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

Stem definitionDrug idCAS RN
calcium channel blockers, nifedipine derivatives 183 88150-42-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amlodipine
  • amlopres
  • racemic amlodipine
  • amlodipine besylate
  • amlodipine besilate
  • amlodipine maleate
  • amlodipine mesylate
  • amlodipine mesilate
A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
  • Molecular weight: 408.88
  • Formula: C20H25ClN2O5
  • CLOGP: 3.43
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 99.88
  • ALOGS: -4.74
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.35 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 74 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 17 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 34 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 31, 1992 FDA PFIZER

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
Drug ineffective 644.44 9.89 2921 361792 674917 45646432
Rheumatoid arthritis 587.82 9.89 606 364107 239609 46081740
Completed suicide 399.25 9.89 2217 362496 143703 46177646
Maternal exposure during pregnancy 379.14 9.89 163 364550 102386 46218963
Blood pressure inadequately controlled 377.58 9.89 297 364416 4109 46317240
Treatment failure 363.67 9.89 136 364577 92951 46228398
Hyponatraemia 351.54 9.89 1646 363067 99686 46221663
Hypotension 348.34 9.89 3049 361664 229540 46091809
Hypertension 342.76 9.89 2665 362048 193691 46127658
Gingival hypertrophy 328.88 9.89 179 364534 1250 46320099
Acute kidney injury 327.71 9.89 3042 361671 232813 46088536
Blood pressure increased 320.44 9.89 1885 362828 124781 46196568
Off label use 315.35 9.89 1713 363000 378128 45943221
Shock 288.29 9.89 570 364143 21275 46300074
Non-cardiogenic pulmonary oedema 277.67 9.89 119 364594 445 46320904
Exposure during pregnancy 267.65 9.89 270 364443 107942 46213407
Contraindicated product administered 266.66 9.89 146 364567 79801 46241548
Pemphigus 247.36 9.89 31 364682 45243 46276106
Oedema peripheral 244.18 9.89 2104 362609 157602 46163747
Bradycardia 225.45 9.89 1071 363642 65227 46256122
Drug intolerance 222.75 9.89 513 364200 146536 46174813
Systemic lupus erythematosus 213.08 9.89 122 364591 65058 46256291
Cerebrovascular accident 212.66 9.89 1435 363278 99604 46221745
Infusion related reaction 211.13 9.89 289 364424 100919 46220430
Synovitis 210.35 9.89 107 364606 60968 46260381
Therapeutic product effect decreased 197.56 9.89 212 364501 82389 46238960
Hyperkalaemia 178.84 9.89 828 363885 49881 46271468
Fall 178.67 9.89 3583 361130 325514 45995835
Abortion spontaneous 178.57 9.89 59 364654 43587 46277762
Pain 174.87 9.89 2649 362064 474299 45847050
Angioedema 170.74 9.89 684 364029 38658 46282691
Therapeutic product effect incomplete 157.17 9.89 229 364484 77924 46243425
Lactic acidosis 153.16 9.89 597 364116 33312 46288037
Dizziness 152.07 9.89 3604 361109 336810 45984539
C-reactive protein abnormal 147.29 9.89 4 364709 21266 46300083
Hand deformity 144.52 9.89 45 364668 34529 46286820
Device expulsion 143.04 9.89 22 364691 27520 46293829
Pregnancy 140.20 9.89 22 364691 27115 46294234
Glossodynia 138.09 9.89 88 364625 44285 46277064
Drug abuse 137.37 9.89 176 364537 63232 46258117
Anti-cyclic citrullinated peptide antibody positive 134.86 9.89 3 364710 19142 46302207
Injection site reaction 133.05 9.89 107 364606 47742 46273607
Cardiac failure congestive 129.86 9.89 1189 363524 90561 46230788
Metabolic acidosis 128.54 9.89 622 364091 38158 46283191
Injection site erythema 128.34 9.89 241 364472 74186 46247163
Vasoplegia syndrome 128.24 9.89 89 364624 1003 46320346
Renal impairment 127.53 9.89 1006 363707 73366 46247983
Alopecia 123.80 9.89 752 363961 161662 46159687
Orthostatic hypotension 123.69 9.89 449 364264 24209 46297140
Rheumatoid factor positive 122.16 9.89 10 364703 20451 46300898
