1786 286133 365003 79091466
Tendon rupture 72.44 9.81 145 287774 11981 79444488
Leukopenia 71.31 9.81 201 287718 116312 79340157
Vital capacity decreased 70.67 9.81 56 287863 1760 79454709
Psoriasis 69.28 9.81 557 287362 89030 79367439
Muscle injury 67.81 9.81 46 287873 48515 79407954
Mucosal inflammation 67.65 9.81 105 287814 75475 79380994
Intentional self-injury 67.27 9.81 17 287902 32402 79424067
Congenital hiatus hernia 66.92 9.81 40 287879 784 79455685
Fall 66.90 9.81 2266 285653 485363 78971106
Computerised tomogram coronary artery abnormal 65.72 9.81 26 287893 192 79456277
Bronchiectasis 65.72 9.81 204 287715 22182 79434287
Acute coronary syndrome 65.24 9.81 196 287723 20937 79435532
Therapy non-responder 65.19 9.81 148 287771 92157 79364312
Respiratory arrest 64.99 9.81 67 287852 57483 79398986
Coronary artery stenosis 64.90 9.81 141 287778 12343 79444126
Cytomegalovirus infection 64.24 9.81 37 287882 42607 79413862
Suicide attempt 63.55 9.81 127 287792 82805 79373664
Device expulsion 63.33 9.81 9 287910 25852 79430617
Myositis 62.24 9.81 181 287738 18987 79437482
Bone marrow failure 61.78 9.81 56 287863 51051 79405418
Pain in extremity 61.38 9.81 1737 286182 362801 79093668
Injury 60.83 9.81 117 287802 77379 79379090
Glycosylated haemoglobin increased 60.75 9.81 180 287739 19080 79437389
Atrial fibrillation 60.29 9.81 1027 286892 196859 79259610
Productive cough 60.25 9.81 534 287385 87797 79368672
Abortion spontaneous 60.22 9.81 16 287903 29491 79426978
Ischaemic stroke 59.20 9.81 257 287662 32874 79423595
Hypersensitivity 57.12 9.81 638 287281 261601 79194868
Vascular stent stenosis 57.10 9.81 46 287873 1481 79454988
Premature delivery 55.56 9.81 9 287910 23458 79433011
Drug resistance 55.02 9.81 43 287876 42170 79414299
Pancreatitis 55.01 9.81 430 287489 68145 79388324
Rheumatoid factor positive 54.64 9.81 82 287837 59757 79396712
Lung diffusion test decreased 54.45 9.81 42 287877 1268 79455201
Malignant mediastinal neoplasm 53.71 9.81 43 287876 1372 79455097
Restrictive pulmonary disease 53.50 9.81 56 287863 2539 79453930
Interstitial lung disease 53.47 9.81 632 287287 111968 79344501
Thrombocytopenia 52.90 9.81 658 287261 264601 79191868
Product substitution issue 52.59 9.81 177 287742 20079 79436390
Septic shock 52.53 9.81 246 287673 122555 79333914
Drug intolerance 52.36 9.81 656 287263 263463 79193006
Eosinophil count increased 52.20 9.81 158 287761 16947 79439522
Blood creatinine increased 52.15 9.81 818 287101 154239 79302230
Arteriosclerosis coronary artery 51.97 9.81 162 287757 17654 79438815
Adjustment disorder 51.80 9.81 68 287851 3932 79452537
Spirometry abnormal 51.76 9.81 36 287883 923 79455546
5-hydroxyindolacetic acid in urine increased 51.60 9.81 23 287896 236 79456233
Hepatojugular reflux 51.45 9.81 31 287888 617 79455852
Needle fatigue 51.37 9.81 35 287884 867 79455602
Mobility decreased 51.25 9.81 670 287249 121505 79334964
Bone erosion 50.88 9.81 161 287758 17686 79438783
Fibromyalgia 49.75 9.81 98 287821 64242 79392227
Crush syndrome 49.70 9.81 21 287898 187 79456282
Ascites 49.52 9.81 126 287793 75436 79381033
Respiratory depression 49.26 9.81 19 287900 27611 79428858
Muscle disorder 49.13 9.81 80 287839 5627 79450842
Cardio-respiratory arrest 49.03 9.81 213 287706 108297 79348172
Gait spastic 48.93 9.81 38 287881 1159 79455310
Exercise tolerance decreased 48.93 9.81 104 287815 8967 79447502
Drug-induced liver injury 48.38 9.81 406 287513 65711 79390758
Hypotension 48.26 9.81 1996 285923 438321 79018148
Toxic epidermal necrolysis 48.00 9.81 54 287865 44527 79411942
Chest pain 47.99 9.81 1347 286572 280957 79175512
Somnolence 47.95 9.81 592 287327 238389 79218080
Polymyositis 47.94 9.81 57 287862 2979 79453490
Stenosis 47.68 9.81 51 287868 2371 79454098
Multiple organ dysfunction syndrome 47.34 9.81 248 287671 119998 79336471
Hepatic function abnormal 47.32 9.81 437 287482 72670 79383799
Blood mercury abnormal 47.32 9.81 21 287898 213 79456256
Electrocardiogram Q wave abnormal 47.10 9.81 29 287890 601 79455868
Depressed level of consciousness 47.00 9.81 545 287374 96107 79360362
Cerebral infarction 46.88 9.81 304 287615 45372 79411097
Haemorrhagic stroke 46.68 9.81 115 287804 10931 79445538
Muscle discomfort 46.11 9.81 22 287897 267 79456202
Nephritic syndrome 46.08 9.81 25 287894 404 79456065
Carotid artery thrombosis 46.05 9.81 56 287863 2997 79453472
Mite allergy 45.89 9.81 37 287882 1193 79455276
Troponin increased 44.58 9.81 162 287757 19093 79437376
Arterial occlusive disease 44.52 9.81 96 287823 8360 79448109
Hyper IgE syndrome 44.52 9.81 27 287892 544 79455925
Cataract 44.16 9.81 379 287540 61741 79394728
Pulmonary function test abnormal 43.98 9.81 64 287855 4080 79452389
Device related infection 43.36 9.81 36 287883 34258 79422211
Neurologic neglect syndrome 43.32 9.81 53 287866 2854 79453615
Blood pressure inadequately controlled 43.22 9.81 79 287840 6098 79450371
Muscle rupture 43.15 9.81 60 287859 3667 79452802
Respiratory failure 43.08 9.81 431 287488 180480 79275989
Arteriosclerosis 42.75 9.81 154 287765 18073 79438396
Poisoning 42.44 9.81 19 287900 25253 79431216
Malignant neoplasm progression 42.28 9.81 302 287617 135688 79320781
