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

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 1001.28 9.65 858 144684 38169 50421413
Myalgia 774.04 9.65 1327 144215 122992 50336590
Blood creatine phosphokinase increased 376.88 9.65 421 145121 25946 50433636
Maternal exposure during pregnancy 359.50 9.65 26 145516 159752 50299830
Sedation complication 310.49 9.65 233 145309 8533 50451049
Creatinine renal clearance decreased 289.86 9.65 254 145288 11627 50447955
Pemphigus 287.09 9.65 14 145528 120152 50339430
Systemic lupus erythematosus 279.41 9.65 37 145505 140585 50318997
Orthostatic hypotension 269.11 9.65 376 145166 29105 50430477
Cognitive disorder 214.69 9.65 424 145118 43699 50415883
Glossodynia 207.98 9.65 40 145502 115529 50344053
Exposure during pregnancy 207.25 9.65 47 145495 120968 50338614
Treatment failure 206.68 9.65 69 145473 137568 50322014
Low density lipoprotein increased 206.49 9.65 153 145389 5493 50454089
Blood calcium decreased 197.83 9.65 270 145272 20436 50439146
Myopathy 194.61 9.65 181 145361 8958 50450624
Drug ineffective 192.64 9.65 1476 144066 817857 49641725
Contraindicated product administered 190.70 9.65 95 145447 148863 50310719
Hand deformity 183.89 9.65 33 145509 100166 50359416
Anti-cyclic citrullinated peptide antibody positive 183.44 9.65 4 145538 70583 50388999
Wound 171.59 9.65 46 145496 105748 50353834
Synovitis 166.22 9.65 74 145468 123791 50335791
Sedation 162.18 9.65 305 145237 30305 50429277
Balance disorder 160.35 9.65 507 145035 70083 50389499
Acute kidney injury 151.35 9.65 1148 144394 226910 50232672
Angina pectoris 137.57 9.65 260 145282 25928 50433654
Pericarditis 135.82 9.65 30 145512 78659 50380923
Muscle spasms 129.53 9.65 707 144835 124846 50334736
Completed suicide 127.31 9.65 115 145427 131774 50327808
High density lipoprotein decreased 126.56 9.65 72 145470 1628 50457954
Duodenal ulcer perforation 106.72 9.65 6 145536 45605 50413977
Blood triglycerides increased 105.77 9.65 146 145396 11166 50448416
Death 105.62 9.65 529 145013 324850 50134732
Arthropathy 105.06 9.65 183 145359 157723 50301859
Helicobacter infection 98.84 9.65 13 145529 49689 50409893
Off label use 96.68 9.65 886 144656 473540 49986042
Immune-mediated myositis 96.42 9.65 51 145491 994 50458588
Constipation 91.93 9.65 876 144666 184832 50274750
Product use issue 88.27 9.65 186 145356 149289 50310293
Psoriasis 86.11 9.65 410 145132 68590 50390992
Therapeutic product effect decreased 85.73 9.65 163 145379 135887 50323695
Fall 84.02 9.65 1391 144151 333541 50126041
Blood glucose increased 82.71 9.65 415 145127 70909 50388673
Infection 82.01 9.65 241 145301 172713 50286869
Folliculitis 81.09 9.65 9 145533 39216 50420366
Blood pressure increased 79.81 9.65 655 144887 132477 50327105
Dyslipidaemia 77.73 9.65 91 145451 5897 50453685
Euglycaemic diabetic ketoacidosis 76.35 9.65 64 145478 2755 50456827
Liver disorder 74.33 9.65 256 145286 36966 50422616
Drug abuse 72.36 9.65 41 145501 59805 50399777
Drug intolerance 71.70 9.65 355 145187 218749 50240833
Depressed level of consciousness 70.95 9.65 317 145225 51636 50407946
Impaired healing 70.78 9.65 58 145484 69728 50389854
Renal failure 70.69 9.65 537 145005 106096 50353486
Hypotension 69.31 9.65 1005 144537 234464 50225118
Infusion related reaction 68.16 9.65 254 145288 169303 50290279
Asthenia 66.83 9.65 1288 144254 317754 50141828
Blood pressure systolic increased 66.64 9.65 239 145303 35210 50424372
Pregnancy 65.92 9.65 5 145537 29572 50430010
Diabetic ketoacidosis 65.33 9.65 153 145389 17719 50441863
Abortion spontaneous 64.31 9.65 20 145522 41752 50417830
Sleep disorder due to general medical condition, insomnia type 63.06 9.65 8 145534 31439 50428143
Discomfort 63.01 9.65 136 145406 108244 50351338
Muscle injury 62.33 9.65 15 145527 37096 50422486
Swelling 60.36 9.65 335 145207 200537 50259045
Device expulsion 58.61 9.65 7 145535 28815 50430767
Muscular weakness 55.06 9.65 464 145078 94549 50365033
Drug interaction 54.04 9.65 840 144702 198781 50260801
Alopecia 54.02 9.65 448 145094 244599 50214983
General physical health deterioration 53.63 9.65 219 145323 142215 50317367
Neutropenia 51.73 9.65 234 145308 147731 50311851
Blister 51.48 9.65 105 145437 85313 50374269
Hypoglycaemia 51.39 9.65 296 145246 53285 50406297
Disease progression 51.12 9.65 126 145416 95740 50363842
Intentional overdose 50.75 9.65 63 145479 62441 50397141
Dermatitis allergic 49.92 9.65 112 145430 12608 50446974
Low density lipoprotein decreased 49.44 9.65 20 145522 203 50459379
Irritable bowel syndrome 49.42 9.65 45 145497 51396 50408186
Abdominal discomfort 48.58 9.65 429 145113 231212 50228370
Pain in extremity 48.35 9.65 1075 144467 271790 50187792
Foetal exposure during pregnancy 48.07 9.65 10 145532 27349 50432233
Hip arthroplasty 47.88 9.65 14 145528 30415 50429167
Premature delivery 47.50 9.65 6 145536 23657 50435925
Asthma 46.93 9.65 427 145115 88910 50370672
Arterial occlusive disease 46.37 9.65 63 145479 4745 50454837
Foetal acidosis 45.80 9.65 11 145531 11 50459571
Hyper IgE syndrome 45.27 9.65 23 145519 411 50459171
Pancreatitis 45.25 9.65 242 145300 42372 50417210
Chronic kidney disease 45.09 9.65 230 145312 39541 50420041
Restrictive pulmonary disease 44.19 9.65 35 145507 1389 50458193
Myocardial infarction 44.00 9.65 420 145122 88607 50370975
Lactic acidosis 43.65 9.65 201 145341 33154 50426428
Reversible airways obstruction 42.69 9.65 30 145512 990 50458592
Hepatitis 42.24 9.65 191 145351 31262 50428320
Rash 41.88 9.65 949 144593 436522 50023060
Febrile neutropenia 41.42 9.65 143 145399 97524 50362058
Angina unstable 40.83 9.65 71 145471 6635 50452947
Pancytopenia 39.85 9.65 117 145425 83913 50375669
Obstructive airways disorder 39.79 9.65 117 145425 15535 50444047
Seizure 39.08 9.65 190 145352 117684 50341898
Mobility decreased 38.92 9.65 376 145166 79572 50380010
Product use in unapproved indication 38.79 9.65 186 145356 115633 50343949
Condition aggravated 38.72 9.65 611 144931 296447 50163135
Drug-induced liver injury 38.02 9.65 171 145371 27924 50431658
Full blood count abnormal 37.59 9.65 150 145392 23238 50436344
Ulnar tunnel syndrome 37.48 9.65 9 145533 9 50459573
Vital capacity decreased 37.43 9.65 27 145515 929 50458653
Glycosylated haemoglobin increased 36.82 9.65 89 145453 10517 50449065
Diabetes mellitus inadequate control 36.07 9.65 101 145441 13044 50446538
Chromaturia 35.14 9.65 107 145435 14483 50445099
Coma 35.05 9.65 69 145473 56810 50402772
Burning sensation 34.79 9.65 237 145305 45209 50414373
Ischaemic stroke 34.77 9.65 113 145429 15835 50443747
Rheumatic fever 34.54 9.65 4 145538 16863 50442719
Lipids increased 34.23 9.65 27 145515 1065 50458517
Diabetes mellitus 34.20 9.65 250 145292 48783 50410799
Stomatitis 33.79 9.65 163 145379 101181 50358401
Necrotising myositis 33.52 9.65 18 145524 362 50459220
Leukopenia 33.51 9.65 92 145450 67436 50392146
Cystitis 32.69 9.65 230 145312 44334 50415248
Muscle discomfort 32.49 9.65 12 145530 93 50459489
Blood creatinine increased 32.20 9.65 348 145194 75812 50383770
Androgenetic alopecia 31.54 9.65 13 145529 139 50459443
Nephritic syndrome 31.54 9.65 14 145528 182 50459400
Bone erosion 31.29 9.65 89 145453 11598 50447984
Coronary artery disease 31.01 9.65 168 145374 29558 50430024
Product substitution issue 31.00 9.65 100 145442 13957 50445625
Bronchiectasis 30.19 9.65 81 145461 10202 50449380
Joint swelling 30.13 9.65 510 145032 244776 50214806
Sinus congestion 29.57 9.65 98 145444 13873 50445709
Weight decreased 29.46 9.65 839 144703 220406 50239176
Hepatocellular injury 29.37 9.65 150 145392 25797 50433785
Type 2 diabetes mellitus 29.19 9.65 184 145358 34191 50425391
Intentional self-injury 29.15 9.65 15 145527 23097 50436485
Blood test abnormal 29.14 9.65 85 145457 11234 50448348
Caesarean section 29 9.65 5 145537 15634 50443948
Confabulation 28.89 9.65 15 145527 281 50459301
Bronchial secretion retention 28.48 9.65 28 145514 1485 50458097
Skin haemorrhage 28.37 9.65 62 145480 6856 50452726
Sputum culture positive 28.18 9.65 27 145515 1387 50458195
Injection site reaction 28.06 9.65 64 145478 49968 50409614
Alanine aminotransferase increased 27.88 9.65 382 145160 87977 50371605
Hyperkeratosis 27.69 9.65 51 145491 4984 50454598
Pertussis 27.25 9.65 19 145523 619 50458963
Dizziness 27.21 9.65 1237 144305 345132 50114450
Malignant mediastinal neoplasm 26.94 9.65 18 145524 546 50459036
Hyperglycaemia 26.77 9.65 188 145354 36217 50423365
Hyperlactacidaemia 26.75 9.65 34 145508 2399 50457183
Crush syndrome 26.66 9.65 11 145531 118 50459464
Coronary artery occlusion 26.08 9.65 63 145479 7440 50452142
Pulmonary function test abnormal 26.06 9.65 25 145517 1286 50458296
Cough 25.80 9.65 891 144651 240373 50219209
Sepsis 25.75 9.65 251 145291 132674 50326908
Amblyopia 25.65 9.65 13 145529 231 50459351
Creutzfeldt-Jakob disease 25.42 9.65 11 145531 134 50459448
Generalised tonic-clonic seizure 25.29 9.65 23 145519 26287 50433295
Cytomegalovirus infection 25.24 9.65 10 145532 17952 50441630
Transcription medication error 25.20 9.65 12 145530 185 50459397
Gangrene 25.15 9.65 47 145495 4645 50454937
Carotid artery thrombosis 25.03 9.65 26 145516 1473 50458109
Blood creatine phosphokinase 24.98 9.65 6 145536 6 50459576
Goitre 24.51 9.65 50 145492 5270 50454312
Intentional product use issue 24.33 9.65 126 145416 76792 50382790
Device dislocation 24.31 9.65 16 145526 21530 50438052
Microalbuminuria 24.05 9.65 14 145528 331 50459251
Thrombocytopenia 23.93 9.65 243 145299 127430 50332152
Polymyositis 23.90 9.65 26 145516 1554 50458028
Myositis 23.88 9.65 63 145479 7857 50451725
Neurologic neglect syndrome 23.83 9.65 25 145517 1433 50458149
Hypersensitivity 23.68 9.65 456 145086 214705 50244877
Respiratory arrest 23.58 9.65 31 145511 29978 50429604
Lung diffusion test decreased 23.39 9.65 17 145525 592 50458990
Degenerative aortic valve disease 23.30 9.65 9 145533 80 50459502
Cataract 23.28 9.65 223 145319 47077 50412505
Glomerular filtration rate decreased 23.13 9.65 80 145462 11572 50448010
Acute myocardial infarction 22.60 9.65 153 145389 29120 50430462
Muscle disorder 22.60 9.65 43 145499 4307 50455275
Aspartate aminotransferase increased 22.52 9.65 332 145210 77666 50381916
Pyrexia 22.50 9.65 880 144662 379323 50080259
Cerebral infarction 22.46 9.65 122 145420 21482 50438100
Hepatic function abnormal 22.43 9.65 166 145376 32515 50427067
Blood pressure inadequately controlled 22.39 9.65 43 145499 4337 50455245
Albuminuria 22.09 9.65 11 145531 188 50459394
Adverse drug reaction 21.98 9.65 83 145459 55139 50404443
Acute coronary syndrome 21.88 9.65 68 145474 9306 50450276
Hypereosinophilic syndrome 21.67 9.65 12 145530 257 50459325
Drug resistance 21.56 9.65 14 145528 18975 50440607
Lipids abnormal 21.47 9.65 12 145530 262 50459320
Anuria 21.29 9.65 76 145466 11168 50448414
Listless 21.08 9.65 30 145512 2360 50457222
Pancreatic neuroendocrine tumour 20.91 9.65 12 145530 276 50459306
Blood calcium increased 20.87 9.65 59 145483 7660 50451922