Arthropathy 120.64 9.89 305 364408 84395 46236954
Injection site pain 118.22 9.89 434 364279 106718 46214631
Hypertensive crisis 117.50 9.89 300 364413 13315 46308034
Hypokalaemia 111.33 9.89 1114 363599 86910 46234439
Hypoglycaemia 107.81 9.89 761 363952 53588 46267761
Arthralgia 100.32 9.89 2129 362584 362474 45958875
Pericarditis 98.47 9.89 32 364681 23895 46297454
Product use issue 96.27 9.89 396 364317 94248 46227101
Intentional overdose 96.15 9.89 850 363863 64094 46257255
Sinusitis 95.15 9.89 608 364105 129160 46192189
Atrial fibrillation 94.45 9.89 1230 363483 102360 46218989
Atrioventricular block complete 91.11 9.89 191 364522 7436 46313913
Blood creatinine increased 89.04 9.89 951 363762 75452 46245897
Migraine 88.64 9.89 267 364446 69759 46251590
Febrile neutropenia 87.70 9.89 410 364303 94217 46227132
Hepatic enzyme increased 85.19 9.89 339 364374 81448 46239901
Cerebral infarction 84.92 9.89 385 364328 22981 46298368
Hypersensitivity 82.12 9.89 764 363949 149557 46171792
Decreased appetite 81.42 9.89 2036 362677 191800 46129549
Myocardial infarction 81.08 9.89 1139 363574 96389 46224960
Injection site swelling 79.27 9.89 120 364593 40207 46281142
Syncope 76.95 9.89 1198 363515 103605 46217744
Intentional self-injury 75.08 9.89 48 364665 24118 46297231
Condition aggravated 74.77 9.89 1406 363307 243646 46077703
Foetal exposure during pregnancy 74.50 9.89 78 364635 30669 46290680
Rhabdomyolysis 73.52 9.89 570 364143 41339 46280010
Swollen tongue 73.10 9.89 434 364279 28798 46292551
Hypertensive emergency 72.98 9.89 76 364637 1542 46319807
Product prescribing error 71.87 9.89 329 364384 19718 46301631
Infection 71.66 9.89 682 364031 132910 46188439
Neutropenia 70.62 9.89 746 363967 142458 46178891
Neurologic neglect syndrome 69.27 9.89 51 364662 635 46320714
Drug resistance 68.41 9.89 25 364688 17343 46304006
Pyrexia 68.28 9.89 2140 362573 346662 45974687
Infective pulmonary exacerbation of cystic fibrosis 68.24 9.89 4 364709 10803 46310546
Musculoskeletal stiffness 67.84 9.89 467 364246 97526 46223823
Sinus bradycardia 66.62 9.89 248 364465 13534 46307815
Sprue-like enteropathy 66.30 9.89 42 364671 401 46320948
Product use in unapproved indication 64.59 9.89 426 364287 89847 46231502
Blood pressure decreased 63.59 9.89 705 364008 56454 46264895
Injection site pruritus 62.26 9.89 136 364577 39607 46281742
Renal failure 62.10 9.89 1239 363474 112355 46208994
Live birth 61.80 9.89 5 364708 10325 46311024
Atrioventricular block first degree 58.32 9.89 141 364572 6045 46315304
Toxicity to various agents 58.21 9.89 2111 362602 209655 46111694
Linear IgA disease 57.96 9.89 62 364651 1299 46320050
Coronary artery disease 57.51 9.89 456 364257 33296 46288053
Depressed level of consciousness 55.82 9.89 593 364120 46976 46274373
Carotid artery thrombosis 55.74 9.89 46 364667 684 46320665
Cardiac failure 55.70 9.89 906 363807 79042 46242307
Fibromyalgia 55.30 9.89 127 364586 36336 46285013
Blood urea increased 54.42 9.89 362 364351 24990 46296359
Angina pectoris 53.71 9.89 376 364337 26399 46294950
Loss of personal independence in daily activities 53.41 9.89 247 364466 56936 46264413
Circulatory collapse 52.75 9.89 319 364394 21305 46300044
Anuria 52.20 9.89 202 364511 11229 46310120
Left ventricular hypertrophy 52.12 9.89 118 364595 4845 46316504
Acute myocardial infarction 52.06 9.89 427 364286 31497 46289852
Cardiogenic shock 51.57 9.89 259 364454 16125 46305224
Asthenia 50.84 9.89 2942 361771 308133 46013216
Chronic kidney disease 49.60 9.89 513 364200 40358 46280991
Abortion induced 49.35 9.89 10 364703 10250 46311099
Injection site bruising 48.67 9.89 131 364582 35505 46285844
Renin increased 47.47 9.89 24 364689 141 46321208
Renal artery stenosis 47.39 9.89 64 364649 1724 46319625
Device dislocation 46.70 9.89 61 364652 21741 46299608
Septic shock 46.20 9.89 264 364449 57629 46263720