Hip arthroplasty 42.24 9.81 40 287879 35716 79420753
Middle insomnia 42.24 9.81 141 287778 15928 79440541
White blood cell count decreased 42.21 9.81 455 287464 187833 79268636
Orbital myositis 42.15 9.81 18 287901 165 79456304
Weight decreased 42.11 9.81 1624 286295 353574 79102895
Mental status changes 42.09 9.81 114 287805 66845 79389624
Cystitis 41.93 9.81 330 287589 52402 79404067
Rhinitis perennial 41.88 9.81 22 287897 332 79456137
Red blood cell sedimentation rate abnormal 41.66 9.81 168 287751 20795 79435674
Type 2 diabetes mellitus 41.39 9.81 350 287569 56772 79399697
Diastolic dysfunction 40.96 9.81 108 287811 10703 79445766
Carotid arteriosclerosis 40.52 9.81 49 287870 2607 79453862
Hemiplegia 40.09 9.81 132 287787 14807 79441662
Ulnar tunnel syndrome 39.89 9.81 10 287909 9 79456460
Mycotic allergy 39.12 9.81 37 287882 1482 79454987
Pulmonary valve disease 38.90 9.81 20 287899 288 79456181
Hypoglycaemia 38.85 9.81 548 287371 101046 79355423
Drug ineffective for unapproved indication 38.80 9.81 79 287840 51159 79405310
Dust allergy 38.77 9.81 37 287882 1499 79454970
Hyperglycaemia 38.49 9.81 406 287513 69929 79386540
Muscle necrosis 38.48 9.81 36 287883 1422 79455047
Liver disorder 38.23 9.81 415 287504 72002 79384467
Sputum culture positive 38.12 9.81 57 287862 3724 79452745
Cerebral haemorrhage 37.96 9.81 346 287573 57327 79399142
Skin haemorrhage 37.81 9.81 112 287807 11869 79444600
Hypertonic bladder 37.68 9.81 60 287859 4141 79452328
Cerebrovascular accident 37.61 9.81 778 287141 154514 79301955
Drug withdrawal syndrome 37.44 9.81 42 287877 34676 79421793
Lipoprotein (a) increased 37.43 9.81 13 287906 63 79456406
Thrombotic microangiopathy 37.43 9.81 13 287906 20156 79436313
Haemophagocytic lymphohistiocytosis 37.33 9.81 16 287903 21821 79434648
Neutropenic sepsis 37.30 9.81 26 287893 27038 79429431
Transient ischaemic attack 37.19 9.81 321 287598 52374 79404095
Amyotrophic lateral sclerosis 37.12 9.81 39 287880 1776 79454693
Drug dependence 37.09 9.81 56 287863 40713 79415756
Haematuria 37.04 9.81 396 287523 68440 79388029
Malignant melanoma in situ 37.02 9.81 45 287874 2407 79454062
Nasal oedema 36.97 9.81 38 287881 1686 79454783
Generalised tonic-clonic seizure 36.50 9.81 64 287855 43846 79412623
Gangrene 36.49 9.81 92 287827 8872 79447597
Autoimmune myositis 36.33 9.81 19 287900 284 79456185
Lipids increased 36.14 9.81 37 287882 1634 79454835
Body temperature decreased 36.14 9.81 219 287700 31926 79424543
Blood immunoglobulin E increased 35.93 9.81 71 287848 5811 79450658
Carotid artery stenosis 35.77 9.81 90 287829 8668 79447801
Hepatocellular injury 35.75 9.81 294 287625 47299 79409170
Discomfort 35.72 9.81 286 287633 125331 79331138
Pancreatic neuroendocrine tumour 35.64 9.81 25 287894 650 79455819
Relapsing-remitting multiple sclerosis 35.36 9.81 35 287884 1484 79454985
Sinus congestion 35.28 9.81 154 287765 19742 79436727
Posterior reversible encephalopathy syndrome 35.24 9.81 26 287893 26255 79430214
Lipids abnormal 35.14 9.81 24 287895 597 79455872
Neutrophil count decreased 34.66 9.81 198 287721 93761 79362708
Palpitations 34.60 9.81 646 287273 125964 79330505
Hypercholesterolaemia 34.49 9.81 170 287749 22925 79433544
Encephalopathy 34.43 9.81 126 287793 67271 79389198
Renal failure 34.43 9.81 960 286959 200008 79256461
Mitral valve incompetence 34.29 9.81 198 287721 28367 79428102
Low cardiac output syndrome 33.92 9.81 29 287890 1016 79455453
Glomerular filtration rate decreased 33.83 9.81 167 287752 22535 79433934
Androgenetic alopecia 33.73 9.81 15 287904 153 79456316
Skin laceration 33.63 9.81 199 287720 28763 79427706
Coronary artery restenosis 33.52 9.81 32 287887 1297 79455172
Poisoning deliberate 33.48 9.81 13 287906 18815 79437654
Dyspnoea exertional 33.42 9.81 470 287449 86603 79369866
Bronchial secretion retention 33.28 9.81 56 287863 4048 79452421
Supine hypertension 32.93 9.81 20 287899 404 79456065
Lower respiratory tract infection 32.81 9.81 303 287616 128917 79327552
Pollakiuria 32.74 9.81 239 287680 37078 79419391
Injection site reaction 32.42 9.81 96 287823 54689 79401780
Micturition urgency 32.41 9.81 110 287809 12531 79443938
Transplant rejection 32.04 9.81 15 287904 19422 79437047
Blood pressure fluctuation 31.92 9.81 377 287542 66768 79389701
Transaminases increased 31.84 9.81 306 287613 51437 79405032
Blood pressure systolic abnormal 31.74 9.81 135 287784 17112 79439357
Rash 31.74 9.81 1736 286183 576622 78879847
Muscle atrophy 31.72 9.81 101 287818 11131 79445338
Ventricular hypokinesia 31.46 9.81 89 287830 9190 79447279
Alanine aminotransferase increased 31.42 9.81 789 287130 161781 79294688
Gastrooesophageal reflux disease 31.35 9.81 540 287379 103706 79352763
Bronchopulmonary aspergillosis 31.28 9.81 21 287898 22273 79434196
Pneumocystis jirovecii pneumonia 31.20 9.81 43 287876 32465 79424004
Knee arthroplasty 30.81 9.81 69 287850 43179 79413290
Pathogen resistance 30.78 9.81 7 287912 14335 79442134
Helicobacter gastritis 30.74 9.81 41 287878 2408 79454061
Agitation 30.72 9.81 222 287697 99493 79356976
Myelosuppression 30.62 9.81 62 287857 40234 79416235