Infusion site streaking 20.80 9.65 14 145528 430 50459152
Blood cholesterol abnormal 20.79 9.65 29 145513 2239 50457343
Malignant neoplasm progression 20.76 9.65 113 145429 68011 50391571
Chest discomfort 20.59 9.65 378 145164 92344 50367238
Blood cholesterol increased 20.50 9.65 246 145296 54969 50404613
Red blood cell sedimentation rate abnormal 20.29 9.65 97 145445 16246 50443336
Cardio-respiratory arrest 20.18 9.65 83 145459 53809 50405773
Tubulointerstitial nephritis 20.14 9.65 92 145450 15119 50444463
Blood immunoglobulin E increased 19.91 9.65 29 145513 2330 50457252
Toxicity to various agents 19.69 9.65 463 145079 212036 50247546
Procollagen type I C-terminal propeptide increased 19.54 9.65 6 145536 24 50459558
Respiratory failure 19.46 9.65 168 145374 91013 50368569
Metastases to bone 19.46 9.65 14 145528 17981 50441601
Myopathy toxic 19.41 9.65 13 145529 396 50459186
Serum procollagen type I N-terminal propeptide increased 19.34 9.65 6 145536 25 50459557
Interstitial lung disease 19.34 9.65 236 145306 52940 50406642
Amylase increased 19.31 9.65 46 145496 5384 50454198
Poisoning 19.04 9.65 6 145536 12423 50447159
Blood glucose abnormal 19.03 9.65 52 145490 6620 50452962
Malaise 18.63 9.65 1160 144382 334372 50125210
Gastrointestinal disorder 18.44 9.65 178 145364 94278 50365304
Bone marrow failure 18.36 9.65 32 145510 27592 50431990
Haemorrhage subcutaneous 18.31 9.65 30 145512 2671 50456911
Coronary artery stenosis 18.23 9.65 39 145503 4250 50455332
Infected dermal cyst 18.18 9.65 13 145529 441 50459141
Urine albumin/creatinine ratio increased 18.15 9.65 10 145532 212 50459370
Multiple sclerosis relapse 18.14 9.65 63 145479 42901 50416681
Bursitis infective 18.13 9.65 20 145522 1214 50458368
Malignant melanoma 18.02 9.65 67 145475 10041 50449541
Hypercreatininaemia 17.82 9.65 12 145530 369 50459213
Dry mouth 17.77 9.65 243 145299 55935 50403647
Peripheral sensorimotor neuropathy 17.76 9.65 20 145522 1242 50458340
Infrequent bowel movements 17.69 9.65 19 145523 1119 50458463
Premature baby 17.66 9.65 16 145526 18321 50441261
Blood pressure abnormal 17.56 9.65 78 145464 12669 50446913
Vertigo 17.55 9.65 227 145315 51605 50407977
Palpitations 17.53 9.65 375 145167 94131 50365451
Pancreatitis acute 17.52 9.65 123 145419 23689 50435893
Chest pain 17.36 9.65 647 144895 176235 50283347
Suicide attempt 17.36 9.65 83 145459 51649 50407933
Hyperphosphataemia 17.27 9.65 24 145518 1847 50457735
Toxic epidermal necrolysis 17.20 9.65 21 145521 20971 50438611
Dyspnoea exertional 17.19 9.65 224 145318 51009 50408573
Head discomfort 17.17 9.65 70 145472 10949 50448633
Reduced facial expression 17.09 9.65 22 145520 1572 50458010
Atrial fibrillation 17.07 9.65 398 145144 101347 50358235
Blood creatine increased 16.95 9.65 41 145501 4846 50454736
Somnolence 16.88 9.65 329 145213 154656 50304926
Drug tolerance decreased 16.83 9.65 3 145539 9157 50450425
Ulcer 16.77 9.65 20 145522 20180 50439402
Ligament pain 16.76 9.65 9 145533 181 50459401
Immunodeficiency 16.74 9.65 11 145531 14817 50444765
Injury 16.70 9.65 78 145464 48847 50410735
Sinonasal obstruction 16.54 9.65 9 145533 186 50459396
Sensorimotor disorder 16.16 9.65 12 145530 432 50459150
Transaminases increased 16.16 9.65 136 145406 27688 50431894
Eosinophil count increased 16.14 9.65 59 145483 8771 50450811
Apolipoprotein A-I decreased 16.09 9.65 5 145537 21 50459561
Ill-defined disorder 15.92 9.65 92 145450 54562 50405020
Transplant rejection 15.91 9.65 4 145538 9605 50449977
Unwanted awareness during anaesthesia 15.83 9.65 10 145532 275 50459307
Lymphopenia 15.81 9.65 13 145529 15608 50443974
Total lung capacity decreased 15.73 9.65 19 145523 1272 50458310
Device related infection 15.70 9.65 22 145520 20713 50438869
Rheumatoid factor positive 15.58 9.65 82 145460 49777 50409805
Injection site erythema 15.58 9.65 139 145403 74797 50384785
Intensive care unit acquired weakness 15.22 9.65 14 145528 683 50458899
Cerebrovascular accident 15.16 9.65 368 145174 94312 50365270
Panniculitis 15.16 9.65 3 145539 8500 50451082
Status epilepticus 15.06 9.65 10 145532 13396 50446186
Oedema peripheral 15.06 9.65 576 144966 157385 50302197
Mucosal inflammation 14.91 9.65 62 145480 40080 50419502
Foreign body 14.88 9.65 23 145519 1948 50457634
Polymyalgia rheumatica 14.88 9.65 27 145515 2609 50456973
Lichen planus 14.81 9.65 23 145519 1956 50457626
Drug specific antibody 14.78 9.65 22 145520 1803 50457779
Obstructive pancreatitis 14.73 9.65 9 145533 233 50459349
Dystonia 14.66 9.65 8 145534 11918 50447664
Sinusitis 14.60 9.65 376 145166 170182 50289400
Hypertension 14.59 9.65 745 144797 210458 50249124
Coma acidotic 14.58 9.65 7 145535 110 50459472
Neurotrophic keratopathy 14.56 9.65 3 145539 0 50459582
Akathisia 14.47 9.65 3 145539 8226 50451356
Adjustment disorder 14.47 9.65 23 145519 1996 50457586
Lipoprotein (a) increased 14.36 9.65 5 145537 32 50459550
Stent placement 14.31 9.65 31 145511 3407 50456175
Hypocholesterolaemia 14.30 9.65 7 145535 115 50459467
Hepatic enzyme increased 14.24 9.65 294 145248 137086 50322496
Neutrophil count decreased 14.21 9.65 76 145466 45950 50413632
Clitoris abscess 14.16 9.65 4 145538 11 50459571
Cardiac murmur 14.11 9.65 65 145477 10719 50448863
Neutropenic sepsis 14.04 9.65 12 145530 14135 50445447
Eyelid disorder 14.02 9.65 18 145524 1283 50458299
Hyperkalaemia 14.00 9.65 205 145337 47884 50411698
Food interaction 13.98 9.65 13 145529 643 50458939
Pulmonary embolism 13.96 9.65 207 145335 101497 50358085
Muscle atrophy 13.91 9.65 44 145498 6077 50453505
Hyperlipidaemia 13.85 9.65 92 145450 17398 50442184
Blood ketone body increased 13.83 9.65 9 145533 261 50459321
Skin necrosis 13.78 9.65 7 145535 10860 50448722
Croup infectious 13.73 9.65 11 145531 444 50459138
Grip strength decreased 13.68 9.65 9 145533 12112 50447470
Premature labour 13.67 9.65 8 145534 11468 50448114
Rheumatoid nodule 13.65 9.65 10 145532 12725 50446857
Arteriosclerosis 13.62 9.65 57 145485 9020 50450562
Haemorrhagic diathesis 13.56 9.65 33 145509 3915 50455667
Hepatic steatosis 13.54 9.65 118 145424 24266 50435316
Haemophagocytic lymphohistiocytosis 13.53 9.65 4 145538 8629 50450953
Photosensitivity reaction 13.48 9.65 73 145469 12838 50446744
Occult blood 13.48 9.65 17 145525 1190 50458392
Respiratory depression 13.44 9.65 9 145533 12001 50447581
Device issue 13.39 9.65 23 145519 19949 50439633
Pruritus 13.34 9.65 967 144575 282601 50176981
Therapy non-responder 13.25 9.65 89 145453 50933 50408649
Posterior reversible encephalopathy syndrome 13.25 9.65 14 145528 14914 50444668
Haemorrhagic stroke 13.21 9.65 39 145503 5189 50454393
Affect lability 13.11 9.65 56 145486 8942 50450640
Nephrolithiasis 13.06 9.65 155 145387 34538 50425044
Blood pressure fluctuation 13.03 9.65 159 145383 35664 50423918
Erythema marginatum 13.03 9.65 4 145538 16 50459566
Neonatal asphyxia 12.93 9.65 8 145534 212 50459370
Polyglandular autoimmune syndrome type II 12.89 9.65 5 145537 45 50459537
Endometriosis 12.88 9.65 33 145509 4042 50455540
Bronchopulmonary aspergillosis 12.88 9.65 3 145539 7589 50451993
Haemoglobin increased 12.87 9.65 28 145514 3087 50456495
Blood pressure systolic abnormal 12.85 9.65 50 145492 7656 50451926
Overdose 12.66 9.65 206 145336 99521 50360061
Transient ischaemic attack 12.61 9.65 145 145397 32065 50427517
Brain injury 12.56 9.65 42 145500 5972 50453610
Sinus pain 12.56 9.65 23 145519 2238 50457344
Myoglobin blood increased 12.56 9.65 17 145525 1276 50458306
Cardiac valve fibroelastoma 12.49 9.65 3 145539 3 50459579
No adverse event 12.39 9.65 52 145490 33526 50426056
Sopor 12.34 9.65 24 145518 19855 50439727
Autoimmune nephritis 12.24 9.65 9 145533 319 50459263
Gastrooesophageal reflux disease 12.22 9.65 297 145245 76131 50383451
Hypercalcaemia 12.20 9.65 31 145511 23321 50436261
Pre-eclampsia 12.12 9.65 4 145538 8040 50451542
Drug ineffective for unapproved indication 12.11 9.65 27 145515 21254 50438328
Low density lipoprotein abnormal 12.08 9.65 7 145535 164 50459418
Respiratory tract congestion 12.05 9.65 76 145466 14123 50445459
Giant cell arteritis 12.05 9.65 20 145522 1800 50457782
Urine ketone body present 12.05 9.65 23 145519 2310 50457272
Adverse event 12.04 9.65 75 145467 43688 50415894
Decubitus ulcer 12.04 9.65 6 145536 9412 50450170
Agitation 12.00 9.65 97 145445 53287 50406295
Blood growth hormone increased 12.00 9.65 10 145532 427 50459155
Hyperparathyroidism secondary 11.99 9.65 17 145525 1333 50458249
Blood pressure diastolic abnormal 11.94 9.65 56 145486 9305 50450277
Rotator cuff syndrome 11.87 9.65 65 145477 11479 50448103
Neurotoxicity 11.81 9.65 15 145527 14725 50444857
Nightmare 11.78 9.65 83 145459 16003 50443579
Cardiac neoplasm unspecified 11.77 9.65 5 145537 58 50459524
Impaired fasting glucose 11.75 9.65 7 145535 173 50459409
Forced vital capacity decreased 11.72 9.65 14 145528 927 50458655
Cardiac failure 11.71 9.65 294 145248 75746 50383836
Blood parathyroid hormone decreased 11.70 9.65 3 145539 7111 50452471
Osteoarthritis 11.70 9.65 269 145273 68337 50391245
Musculoskeletal pain 11.70 9.65 281 145261 71896 50387686
Hemiplegia 11.59 9.65 47 145495 7334 50452248
Acute hepatic failure 11.51 9.65 17 145525 15660 50443922
Multi-organ disorder 11.45 9.65 16 145526 1237 50458345
Erythema multiforme 11.44 9.65 54 145488 8996 50450586
Tendon pain 11.44 9.65 26 145516 2952 50456630
Acute myeloid leukaemia 11.41 9.65 16 145526 15058 50444524
Blood triglycerides decreased 11.40 9.65 5 145537 63 50459519
Duplicate therapy error 11.33 9.65 5 145537 64 50459518
Diffuse alopecia 11.16 9.65 11 145531 585 50458997
Hypertriglyceridaemia 11.16 9.65 38 145504 5453 50454129
Polycystic ovaries 11.04 9.65 23 145519 2461 50457121
Lower respiratory tract infection 11.00 9.65 200 145342 95001 50364581
Sleep apnoea syndrome 11.00 9.65 111 145431 23757 50435825
Aspergillus infection 10.99 9.65 3 145539 6818 50452764
Campylobacter test positive 10.94 9.65 4 145538 30 50459552
Total bile acids increased 10.86 9.65 6 145536 128 50459454
Product residue present 10.86 9.65 29 145513 3643 50455939
Injection site pain 10.81 9.65 240 145302 110784 50348798
Abdominal pain upper 10.80 9.65 561 144981 158748 50300834
Carotid artery stenosis 10.75 9.65 34 145508 4697 50454885
BRAF V600E mutation positive 10.72 9.65 4 145538 32 50459550
Thrombotic microangiopathy 10.65 9.65 6 145536 8785 50450797
Ascites 10.64 9.65 60 145482 35801 50423781
Diabetic nephropathy 10.64 9.65 16 145526 1323 50458259
Sinus disorder 10.60 9.65 90 145452 18368 50441214
Sneezing 10.60 9.65 73 145469 13971 50445611
Hypertrophic cardiomyopathy 10.59 9.65 16 145526 1329 50458253
Bronchopulmonary aspergillosis allergic 10.58 9.65 15 145527 1176 50458406
Mydriasis 10.56 9.65 9 145533 10618 50448964
Bladder cancer 10.55 9.65 27 145515 3305 50456277
Encephalitis 10.55 9.65 4 145538 7376 50452206
Pseudophaeochromocytoma 10.51 9.65 5 145537 77 50459505
Abortion induced 10.46 9.65 7 145535 9337 50450245