Injection site warmth 46.11 9.89 25 364688 13747 46307602
Pulmonary oedema 45.78 9.89 605 364108 50500 46270849
Drug dependence 45.45 9.89 53 364660 19848 46301501
Confusional state 45.16 9.89 1599 363114 158293 46163056
Caesarean section 45.06 9.89 38 364675 16565 46304784
Pemphigoid 44.62 9.89 121 364592 5570 46315779
Balance disorder 44.49 9.89 730 363983 63791 46257558
Psoriatic arthropathy 44.40 9.89 141 364572 36238 46285111
Drug interaction 44.29 9.89 1975 362738 201119 46120230
Multiple sclerosis relapse 44.23 9.89 174 364539 41951 46279398
Melaena 43.97 9.89 369 364344 27403 46293946
Inappropriate antidiuretic hormone secretion 43.74 9.89 222 364491 13880 46307469
Lower respiratory tract infection 42.47 9.89 254 364459 54835 46266514
Blood glucose increased 42.23 9.89 794 363919 71219 46250130
Transient ischaemic attack 41.83 9.89 437 364276 34466 46286883
Oliguria 41.83 9.89 157 364556 8602 46312747
Hyperglycaemia 41.05 9.89 437 364276 34634 46286715
Drug withdrawal syndrome 41.02 9.89 96 364617 27288 46294061
Rheumatoid nodule 40.94 9.89 10 364703 9010 46312339
Atrioventricular block 40.25 9.89 131 364582 6680 46314669
Premature labour 40.09 9.89 19 364694 11280 46310069
Creatinine renal clearance decreased 39.91 9.89 132 364581 6788 46314561
Oedema 39.84 9.89 741 363972 66330 46255019
Haemorrhage subcutaneous 39.75 9.89 77 364636 2829 46318520
Dyspnoea 39.08 9.89 4598 360115 510950 45810399
Glomerular filtration rate decreased 39.05 9.89 188 364525 11506 46309843
Proteinuria 38.99 9.89 242 364471 16311 46305038
Hepatic function abnormal 38.48 9.89 425 364288 33996 46287353
Carotid artery stenosis 38.29 9.89 107 364606 5013 46316336
Overdose 38.07 9.89 1055 363658 100924 46220425
Rash 37.90 9.89 2340 362373 354172 45967177
Anti-neutrophil cytoplasmic antibody positive vasculitis 37.83 9.89 60 364653 1875 46319474
Dehydration 37.79 9.89 1565 363148 157975 46163374
Palpitations 37.70 9.89 993 363720 94266 46227083
Blood pressure systolic increased 37.66 9.89 367 364346 28420 46292929
Diabetes mellitus inadequate control 37.52 9.89 203 364510 13011 46308338
Hemiplegia 37.07 9.89 129 364584 6809 46314540
Seizure 36.85 9.89 708 364005 122346 46199003
Metastases to bone 36.31 9.89 50 364663 17426 46303923
Renal disorder 36.29 9.89 343 364370 26343 46295006
Abdominal discomfort 36.26 9.89 901 363812 150264 46171085
Leukopenia 35.73 9.89 351 364362 67992 46253357
Premature baby 35.49 9.89 54 364659 18058 46303291
Sedation complication 35.35 9.89 84 364629 3561 46317788
Foot deformity 34.24 9.89 42 364671 15383 46305966
Subacute cutaneous lupus erythematosus 34.21 9.89 57 364656 1858 46319491
Distributive shock 34.00 9.89 30 364683 491 46320858
Accidental exposure to product 33.96 9.89 71 364642 21010 46300339
Vasodilatation 33.61 9.89 64 364649 2321 46319028
Aortic dissection 33.41 9.89 51 364662 1541 46319808
Hepatotoxicity 33.35 9.89 93 364620 24916 46296433
Mood swings 33.26 9.89 47 364666 16205 46305144
Wound 33.17 9.89 197 364516 42605 46278744
Unintended pregnancy 33.15 9.89 3 364710 5657 46315692
Uterine perforation 33.10 9.89 8 364705 7259 46314090
Bladder irritation 33.09 9.89 19 364694 149 46321200
Supraventricular extrasystoles 32.58 9.89 88 364625 4041 46317308
Adjustment disorder 32.49 9.89 47 364666 1352 46319997
Atrioventricular block second degree 32.04 9.89 83 364630 3716 46317633
Stillbirth 31.91 9.89 6 364707 6485 46314864
Ischaemic stroke 31.90 9.89 232 364481 16490 46304859
Injection site urticaria 31.74 9.89 28 364685 11939 46309410
Nodal rhythm 31.70 9.89 52 364661 1673 46319676
Joint swelling 31.41 9.89 1023 363690 165050 46156299
Blood creatine phosphokinase increased 31.30 9.89 343 364370 27381 46293968
Intestinal malrotation 30.93 9.89 24 364689 325 46321024
Allergic reaction to excipient 30.61 9.89 23 364690 296 46321053