Blood cholesterol abnormal 30.26 9.81 48 287871 3302 79453167
Upper-airway cough syndrome 30.20 9.81 102 287817 11591 79444878
Cytomegalovirus viraemia 30.17 9.81 5 287914 12816 79443653
Lactic acidosis 29.98 9.81 387 287532 69972 79386497
Prescribed overdose 29.90 9.81 57 287862 37826 79418643
Blood glucose abnormal 29.83 9.81 95 287824 10471 79445998
Wheezing 29.74 9.81 589 287330 116075 79340394
Pulmonary mass 29.64 9.81 193 287726 28841 79427628
Vomiting 29.63 9.81 2038 285881 663790 78792679
Gastrointestinal disorder 29.56 9.81 290 287629 121915 79334554
N-terminal prohormone brain natriuretic peptide abnormal 29.47 9.81 16 287903 259 79456210
Akathisia 29.41 9.81 6 287913 13253 79443216
Myocardial ischaemia 29.41 9.81 175 287744 25344 79431125
Haemoglobin increased 29.33 9.81 67 287852 6065 79450404
Left ventricular enlargement 29.02 9.81 23 287896 723 79455746
Haematotoxicity 28.80 9.81 10 287909 15509 79440960
Dermatomyositis 28.80 9.81 49 287870 3574 79452895
Tricuspid valve incompetence 28.66 9.81 144 287775 19568 79436901
Oropharyngeal discomfort 28.60 9.81 73 287846 7093 79449376
Multiple allergies 28.58 9.81 93 287826 10367 79446102
Nipple inflammation 28.54 9.81 10 287909 50 79456419
Mydriasis 28.49 9.81 14 287905 17629 79438840
Acute respiratory distress syndrome 28.47 9.81 74 287845 43993 79412476
Sopor 28.46 9.81 47 287872 32963 79423506
Aspergillus infection 28.33 9.81 17 287902 19144 79437325
Occult blood 28.29 9.81 33 287886 1690 79454779
Skin necrosis 28.24 9.81 15 287904 18072 79438397
Dyspnoea 28.21 9.81 3519 284400 853506 78602963
Aspartate aminotransferase increased 28.03 9.81 677 287242 137964 79318505
Eczema 27.95 9.81 247 287672 40571 79415898
Inspiratory capacity abnormal 27.91 9.81 12 287907 112 79456357
Blood thyroid stimulating hormone abnormal 27.86 9.81 25 287894 935 79455534
Intentional product use issue 27.85 9.81 384 287535 151728 79304741
Musculoskeletal toxicity 27.58 9.81 14 287905 196 79456273
Dizziness 27.35 9.81 2231 285688 524210 78932259
Status epilepticus 27.32 9.81 30 287889 25011 79431458
Candida infection 27.20 9.81 61 287858 38153 79418316
Aortic valve incompetence 27.19 9.81 86 287833 9444 79447025
Injection site erythema 27.14 9.81 168 287751 78029 79378440
Caesarean section 27.14 9.81 6 287913 12529 79443940
Blood pressure diastolic abnormal 27.03 9.81 139 287780 19063 79437406
Pericardial disease 27.01 9.81 20 287899 567 79455902
Hepatitis 26.98 9.81 314 287605 55413 79401056
Neuroleptic malignant syndrome 26.91 9.81 36 287883 27523 79428946
Tumour lysis syndrome 26.88 9.81 28 287891 23911 79432558
Cytokine release syndrome 26.83 9.81 56 287863 35942 79420527
Albuminuria 26.82 9.81 22 287897 727 79455742
Unresponsive to stimuli 26.75 9.81 107 287812 55681 79400788
Adverse event 26.71 9.81 119 287800 60095 79396374
Tachycardia 26.70 9.81 466 287453 177302 79279167
Aortic aneurysm 26.70 9.81 79 287840 8367 79448102
Vascular stent thrombosis 26.66 9.81 48 287871 3662 79452807
Stent placement 26.62 9.81 67 287852 6453 79450016
Hyperkalaemia 26.36 9.81 569 287350 113829 79342640
Hepatic encephalopathy 26.31 9.81 29 287890 24137 79432332
Withdrawal syndrome 26.30 9.81 35 287884 26819 79429650
Cardiac arrest 26.21 9.81 450 287469 171646 79284823
Aggression 26.21 9.81 95 287824 50863 79405606
Pancreatitis acute 26.05 9.81 284 287635 49320 79407149
Goitre 25.92 9.81 60 287859 5479 79450990
Serotonin syndrome 25.86 9.81 80 287839 44947 79411522
Ejection fraction decreased 25.65 9.81 213 287706 34364 79422105
Myoglobin blood increased 25.55 9.81 43 287876 3108 79453361
Ulcer 25.54 9.81 43 287876 29929 79426540
Affect lability 25.45 9.81 94 287825 11165 79445304
Blood triglycerides abnormal 25.43 9.81 18 287901 475 79455994
Joint swelling 25.42 9.81 821 287098 287825 79168644
Amblyopia 25.39 9.81 14 287905 234 79456235
Colitis ulcerative 25.23 9.81 213 287706 34529 79421940
Sinusitis 25.21 9.81 526 287393 194975 79261494
Dystonia 25.21 9.81 24 287895 21375 79435094
Hyperlipidaemia 25.16 9.81 171 287748 25922 79430547
Physical examination abnormal 25.10 9.81 15 287904 294 79456175
Rheumatoid nodule 25.05 9.81 16 287903 17422 79439047
Substance abuse 25.00 9.81 4 287915 10522 79445947
Adverse drug reaction 24.98 9.81 139 287780 66253 79390216
Peripheral arterial occlusive disease 24.93 9.81 76 287843 8182 79448287
Blood creatine phosphokinase 24.91 9.81 12 287907 149 79456320
Lipase increased 24.45 9.81 121 287798 16345 79440124
Gait disturbance 24.38 9.81 948 286971 206558 79249911
Neoplasm progression 24.23 9.81 100 287819 51582 79404887
Tubulointerstitial nephritis 23.96 9.81 227 287692 38008 79418461
Total bile acids increased 23.87 9.81 10 287909 87 79456382
Guillain-Barre syndrome 23.86 9.81 79 287840 8886 79447583
Lip dry 23.76 9.81 13 287906 15405 79441064
Aplastic anaemia 23.64 9.81 18 287901 17887 79438582
Bundle branch block left 23.46 9.81 93 287826 11420 79445049
Blood test abnormal 23.42 9.81 126 287793 17584 79438885
Eye haemorrhage 23.36 9.81 83 287836 9674 79446795
Miosis 23.35 9.81 14 287905 15775 79440694
Inflammation 23.30 9.81 221 287698 93532 79362937
Left ventricular hypertrophy 23.29 9.81 91 287828 11100 79445369