Tri-iodothyronine free decreased 10.45 9.65 8 145534 302 50459280
Tendonitis 10.43 9.65 83 145459 16622 50442960
Blood cholesterol decreased 10.42 9.65 12 145530 764 50458818
Sensory loss 10.39 9.65 47 145495 7691 50451891
Therapeutic product effect incomplete 10.34 9.65 193 145349 91322 50368260
Haematuria 10.34 9.65 116 145426 25497 50434085
Endometrial disorder 10.31 9.65 11 145531 643 50458939
Pulseless electrical activity 10.30 9.65 43 145499 6798 50452784
Injection site swelling 10.29 9.65 74 145468 41699 50417883
Monocyte count decreased 10.24 9.65 19 145523 1867 50457715
Vascular pseudoaneurysm 10.24 9.65 16 145526 1368 50458214
Sudden hearing loss 10.24 9.65 14 145528 1061 50458521
Thyroid disorder 10.23 9.65 67 145475 12610 50446972
Pulmonary haemorrhage 10.19 9.65 3 145539 6489 50453093
Vitamin B12 decreased 10.18 9.65 24 145518 2791 50456791
Hypercholesterolaemia 10.15 9.65 63 145479 11640 50447942
Mental disorder 10.15 9.65 31 145511 21960 50437622
Blood creatine phosphokinase MM increased 10.12 9.65 4 145538 38 50459544
Enthesopathy 10.12 9.65 4 145538 7189 50452393
Knee arthroplasty 10.09 9.65 61 145481 35785 50423797
Osteogenesis imperfecta 10.00 9.65 8 145534 322 50459260
Product dispensing issue 9.96 9.65 5 145537 87 50459495
International normalised ratio increased 9.95 9.65 177 145365 42975 50416607
Restless legs syndrome 9.93 9.65 79 145463 15818 50443764
Amyotrophy 9.90 9.65 6 145536 153 50459429
Infusion site scar 9.88 9.65 8 145534 328 50459254
Hypomagnesaemia 9.87 9.65 106 145436 23050 50436532
Hepatic encephalopathy 9.78 9.65 8 145534 9628 50449954
Urea urine increased 9.77 9.65 3 145539 12 50459570
Basophil count increased 9.74 9.65 12 145530 820 50458762
Atelectasis 9.74 9.65 24 145518 18246 50441336
Calculus bladder 9.74 9.65 10 145532 559 50459023
Eczema 9.71 9.65 104 145438 22598 50436984

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 1088.61 10.24 1479 128787 72540 29371721
Rhabdomyolysis 941.01 10.24 1246 129020 59562 29384699
Blood creatine phosphokinase increased 452.46 10.24 713 129553 39931 29404330
Toxicity to various agents 331.66 10.24 176 130090 173485 29270776
Myopathy 238.14 10.24 262 130004 10271 29433990
Death 208.66 10.24 790 129476 341294 29102967
Drug abuse 206.61 10.24 49 130217 79834 29364427
High density lipoprotein decreased 204.62 10.24 140 130126 2839 29441422
Completed suicide 189.64 10.24 80 130186 90166 29354095
Low density lipoprotein increased 170.83 10.24 140 130126 3764 29440497
Blood triglycerides increased 138.31 10.24 222 130044 12612 29431649
Rheumatoid factor negative 128.63 10.24 66 130200 764 29443497
Low density lipoprotein decreased 123.99 10.24 69 130197 951 29443310
Neutropenia 118.43 10.24 252 130014 131459 29312802
Foetal exposure during pregnancy 112.22 10.24 10 130256 33857 29410404
Tendon rupture 109.64 10.24 137 130129 6158 29438103
Pyrexia 101.36 10.24 797 129469 286825 29157436
Angina pectoris 95.60 10.24 305 129961 27545 29416716
Acute kidney injury 89.82 10.24 1653 128613 263614 29180647
Blood cholesterol increased 86.82 10.24 204 130062 15391 29428870
Bone erosion 82.91 10.24 80 130186 2680 29441581
Overdose 82.84 10.24 140 130126 79679 29364582
Off label use 78.36 10.24 898 129368 299902 29144359
Asthma 78.25 10.24 326 129940 33523 29410738
Pneumonia 76.13 10.24 975 129291 319197 29125064
Full blood count abnormal 75.67 10.24 189 130077 14824 29429437
Myocardial infarction 75.45 10.24 780 129486 109516 29334745
Red blood cell sedimentation rate abnormal 75.37 10.24 70 130196 2233 29442028
Intentional overdose 73.42 10.24 39 130227 38489 29405772
Febrile neutropenia 71.45 10.24 254 130012 111986 29332275
Sepsis 70.99 10.24 355 129911 142327 29301934
Leukopenia 68.91 10.24 85 130181 55118 29389143
Blood pressure systolic increased 67.68 10.24 195 130071 16650 29427611
Chest discomfort 67.55 10.24 389 129877 45594 29398667
Coronary artery disease 65.68 10.24 375 129891 43815 29400446
Muscle spasms 63.32 10.24 497 129769 64585 29379676
Muscular weakness 62.11 10.24 477 129789 61575 29382686
Chromaturia 61.22 10.24 158 130108 12644 29431617
Diabetes mellitus 61.17 10.24 341 129925 39490 29404771
Coronary artery occlusion 60.55 10.24 136 130130 9958 29434303
Mucosal inflammation 60.17 10.24 32 130234 31563 29412698
Pancytopenia 57.85 10.24 181 130085 82987 29361274
Arthralgia 57.64 10.24 899 129367 138718 29305543
Seizure 57.09 10.24 214 130052 92909 29351352
Disease progression 55.77 10.24 180 130086 81736 29362525
Computerised tomogram coronary artery abnormal 55.29 10.24 24 130242 184 29444077
Cardiac failure 55.26 10.24 563 129703 78724 29365537
Multiple organ dysfunction syndrome 54.80 10.24 123 130143 62993 29381268
Erectile dysfunction 54.46 10.24 189 130077 17820 29426441
Thrombocytopenia 53.87 10.24 360 129906 134463 29309798
Septic shock 53.43 10.24 123 130143 62437 29381824
Cardiac failure chronic 52.83 10.24 99 130167 6368 29437893
White blood cell count decreased 52.12 10.24 190 130076 83172 29361089
Blood pressure increased 50.45 10.24 522 129744 73281 29370980
Drug dependence 50.16 10.24 15 130251 20966 29423295
Pain in extremity 49.39 10.24 721 129545 109712 29334549
Productive cough 48.91 10.24 269 129997 30990 29413271
Angina unstable 47.80 10.24 130 130136 10735 29433526
Bone marrow failure 47.74 10.24 31 130235 27418 29416843
Malignant neoplasm progression 46.40 10.24 168 130098 73691 29370570
Acute coronary syndrome 46 10.24 139 130127 12186 29432075
Diastolic dysfunction 45.78 10.24 81 130185 4983 29439278
Orbital myositis 44.64 10.24 18 130248 112 29444149
5-hydroxyindolacetic acid in urine increased 43.50 10.24 21 130245 211 29444050
Cytomegalovirus infection 43.49 10.24 24 130242 23191 29421070
Conjunctivitis allergic 43.35 10.24 30 130236 620 29443641
Ascites 43.00 10.24 59 130207 36560 29407701
Hepatic enzyme increased 40.87 10.24 272 129994 33527 29410734
Agitation 40.55 10.24 105 130161 51199 29393062
Intentional self-injury 40.42 10.24 4 130262 12457 29431804
Ill-defined disorder 40.15 10.24 128 130138 11550 29432711
Middle insomnia 40.09 10.24 82 130184 5626 29438635
Carotid arteriosclerosis 40.06 10.24 40 130226 1398 29442863
Suicide attempt 40.01 10.24 55 130211 34055 29410206
Wheezing 39.89 10.24 267 129999 32973 29411288
Diabetic ketoacidosis 39.67 10.24 158 130108 15915 29428346
Blood mercury abnormal 39.61 10.24 19 130247 188 29444073
Gait spastic 39.46 10.24 29 130237 661 29443600
Acute myocardial infarction 39.19 10.24 355 129911 48083 29396178
Needle fatigue 38.39 10.24 27 130239 573 29443688
Coronary artery stenosis 38.13 10.24 103 130163 8470 29435791
Infection 38.09 10.24 191 130075 76560 29367701
Euglycaemic diabetic ketoacidosis 37.67 10.24 52 130214 2578 29441683
Asthenia 37.54 10.24 1226 129040 214024 29230237
Myositis 37.47 10.24 115 130151 10168 29434093
Chest pain 37.43 10.24 697 129569 111276 29332985
Fractured coccyx 37.42 10.24 17 130249 147 29444114
Hospitalisation 37.21 10.24 93 130173 45895 29398366
Presyncope 37.20 10.24 155 130111 15934 29428327
Vascular stent stenosis 37.02 10.24 33 130233 997 29443264
Amyotrophic lateral sclerosis 37.00 10.24 31 130235 860 29443401
Premature baby 36.77 10.24 15 130251 17265 29426996
Psychotic disorder 36.76 10.24 22 130244 20332 29423929
Respiratory failure 36.48 10.24 264 130002 96867 29347394
Obstructive airways disorder 36.30 10.24 119 130147 10897 29433364
Congenital hiatus hernia 35.74 10.24 23 130243 419 29443842
Myoglobin blood increased 35.67 10.24 44 130222 1951 29442310
Mycotic allergy 35.24 10.24 19 130247 245 29444016
General physical health deterioration 34.68 10.24 288 129978 102569 29341692
Somnolence 34.50 10.24 257 130009 93698 29350563
Lung diffusion test decreased 34.31 10.24 25 130241 562 29443699
Hepatojugular reflux 34.10 10.24 23 130243 455 29443806
Vomiting 33.75 10.24 696 129570 211564 29232697
Relapsing-remitting multiple sclerosis 33.61 10.24 27 130239 705 29443556
Sleep disorder due to a general medical condition 33.31 10.24 54 130212 3092 29441169
Haemorrhagic stroke 33.02 10.24 77 130189 5779 29438482
Mental status changes 32.87 10.24 65 130201 34862 29409399
Supine hypertension 32.28 10.24 19 130247 293 29443968
Hepatic neoplasm 32.04 10.24 40 130226 1796 29442465
Gait disturbance 32.02 10.24 477 129789 72872 29371389
Product use in unapproved indication 31.72 10.24 238 130028 86637 29357624
Muscle disorder 31.56 10.24 44 130222 2202 29442059
Spirometry abnormal 31.43 10.24 20 130246 357 29443904
Immune-mediated myositis 31.35 10.24 37 130229 1566 29442695
Skin laceration 30.80 10.24 113 130153 10949 29433312
Drug resistance 30.35 10.24 30 130236 21510 29422751
Hypercholesterolaemia 30.25 10.24 85 130181 7153 29437108
Arteriosclerosis coronary artery 30.09 10.24 109 130157 10496 29433765
Plasmapheresis 29.68 10.24 18 130248 294 29443967
Glycosylated haemoglobin increased 29.44 10.24 100 130166 9326 29434935
Mite allergy 29.42 10.24 18 130248 299 29443962
Muscle rupture 29.38 10.24 40 130226 1957 29442304
Drug withdrawal syndrome 29.04 10.24 22 130244 17962 29426299
Eosinophilia 29.03 10.24 182 130084 21979 29422282
Neutrophil count decreased 28.75 10.24 97 130169 43470 29400791
Neutropenic sepsis 28.74 10.24 8 130258 11719 29432542
Loss of personal independence in daily activities 28.53 10.24 201 130065 25239 29419022
Candida infection 28.14 10.24 16 130250 15209 29429052
Haemophagocytic lymphohistiocytosis 28.02 10.24 6 130260 10498 29433763
Coma 28.02 10.24 85 130181 39365 29404896
Respiratory arrest 28.00 10.24 44 130222 25789 29418472
Pancreatitis 27.93 10.24 253 130013 34261 29410000
Left ventricular enlargement 27.73 10.24 23 130243 629 29443632
Type 2 diabetes mellitus 27.70 10.24 126 130140 13455 29430806
Breast pain 27.34 10.24 31 130235 1256 29443005
Gynaecomastia 27.28 10.24 89 130177 8128 29436133
Rhinitis perennial 27.19 10.24 15 130251 203 29444058
Blood thyroid stimulating hormone abnormal 27.00 10.24 16 130250 250 29444011
Electrocardiogram Q wave abnormal 26.99 10.24 17 130249 298 29443963
Platelet count decreased 26.91 10.24 313 129953 104359 29339902
Autoimmune hepatitis 26.80 10.24 53 130213 3549 29440712
Blood pressure inadequately controlled 26.70 10.24 42 130224 2344 29441917
Blood glucose increased 26.69 10.24 386 129880 58598 29385663
Pulmonary function test abnormal 26.63 10.24 39 130227 2043 29442218
Encephalopathy 26.52 10.24 61 130205 30982 29413279
Growth hormone deficiency 26.44 10.24 15 130251 215 29444046
Pericardial disease 26.34 10.24 18 130248 364 29443897
Serotonin syndrome 26.31 10.24 23 130243 17489 29426772
Lipoma 26.30 10.24 32 130234 1399 29442862
Low cardiac output syndrome 26.29 10.24 20 130246 481 29443780
Bundle branch block left 26.13 10.24 66 130200 5211 29439050
Nipple inflammation 26.12 10.24 10 130256 53 29444208
Occult blood 26.12 10.24 21 130245 549 29443712
N-terminal prohormone brain natriuretic peptide increased 25.89 10.24 37 130229 1895 29442366
Coronary artery restenosis 25.87 10.24 27 130239 995 29443266