Pulmonary renal syndrome 30.56 9.89 25 364688 367 46320982
Dysarthria 30.36 9.89 436 364277 37062 46284287
Psychotic disorder 30.26 9.89 84 364629 22537 46298812
Red blood cell sedimentation rate increased 29.87 9.89 86 364627 22803 46298546
Altered state of consciousness 29.73 9.89 296 364417 23052 46298297
Ovarian cyst 29.57 9.89 40 364673 14047 46307302
Malaise 29.00 9.89 2983 361730 328249 45993100
Intentional product use issue 28.89 9.89 268 364445 52512 46268837
Hyperaldosteronism 28.89 9.89 21 364692 256 46321093
Hyperdynamic left ventricle 28.82 9.89 17 364696 141 46321208
Therapeutic response decreased 28.67 9.89 208 364505 42937 46278412
Urticaria 28.45 9.89 702 364011 117190 46204159
Colitis ulcerative 28.33 9.89 60 364653 17672 46303677
Lacunar infarction 28.23 9.89 75 364638 3410 46317939
Hyperuricaemia 28.12 9.89 91 364622 4626 46316723
Gingival swelling 28.03 9.89 81 364632 3869 46317480
Premature delivery 28.02 9.89 84 364629 21985 46299364
Urine output decreased 27.89 9.89 165 364548 10932 46310417
Glomerulonephritis rapidly progressive 27.86 9.89 31 364682 680 46320669
Tenosynovitis 27.66 9.89 12 364701 7503 46313846
Mucosal inflammation 27.32 9.89 185 364528 38791 46282558
Cholecystitis chronic 27.32 9.89 25 364688 10474 46310875
Hypoglycaemic coma 26.81 9.89 61 364652 2513 46318836
Bone marrow failure 26.62 9.89 130 364583 29539 46291810
Anaphylactic reaction 26.42 9.89 276 364437 52836 46268513
Multiple sclerosis 26.28 9.89 102 364611 24689 46296660
Arrhythmia 26.20 9.89 400 364313 34441 46286908
Discomfort 25.97 9.89 236 364477 46434 46274915
Chronic pigmented purpura 25.94 9.89 12 364701 56 46321293
Drug level increased 25.56 9.89 238 364475 18203 46303146
Nocturia 25.53 9.89 117 364596 7015 46314334
Metabolic alkalosis 25.47 9.89 61 364652 2599 46318750
Gingival bleeding 25.46 9.89 167 364546 11472 46309877
Loose tooth 25.46 9.89 69 364644 3175 46318174
Anaemia 25.38 9.89 2324 362389 253455 46067894
Parkinsonism 25.27 9.89 126 364587 7822 46313527
Bundle branch block right 25.23 9.89 89 364624 4730 46316619
Bone erosion 25.16 9.89 22 364691 9421 46311928
Pathogen resistance 25.12 9.89 8 364705 6052 46315297
Sinus arrest 25.08 9.89 47 364666 1684 46319665
Foetal death 24.99 9.89 19 364694 8724 46312625
Angina unstable 24.95 9.89 121 364592 7427 46313922
Acute myeloid leukaemia 24.70 9.89 54 364659 15724 46305625
Device issue 24.69 9.89 77 364636 19903 46301446
Amenorrhoea 24.58 9.89 20 364693 8875 46312474
Product label on wrong product 24.55 9.89 7 364706 3 46321346
Joint effusion 24.24 9.89 35 364678 11960 46309389
Lip swelling 24.15 9.89 304 364409 25091 46296258
Haematotoxicity 24.08 9.89 12 364701 6921 46314428
Nephrosclerosis 23.97 9.89 34 364679 960 46320389
Immunodeficiency 23.87 9.89 41 364672 13065 46308284
Suicidal ideation 23.76 9.89 304 364409 56078 46265271
Glycosylated haemoglobin increased 23.76 9.89 156 364557 10720 46310629
No adverse event 23.74 9.89 163 364550 34068 46287281
Hip arthroplasty 23.67 9.89 68 364645 18044 46303305
Generalised tonic-clonic seizure 23.67 9.89 120 364593 27002 46294347
Gastrointestinal haemorrhage 23.63 9.89 781 363932 76592 46244757
Body temperature increased 23.44 9.89 107 364606 24754 46296595
Device difficult to use 23.39 9.89 17 364696 7987 46313362
Hypomagnesaemia 23.36 9.89 271 364442 21939 46299410
Chest pain 23.31 9.89 1638 363075 174686 46146663
Wrong technique in product usage process 23.10 9.89 293 364420 54129 46267220
Irritability 23.08 9.89 132 364581 28814 46292535
Personality disorder 22.97 9.89 65 364648 3068 46318281
Panniculitis 22.82 9.89 8 364705 5696 46315653
Osteopenia 22.67 9.89 63 364650 16898 46304451
Impaired healing 22.59 9.89 181 364532 36562 46284787
Staphylococcal infection 22.56 9.89 175 364538 35596 46285753
Ischaemia 22.55 9.89 81 364632 4343 46317006
Blood pressure abnormal 22.45 9.89 168 364545 12049 46309300