Ventricular extrasystoles 23.27 9.81 136 287783 19568 79436901
Forced vital capacity decreased 23.15 9.81 30 287889 1713 79454756
Eosinophilia 23.08 9.81 258 287661 45087 79411382
Bacterial infection 23.03 9.81 49 287870 31231 79425238
Enterococcal infection 23.00 9.81 14 287905 15646 79440823
Abnormal behaviour 22.89 9.81 62 287857 36359 79420110
Total lung capacity decreased 22.71 9.81 39 287880 2866 79453603
Chronic obstructive pulmonary disease 22.70 9.81 434 287485 84985 79371484
Diabetic metabolic decompensation 22.54 9.81 42 287877 3290 79453179
Immune reconstitution inflammatory syndrome 22.33 9.81 11 287908 13830 79442639
Normochromic normocytic anaemia 22.30 9.81 70 287849 7657 79448812
Mycobacterium test positive 22.25 9.81 16 287903 433 79456036
Abdominal discomfort 22.10 9.81 713 287206 250014 79206455
Necrotising myositis 22.02 9.81 25 287894 1243 79455226
Lower limb fracture 21.99 9.81 31 287888 23184 79433285
Grip strength decreased 21.94 9.81 28 287891 21841 79434628
Vertigo 21.92 9.81 361 287558 68721 79387748
Hepatic neoplasm 21.71 9.81 42 287877 3384 79453085
Creutzfeldt-Jakob disease 21.64 9.81 12 287907 203 79456266
Coordination abnormal 21.44 9.81 121 287798 17191 79439278
Carcinoid tumour 21.30 9.81 17 287902 540 79455929
Blood pressure diastolic decreased 21.28 9.81 184 287735 30032 79426437
Panniculitis 21.25 9.81 9 287910 12362 79444107
Hyperthyroidism 21.09 9.81 145 287774 22064 79434405
Anaemia 20.78 9.81 1356 286563 443659 79012810
Confabulation 20.77 9.81 16 287903 482 79455987
Discontinued product administered 20.75 9.81 9 287910 86 79456383
Coagulopathy 20.65 9.81 64 287855 35942 79420527
Mucormycosis 20.61 9.81 3 287916 8466 79448003
Plasmapheresis 20.57 9.81 18 287901 651 79455818
Growth hormone deficiency 20.54 9.81 15 287904 416 79456053
Pulmonary haemorrhage 20.47 9.81 14 287905 14703 79441766
Ventricular hyperkinesia 20.43 9.81 13 287906 286 79456183
Device issue 20.35 9.81 42 287877 27066 79429403
Sinus pain 20.29 9.81 43 287876 3699 79452770
Haemorrhage subcutaneous 20.25 9.81 50 287869 4759 79451710
Sneezing 20.19 9.81 131 287788 19552 79436917
Metabolic acidosis 20.15 9.81 414 287505 82115 79374354
Anastomotic infection 20.09 9.81 10 287909 134 79456335
Hepatic enzyme abnormal 20.06 9.81 68 287851 7742 79448727
Dermatitis allergic 20.05 9.81 123 287796 18007 79438462
Platelet distribution width increased 20.02 9.81 10 287909 135 79456334
Progressive multifocal leukoencephalopathy 20.02 9.81 27 287892 20573 79435896
Neurotoxicity 19.96 9.81 56 287863 32462 79424007
Aortic stenosis 19.91 9.81 66 287853 7429 79449040
Cholestasis 19.88 9.81 281 287638 51828 79404641
Acute myeloid leukaemia 19.85 9.81 52 287867 30833 79425636
Ageusia 19.78 9.81 115 287804 16517 79439952
Brain natriuretic peptide abnormal 19.74 9.81 19 287900 778 79455691
Low density lipoprotein abnormal 19.70 9.81 15 287904 444 79456025
Myopathy toxic 19.67 9.81 22 287897 1076 79455393
Photosensitivity reaction 19.51 9.81 137 287782 20990 79435479
Pneumonia 19.45 9.81 2087 285832 658159 78798310
Mean platelet volume increased 19.31 9.81 22 287897 1098 79455371
Endocrine ophthalmopathy 19.26 9.81 18 287901 710 79455759
Autoimmune hepatitis 19.24 9.81 89 287830 11694 79444775
Fractured coccyx 19.21 9.81 21 287898 1001 79455468
Benign prostatic hyperplasia 19.18 9.81 88 287831 11524 79444945
Rheumatic disorder 19.15 9.81 38 287881 3120 79453349
Glomerular filtration rate 19.09 9.81 10 287909 150 79456319
Pulmonary embolism 18.98 9.81 473 287446 171181 79285288
Ketoacidosis 18.97 9.81 67 287852 7787 79448682
Oral candidiasis 18.95 9.81 50 287869 29578 79426891
Oedema peripheral 18.84 9.81 1102 286817 251186 79205283
Blood cholesterol decreased 18.83 9.81 27 287892 1698 79454771
Eyelid disorder 18.78 9.81 29 287890 1949 79454520
Cystitis haemorrhagic 18.66 9.81 5 287914 9167 79447302
Chronic sinusitis 18.64 9.81 12 287907 13014 79443455
Epilepsy 18.58 9.81 80 287839 40780 79415689
Cytopenia 18.54 9.81 28 287891 20355 79436114
Hepatitis C 18.46 9.81 10 287909 11915 79444554
Mitral valve thickening 18.43 9.81 14 287905 413 79456056
Cardiac discomfort 18.42 9.81 23 287896 1265 79455204
Total cholesterol/HDL ratio abnormal 18.39 9.81 8 287911 77 79456392
Injection site pain 18.34 9.81 344 287575 129494 79326975
Dyspnoea at rest 18.25 9.81 63 287856 7239 79449230
Dysgeusia 18.22 9.81 299 287620 56878 79399591
Procollagen type I C-terminal propeptide increased 18.20 9.81 6 287913 24 79456445
Blood creatine increased 18.17 9.81 75 287844 9380 79447089
Suicidal ideation 18.11 9.81 182 287737 76158 79380311
Gynaecomastia 18.10 9.81 65 287854 7616 79448853
Supraventricular extrasystoles 18.09 9.81 61 287858 6926 79449543
Blood calcium increased 18.06 9.81 80 287839 10320 79446149
Incorrect route of product administration 18.04 9.81 65 287854 34864 79421605
Retro-orbital neoplasm 18.01 9.81 7 287912 49 79456420
Multi-organ disorder 17.98 9.81 33 287886 2555 79453914
Parosmia 17.95 9.81 61 287858 6953 79449516
Intermittent claudication 17.81 9.81 39 287880 3432 79453037
Therapy partial responder 17.74 9.81 22 287897 17375 79439094