Hypertonic bladder 25.85 10.24 32 130234 1424 29442837
Neuroleptic malignant syndrome 25.76 10.24 20 130246 16128 29428133
Hyperthyroidism 25.73 10.24 90 130176 8518 29435743
Blood cholesterol decreased 25.73 10.24 26 130240 922 29443339
Ventricular hypokinesia 25.71 10.24 60 130206 4505 29439756
Muscle discomfort 25.67 10.24 10 130256 56 29444205
Rales 25.53 10.24 82 130184 7428 29436833
Fatigue 25.50 10.24 1669 128597 315152 29129109
Stenosis 25.46 10.24 27 130239 1014 29443247
Pulmonary valve disease 25.32 10.24 16 130250 282 29443979
Diabetic neuropathy 25.29 10.24 53 130213 3700 29440561
Dyslipidaemia 25.15 10.24 71 130195 5990 29438271
Dizziness 24.93 10.24 1047 129219 188637 29255624
Left ventricular dysfunction 24.84 10.24 91 130175 8811 29435450
Cardio-respiratory arrest 24.49 10.24 127 130139 50474 29393787
Tricuspid valve incompetence 24.43 10.24 87 130179 8307 29435954
Respiratory distress 24.39 10.24 67 130199 32039 29412222
Diabetes mellitus inadequate control 24.32 10.24 112 130154 12022 29432239
Brain natriuretic peptide abnormal 24.19 10.24 16 130250 306 29443955
Product substitution issue 24.12 10.24 92 130174 9080 29435181
Lipoprotein (a) increased 24.10 10.24 9 130257 44 29444217
Chronic obstructive pulmonary disease 23.98 10.24 281 129985 40674 29403587
Interstitial lung disease 23.89 10.24 372 129894 57346 29386915
Micturition urgency 23.86 10.24 63 130203 5110 29439151
Nodular rash 23.83 10.24 11 130255 99 29444162
Blood uric acid increased 23.38 10.24 67 130199 5701 29438560
Transient ischaemic attack 23.32 10.24 179 130087 23091 29421170
Muscle injury 23.19 10.24 27 130239 1126 29443135
Exercise tolerance decreased 23.16 10.24 55 130211 4176 29440085
Thrombotic microangiopathy 23.07 10.24 5 130261 8676 29435585
Food aversion 23.06 10.24 16 130250 332 29443929
N-terminal prohormone brain natriuretic peptide abnormal 22.94 10.24 13 130253 186 29444075
Cardiac discomfort 22.80 10.24 18 130248 458 29443803
Seronegative arthritis 22.66 10.24 24 130242 900 29443361
Body temperature decreased 22.55 10.24 100 130166 10564 29433697
Respiratory depression 22.54 10.24 16 130250 13507 29430754
Pulmonary arterial pressure abnormal 22.52 10.24 13 130253 193 29444068
Melanoderma 22.38 10.24 12 130254 153 29444108
Dust allergy 22.37 10.24 18 130248 471 29443790
Neurotoxicity 22.19 10.24 19 130247 14594 29429667
Muscle rigidity 22.01 10.24 7 130259 9404 29434857
Hepatitis C 21.98 10.24 6 130260 8904 29435357
Total cholesterol/HDL ratio increased 21.97 10.24 12 130254 159 29444102
Cardiac arrest 21.97 10.24 256 130010 85335 29358926
Fractional exhaled nitric oxide increased 21.95 10.24 16 130250 360 29443901
Neoplasm progression 21.83 10.24 30 130236 18582 29425679
Abnormal behaviour 21.79 10.24 43 130223 23084 29421177
Device related infection 21.77 10.24 22 130244 15614 29428647
Guillain-Barre syndrome 21.73 10.24 60 130206 4998 29439263
Helicobacter gastritis 21.58 10.24 25 130241 1037 29443224
Aggression 21.54 10.24 82 130184 35459 29408802
Ileus 21.54 10.24 19 130247 14383 29429878
Chronic kidney disease 21.38 10.24 250 130016 36166 29408095
Right atrial enlargement 20.73 10.24 13 130253 226 29444035
Prinzmetal angina 20.51 10.24 22 130244 837 29443424
Posterior reversible encephalopathy syndrome 20.42 10.24 7 130259 8969 29435292
Carotid artery stenosis 20.18 10.24 54 130212 4415 29439846
Musculoskeletal stiffness 20.18 10.24 253 130013 37205 29407056
Polymyositis 20.15 10.24 27 130239 1301 29442960
Arteriosclerosis 20.06 10.24 94 130172 10162 29434099
Electrocardiogram QRS complex abnormal 20.03 10.24 14 130252 294 29443967
Substance abuse 20 10.24 3 130263 6784 29437477
Transaminases abnormal 19.87 10.24 13 130253 244 29444017
Pancreatitis acute 19.85 10.24 179 130087 24206 29420055
Hepatic encephalopathy 19.73 10.24 17 130249 13018 29431243
Immune reconstitution inflammatory syndrome 19.73 10.24 5 130261 7797 29436464
Paraplegia 19.72 10.24 38 130228 2496 29441765
Mean platelet volume increased 19.68 10.24 16 130250 425 29443836
Toxic epidermal necrolysis 19.59 10.24 31 130235 18122 29426139
Atrial fibrillation 19.47 10.24 606 129660 105040 29339221
Bacteraemia 19.46 10.24 26 130240 16297 29427964
Aortic aneurysm 19.43 10.24 66 130200 6154 29438107
Ventricular hyperkinesia 19.42 10.24 12 130254 203 29444058
Staphylococcal infection 19.36 10.24 65 130201 29175 29415086
Psoriasis 19.25 10.24 222 130044 32005 29412256
Walking disability 19.21 10.24 20 130246 735 29443526
Mitral valve incompetence 19.21 10.24 112 130154 13181 29431080
Poisoning 19.20 10.24 10 130256 9983 29434278
Dyspnoea 19.19 10.24 1679 128587 325053 29119208
Discomfort 19.18 10.24 121 130145 14642 29429619
Physical examination abnormal 19.06 10.24 13 130253 262 29443999
Depressed level of consciousness 18.85 10.24 91 130175 36851 29407410
Diabetic metabolic decompensation 18.80 10.24 27 130239 1389 29442872
Inspiratory capacity abnormal 18.68 10.24 9 130257 90 29444171
Nipple disorder 18.67 10.24 11 130255 170 29444091
Miosis 18.65 10.24 6 130260 8003 29436258
Oxygen saturation increased 18.60 10.24 13 130253 273 29443988
Meningitis eosinophilic 18.59 10.24 6 130260 17 29444244
Dermatomyositis 18.55 10.24 23 130243 1025 29443236
Drug interaction 18.47 10.24 1054 129212 196331 29247930
Lymphomatoid papulosis 18.28 10.24 11 130255 177 29444084
Blood pressure fluctuation 18.27 10.24 150 130116 19744 29424517
Enterococcal infection 17.88 10.24 7 130259 8261 29436000
Atrial septal defect 17.86 10.24 4 130262 6785 29437476
Tendonitis 17.86 10.24 76 130190 7885 29436376
Plantar fasciitis 17.86 10.24 25 130241 1256 29443005
Vascular stent thrombosis 17.75 10.24 37 130229 2573 29441688
Blood creatine phosphokinase 17.73 10.24 8 130258 68 29444193
Muscle atrophy 17.72 10.24 66 130200 6440 29437821
Hypochromasia 17.70 10.24 13 130253 296 29443965
Haematuria 17.70 10.24 283 129983 43856 29400405
Malignant melanoma in situ 17.69 10.24 24 130242 1170 29443091
Akathisia 17.68 10.24 4 130262 6738 29437523
Decreased ventricular preload 17.65 10.24 6 130260 21 29444240
Mitral valve thickening 17.64 10.24 14 130252 359 29443902
Intermittent claudication 17.58 10.24 32 130234 2013 29442248
Cerebral infarction 17.54 10.24 176 130090 24499 29419762
Stomatitis 17.48 10.24 94 130172 37019 29407242
Dyspepsia 17.32 10.24 206 130060 29919 29414342
Pruritus 17.19 10.24 653 129613 116196 29328065
Mycobacterium test positive 17.12 10.24 14 130252 375 29443886
Brain natriuretic peptide increased 17.02 10.24 49 130217 4181 29440080
Aspergillus infection 17.01 10.24 13 130253 10568 29433693
Pneumocystis jirovecii pneumonia 16.87 10.24 30 130236 16749 29427512
Inappropriate antidiuretic hormone secretion 16.86 10.24 14 130252 10918 29433343
Drug-induced liver injury 16.64 10.24 157 130109 21498 29422763
Ejection fraction decreased 16.62 10.24 124 130142 15854 29428407
Left ventricular hypertrophy 16.62 10.24 66 130200 6637 29437624
Transplant rejection 16.57 10.24 10 130256 9202 29435059
Electrocardiogram abnormal 16.50 10.24 70 130196 7252 29437009
Product use issue 16.44 10.24 146 130120 51298 29392963
Anaemia 16.36 10.24 721 129545 200230 29244031
Pollakiuria 16.33 10.24 129 130137 16787 29427474
Histamine level increased 16.31 10.24 7 130259 52 29444209
Dysphagia 16.22 10.24 159 130107 54767 29389494
Lipids increased 16.21 10.24 19 130247 798 29443463
Paraesthesia 16.21 10.24 330 129936 53515 29390746
Musculoskeletal discomfort 16.18 10.24 63 130203 6278 29437983
Mania 16.16 10.24 9 130257 8654 29435607
Cytomegalovirus viraemia 16.08 10.24 4 130262 6316 29437945
No adverse event 16.04 10.24 33 130233 17445 29426816
Lipids abnormal 15.98 10.24 12 130254 283 29443978
Acute respiratory distress syndrome 15.87 10.24 50 130216 22885 29421376
Unresponsive to stimuli 15.86 10.24 57 130209 25069 29419192
Ureteric cancer 15.79 10.24 10 130256 177 29444084
Oxygen consumption decreased 15.69 10.24 10 130256 179 29444082
Tumour lysis syndrome 15.67 10.24 23 130243 13861 29430400
Arterial spasm 15.64 10.24 8 130258 92 29444169
Hemiplegia 15.61 10.24 64 130202 6530 29437731
Cytokine release syndrome 15.53 10.24 21 130245 13098 29431163
Weight decreased 15.52 10.24 813 129453 150092 29294169
Aortic valve incompetence 15.49 10.24 53 130213 4960 29439301
Tachycardia 15.47 10.24 225 130041 72185 29372076
Ventricular arrhythmia 15.40 10.24 50 130216 4554 29439707
Bronchopulmonary aspergillosis 15.40 10.24 19 130247 12325 29431936
Drug intolerance 15.40 10.24 299 129967 48080 29396181
Monoparesis 15.38 10.24 29 130237 1874 29442387
Delusion 15.37 10.24 16 130250 11200 29433061
Peritonitis 15.36 10.24 26 130240 14798 29429463
Body temperature increased 15.33 10.24 25 130241 14440 29429821
Cardiovascular somatic symptom disorder 15.20 10.24 6 130260 35 29444226
Skin ulcer 15.18 10.24 138 130128 18702 29425559
Angiocardiogram 15.18 10.24 10 130256 190 29444071
Confusional state 15.15 10.24 438 129828 127439 29316822
Blood pressure systolic abnormal 15.12 10.24 31 130235 2130 29442131
AST/ALT ratio abnormal 15.04 10.24 5 130261 16 29444245
Sedation 15.03 10.24 34 130232 17371 29426890
Dyspnoea exertional 15.02 10.24 235 130031 36255 29408006
Troponin increased 15.02 10.24 80 130186 9103 29435158
Drug ineffective 14.98 10.24 1387 128879 361783 29082478
Aldolase increased 14.98 10.24 7 130259 65 29444196
Low density lipoprotein abnormal 14.96 10.24 11 130255 251 29444010
Blood pressure diastolic abnormal 14.88 10.24 34 130232 2517 29441744
Haemolysis 14.86 10.24 6 130260 6950 29437311
Cytopenia 14.75 10.24 13 130253 9846 29434415
Withdrawal syndrome 14.70 10.24 16 130250 10976 29433285
Pneumonia aspiration 14.69 10.24 98 130168 36639 29407622
Coagulopathy 14.65 10.24 36 130230 17871 29426390
Lipase increased 14.58 10.24 74 130192 8263 29435998
Carcinoid tumour 14.52 10.24 10 130256 205 29444056
Osteonecrosis of jaw 14.46 10.24 32 130234 16478 29427783
Base excess decreased 14.39 10.24 10 130256 208 29444053
Very low density lipoprotein increased 14.39 10.24 5 130261 19 29444242
Hepatic function abnormal 14.37 10.24 248 130018 39011 29405250
Cerebral haemorrhage 14.34 10.24 206 130060 31220 29413041
Mesenteric artery thrombosis 14.22 10.24 13 130253 406 29443855
Eczema 14.21 10.24 107 130159 13719 29430542
Haemoglobin decreased 14.18 10.24 366 129900 108009 29336252
Pulmonary haemorrhage 14.14 10.24 12 130254 9258 29435003
Syncope 14.00 10.24 463 129803 80908 29363353
Cough 13.90 10.24 687 129579 126040 29318221
Poisoning deliberate 13.88 10.24 4 130262 5727 29438534
Prostatic haemorrhage 13.79 10.24 10 130256 223 29444038
Retroperitoneal fibrosis 13.76 10.24 11 130255 285 29443976
Expired product administered 13.75 10.24 35 130231 2776 29441485
Stent placement 13.72 10.24 46 130220 4260 29440001
Albuminuria 13.70 10.24 12 130254 354 29443907
Drug-disease interaction 13.64 10.24 12 130254 356 29443905
Blood triglycerides 13.29 10.24 3 130263 0 29444261
Muscle necrosis 13.13 10.24 17 130249 792 29443469