Suicide attempt 22.43 9.89 576 364137 54460 46266889
Injection site haemorrhage 22.08 9.89 85 364628 20624 46300725
Blood potassium decreased 22.07 9.89 419 364294 37644 46283705
Conjoined twins 22.07 9.89 18 364695 263 46321086
Listless 22.06 9.89 49 364664 1986 46319363
Scleral discolouration 21.81 9.89 20 364693 345 46321004
Injection site rash 21.69 9.89 58 364655 15755 46305594
Sleep disorder due to general medical condition, insomnia type 21.63 9.89 7 364706 5242 46316107
Myocardial depression 21.38 9.89 23 364690 485 46320864
Labile hypertension 21.38 9.89 23 364690 485 46320864
Harlequin syndrome 21.34 9.89 9 364704 32 46321317
Lichen nitidus 21.17 9.89 11 364702 69 46321280
Folliculitis 21.15 9.89 11 364702 6192 46315157
Hyperkaliuria 21.07 9.89 10 364703 50 46321299
Blood potassium increased 21.07 9.89 214 364499 16753 46304596
Ill-defined disorder 21.04 9.89 123 364590 26704 46294645
Injury 21.01 9.89 231 364482 43796 46277553
Status epilepticus 20.94 9.89 49 364664 13930 46307419
Unintentional medical device removal 20.76 9.89 5 364708 4548 46316801
Taste disorder 20.72 9.89 96 364617 5782 46315567
Lymphocele 20.71 9.89 29 364684 809 46320540
Gangrene 20.65 9.89 82 364631 4613 46316736
Tubulointerstitial nephritis 20.57 9.89 191 364522 14597 46306752
Lymphocyte stimulation test positive 20.55 9.89 25 364688 605 46320744
Schizophrenia 20.46 9.89 22 364691 8546 46312803
Swelling 20.32 9.89 781 363932 123730 46197619
Gallbladder adenocarcinoma 20.31 9.89 11 364702 76 46321273
Gestational diabetes 20.24 9.89 16 364697 7203 46314146
Suspected suicide 20.18 9.89 81 364632 4580 46316769
Blood aldosterone increased 20.16 9.89 14 364699 158 46321191
Retinal ischaemia 20.13 9.89 18 364695 300 46321049
Generalised oedema 20.04 9.89 186 364527 14213 46307136
Faeces discoloured 20.03 9.89 210 364503 16577 46304772
Ear infection 19.98 9.89 102 364611 22911 46298438
Premature rupture of membranes 19.89 9.89 5 364708 4418 46316931
Loss of consciousness 19.84 9.89 1035 363678 107203 46214146
Galactorrhoea 19.79 9.89 3 364710 3794 46317555
Arteriosclerosis 19.70 9.89 137 364576 9596 46311753
Diabetic nephropathy 19.64 9.89 37 364676 1331 46320018
Retinopathy hypertensive 19.61 9.89 16 364697 234 46321115
Psoriasis 19.52 9.89 466 364247 78138 46243211
Influenza like illness 19.51 9.89 324 364389 57246 46264103
Hypertensive heart disease 19.40 9.89 54 364659 2524 46318825
Tongue oedema 19.29 9.89 72 364641 3934 46317415
Gingival atrophy 19.28 9.89 8 364705 27 46321322
Aortic aneurysm 19.24 9.89 65 364648 3379 46317970
Bradyarrhythmia 19.21 9.89 46 364667 1960 46319389
Neurotoxicity 19.05 9.89 50 364663 13667 46307682
Gastric ulcer haemorrhage 19.04 9.89 82 364631 4786 46316563
Duodenal ulcer perforation 19.03 9.89 23 364690 8479 46312870
Ageusia 19.00 9.89 154 364559 11318 46310031
Crohn's disease 18.99 9.89 15 364698 6756 46314593
Sickle cell anaemia with crisis 18.97 9.89 4 364709 3988 46317361
Transcription medication error 18.90 9.89 14 364699 176 46321173
Death 18.89 9.89 2314 362399 333234 45988115
Peripheral swelling 18.62 9.89 1455 363258 156616 46164733
Acute coronary syndrome 18.57 9.89 140 364573 10064 46311285
Pollakiuria 18.42 9.89 279 364434 23982 46297367
Agitation 18.41 9.89 313 364400 55102 46266247
Ventricular failure 18.14 9.89 18 364695 344 46321005
Hypocalcaemia 18.07 9.89 302 364411 26483 46294866
Oral discharge 18.05 9.89 13 364700 156 46321193
Complication of device insertion 18.03 9.89 8 364705 4936 46316413
Urine albumin/creatinine ratio increased 17.92 9.89 13 364700 158 46321191
Product substitution issue 17.91 9.89 188 364525 14843 46306506
Skin weeping 17.91 9.89 15 364698 228 46321121
Rectourethral fistula 17.88 9.89 8 364705 34 46321315
C-reactive protein increased 17.86 9.89 336 364377 58254 46263095
Dyspnoea exertional 17.84 9.89 517 364196 49772 46271577