Burning sensation 17.72 9.81 304 287615 58328 79398141
Hypertension 17.69 9.81 1406 286513 329586 79126883
Burns second degree 17.62 9.81 33 287886 2595 79453874
Angiocardiogram 17.61 9.81 11 287908 234 79456235
Lipoma 17.58 9.81 36 287883 3023 79453446
Multiple-drug resistance 17.55 9.81 5 287914 8803 79447666
Monoparesis 17.51 9.81 39 287880 3472 79452997
Intentional product misuse 17.50 9.81 240 287679 94925 79361544
Syncope 17.50 9.81 804 287115 178645 79277824
Blood creatine phosphokinase abnormal 17.40 9.81 14 287905 450 79456019
Prostatic specific antigen increased 17.37 9.81 79 287840 10307 79446162
Hypereosinophilic syndrome 17.36 9.81 15 287904 533 79455936
Needle issue 17.29 9.81 93 287826 12975 79443494
Serum procollagen type I N-terminal propeptide increased 17.29 9.81 6 287913 29 79456440
Atrial enlargement 17.16 9.81 20 287899 1023 79455446
Right atrial enlargement 17.16 9.81 13 287906 382 79456087
Skin exfoliation 17.13 9.81 287 287632 54813 79401656
Personality disorder 17.11 9.81 55 287864 6091 79450378
Osteonecrosis of jaw 17.09 9.81 89 287830 43137 79413332
Haematocrit increased 17.05 9.81 42 287877 3992 79452477
Unwanted awareness during anaesthesia 17.04 9.81 12 287907 314 79456155
Renal cyst 16.96 9.81 101 287818 14631 79441838
Decubitus ulcer 16.89 9.81 19 287900 15668 79440801
Sensory loss 16.89 9.81 92 287827 12899 79443570
Sinonasal obstruction 16.84 9.81 12 287907 320 79456149
Vascular device infection 16.83 9.81 8 287911 10268 79446201
Blood urine present 16.77 9.81 133 287786 21164 79435305
Catarrh 16.71 9.81 29 287890 2149 79454320
Body temperature increased 16.71 9.81 93 287826 44327 79412142
Hepatitis E antibody positive 16.71 9.81 11 287908 257 79456212
Sputum discoloured 16.70 9.81 135 287784 21608 79434861
Paraplegia 16.68 9.81 48 287871 5005 79451464
Diabetic foot 16.62 9.81 39 287880 3593 79452876
Heart rate decreased 16.60 9.81 351 287568 69965 79386504
Metastases to bone 16.57 9.81 40 287879 24387 79432082
Systolic dysfunction 16.56 9.81 40 287879 3755 79452714
Nocturia 16.53 9.81 95 287824 13586 79442883
Total cholesterol/HDL ratio increased 16.52 9.81 11 287908 262 79456207
Helicobacter test false negative 16.50 9.81 7 287912 63 79456406
Drug-disease interaction 16.49 9.81 20 287899 1067 79455402
Pertussis 16.48 9.81 18 287901 857 79455612
Paradoxical drug reaction 16.47 9.81 3 287916 7182 79449287
Psychomotor hyperactivity 16.46 9.81 22 287897 16827 79439642
Nipple disorder 16.38 9.81 10 287909 204 79456265
Very low density lipoprotein increased 16.34 9.81 10 287909 205 79456264
Meningitis eosinophilic 16.26 9.81 5 287914 15 79456454
Cardiovascular somatic symptom disorder 16.22 9.81 6 287913 36 79456433
Product residue present 16.22 9.81 38 287881 3498 79452971
No adverse event 16.19 9.81 74 287845 37118 79419351
Sensorimotor disorder 16.16 9.81 18 287901 876 79455593
Oesophageal carcinoma 16.15 9.81 10 287909 11074 79445395
Decreased ventricular preload 16.08 9.81 6 287913 37 79456432
Skin toxicity 16.06 9.81 5 287914 8309 79448160
Staphylococcal infection 15.98 9.81 134 287785 58161 79398308
Myelodysplastic syndrome 15.91 9.81 56 287863 30245 79426224
Brain oedema 15.88 9.81 43 287876 25220 79431249
Infusion site streaking 15.82 9.81 14 287905 514 79455955
Toxic shock syndrome 15.82 9.81 21 287898 1228 79455241
Blood immunoglobulin G increased 15.81 9.81 34 287885 2955 79453514
AST/ALT ratio abnormal 15.79 9.81 5 287914 17 79456452
Encephalitis 15.76 9.81 18 287901 14742 79441727
Granulocytopenia 15.73 9.81 11 287908 11420 79445049
Muscle contractions involuntary 15.70 9.81 39 287880 3726 79452743
Hepatitis E virus test positive 15.68 9.81 11 287908 286 79456183
Blood thyroid stimulating hormone increased 15.61 9.81 73 287846 9635 79446834
Respiratory distress 15.59 9.81 135 287784 58204 79398265
Rhinorrhoea 15.52 9.81 372 287547 75702 79380767
Prostatic haemorrhage 15.49 9.81 9 287910 167 79456302
Cardiac murmur 15.43 9.81 104 287815 15720 79440749
Drug tolerance 15.41 9.81 6 287913 8669 79447800
Swelling of eyelid 15.39 9.81 39 287880 3772 79452697
Hernia 15.39 9.81 110 287809 16949 79439520
Drug use disorder 15.34 9.81 6 287913 8645 79447824
Lethargy 15.31 9.81 204 287715 81088 79375381
Endometriosis 15.30 9.81 38 287881 3630 79452839
Left ventricular dysfunction 15.30 9.81 121 287798 19240 79437229
Kidney transplant rejection 15.27 9.81 9 287910 10237 79446232
Plasma cell myeloma 15.25 9.81 121 287798 53138 79403331
Movement disorder 15.22 9.81 158 287761 27101 79429368
Escherichia infection 15.21 9.81 26 287893 17991 79438478
Tryptase increased 15.11 9.81 15 287904 638 79455831
Deep vein thrombosis 15.09 9.81 327 287592 120592 79335877
Complication associated with device 15.00 9.81 25 287894 17471 79438998
Cataract operation 14.99 9.81 47 287872 5138 79451331
Palmar-plantar erythrodysaesthesia syndrome 14.99 9.81 65 287854 33069 79423400
Oxygen saturation increased 14.96 9.81 14 287905 553 79455916
Nodular rash 14.91 9.81 11 287908 310 79456159
Polymyalgia rheumatica 14.88 9.81 43 287876 4494 79451975
Klebsiella infection 14.88 9.81 21 287898 15699 79440770
Respiratory tract congestion 14.84 9.81 123 287796 19831 79436638