Joint swelling 12.96 10.24 298 129968 49332 29394929
Flatulence 12.92 10.24 127 130139 17582 29426679
Plasma cell myeloma 12.91 10.24 103 130163 37012 29407249
Hypercreatinaemia 12.91 10.24 8 130258 136 29444125
Accident at work 12.86 10.24 15 130251 627 29443634
Blood cholesterol abnormal 12.77 10.24 23 130243 1435 29442826
Tongue dry 12.68 10.24 9 130257 194 29444067
Dry mouth 12.54 10.24 149 130117 21635 29422626
Hepatocellular injury 12.54 10.24 146 130120 21097 29423164
Progressive multifocal leukoencephalopathy 12.45 10.24 12 130254 8707 29435554
Peripheral swelling 12.37 10.24 368 129898 63371 29380890
Aplastic anaemia 12.37 10.24 9 130257 7501 29436760
Ischaemic stroke 12.36 10.24 116 130150 15861 29428400
Urine odour abnormal 12.30 10.24 18 130248 942 29443319
Lethargy 12.30 10.24 106 130160 37474 29406787
Cardiac autonomic neuropathy 12.28 10.24 6 130260 62 29444199
Medication error 12.18 10.24 50 130216 21161 29423100
Hepatic failure 12.13 10.24 85 130181 31427 29412834
High density lipoprotein increased 12.10 10.24 11 130255 341 29443920
Gait inability 12.08 10.24 129 130137 18246 29426015
Peripheral arterial occlusive disease 11.81 10.24 49 130217 5027 29439234
Chronic cutaneous lupus erythematosus 11.80 10.24 6 130260 68 29444193
Mucormycosis 11.77 10.24 4 130262 5154 29439107
Hallucination, auditory 11.72 10.24 15 130251 9578 29434683
Generalised tonic-clonic seizure 11.70 10.24 44 130222 19095 29425166
Oedema genital 11.63 10.24 11 130255 359 29443902
Nervous system disorder 11.57 10.24 24 130242 12650 29431611
Abscess of salivary gland 11.55 10.24 4 130262 15 29444246
Left atrial dilatation 11.51 10.24 24 130242 1669 29442592
Epilepsy 11.51 10.24 42 130224 18390 29425871
Blood chloride increased 11.50 10.24 32 130234 2677 29441584
Nasal inflammation 11.50 10.24 9 130257 226 29444035
Photosensitivity reaction 11.48 10.24 75 130191 9183 29435078
Acute hepatic failure 11.45 10.24 22 130244 11930 29432331
Obsessive-compulsive disorder 11.44 10.24 3 130263 4573 29439688
Myoglobinuria 11.42 10.24 15 130251 709 29443552
Breath sounds abnormal 11.40 10.24 51 130215 5406 29438855
Musculoskeletal toxicity 11.40 10.24 7 130259 117 29444144
Cardiac aneurysm 11.40 10.24 16 130250 806 29443455
Stevens-Johnson syndrome 11.39 10.24 36 130230 16461 29427800
Chemical burns of eye 11.35 10.24 4 130262 16 29444245
Hyponatraemia 11.24 10.24 220 130046 67413 29376848
Familial periodic paralysis 11.15 10.24 6 130260 77 29444184
Colitis ulcerative 11.05 10.24 95 130171 12674 29431587
Aortic stenosis 11.03 10.24 40 130226 3854 29440407
Orthostatic hypotension 10.99 10.24 150 130116 22479 29421782
Reversible airways obstruction 10.98 10.24 9 130257 242 29444019
Movement disorder 10.96 10.24 80 130186 10157 29434104
Left atrial enlargement 10.95 10.24 15 130251 738 29443523
Thrombosis 10.94 10.24 129 130137 42916 29401345
Forced vital capacity decreased 10.90 10.24 14 130252 647 29443614
Product odour abnormal 10.83 10.24 14 130252 651 29443610
Cerebellar atrophy 10.79 10.24 12 130254 476 29443785
Low birth weight baby 10.78 10.24 8 130258 6600 29437661
Kidney transplant rejection 10.77 10.24 9 130257 6996 29437265
Left ventricular dilatation 10.75 10.24 14 130252 656 29443605
Hypoalbuminaemia 10.74 10.24 18 130248 10287 29433974
Acute myeloid leukaemia 10.73 10.24 37 130229 16476 29427785
Hypothermia 10.73 10.24 15 130251 9224 29435037
Normochromic normocytic anaemia 10.72 10.24 38 130228 3620 29440641
Echocardiogram abnormal 10.69 10.24 16 130250 855 29443406
Toxic cataract 10.64 10.24 4 130262 20 29444241
Cystitis haemorrhagic 10.63 10.24 4 130262 4838 29439423
Idiopathic interstitial pneumonia 10.58 10.24 7 130259 134 29444127
Hypoxia 10.55 10.24 146 130120 47233 29397028
Transaminases increased 10.52 10.24 149 130117 22513 29421748
Mitral valve disease 10.48 10.24 19 130247 1191 29443070
Blood bilirubin increased 10.48 10.24 97 130169 33796 29410465
Polymyalgia rheumatica 10.47 10.24 19 130247 1192 29443069
Drug hypersensitivity 10.46 10.24 384 129882 68022 29376239
Parkinsonism 10.41 10.24 10 130256 7268 29436993
Diaphragm muscle weakness 10.40 10.24 7 130259 138 29444123
Blood iron decreased 10.40 10.24 43 130223 4405 29439856
Hyperammonaemia 10.40 10.24 6 130260 5657 29438604
Blood pressure ambulatory increased 10.38 10.24 5 130261 50 29444211
Pseudomonas infection 10.38 10.24 20 130246 10832 29433429
Adjustment disorder 10.35 10.24 17 130249 984 29443277
Muscle fatigue 10.35 10.24 19 130247 1203 29443058
Palmar-plantar erythrodysaesthesia syndrome 10.33 10.24 32 130234 14727 29429534
Venous occlusion 10.31 10.24 10 130256 337 29443924
Neutrophil count increased 10.29 10.24 32 130234 14710 29429551
Tendon calcification 10.29 10.24 5 130261 51 29444210
Myocardial ischaemia 10.29 10.24 112 130154 15916 29428345
Ventricular hypertrophy 10.28 10.24 3 130263 4261 29440000
Acute respiratory failure 10.27 10.24 71 130195 26331 29417930
Tendon disorder 10.25 10.24 29 130237 2449 29441812
Prostatic specific antigen abnormal 10.25 10.24 11 130255 419 29443842

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 1742.91 9.62 1892 230799 89834 64176207
Myalgia 1497.85 9.62 2314 230377 156303 64109738
Blood creatine phosphokinase increased 725.57 9.62 973 231718 57585 64208456
Myopathy 391.08 9.62 396 232295 17284 64248757
Completed suicide 347.95 9.62 188 232503 224226 64041815
Sedation complication 279.98 9.62 259 232432 10095 64255946
Maternal exposure during pregnancy 266.31 9.62 21 232670 95863 64170178
Creatinine renal clearance decreased 251.85 9.62 285 232406 14136 64251905
Toxicity to various agents 248.90 9.62 593 232098 362920 63903121
Drug abuse 246.18 9.62 85 232606 132289 64133752
Acute kidney injury 245.50 9.62 2587 230104 446653 63819388
Low density lipoprotein increased 241.70 9.62 210 232481 7530 64258511
Orthostatic hypotension 223.33 9.62 510 232181 46228 64219813
High density lipoprotein decreased 205.81 9.62 145 232546 3801 64262240
Angina pectoris 199.10 9.62 477 232214 44604 64221437
Blood triglycerides increased 177.15 9.62 275 232416 18591 64247450
Systemic lupus erythematosus 166.23 9.62 38 232653 77574 64188467
Death 165.36 9.62 1042 231649 481663 63784378
Exposure during pregnancy 162.48 9.62 40 232651 77635 64188406
Pemphigus 151.21 9.62 20 232671 60681 64205360
Off label use 150.08 9.62 1510 231181 631296 63634745
Synovitis 146.29 9.62 88 232603 99002 64167039
Neutropenia 139.56 9.62 423 232268 239201 64026840
Cognitive disorder 139.53 9.62 477 232214 54610 64211431
Blood calcium decreased 135.77 9.62 291 232400 25263 64240778
Balance disorder 135.36 9.62 631 232060 83295 64182746
Full blood count abnormal 127.24 9.62 311 232380 29446 64236595
Muscle spasms 127.07 9.62 908 231783 140115 64125926
Glossodynia 124.71 9.62 39 232652 64657 64201384
Anti-cyclic citrullinated peptide antibody positive 124.24 9.62 16 232675 49546 64216495
Low density lipoprotein decreased 124.09 9.62 66 232625 1024 64265017
Hand deformity 122.50 9.62 37 232654 62734 64203307
Intentional overdose 120.48 9.62 89 232602 89855 64176186
Immune-mediated myositis 116.08 9.62 88 232603 2590 64263451
Blood pressure systolic increased 114.72 9.62 416 232275 49037 64217004
Blood pressure increased 110.52 9.62 1028 231663 171524 64094517
Myocardial infarction 108.77 9.62 993 231698 164828 64101213
Euglycaemic diabetic ketoacidosis 106.73 9.62 114 232577 5296 64260745
Asthenia 106.21 9.62 2149 230542 425895 63840146
Infection 105.02 9.62 330 232361 184550 64081491
Treatment failure 103.74 9.62 163 232528 116653 64149388
Wound 103.30 9.62 75 232616 76402 64189639
Diabetic ketoacidosis 102.12 9.62 287 232404 29558 64236483
Drug ineffective 100.30 9.62 2290 230401 837957 63428084
Rheumatoid factor negative 96.54 9.62 56 232635 1037 64265004
Muscular weakness 96.28 9.62 787 231904 126551 64139490
Dyslipidaemia 94.24 9.62 140 232551 9102 64256939
Asthma 88.58 9.62 618 232073 94607 64171434
Blood glucose increased 88.03 9.62 631 232060 97442 64168599
Contraindicated product administered 85.21 9.62 162 232529 107667 64158374
Febrile neutropenia 84.88 9.62 368 232323 187289 64078752
Sedation 84.76 9.62 335 232356 41127 64224914
Bone erosion 83.41 9.62 150 232541 11445 64254596
Duodenal ulcer perforation 82.53 9.62 13 232678 34612 64231429
Cardiac failure 80.92 9.62 781 231910 131592 64134449
Diabetes mellitus 79.54 9.62 460 232231 66014 64200027
Pyrexia 78.73 9.62 1481 231210 557163 63708878
Tendon rupture 77.08 9.62 139 232552 10628 64255413
Pancytopenia 77.07 9.62 262 232429 143047 64122994
Therapeutic product effect decreased 76.51 9.62 191 232500 115160 64150881
Overdose 76.45 9.62 306 232385 159260 64106781
Chromaturia 74.98 9.62 215 232476 22396 64243645
Leukopenia 74.94 9.62 158 232533 101084 64164957
Coronary artery disease 74.80 9.62 422 232269 60011 64206030
Product use issue 73.28 9.62 290 232401 151425 64114616
Seizure 73.22 9.62 331 232360 166561 64099480
Angina unstable 71.90 9.62 167 232524 15300 64250741
Acute myocardial infarction 71.75 9.62 464 232227 69254 64196787
Sepsis 70.29 9.62 514 232177 229827 64036214
Drug resistance 69.75 9.62 20 232671 35082 64230959
Acute coronary syndrome 69.33 9.62 189 232502 19121 64246920
Infusion related reaction 69.30 9.62 331 232360 164136 64101905
Pericarditis 69.12 9.62 74 232617 62442 64203599
Helicobacter infection 68.95 9.62 26 232665 38336 64227705
Disease progression 68.94 9.62 270 232421 141410 64124631
Product use in unapproved indication 67.32 9.62 368 232323 176250 64089791
Erectile dysfunction 67.31 9.62 144 232547 12483 64253558
Folliculitis 65.86 9.62 14 232677 30063 64235978
Coronary artery occlusion 65.69 9.62 151 232540 13740 64252301
Cardiac failure chronic 65.08 9.62 117 232574 8924 64257117
General physical health deterioration 63.89 9.62 453 232238 203972 64062069
Liver disorder 63.70 9.62 369 232322 52982 64213059
Type 2 diabetes mellitus 63.30 9.62 267 232424 33753 64232288
Coma 62.96 9.62 139 232552 87476 64178565
Drug interaction 61.85 9.62 1727 230964 360356 63905685
Chronic kidney disease 61.77 9.62 389 232302 57530 64208511
Respiratory arrest 61.67 9.62 60 232631 52925 64213116
Pancreatitis 60.90 9.62 396 232295 59211 64206830
Diabetes mellitus inadequate control 60.58 9.62 192 232499 21129 64244912
Computerised tomogram coronary artery abnormal 59.92 9.62 24 232667 184 64265857
Pregnancy 59.55 9.62 4 232687 20861 64245180
Alopecia 59.48 9.62 352 232339 165338 64100703
Obstructive airways disorder 58.90 9.62 201 232490 22984 64243057
Bone marrow failure 58.52 9.62 52 232639 47900 64218141
Sleep disorder due to general medical condition, insomnia type 57.99 9.62 12 232679 26258 64239783
Impaired healing 57.95 9.62 80 232611 60393 64205648
Intentional self-injury 56.88 9.62 17 232674 29027 64237014
Psoriasis 56.80 9.62 448 232243 71255 64194786
Myositis 56.52 9.62 158 232533 16219 64249822
Cytomegalovirus infection 56.35 9.62 32 232659 37167 64228874
Constipation 56.25 9.62 1150 231541 228187 64037854