Drug hypersensitivity 17.80 9.89 1651 363062 242174 46079175
Prescription drug used without a prescription 17.79 9.89 36 364677 1366 46319983
Device deployment issue 17.73 9.89 3 364710 3500 46317849
Upper respiratory tract infection 17.71 9.89 370 364343 63186 46258163
Acute motor-sensory axonal neuropathy 17.65 9.89 18 364695 356 46320993
Respiratory failure 17.65 9.89 908 363805 93908 46227441
Mydriasis 17.46 9.89 35 364678 10518 46310831
Gastrointestinal toxicity 17.46 9.89 6 364707 4325 46317024
Aggression 17.45 9.89 105 364608 22639 46298710
Dysgeusia 17.45 9.89 427 364286 40064 46281285
Pseudolymphoma 17.44 9.89 23 364690 605 46320744
Myocardial ischaemia 17.40 9.89 164 364549 12585 46308764
Cytomegalovirus infection 17.16 9.89 78 364635 18066 46303283
Maternal drugs affecting foetus 17.09 9.89 11 364702 5507 46315842
Pancreatic toxicity 17.01 9.89 7 364706 23 46321326
Autoimmune enteropathy 16.97 9.89 5 364708 3 46321346
Venoocclusive liver disease 16.94 9.89 6 364707 4245 46317104
Vitello-intestinal duct remnant 16.86 9.89 8 364705 40 46321309
Vaginal haemorrhage 16.74 9.89 124 364589 25480 46295869
Hypoperfusion 16.70 9.89 35 364678 1362 46319987
Myalgia 16.70 9.89 1146 363567 121942 46199407
Haematemesis 16.67 9.89 317 364396 28489 46292860
Heart rate decreased 16.64 9.89 344 364369 31379 46289970
Fryns syndrome 16.63 9.89 9 364704 62 46321287
Congenital bladder anomaly 16.63 9.89 13 364700 178 46321171
Head discomfort 16.63 9.89 138 364575 10213 46311136
Benign neoplasm of adrenal gland 16.58 9.89 7 364706 25 46321324
Haemodialysis 16.51 9.89 126 364587 9091 46312258
Menstruation irregular 16.51 9.89 16 364697 6523 46314826
Thrombocytopenia 16.50 9.89 814 363899 125767 46195582
Lichen planus 16.45 9.89 41 364672 1792 46319557
Therapy partial responder 16.42 9.89 8 364705 4674 46316675
Urachal abnormality 16.40 9.89 13 364700 182 46321167
Dermatosis 16.37 9.89 16 364697 300 46321049
Fear of injection 16.28 9.89 6 364707 4141 46317208
Putamen haemorrhage 16.26 9.89 12 364701 150 46321199
Post transplant lymphoproliferative disorder 16.15 9.89 5 364708 3851 46317498
Nephrogenic systemic fibrosis 16.14 9.89 77 364636 4695 46316654
Multiple drug therapy 16.12 9.89 27 364686 884 46320465
Rectal ulcer haemorrhage 16.11 9.89 13 364700 187 46321162
Nodule 16.04 9.89 65 364648 15540 46305809
Carotid arteriosclerosis 15.97 9.89 28 364685 952 46320397
Febrile bone marrow aplasia 15.97 9.89 18 364695 6844 46314505
Fibromuscular dysplasia 15.95 9.89 9 364704 68 46321281
Feeling abnormal 15.87 9.89 1158 363555 123902 46197447
Haematochezia 15.74 9.89 394 364319 37099 46284250
Hallucination, gustatory 15.74 9.89 9 364704 70 46321279
Intestinal villi atrophy 15.62 9.89 12 364701 160 46321189
Product storage error 15.61 9.89 44 364669 11748 46309601
Hyperplastic cholecystopathy 15.57 9.89 10 364703 98 46321251
Ventricular septal defect 15.56 9.89 6 364707 4028 46317321
CD30 expression 15.42 9.89 7 364706 31 46321318
Persistent cloaca 15.39 9.89 13 364700 200 46321149
Helicobacter infection 15.38 9.89 44 364669 11692 46309657
Lymphocyte count decreased 15.30 9.89 127 364586 25462 46295887
Swelling face 15.29 9.89 532 364181 52527 46268822
Subdural haematoma 15.23 9.89 162 364551 12835 46308514
Hypergastrinaemia 15.16 9.89 10 364703 103 46321246
Presyncope 15.15 9.89 272 364441 24182 46297167
Inflammation 15.10 9.89 279 364434 48502 46272847
Cystic fibrosis 15.06 9.89 5 364708 3683 46317666
Eating disorder 15.05 9.89 178 364535 14476 46306873
Sinus rhythm 15.05 9.89 21 364692 584 46320765
Aspergillus infection 15.04 9.89 19 364694 6871 46314478
Enthesopathy 15.01 9.89 9 364704 4681 46316668
Disorientation 14.93 9.89 386 364327 36532 46284817
Soft tissue disorder 14.91 9.89 7 364706 4179 46317170
Blood cholinesterase decreased 14.87 9.89 11 364702 138 46321211