Suspected suicide 14.79 9.81 10 287909 10566 79445903
Right ventricular failure 14.77 9.81 40 287879 23457 79433012
Hypocholesterolaemia 14.72 9.81 9 287910 184 79456285
Hypogammaglobulinaemia 14.71 9.81 15 287904 12936 79443533
Ligament pain 14.67 9.81 10 287909 248 79456221
Prinzmetal angina 14.66 9.81 24 287895 1696 79454773
Melanoderma 14.59 9.81 12 287907 398 79456071
Non-alcoholic steatohepatitis 14.58 9.81 28 287891 2244 79454225
Hepatotoxicity 14.55 9.81 117 287802 51235 79405234
Apolipoprotein A-I decreased 14.44 9.81 5 287914 24 79456445
Lymphopenia 14.40 9.81 59 287860 30498 79425971
Atrial thrombosis 14.34 9.81 37 287882 3619 79452850
Coeliac disease 14.25 9.81 12 287907 11339 79445130
Oedema genital 14.17 9.81 14 287905 592 79455877
Carnitine palmitoyltransferase deficiency 14.15 9.81 4 287915 8 79456461
Medication error 14.14 9.81 169 287750 68473 79387996
Loss of personal independence in daily activities 14.08 9.81 477 287442 102103 79354366
Listless 14.05 9.81 38 287881 3823 79452646
Pre-eclampsia 14.03 9.81 4 287915 7037 79449432
Thyroid disorder 14.01 9.81 93 287826 13986 79442483
High density lipoprotein increased 14.00 9.81 19 287900 1135 79455334
Lymphomatoid papulosis 13.98 9.81 11 287908 342 79456127
Pemphigoid 13.96 9.81 99 287820 15216 79441253
Abscess of salivary gland 13.95 9.81 5 287914 27 79456442
Injection site hypersensitivity 13.95 9.81 25 287894 1900 79454569
Lichen planus 13.91 9.81 31 287888 2760 79453709
Epstein-Barr virus infection 13.90 9.81 19 287900 14397 79442072
Bacteraemia 13.88 9.81 66 287853 32758 79423711
Histamine level increased 13.85 9.81 7 287912 97 79456372
Malignant melanoma 13.85 9.81 96 287823 14645 79441824
Conjunctivitis 13.85 9.81 47 287872 25668 79430801
Blood pressure diastolic increased 13.84 9.81 95 287824 14447 79442022
Flatulence 13.82 9.81 224 287695 42500 79413969
Gastrointestinal toxicity 13.77 9.81 6 287913 8103 79448366
Infrequent bowel movements 13.73 9.81 23 287896 1656 79454813
Exposure to toxic agent 13.71 9.81 8 287911 9150 79447319
Transcription medication error 13.64 9.81 12 287907 437 79456032
Clostridium difficile colitis 13.60 9.81 65 287854 32218 79424251
Loss of control of legs 13.58 9.81 25 287894 1940 79454529
Presyncope 13.57 9.81 216 287703 40838 79415631
Food interaction 13.50 9.81 23 287896 1679 79454790
Mesenteric artery thrombosis 13.50 9.81 14 287905 628 79455841
Tendon pain 13.44 9.81 48 287871 5610 79450859
Sputum culture 13.42 9.81 9 287910 217 79456252
Arterial spasm 13.42 9.81 8 287911 156 79456313
Ureteric cancer 13.40 9.81 10 287909 287 79456182
Oxygen consumption decreased 13.39 9.81 12 287907 448 79456021
Peripheral venous disease 13.39 9.81 23 287896 15886 79440583
Left atrial enlargement 13.38 9.81 19 287900 1184 79455285
Arthralgia 13.37 9.81 2303 285616 569500 78886969
Hypopnoea 13.34 9.81 46 287873 5283 79451186
Transaminases abnormal 13.31 9.81 16 287903 846 79455623
Peripheral artery restenosis 13.26 9.81 4 287915 11 79456458
Clitoris abscess 13.26 9.81 4 287915 11 79456458
Blood pressure ambulatory increased 13.26 9.81 6 287913 64 79456405
Cardiac autonomic neuropathy 13.26 9.81 6 287913 64 79456405
Injection site bruising 13.26 9.81 90 287829 40912 79415557
Electrocardiogram QT prolonged 13.23 9.81 238 287681 90148 79366321
Nephrolithiasis 13.23 9.81 268 287651 53023 79403446
Myoglobinuria 13.17 9.81 18 287901 1082 79455387
Hepatic cirrhosis 13.17 9.81 73 287846 34833 79421636
Left ventricular dilatation 13.16 9.81 18 287901 1083 79455386
Metastases to liver 13.14 9.81 55 287864 28259 79428210
Chronic spontaneous urticaria 13.13 9.81 19 287900 1205 79455264
Base excess decreased 13.12 9.81 11 287908 375 79456094
Mania 13.11 9.81 29 287890 18231 79438238
Haemorrhagic cerebral infarction 13.10 9.81 21 287898 1458 79455011
Haemorrhagic diathesis 13.09 9.81 50 287869 6034 79450435
Chronic cutaneous lupus erythematosus 13.08 9.81 12 287907 462 79456007
Bronchopulmonary aspergillosis allergic 13.07 9.81 32 287887 3029 79453440
Injection site swelling 13.07 9.81 108 287811 47024 79409445
Parkinsonism 13.04 9.81 25 287894 16559 79439910
Premature labour 13.04 9.81 7 287912 8383 79448086
Hyperreflexia 13.02 9.81 7 287912 8378 79448091
Amylase increased 13.00 9.81 77 287842 11132 79445337
Breast cancer stage I 12.99 9.81 4 287915 6696 79449773
Vertebrobasilar insufficiency 12.99 9.81 10 287909 301 79456168
Sinus disorder 12.92 9.81 131 287788 22333 79434136
Electrocardiogram abnormal 12.90 9.81 104 287815 16633 79439836
Bradypnoea 12.90 9.81 3 287916 6049 79450420
Herpes simplex 12.86 9.81 15 287904 12172 79444297
Basophil count increased 12.84 9.81 21 287898 1482 79454987
Extrasystoles 12.83 9.81 57 287862 7362 79449107
Hypercreatinaemia 12.79 9.81 10 287909 308 79456161
Diabetic nephropathy 12.79 9.81 31 287888 2916 79453553
Head discomfort 12.79 9.81 93 287826 14409 79442060
BK virus infection 12.75 9.81 8 287911 8796 79447673
Female genital tract fistula 12.66 9.81 3 287916 5972 79450497
Hepatic steatosis 12.64 9.81 199 287720 37539 79418930
Retroperitoneal fibrosis 12.61 9.81 14 287905 679 79455790
Arthritis 12.59 9.81 521 287398 114359 79342110