Pulmonary function test abnormal 56.04 9.62 63 232628 3101 64262940
Chest discomfort 55.49 9.62 652 232039 115454 64150587
Somnolence 54.88 9.62 470 232221 203175 64062866
Condition aggravated 53.69 9.62 983 231708 371443 63894598
Reversible airways obstruction 52.91 9.62 39 232652 1099 64264942
Glycosylated haemoglobin increased 52.80 9.62 152 232539 15867 64250174
Pain in extremity 51.83 9.62 1446 231245 301639 63964402
Mucosal inflammation 51.23 9.62 92 232599 62492 64203549
Arthropathy 51.21 9.62 243 232448 120724 64145317
Lung diffusion test decreased 51.18 9.62 39 232652 1157 64264884
Red blood cell sedimentation rate abnormal 51.14 9.62 152 232539 16154 64249887
Device expulsion 50.23 9.62 8 232683 21128 64244913
Stomatitis 50.10 9.62 214 232477 109391 64156650
Thrombocytopenia 48.74 9.62 544 232147 223257 64042784
Coronary artery stenosis 48.55 9.62 118 232573 11130 64254911
Mobility decreased 48.33 9.62 498 232193 85342 64180699
Product substitution issue 48.17 9.62 158 232533 17703 64248338
5-hydroxyindolacetic acid in urine increased 47.34 9.62 21 232670 213 64265828
Ischaemic stroke 47.29 9.62 219 232472 28816 64237225
Abortion spontaneous 46.96 9.62 16 232675 25127 64240914
Carotid arteriosclerosis 46.76 9.62 47 232644 2032 64264009
Premature delivery 46.59 9.62 6 232685 18583 64247458
Interstitial lung disease 46.33 9.62 548 232143 97184 64168857
Cardio-respiratory arrest 45.65 9.62 191 232500 98202 64167839
Malignant neoplasm progression 45.32 9.62 231 232460 112640 64153401
Irritable bowel syndrome 45.03 9.62 41 232650 37328 64228713
Polymyositis 44.69 9.62 52 232639 2658 64263383
Haemorrhagic stroke 44.68 9.62 106 232585 9845 64256196
Orbital myositis 44.61 9.62 18 232673 141 64265900
Drug-induced liver injury 44.16 9.62 309 232382 47334 64218707
White blood cell count decreased 43.99 9.62 361 232330 157476 64108565
Septic shock 43.93 9.62 213 232478 105224 64160817
Suicide attempt 43.71 9.62 122 232569 70885 64195156
Cerebral infarction 43.35 9.62 275 232416 40769 64225272
Restrictive pulmonary disease 43.26 9.62 46 232645 2126 64263915
Blood mercury abnormal 43.24 9.62 19 232672 188 64265853
Blood cholesterol increased 43.11 9.62 319 232372 49747 64216294
Multiple organ dysfunction syndrome 42.76 9.62 204 232487 101209 64164832
Hepatic function abnormal 42.55 9.62 386 232305 63927 64202114
Muscle disorder 42.12 9.62 69 232622 4882 64261159
Fall 41.43 9.62 1869 230822 414957 63851084
Respiratory failure 41.21 9.62 377 232314 160806 64105235
Blister 40.86 9.62 152 232539 80815 64185226
Conjunctivitis allergic 40.62 9.62 32 232659 998 64265043
Weight decreased 40.43 9.62 1332 231359 284407 63981634
Chest pain 40.35 9.62 1126 231565 234854 64031187
Agitation 40.10 9.62 173 232518 88194 64177847
Ascites 40.07 9.62 104 232587 61897 64204144
Ulnar tunnel syndrome 39.90 9.62 10 232681 9 64266032
Lipids abnormal 39.66 9.62 24 232667 482 64265559
Hepatitis 39.57 9.62 291 232400 45291 64220750
Needle fatigue 38.79 9.62 25 232666 563 64265478
Lipoprotein (a) increased 38.67 9.62 13 232678 56 64265985
Productive cough 38.54 9.62 419 232272 72784 64193257
Congenital hiatus hernia 38.28 9.62 22 232669 400 64265641
Vascular stent stenosis 37.84 9.62 34 232657 1275 64264766
Device related infection 37.62 9.62 33 232658 30593 64235448
Hyper IgE syndrome 37.57 9.62 23 232668 472 64265569
Haematuria 37.52 9.62 358 232333 60113 64205928
Poisoning 37.41 9.62 16 232675 21863 64244178
Respiratory depression 37.21 9.62 19 232672 23424 64242617
Haemophagocytic lymphohistiocytosis 36.95 9.62 9 232682 17600 64248441
Amyotrophic lateral sclerosis 36.56 9.62 37 232654 1613 64264428
Neutrophil count decreased 36.34 9.62 149 232542 77047 64188994
Pulmonary valve disease 35.92 9.62 18 232673 245 64265796
Posterior reversible encephalopathy syndrome 35.83 9.62 19 232672 22927 64243114
Gait spastic 35.80 9.62 28 232663 864 64265177
Blood pressure inadequately controlled 35.39 9.62 67 232624 5317 64260724
Rales 35.21 9.62 128 232563 15101 64250940
Middle insomnia 34.80 9.62 114 232577 12763 64253278
Toxic epidermal necrolysis 34.78 9.62 50 232641 37116 64228925
Hepatocellular injury 34.38 9.62 280 232411 44955 64221086
Mental status changes 34.11 9.62 110 232581 61052 64204989
Coronary artery restenosis 34.10 9.62 32 232659 1270 64264771
Muscle discomfort 33.91 9.62 14 232677 117 64265924
Hepatojugular reflux 33.77 9.62 22 232669 505 64265536
Hypoglycaemia 33.76 9.62 483 232208 89409 64176632
Androgenetic alopecia 33.74 9.62 15 232676 153 64265888
Lipids increased 33.66 9.62 33 232658 1384 64264657
Lactic acidosis 33.49 9.62 354 232337 61056 64204985
Atrial fibrillation 33.46 9.62 831 231860 170258 64095783
Supine hypertension 33.23 9.62 19 232672 342 64265699
Generalised tonic-clonic seizure 33.15 9.62 58 232633 39799 64226242
Neurotoxicity 33.10 9.62 30 232661 27374 64238667
Drug dependence 33.00 9.62 43 232648 33269 64232772
Diastolic dysfunction 33.00 9.62 88 232603 8787 64257254
Blood creatinine increased 32.96 9.62 680 232011 135102 64130939
Arterial occlusive disease 32.75 9.62 76 232615 6957 64259084
Eosinophilia 32.43 9.62 242 232449 37834 64228207
Transient ischaemic attack 32.25 9.62 271 232420 43911 64222130
Thrombotic microangiopathy 32.16 9.62 10 232681 16645 64249396
Encephalopathy 31.96 9.62 107 232584 58712 64207329
Cough 31.34 9.62 1361 231330 300787 63965254
Neutropenic sepsis 31.19 9.62 23 232668 23249 64242792
Serotonin syndrome 31.03 9.62 59 232632 39223 64226818
Electrocardiogram Q wave abnormal 30.99 9.62 19 232672 391 64265650
Hypertonic bladder 30.94 9.62 49 232642 3369 64262672
Left ventricular enlargement 30.81 9.62 23 232668 661 64265380
Muscle atrophy 30.63 9.62 91 232600 9667 64256374
Drug withdrawal syndrome 30.37 9.62 41 232650 31250 64234791
Pancreatitis acute 30.30 9.62 261 232430 42594 64223447
Exercise tolerance decreased 30.25 9.62 78 232613 7632 64258409
Vomiting 30.25 9.62 1653 231038 549464 63716577
Renal failure 30.22 9.62 864 231827 180824 64085217
Albuminuria 29.54 9.62 22 232669 630 64265411
Necrotising myositis 29.42 9.62 25 232666 869 64265172
Vital capacity decreased 29.34 9.62 27 232664 1045 64264996
Pathogen resistance 29.24 9.62 5 232686 12538 64253503
Blood creatine phosphokinase 29.20 9.62 12 232679 99 64265942
Rhinitis perennial 29.07 9.62 15 232676 218 64265823
Swelling 29.02 9.62 405 232286 159813 64106228
Dizziness 28.95 9.62 1860 230831 428303 63837738
Nipple inflammation 28.55 9.62 10 232681 50 64265991
Hypotension 28.36 9.62 1662 231029 379312 63886729
Cataract 28.19 9.62 296 232395 50966 64215075
Akathisia 28.17 9.62 4 232687 11506 64254535
Injection site reaction 28.11 9.62 81 232610 46583 64219458
Therapy non-responder 28.10 9.62 132 232559 65767 64200274
Carotid artery stenosis 27.78 9.62 77 232614 7864 64258177
Transplant rejection 27.78 9.62 14 232677 17387 64248654
Cerebral haemorrhage 27.62 9.62 294 232397 50796 64215245
Arteriosclerosis 27.53 9.62 122 232569 15755 64250286
Vascular stent thrombosis 27.43 9.62 46 232645 3318 64262723
Muscle injury 27.36 9.62 33 232658 26404 64239637
Hypercholesterolaemia 27.32 9.62 119 232572 15254 64250787
Troponin increased 27.21 9.62 119 232572 15280 64250761
Gynaecomastia 26.92 9.62 64 232627 5952 64260089
Rash 26.90 9.62 1366 231325 457183 63808858
Goitre 26.83 9.62 57 232634 4916 64261125
Candida infection 26.79 9.62 45 232646 31374 64234667
Hemiplegia 26.77 9.62 104 232587 12664 64253377
Sinusitis 26.74 9.62 368 232323 145560 64120481
Bronchopulmonary aspergillosis 26.71 9.62 18 232673 19067 64246974
Injection site erythema 26.68 9.62 148 232543 70652 64195389
Arteriosclerosis coronary artery 26.68 9.62 119 232572 15410 64250631
Muscle rupture 26.42 9.62 44 232647 3156 64262885
Neoplasm progression 26.24 9.62 69 232622 40895 64225146
Gait disturbance 26.01 9.62 809 231882 171346 64094695
Injection site pain 25.76 9.62 267 232424 111141 64154900
Stent placement 25.72 9.62 60 232631 5511 64260530
Low cardiac output syndrome 25.69 9.62 22 232669 773 64265268
Eosinophil count increased 25.66 9.62 110 232581 14002 64252039
Hepatic encephalopathy 25.52 9.62 23 232668 21043 64244998
Myelosuppression 25.46 9.62 29 232662 23801 64242240
Total bile acids increased 25.38 9.62 10 232681 73 64265968
Pneumonia 25.29 9.62 1709 230982 557867 63708174
Caesarean section 25.20 9.62 5 232686 11269 64254772
Injury 25.16 9.62 110 232581 55882 64210159
Pericardial disease 25.08 9.62 18 232673 486 64265555
Aspergillus infection 24.93 9.62 14 232677 16365 64249676
Relapsing-remitting multiple sclerosis 24.83 9.62 25 232666 1083 64264958
Lipase increased 24.47 9.62 110 232581 14292 64251749
Mitral valve incompetence 24.47 9.62 167 232524 25371 64240670
Haematotoxicity 24.44 9.62 8 232683 12888 64253153
Chronic obstructive pulmonary disease 24.42 9.62 376 232315 70672 64195369
Hospitalisation 24.28 9.62 165 232526 75042 64190999
Burning sensation 24.20 9.62 280 232411 49384 64216657
Pneumocystis jirovecii pneumonia 24.10 9.62 39 232652 27595 64238446
Amblyopia 23.92 9.62 13 232678 211 64265830
Dermatitis allergic 23.90 9.62 113 232578 14996 64251045
Pollakiuria 23.87 9.62 195 232496 31335 64234706
Cytomegalovirus viraemia 23.79 9.62 5 232686 10823 64255218
Eczema 23.69 9.62 186 232505 29534 64236507
Tachycardia 23.69 9.62 388 232303 149191 64116850
Blood cholesterol abnormal 23.67 9.62 38 232653 2643 64263398
Skin laceration 23.59 9.62 160 232531 24257 64241784
Dystonia 23.57 9.62 20 232671 18845 64247196
Creutzfeldt-Jakob disease 23.52 9.62 12 232679 170 64265871
Mite allergy 23.35 9.62 20 232671 703 64265338
Growth hormone deficiency 23.35 9.62 15 232676 336 64265705
Substance abuse 23.28 9.62 3 232688 9289 64256752
Aortic aneurysm 23.18 9.62 70 232621 7504 64258537
Crush syndrome 23.04 9.62 12 232679 178 64265863
Neuroleptic malignant syndrome 23.02 9.62 34 232657 24962 64241079
Spirometry abnormal 22.94 9.62 18 232673 558 64265483
Immunodeficiency 22.84 9.62 15 232676 16109 64249932
Poisoning deliberate 22.76 9.62 10 232681 13448 64252593
Peripheral arterial occlusive disease 22.74 9.62 66 232625 6921 64259120
Photosensitivity reaction 22.54 9.62 127 232564 18046 64247995
Aggression 22.54 9.62 88 232603 46144 64219897
Blood glucose abnormal 22.40 9.62 77 232614 8836 64257205
N-terminal prohormone brain natriuretic peptide abnormal 22.40 9.62 13 232678 241 64265800
Hepatic neoplasm 22.38 9.62 40 232651 3037 64263004
Plasmapheresis 22.29 9.62 18 232673 582 64265459
Physical examination abnormal 22.26 9.62 13 232678 244 64265797
Stenosis 22.21 9.62 30 232661 1785 64264256
Unresponsive to stimuli 22.04 9.62 100 232591 50293 64215748
Cardiac arrest 22.03 9.62 407 232284 153657 64112384
Mydriasis 22.03 9.62 14 232677 15298 64250743
Abnormal behaviour 22.03 9.62 56 232635 33566 64232475
Transaminases increased 21.99 9.62 252 232439 44342 64221699
Malignant mediastinal neoplasm 21.95 9.62 17 232674 517 64265524
Nephritic syndrome 21.84 9.62 13 232678 253 64265788
Hyperkalaemia 21.83 9.62 498 232193 100631 64165410