Cytokine release syndrome 14.83 9.89 16 364697 6207 46315142
Substance abuse 14.80 9.89 7 364706 4160 46317189
Acne 14.74 9.89 93 364620 19826 46301523
Hypernatraemia 14.71 9.89 93 364620 6308 46315041
Blood glucose decreased 14.63 9.89 218 364495 18674 46302675
Device use error 14.58 9.89 11 364702 5070 46316279
Retroperitoneal oedema 14.52 9.89 6 364707 20 46321329
Weight increased 14.51 9.89 1097 363616 163376 46157973
Bursitis 14.50 9.89 93 364620 19749 46301600
Infected dermal cyst 14.47 9.89 18 364695 446 46320903
Dysphoria 14.41 9.89 9 364704 4580 46316769
Osteonecrosis 14.40 9.89 130 364583 25614 46295735
Blood uric acid increased 14.36 9.89 68 364645 4133 46317216
Tendonitis 14.34 9.89 60 364653 14217 46307132
Nephrogenic anaemia 14.33 9.89 40 364673 1873 46319476
Dementia 14.31 9.89 179 364534 14751 46306598
Osteoporosis 14.27 9.89 227 364486 40381 46280968
Renal cell carcinoma 14.15 9.89 60 364653 3478 46317871
Apical granuloma 14.15 9.89 7 364706 39 46321310
Acute hepatic failure 14.09 9.89 63 364650 14658 46306691
Breast cancer metastatic 14.04 9.89 57 364656 13621 46307728
Hypertensive angiopathy 14.03 9.89 9 364704 88 46321261
Respiratory tract infection 14.00 9.89 158 364555 29814 46291535
Kidney fibrosis 13.99 9.89 33 364680 1392 46319957
Gout 13.99 9.89 143 364570 11213 46310136
Secondary hypertension 13.96 9.89 10 364703 119 46321230
Lymphadenopathy 13.95 9.89 181 364532 33307 46288042
Microalbuminuria 13.92 9.89 15 364698 317 46321032
Sinus arrhythmia 13.91 9.89 32 364681 1328 46320021
Bromhidrosis 13.89 9.89 5 364708 10 46321339
Electrocardiogram U wave present 13.86 9.89 9 364704 90 46321259
Congenital nail disorder 13.78 9.89 9 364704 91 46321258
Peripheral arterial occlusive disease 13.76 9.89 62 364651 3690 46317659
Organ failure 13.70 9.89 47 364666 2463 46318886
Pulmonary hypoplasia 13.64 9.89 14 364699 279 46321070
Muscle spasms 13.64 9.89 1128 363585 121985 46199364
Bowel movement irregularity 13.63 9.89 58 364655 3367 46317982
Transplant dysfunction 13.61 9.89 10 364703 4672 46316677
Congenital acrochordon 13.60 9.89 8 364705 66 46321283
Gingivitis 13.58 9.89 103 364610 7417 46313932
Herpes zoster 13.56 9.89 415 364298 67457 46253892
Platelet aggregation decreased 13.50 9.89 6 364707 25 46321324
Carcinoid tumour of the caecum 13.50 9.89 6 364707 25 46321324
Burn oesophageal 13.47 9.89 11 364702 161 46321188
Product monitoring error 13.46 9.89 40 364673 1941 46319408
Genital haemorrhage 13.43 9.89 19 364694 6547 46314802
Insulin-like growth factor decreased 13.42 9.89 16 364697 379 46320970
Hypothermia 13.42 9.89 150 364563 12033 46309316
Yellow skin 13.39 9.89 41 364672 2023 46319326
Hypertensive encephalopathy 13.39 9.89 21 364692 650 46320699
Cerebral ischaemia 13.38 9.89 90 364623 6235 46315114
Thalamus haemorrhage 13.36 9.89 19 364694 538 46320811
Skin tightness 13.30 9.89 63 364650 3830 46317519
Ankylosing spondylitis 13.28 9.89 20 364693 6717 46314632
Abnormal loss of weight 13.17 9.89 75 364638 4900 46316449
Drug screen positive 13.12 9.89 7 364706 3884 46317465
Suspected product quality issue 13.09 9.89 11 364702 168 46321181
Small for dates baby 13.08 9.89 6 364707 3631 46317718
Joint stiffness 13.02 9.89 142 364571 26966 46294383
Norepinephrine increased 13.02 9.89 8 364705 72 46321277
Knee arthroplasty 13.02 9.89 120 364593 23545 46297804
Facial nerve disorder 13.00 9.89 19 364694 552 46320797
Albuminuria 12.99 9.89 12 364701 209 46321140
Blood calcium decreased 12.99 9.89 183 364530 15490 46305859
Stomatitis haemorrhagic 12.97 9.89 6 364707 28 46321321
Gastrointestinal ischaemia 12.95 9.89 12 364701 210 46321139
Device malfunction 12.94 9.89 57 364656 13317 46308032
Tonsillar inflammation 12.93 9.89 9 364704 102 46321247
Incorrect route of product administration 12.91 9.89 75 364638 16308 46305041
Anorexia nervosa 12.82 9.89 11 364702 173 46321176