Microalbuminuria 12.50 9.81 16 287903 902 79455567
Abortion induced 12.49 9.81 5 287914 7104 79449365
Degenerative bone disease 12.49 9.81 7 287912 121 79456348
Acute hepatic failure 12.47 9.81 61 287858 30052 79426417
Aldolase increased 12.47 9.81 9 287910 245 79456224
Sinus tachycardia 12.44 9.81 80 287839 36828 79419641
Pruritus 12.34 9.81 1616 286303 393032 79063437
Skin test negative 12.30 9.81 5 287914 40 79456429
Electrocardiogram ambulatory abnormal 12.30 9.81 5 287914 40 79456429
Blood creatine phosphokinase MM increased 12.30 9.81 5 287914 40 79456429
Degenerative aortic valve disease 12.26 9.81 8 287911 184 79456285
Nightmare 12.20 9.81 145 287774 25716 79430753
Hypomania 12.16 9.81 6 287913 7538 79448931
X-ray abnormal 12.15 9.81 3 287916 5810 79450659
Motor dysfunction 12.15 9.81 93 287826 14640 79441829
Coma acidotic 12.14 9.81 7 287912 128 79456341
Erythema marginatum 12.13 9.81 4 287915 16 79456453
Hypercalcaemia 12.10 9.81 85 287834 38345 79418124
Cardiac disorder 12.07 9.81 317 287602 65440 79391029
Eructation 12.06 9.81 74 287845 10835 79445634
Normocytic anaemia 12.04 9.81 38 287881 4169 79452300
Hypertriglyceridaemia 11.99 9.81 83 287836 12657 79443812
Anuria 11.94 9.81 122 287797 20841 79435628
Red cell distribution width increased 11.90 9.81 95 287824 15147 79441322
Electrocardiogram QRS complex abnormal 11.87 9.81 13 287906 621 79455848
Psoriatic arthropathy 11.85 9.81 204 287715 77795 79378674
Platelet count decreased 11.84 9.81 578 287341 194086 79262383
Potentiating drug interaction 11.83 9.81 63 287856 8756 79447713
Multiple drug therapy 11.82 9.81 37 287882 4041 79452428
Neurotrophic keratopathy 11.81 9.81 3 287916 3 79456466
Cardiac valve fibroelastoma 11.81 9.81 3 287916 3 79456466
Confusional state 11.77 9.81 988 286931 317009 79139460
Diffuse alopecia 11.77 9.81 16 287903 957 79455512
Sinus rhythm 11.76 9.81 15 287904 843 79455626
Breast pain 11.75 9.81 60 287859 8205 79448264
Malaise 11.67 9.81 1975 285944 487894 78968575
Gamma-glutamyltransferase increased 11.65 9.81 269 287650 54411 79402058
Rotator cuff syndrome 11.64 9.81 89 287830 14006 79442463
Cyanosis 11.63 9.81 49 287870 25133 79431336
Pulmonary tuberculosis 11.60 9.81 7 287912 7858 79448611
Respiratory acidosis 11.59 9.81 14 287905 11186 79445283
Liver function test increased 11.58 9.81 205 287714 39568 79416901
Immunodeficiency 11.58 9.81 40 287879 21728 79434741
Blood immunoglobulin M increased 11.56 9.81 19 287900 1347 79455122
Lung opacity 11.53 9.81 43 287876 5131 79451338
Flushing 11.51 9.81 237 287682 88031 79368438
Streptococcal infection 11.50 9.81 9 287910 8821 79447648
Thalamus haemorrhage 11.48 9.81 22 287897 1760 79454709
Electrolyte imbalance 11.43 9.81 65 287854 30816 79425653
Psychotic disorder 11.42 9.81 95 287824 41307 79415162
Impaired quality of life 11.42 9.81 90 287829 14296 79442173
Episcleral venous pressure increased 11.42 9.81 4 287915 20 79456449
Toxic cataract 11.42 9.81 4 287915 20 79456449
Pleuritic pain 11.26 9.81 12 287907 10140 79446329
Hepatitis B reactivation 11.23 9.81 4 287915 6104 79450365
Hyperplastic cholecystopathy 11.18 9.81 8 287911 215 79456254
Mitral valve disease 11.17 9.81 31 287888 3166 79453303
Tardive dyskinesia 11.17 9.81 13 287906 10558 79445911
Urine albumin/creatinine ratio increased 11.16 9.81 12 287907 561 79455908
Hepatosplenomegaly 11.11 9.81 4 287915 6065 79450404
Arcus lipoides 11.10 9.81 4 287915 22 79456447
Ventricular arrhythmia 11.09 9.81 62 287857 8778 79447691
Respiratory disorder 11.03 9.81 106 287813 44750 79411719
Colorectal cancer 11.03 9.81 9 287910 8638 79447831
Creatinine renal clearance increased 11.03 9.81 15 287904 898 79455571
Hepatic failure 11.03 9.81 155 287764 61057 79395412
Lichenoid keratosis 11.02 9.81 36 287883 4021 79452448
Unevaluable event 11.02 9.81 138 287781 55447 79401022
Hepatic enzyme increased 10.95 9.81 543 287376 182067 79274402
Bursitis 10.94 9.81 80 287839 35764 79420705
Tenosynovitis 10.93 9.81 25 287894 15529 79440940
Eye disorder 10.92 9.81 131 287788 23281 79433188
Blood triglycerides decreased 10.92 9.81 8 287911 223 79456246
High density lipoprotein abnormal 10.92 9.81 7 287912 156 79456313
Hypochromasia 10.88 9.81 13 287906 683 79455786
Essential hypertension 10.85 9.81 47 287872 6006 79450463
Neoplasm 10.82 9.81 63 287856 9053 79447416
Neuropathy peripheral 10.79 9.81 409 287510 140896 79315573
Pericardial fibrosis 10.77 9.81 7 287912 160 79456309
Therapeutic response decreased 10.76 9.81 173 287746 66680 79389789
Maternal condition affecting foetus 10.73 9.81 7 287912 161 79456308
Pseudomonas infection 10.73 9.81 39 287880 20864 79435605
Drug specific antibody 10.73 9.81 27 287892 2601 79453868
Apnoea 10.72 9.81 16 287903 11688 79444781
Steroid dependence 10.71 9.81 27 287892 2603 79453866
Blood immunoglobulin A decreased 10.70 9.81 19 287900 1434 79455035
Hyperkeratosis 10.69 9.81 56 287863 7734 79448735
Expired product administered 10.60 9.81 52 287867 6999 79449470
Myoglobin urine present 10.60 9.81 15 287904 932 79455537
Hospitalisation 10.59 9.81 259 287660 93977 79362492
Intensive care 10.52 9.81 16 287903 1061 79455408