Bronchiectasis 21.82 9.62 105 232586 14035 64252006
Hip arthroplasty 21.73 9.62 27 232664 21324 64244717
Acute hepatic failure 21.71 9.62 38 232653 26074 64239967
Aspartate aminotransferase increased 21.70 9.62 576 232115 119212 64146829
Adjustment disorder 21.67 9.62 37 232654 2708 64263333
Ventricular hyperkinesia 21.53 9.62 13 232678 260 64265781
Depressed level of consciousness 21.48 9.62 413 232278 81023 64185018
Status epilepticus 21.42 9.62 28 232663 21635 64244406
Sopor 21.35 9.62 47 232644 29614 64236427
Haemorrhage subcutaneous 21.28 9.62 48 232643 4313 64261728
Musculoskeletal toxicity 21.25 9.62 11 232680 161 64265880
Left ventricular hypertrophy 21.22 9.62 79 232612 9427 64256614
Tricuspid valve incompetence 21.21 9.62 119 232572 16884 64249157
Inspiratory capacity abnormal 21.13 9.62 9 232682 82 64265959
Mycobacterium test positive 21.10 9.62 15 232676 399 64265642
Myocardial ischaemia 21.08 9.62 150 232541 23101 64242940
Carotid artery thrombosis 20.95 9.62 29 232662 1766 64264275
Blood pressure systolic abnormal 20.86 9.62 81 232610 9861 64256180
Gangrene 20.77 9.62 66 232625 7272 64258769
Skin necrosis 20.75 9.62 13 232678 14316 64251725
Blood test abnormal 20.62 9.62 97 232594 12846 64253195
Aortic stenosis 20.59 9.62 60 232631 6305 64259736
Prostatic specific antigen increased 20.57 9.62 74 232617 8686 64257355
Helicobacter gastritis 20.55 9.62 32 232659 2168 64263873
Body temperature decreased 20.52 9.62 162 232529 25766 64240275
Bundle branch block left 20.44 9.62 81 232610 9953 64256088
Acute respiratory distress syndrome 20.36 9.62 72 232619 38863 64227178
Myoglobin blood increased 20.35 9.62 36 232655 2711 64263330
Paraplegia 20.34 9.62 48 232643 4442 64261599
Autoimmune hepatitis 20.22 9.62 81 232610 10003 64256038
Blood cholesterol decreased 20.19 9.62 26 232665 1476 64264565
Brain natriuretic peptide abnormal 20.10 9.62 18 232673 672 64265369
Hypertension 20.03 9.62 1135 231556 258126 64007915
Forced vital capacity decreased 20.00 9.62 26 232665 1490 64264551
Mean platelet volume increased 19.99 9.62 21 232670 957 64265084
Hyperthyroidism 19.94 9.62 123 232568 18056 64247985
Oropharyngeal discomfort 19.94 9.62 53 232638 5282 64260759
Confabulation 19.71 9.62 15 232676 444 64265597
Withdrawal syndrome 19.70 9.62 34 232657 23458 64242583
Cystitis 19.64 9.62 238 232453 42437 64223604
Ulcer 19.53 9.62 33 232658 22957 64243084
Blood pressure diastolic abnormal 19.49 9.62 90 232601 11827 64254214
Aortic valve incompetence 19.39 9.62 70 232621 8231 64257810
Drug intolerance 19.35 9.62 523 232168 187469 64078572
Mitral valve thickening 19.22 9.62 14 232677 387 64265654
Blood pressure fluctuation 19.18 9.62 278 232413 51593 64214448
Lipoma 19.18 9.62 34 232657 2565 64263476
Right atrial enlargement 19.09 9.62 13 232678 322 64265719
Rheumatic fever 19.02 9.62 5 232686 9289 64256752
Suspected suicide 19.00 9.62 4 232687 8650 64257391
Pulmonary embolism 18.99 9.62 393 232298 145963 64120078
Pruritus 18.89 9.62 1339 231352 311061 63954980
Intermittent claudication 18.84 9.62 37 232654 3017 64263024
Adverse drug reaction 18.84 9.62 92 232599 45372 64220669
Dyspnoea exertional 18.79 9.62 372 232319 73358 64192683
Haemoglobin increased 18.76 9.62 51 232640 5150 64260891
Confusional state 18.72 9.62 761 231930 260383 64005658
Dry mouth 18.61 9.62 314 232377 60104 64205937
Acute myeloid leukaemia 18.57 9.62 45 232646 27418 64238623
Sinus congestion 18.56 9.62 107 232584 15332 64250709
Dermatomyositis 18.54 9.62 35 232656 2771 64263270
Immune reconstitution inflammatory syndrome 18.50 9.62 11 232680 12459 64253582
Very low density lipoprotein increased 18.47 9.62 10 232681 161 64265880
Fractured coccyx 18.43 9.62 20 232671 946 64265095
Drug-disease interaction 18.40 9.62 18 232673 753 64265288
Procollagen type I C-terminal propeptide increased 18.20 9.62 6 232685 24 64266017
Enterococcal infection 18.20 9.62 14 232677 13852 64252189
Tenosynovitis 18.18 9.62 10 232681 11823 64254218
Glomerular filtration rate decreased 18.17 9.62 127 232564 19445 64246596
Injection site swelling 18.12 9.62 82 232609 41271 64224770
Alanine aminotransferase increased 18.08 9.62 642 232049 138389 64127652
Cerebrovascular accident 18.07 9.62 636 232055 136947 64129094
Drug ineffective for unapproved indication 18.06 9.62 55 232636 31078 64234963
Skin haemorrhage 18.05 9.62 70 232621 8515 64257526
Retro-orbital neoplasm 18.02 9.62 7 232684 49 64265992
Sensorimotor disorder 17.97 9.62 18 232673 775 64265266
Device issue 17.90 9.62 34 232657 22614 64243427
Nipple disorder 17.89 9.62 10 232681 172 64265869
Infusion site streaking 17.87 9.62 14 232677 433 64265608
Anaemia 17.84 9.62 1152 231539 377528 63888513
Malignant melanoma in situ 17.74 9.62 27 232664 1793 64264248
Angiocardiogram 17.70 9.62 11 232680 232 64265809
Cytokine release syndrome 17.60 9.62 30 232661 20799 64245242
Cholestasis 17.60 9.62 243 232448 44629 64221412
Bacterial infection 17.58 9.62 40 232651 24910 64241131
Arthralgia 17.54 9.62 1837 230854 440423 63825618
Myasthenia gravis 17.53 9.62 53 232638 5685 64260356
Guillain-Barre syndrome 17.50 9.62 64 232627 7571 64258470
Bacteraemia 17.49 9.62 45 232646 26866 64239175
Serum procollagen type I N-terminal propeptide increased 17.46 9.62 6 232685 28 64266013
Pertussis 17.44 9.62 18 232673 803 64265238
Hepatitis C 17.38 9.62 9 232682 11006 64255035
Tumour lysis syndrome 17.36 9.62 27 232664 19413 64246628
Hypersensitivity 17.35 9.62 558 232133 195894 64070147
Hyperlipidaemia 17.34 9.62 142 232549 22834 64243207
Bladder cancer 17.30 9.62 82 232609 10892 64255149
Intentional product use issue 17.28 9.62 241 232450 95123 64170918
Neurologic neglect syndrome 17.20 9.62 25 232666 1593 64264448
Aplastic anaemia 17.10 9.62 15 232676 13905 64252136
Malignant melanoma 17.02 9.62 92 232599 12872 64253169
Mucormycosis 16.95 9.62 3 232688 7338 64258703
Occult blood 16.89 9.62 23 232668 1379 64264662
Ligament pain 16.87 9.62 10 232681 193 64265848
Hypereosinophilic syndrome 16.76 9.62 14 232677 475 64265566
Decreased ventricular preload 16.66 9.62 6 232685 33 64266008
Miosis 16.65 9.62 14 232677 13252 64252789
Polymyalgia rheumatica 16.42 9.62 37 232654 3322 64262719
Syncope 16.30 9.62 710 231981 156925 64109116
Meningitis eosinophilic 16.26 9.62 5 232686 15 64266026
Pulmonary haemorrhage 16.25 9.62 14 232677 13095 64252946
Transcription medication error 16.25 9.62 12 232679 339 64265702
Cardiovascular somatic symptom disorder 16.22 9.62 6 232685 36 64266005
Mycotic allergy 16.21 9.62 19 232672 979 64265062
Platelet count decreased 16.13 9.62 471 232220 167240 64098801
Unwanted awareness during anaesthesia 16.10 9.62 11 232680 274 64265767
Coagulopathy 16.05 9.62 60 232631 31860 64234181
Ileus 16.03 9.62 37 232654 22929 64243112
Suicidal ideation 15.99 9.62 158 232533 66384 64199657
Total cholesterol/HDL ratio increased 15.92 9.62 10 232681 215 64265826
Blood uric acid increased 15.91 9.62 65 232626 8098 64257943
Melanoderma 15.86 9.62 12 232679 352 64265689
Degenerative aortic valve disease 15.83 9.62 8 232683 111 64265930
AST/ALT ratio abnormal 15.80 9.62 5 232686 17 64266024
High density lipoprotein increased 15.74 9.62 19 232672 1010 64265031
Carcinoid tumour 15.72 9.62 13 232678 435 64265606
Prinzmetal angina 15.66 9.62 23 232668 1480 64264561
Colitis ulcerative 15.63 9.62 139 232552 22889 64243152
Hypocholesterolaemia 15.59 9.62 9 232682 165 64265876
Diabetic metabolic decompensation 15.57 9.62 32 232659 2696 64263345
Lethargy 15.56 9.62 177 232514 72417 64193624
Lichenoid keratosis 15.50 9.62 36 232655 3298 64262743
Mesenteric artery thrombosis 15.45 9.62 14 232677 531 64265510
Presyncope 15.42 9.62 194 232497 34895 64231146
Lichen planus 15.34 9.62 29 232662 2299 64263742
Hyperkeratosis 15.31 9.62 56 232635 6625 64259416
Blood thyroid stimulating hormone abnormal 15.21 9.62 16 232675 730 64265311
Hepatic steatosis 15.19 9.62 175 232516 30832 64235209
Osteonecrosis of jaw 15.14 9.62 83 232608 39742 64226299
Oxygen consumption decreased 15.13 9.62 12 232679 378 64265663
Rheumatoid nodule 15.10 9.62 14 232677 12637 64253404
Product residue present 15.06 9.62 35 232656 3207 64262834
Myopathy toxic 15.00 9.62 17 232674 844 64265197
Cystitis haemorrhagic 14.97 9.62 5 232686 7951 64258090
Nodular rash 14.95 9.62 11 232680 309 64265732
Nephrolithiasis 14.94 9.62 231 232460 43452 64222589
Encephalitis 14.90 9.62 14 232677 12557 64253484
Cardiac discomfort 14.88 9.62 19 232672 1070 64264971
Head discomfort 14.88 9.62 83 232608 11751 64254290
Injection site bruising 14.84 9.62 74 232617 36299 64229742
Histamine level increased 14.82 9.62 7 232684 83 64265958
Lymphomatoid papulosis 14.77 9.62 11 232680 315 64265726
Oedema peripheral 14.76 9.62 913 231778 209404 64056637
Pancreatic neuroendocrine tumour 14.75 9.62 13 232678 475 64265566
Progressive multifocal leukoencephalopathy 14.74 9.62 27 232664 18205 64247836
Hyperglycaemia 14.67 9.62 305 232386 60663 64205378
Right ventricular failure 14.66 9.62 35 232656 21436 64244605
Hypercreatinaemia 14.64 9.62 10 232681 249 64265792
Gastrooesophageal reflux disease 14.54 9.62 398 232293 82745 64183296
Apolipoprotein A-I decreased 14.44 9.62 5 232686 24 64266017
Respiratory distress 14.42 9.62 120 232571 52211 64213830
Oxygen saturation increased 14.41 9.62 13 232678 490 64265551
Granulocytopenia 14.41 9.62 10 232681 10430 64255611
Fibromyalgia 14.40 9.62 73 232618 35658 64230383
Ureteric cancer 14.40 9.62 10 232681 256 64265785
Panniculitis 14.39 9.62 7 232684 8872 64257169
Deep vein thrombosis 14.37 9.62 280 232411 104902 64161139
Atrial thrombosis 14.31 9.62 33 232658 3009 64263032
Food aversion 14.29 9.62 15 232676 683 64265358
Amylase increased 14.29 9.62 71 232620 9614 64256427
Brain oedema 14.28 9.62 37 232654 22038 64244003
Metastases to bone 14.20 9.62 33 232658 20402 64245639
Prostatic haemorrhage 14.14 9.62 8 232683 141 64265900
Lower respiratory tract infection 14.13 9.62 248 232443 94366 64171675
Neurotrophic keratopathy 13.89 9.62 3 232688 0 64266041
Pancreatic carcinoma 13.88 9.62 74 232617 10299 64255742
Lung neoplasm malignant 13.81 9.62 128 232563 21320 64244721
Dust allergy 13.80 9.62 18 232673 1035 64265006
Gastrointestinal disorder 13.77 9.62 234 232457 89475 64176566
Mental disorder 13.76 9.62 49 232642 26396 64239645
Palpitations 13.71 9.62 483 232208 104005 64162036
Ventricular hypokinesia 13.70 9.62 60 232631 7709 64258332
Body temperature increased 13.62 9.62 77 232614 36589 64229452
Medication error 13.58 9.62 115 232576 49851 64216190
Base excess decreased 13.56 9.62 11 232680 358 64265683
Haemorrhagic cerebral infarction 13.53 9.62 20 232671 1294 64264747
Arterial spasm 13.52 9.62 8 232683 154 64265887
No adverse event 13.52 9.62 55 232636 28506 64237535
Plasma cell myeloma 13.46 9.62 104 232587 45971 64220070
Dyspepsia 13.36 9.62 382 232309 79930 64186111
Electrocardiogram QRS complex abnormal 13.34 9.62 13 232678 541 64265500
Cytopenia 13.34 9.62 22 232669 15449 64250592
Total lung capacity decreased 13.32 9.62 23 232668 1699 64264342
Mania 13.27 9.62 24 232667 16262 64249779
Kidney transplant rejection 13.27 9.62 9 232682 9502 64256539
Electrocardiogram ambulatory abnormal 13.27 9.62 4 232687 11 64266030
Clitoris abscess 13.27 9.62 4 232687 11 64266030
Epilepsy 13.24 9.62 69 232622 33462 64232579
Exposure to toxic agent 13.21 9.62 3 232688 6156 64259885
Sinus pain 13.20 9.62 29 232662 2560 64263481
Essential hypertension 13.16 9.62 45 232646 5149 64260892
Renal cyst 13.13 9.62 84 232607 12486 64253555
Paradoxical drug reaction 13.09 9.62 3 232688 6117 64259924
Supraventricular extrasystoles 13.07 9.62 49 232642 5866 64260175
Lymphopenia 13.05 9.62 48 232643 25609 64240432
Thalamus haemorrhage 13.02 9.62 22 232669 1597 64264444
Anaphylactic reaction 12.99 9.62 172 232519 68492 64197549
Electrolyte imbalance 12.98 9.62 47 232644 25196 64240845
Psychomotor hyperactivity 12.98 9.62 20 232671 14431 64251610
Cyanosis 12.95 9.62 39 232652 22116 64243925
Aldolase increased 12.94 9.62 9 232682 231 64265810
Multiple sclerosis relapse 12.90 9.62 91 232600 41044 64224997
Diabetic neuropathy 12.88 9.62 47 232644 5554 64260487
Ketoacidosis 12.87 9.62 54 232637 6809 64259232
Infrequent bowel movements 12.85 9.62 20 232671 1355 64264686
Eye haemorrhage 12.84 9.62 62 232629 8298 64257743
Blood loss anaemia 12.81 9.62 90 232601 13802 64252239
Wheezing 12.78 9.62 381 232310 80198 64185843
Blood triglycerides decreased 12.74 9.62 8 232683 172 64265869
Discomfort 12.73 9.62 210 232481 80668 64185373
Hepatic failure 12.70 9.62 133 232558 55261 64210780
Escherichia infection 12.68 9.62 22 232669 15146 64250895
Myotonic dystrophy 12.64 9.62 6 232685 72 64265969
Thrombosis 12.63 9.62 179 232512 70463 64195578
Listless 12.62 9.62 33 232658 3257 64262784
Micturition urgency 12.59 9.62 72 232619 10287 64255754
Hyperreflexia 12.59 9.62 5 232686 7143 64258898
Left atrial enlargement 12.54 9.62 17 232674 1015 64265026
Tendonitis 12.54 9.62 120 232571 20162 64245879
Clostridium difficile colitis 12.52 9.62 53 232638 27170 64238871
Myelodysplastic syndrome 12.50 9.62 54 232637 27525 64238516
Sneezing 12.46 9.62 96 232595 15155 64250886
Muscle rigidity 12.32 9.62 28 232663 17445 64248596
Blood creatine phosphokinase MM increased 12.30 9.62 5 232686 40 64266001
Skin test negative 12.30 9.62 5 232686 40 64266001
Klebsiella infection 12.29 9.62 18 232673 13263 64252778
Tendon pain 12.29 9.62 42 232649 4806 64261235
Sinonasal obstruction 12.23 9.62 8 232683 185 64265856
Injection site pruritus 12.20 9.62 83 232608 37743 64228298
Knee arthroplasty 12.15 9.62 53 232638 26946 64239095
Coma acidotic 12.14 9.62 7 232684 128 64265913
Erythema marginatum 12.13 9.62 4 232687 16 64266025
Hallucination 12.12 9.62 187 232504 72601 64193440
Breast pain 12.05 9.62 54 232637 7007 64259034
Urine albumin/creatinine ratio increased 12.01 9.62 10 232681 338 64265703
Benign prostatic hyperplasia 12.00 9.62 65 232626 9100 64256941
Tubulointerstitial nephritis 11.97 9.62 167 232524 30742 64235299
Joint swelling 11.95 9.62 645 232046 214737 64051304
Eructation 11.91 9.62 65 232626 9126 64256915
Nocturia 11.91 9.62 75 232616 11090 64254951
Malaise 11.86 9.62 1617 231074 394630 63871411
Cardiac valve fibroelastoma 11.82 9.62 3 232688 3 64266038
Creatinine renal clearance increased 11.80 9.62 15 232676 841 64265200
Cardiac neoplasm unspecified 11.70 9.62 5 232686 46 64265995
Duplicate therapy error 11.68 9.62 8 232683 200 64265841
Microalbuminuria 11.67 9.62 15 232676 850 64265191
Electrocardiogram abnormal 11.66 9.62 86 232605 13395 64252646
Hypercalcaemia 11.66 9.62 66 232625 31350 64234691
Autoimmune nephritis 11.64 9.62 12 232679 535 64265506
Vertigo 11.63 9.62 287 232404 58724 64207317
Flatulence 11.59 9.62 187 232504 35479 64230562
Blood urine present 11.58 9.62 109 232582 18231 64247810
Pre-eclampsia 11.58 9.62 4 232687 6227 64259814
Coordination abnormal 11.57 9.62 93 232598 14871 64251170
Decubitus ulcer 11.56 9.62 19 232672 13360 64252681
Palmar-plantar erythrodysaesthesia syndrome 11.55 9.62 59 232632 28760 64237281
Hypochromasia 11.45 9.62 13 232678 647 64265394
Liver function test abnormal 11.44 9.62 288 232403 59113 64206928
Myoglobinuria 11.44 9.62 16 232675 984 64265057
Bronchial secretion retention 11.43 9.62 27 232664 2500 64263541
Toxic cataract 11.42 9.62 4 232687 20 64266021
Oedema genital 11.38 9.62 11 232680 453 64265588
Pneumonia aspiration 11.38 9.62 148 232543 59123 64206918
Upper-airway cough syndrome 11.35 9.62 62 232629 8708 64257333
Electrocardiogram QT prolonged 11.31 9.62 210 232481 79238 64186803
Pulmonary arterial pressure abnormal 11.27 9.62 13 232678 658 64265383
Non-alcoholic steatohepatitis 11.27 9.62 23 232668 1929 64264112
Cardiac autonomic neuropathy 11.25 9.62 5 232686 51 64265990
Blood pressure ambulatory increased 11.25 9.62 5 232686 51 64265990
Hypertriglyceridaemia 11.17 9.62 74 232617 11131 64254910
Expired product administered 11.14 9.62 47 232644 5940 64260101
Retroperitoneal fibrosis 11.14 9.62 12 232679 563 64265478
Infected dermal cyst 11.11 9.62 14 232677 778 64265263
Psychotic disorder 11.09 9.62 76 232615 34502 64231539
Product monitoring error 11.03 9.62 3 232688 5451 64260590
Peripheral sensorimotor neuropathy 11.03 9.62 27 232664 2558 64263483
Seronegative arthritis 11.02 9.62 28 232663 2715 64263326
Chronic cutaneous lupus erythematosus 10.96 9.62 8 232683 222 64265819
Eyelid disorder 10.92 9.62 19 232672 1412 64264629
Premature labour 10.92 9.62 7 232684 7613 64258428
Heart rate decreased 10.91 9.62 268 232423 54799 64211242
Monoparesis 10.81 9.62 29 232662 2905 64263136
Neuropathy peripheral 10.81 9.62 332 232359 117193 64148848
Oral candidiasis 10.80 9.62 45 232646 23167 64242874
Left ventricular dilatation 10.79 9.62 15 232676 917 64265124
Hypercreatininaemia 10.79 9.62 14 232677 801 64265240
Low density lipoprotein abnormal 10.79 9.62 9 232682 305 64265736
Metastases to liver 10.78 9.62 47 232644 23894 64242147
Grip strength decreased 10.74 9.62 16 232675 11708 64254333
Endometriosis 10.70 9.62 28 232663 2764 64263277
Hepatosplenomegaly 10.70 9.62 3 232688 5340 64260701
Neoplasm 10.70 9.62 52 232639 6979 64259062
Strangulated hernia 10.68 9.62 5 232686 58 64265983
Ejection fraction decreased 10.67 9.62 154 232537 28553 64237488
Fear of injection 10.63 9.62 4 232687 5908 64260133
Rheumatoid factor positive 10.62 9.62 78 232613 34860 64231181
Peripheral artery restenosis 10.61 9.62 3 232688 6 64266035
Prostatomegaly 10.61 9.62 29 232662 2938 64263103
Diabetic nephropathy 10.57 9.62 27 232664 2627 64263414
Flushing 10.55 9.62 210 232481 78438 64187603
Epstein-Barr virus infection 10.54 9.62 18 232673 12470 64253571
Urine ketone body present 10.53 9.62 31 232660 3276 64262765
Muscle mass 10.53 9.62 10 232681 403 64265638
Diaphragm muscle weakness 10.51 9.62 7 232684 167 64265874
Hypogammaglobulinaemia 10.51 9.62 13 232678 10286 64255755
Dermatitis bullous 10.48 9.62 77 232614 11977 64254064
Schizophrenia 10.47 9.62 15 232676 11153 64254888
Malignant neoplasm of ampulla of Vater 10.42 9.62 4 232687 27 64266014
Abscess of salivary gland 10.42 9.62 4 232687 27 64266014
Abortion induced 10.41 9.62 5 232686 6383 64259658
Atheroembolism 10.34 9.62 8 232683 243 64265798
Left ventricular dysfunction 10.33 9.62 100 232591 16854 64249187
Delusion 10.32 9.62 32 232659 17982 64248059
Staphylococcal infection 10.31 9.62 125 232566 50553 64215488
Contraindication to surgery 10.30 9.62 3 232688 7 64266034
Accident at work 10.23 9.62 15 232676 964 64265077
Sinus tachycardia 10.20 9.62 71 232620 32117 64233924
Body mass index decreased 10.18 9.62 11 232680 518 64265523
Hypokinesia 10.17 9.62 98 232593 16498 64249543
Bradypnoea 10.14 9.62 3 232688 5156 64260885
Dyspnoea 10.14 9.62 2824 229867 715850 63550191
Blood pressure diastolic increased 10.12 9.62 70 232621 10682 64255359
Pseudomonas infection 10.08 9.62 32 232659 17851 64248190
Transaminases abnormal 10.03 9.62 13 232678 743 64265298
Reduced facial expression 10.02 9.62 23 232668 2090 64263951
Idiopathic interstitial pneumonia 10.02 9.62 7 232684 181 64265860
Hypervolaemia 10.01 9.62 89 232602 38196 64227845
Enthesopathy 10.01 9.62 12 232679 9626 64256415
Ventricular extrasystoles 10.00 9.62 102 232589 17427 64248614
Campylobacter test positive 9.98 9.62 5 232686 68 64265973
Complication associated with device 9.97 9.62 25 232666 15055 64250986
Infusion site scar 9.95 9.62 8 232683 257 64265784
Pulmonary tuberculosis 9.91 9.62 7 232684 7237 64258804
Left atrial dilatation 9.85 9.62 27 232664 2739 64263302
Blood bicarbonate decreased 9.85 9.62 39 232652 4790 64261251
Acute respiratory failure 9.84 9.62 124 232567 49810 64216231
Potentiating drug interaction 9.82 9.62 55 232636 7797 64258244
Anxiety 9.78 9.62 615 232076 202034 64064007
Apnoea 9.77 9.62 14 232677 10408 64255633
Conjunctivitis 9.76 9.62 39 232652 20315 64245726
Liver injury 9.75 9.62 157 232534 29775 64236266
Obstructive pancreatitis 9.75 9.62 12 232679 651 64265390
Walking disability 9.74 9.62 21 232670 1830 64264211
Atelectasis 9.73 9.62 58 232633 27208 64238833
Polycystic ovaries 9.72 9.62 23 232668 2132 64263909
Unevaluable event 9.72 9.62 126 232565 50363 64215678
Gout 9.67 9.62 119 232572 21294 64244747
Incontinence 9.67 9.62 18 232673 12063 64253978
Normocytic anaemia 9.64 9.62 30 232661 3269 64262772
Arteriovenous fistula site haematoma 9.63 9.62 4 232687 34 64266007

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 D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019161 Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
CHEBI has role CHEBI:35679 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 RX TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 10MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 RX 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
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 0310-0752 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 0310-0755 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 0310-7570 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 0310-7590 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 0904-6779 TABLET, COATED 10 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6780 TABLET, COATED 20 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6781 TABLET, COATED 40 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-179 TABLET, COATED 5 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-179 TABLET, COATED 5 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-180 TABLET, COATED 10 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-180 TABLET, COATED 10 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-181 TABLET, COATED 20 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-181 TABLET, COATED 20 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-182 TABLET, COATED 40 mg ORAL ANDA 21 sections
Rosuvastatin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 13668-182 TABLET, COATED 40 mg ORAL ANDA 21 sections