Angiopathy 10.48 9.81 52 287867 7030 79449439
Prostatomegaly 10.46 9.81 32 287887 3451 79453018
Immune effector cell-associated neurotoxicity syndrome 10.46 9.81 4 287915 5844 79450625
Feeding disorder 10.43 9.81 97 287822 16157 79440312
Renal impairment 10.43 9.81 682 287237 157101 79299368
Infective spondylitis 10.43 9.81 11 287908 503 79455966
Road traffic accident 10.39 9.81 104 287815 43560 79412909
Noninfective encephalitis 10.37 9.81 12 287907 609 79455860
Vaginal haemorrhage 10.36 9.81 42 287877 21775 79434694
Complications of transplanted kidney 10.36 9.81 5 287914 6361 79450108
Complication of device insertion 10.31 9.81 5 287914 6345 79450124
Blood growth hormone increased 10.30 9.81 13 287906 723 79455746
Contraindication to surgery 10.30 9.81 3 287916 7 79456462
Angiogram 10.25 9.81 6 287913 113 79456356
Strangulated hernia 10.25 9.81 5 287914 64 79456405
Nervous system disorder 10.22 9.81 56 287863 26800 79429669
Pneumonia aspiration 10.22 9.81 175 287744 66792 79389677
Pulmonary arterial pressure abnormal 10.21 9.81 13 287906 729 79455740
Blood loss anaemia 10.21 9.81 93 287826 15405 79441064
Liver function test abnormal 10.20 9.81 305 287614 64170 79392299
Metastases to central nervous system 10.20 9.81 28 287891 16347 79440122
Multiple sclerosis relapse 10.20 9.81 113 287806 46420 79410049
Diabetic neuropathy 10.19 9.81 47 287872 6169 79450300
Cerebral haematoma 10.16 9.81 56 287863 7886 79448583
Oedema mouth 10.09 9.81 29 287890 3022 79453447
Atheroembolism 10.07 9.81 9 287910 335 79456134
Urine ketone body present 10.02 9.81 32 287887 3533 79452936
Procedural pain 10.01 9.81 46 287873 23038 79433431
Campylobacter test positive 9.98 9.81 5 287914 68 79456401
Acute respiratory failure 9.95 9.81 153 287766 59388 79397081
Schizophrenia 9.92 9.81 26 287893 15414 79441055
Coma scale abnormal 9.91 9.81 10 287909 8668 79447801
Respiratory tract infection 9.91 9.81 238 287681 48451 79408018
Mean cell haemoglobin increased 9.88 9.81 36 287883 4249 79452220
Tonsillitis 9.86 9.81 6 287913 6708 79449761
Reduced facial expression 9.85 9.81 27 287892 2738 79453731
Diaphragm muscle weakness 9.85 9.81 7 287912 186 79456283
Atelectasis 9.84 9.81 72 287847 32185 79424284
Blood bicarbonate decreased 9.84 9.81 41 287878 5150 79451319
Cushingoid 9.82 9.81 12 287907 9540 79446929
Amenorrhoea 9.82 9.81 8 287911 7684 79448785
Polyomavirus-associated nephropathy 9.82 9.81 4 287915 5623 79450846
Vascular purpura 9.81 9.81 29 287890 3069 79453400
Blood pressure abnormal 9.81 9.81 100 287819 17069 79439400

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BH52 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC C10AA07 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
HMG CoA reductase 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 D000963 Antimetabolites
MeSH PA D000924 Anticholesteremic Agents
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 antilipemic drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:49205 CETP inhibitors
CHEBI has role CHEBI:67079 anti-inflammatory agents
CHEBI has role CHEBI:77307 cardioprotective agents
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
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

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
C0965129 UMLSCUI
CHEBI:38545 CHEBI
FBI PDB_CHEM_ID
CHEMBL1496 ChEMBL_ID
CHEMBL1744447 ChEMBL_ID
D000068718 MESH_DESCRIPTOR_UI
DB01098 DRUGBANK_ID
2954 IUPHAR_LIGAND_ID
8021 INN_ID
953412-08-3 SECONDARY_CAS_RN
413KH5ZJ73 UNII
446157 PUBCHEM_CID
301542 RXNORM
107656 MMSL
17146 MMSL
17536 MMSL
34243 MMSL
46321 MMSL
d04851 MMSL
009902 NDDF
009903 NDDF
019242 NDDF
1217216007 SNOMEDCT_US
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 0310-0751 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
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 0310-0752 TABLET, FILM COATED 20 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 0310-0754 TABLET, FILM COATED 40 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
CRESTOR HUMAN PRESCRIPTION DRUG LABEL 1 0310-0755 TABLET, FILM COATED 5 mg ORAL NDA 27 sections
CRESTOR HUMAN PRESCRIPTION DRUG LABEL 1 0310-0755 TABLET, FILM COATED 5 mg ORAL NDA 27 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7560 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7560 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7570 TABLET, FILM COATED 10 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7570 TABLET, FILM COATED 10 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7580 TABLET, FILM COATED 20 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7580 TABLET, FILM COATED 20 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7580 TABLET, FILM COATED 20 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7590 TABLET, FILM COATED 40 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7590 TABLET, FILM COATED 40 mg ORAL NDA 29 sections
Crestor HUMAN PRESCRIPTION DRUG LABEL 1 0310-7590 TABLET, FILM COATED 40 mg ORAL NDA 29 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 0904-6778 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 0904-6779 TABLET, COATED 10 mg ORAL ANDA 21 sections