Saliva discolouration 12.80 9.89 6 364707 29 46321320
Cardiac failure chronic 12.75 9.89 58 364655 3466 46317883
Venous aneurysm 12.70 9.89 4 364709 4 46321345
Oropharyngeal swelling 12.67 9.89 24 364689 867 46320482
Intentional product misuse 12.65 9.89 276 364437 46852 46274497
Femoral artery dissection 12.64 9.89 6 364707 30 46321319
Jaundice hepatocellular 12.64 9.89 6 364707 30 46321319
Mania 12.57 9.89 43 364670 10803 46310546
Transplant rejection 12.56 9.89 36 364677 9560 46311789
Duodenal ulcer 12.56 9.89 98 364615 7120 46314229
Urinary retention 12.51 9.89 279 364434 25782 46295567
Gravitational oedema 12.51 9.89 27 364686 1073 46320276
Psychogenic visual disorder 12.49 9.89 5 364708 15 46321334
Hypoglossal nerve paralysis 12.49 9.89 5 364708 15 46321334
Diverticulum intestinal haemorrhagic 12.44 9.89 29 364684 1214 46320135
Haemodynamic instability 12.41 9.89 103 364610 7622 46313727
Capillary disorder 12.41 9.89 8 364705 79 46321270
Tuberculosis 12.37 9.89 40 364673 10225 46311124
Injection site induration 12.36 9.89 28 364685 8051 46313298
Adenoma benign 12.33 9.89 21 364692 697 46320652
Psychomotor retardation 12.29 9.89 54 364659 3179 46318170
Immune reconstitution inflammatory syndrome 12.28 9.89 16 364697 5709 46315640
Fatigue 12.26 9.89 4420 360293 604277 45717072
Blood cholinesterase increased 12.25 9.89 5 364708 16 46321333
Acral lentiginous melanoma 12.24 9.89 4 364709 5 46321344
Device breakage 12.22 9.89 37 364676 9655 46311694
Nephrolithiasis 12.21 9.89 183 364530 32868 46288481
Blood loss anaemia 12.14 9.89 111 364602 8446 46312903
Renal tubular necrosis 12.09 9.89 133 364580 10626 46310723
Electrocardiogram abnormal 12.09 9.89 95 364618 6917 46314432
Duodenal ulcer repair 12.08 9.89 7 364706 56 46321293
Bifascicular block 12.03 9.89 9 364704 115 46321234
Biopsy kidney 12.03 9.89 9 364704 115 46321234
Thirst 12.03 9.89 135 364578 10841 46310508
Atrial pressure increased 12.02 9.89 5 364708 17 46321332
Gastric cancer 11.97 9.89 50 364663 2879 46318470
Gastrointestinal disorder 11.97 9.89 364 364349 59212 46262137
Hypomania 11.96 9.89 10 364703 4378 46316971
Hyperprolactinaemia 11.93 9.89 4 364709 2928 46318421
Cerebral haemorrhage 11.87 9.89 298 364415 28073 46293276
Dry eye 11.86 9.89 166 364547 30156 46291193
Accelerated hypertension 11.84 9.89 15 364698 379 46320970
Ischaemic cardiomyopathy 11.82 9.89 46 364667 2564 46318785
Hypereosinophilic syndrome 11.78 9.89 12 364701 237 46321112
Cytotoxic oedema 11.78 9.89 9 364704 119 46321230
Fungal infection 11.77 9.89 161 364552 29359 46291990
Ear pain 11.73 9.89 113 364600 21979 46299370
Candida infection 11.71 9.89 114 364599 22126 46299223
Congenital diaphragmatic hernia 11.71 9.89 11 364702 196 46321153
Cognitive disorder 11.70 9.89 374 364339 36509 46284840
Periodontitis 11.69 9.89 56 364657 3420 46317929
Bladder sphincter atony 11.67 9.89 10 364703 157 46321192
Tachypnoea 11.67 9.89 167 364546 14184 46307165
Normal newborn 11.65 9.89 18 364695 5983 46315366
Sinus node dysfunction 11.58 9.89 65 364648 4224 46317125
Adrenal neoplasm 11.58 9.89 13 364700 288 46321061
Enterochromaffin cell hyperplasia 11.58 9.89 7 364706 61 46321288
Tongue abscess 11.58 9.89 3 364710 0 46321349
Herpes zoster reactivation 11.58 9.89 3 364710 0 46321349
Carbohydrate metabolism disorder 11.58 9.89 3 364710 0 46321349
Cardiac index increased 11.58 9.89 3 364710 0 46321349
Typical aura without headache 11.58 9.89 3 364710 0 46321349
Blood pressure difference of extremities 11.58 9.89 3 364710 0 46321349
Morganella test positive 11.58 9.89 3 364710 0 46321349
Ventricular drainage 11.58 9.89 3 364710 0 46321349
Diabetes mellitus 11.58 9.89 490 364223 49575 46271774
Retroperitoneal haematoma 11.53 9.89 46 364667 2594 46318755
Finger deformity 11.52 9.89 14 364699 5148 46316201
Infusion site streaking 11.50 9.89 14 364699 339 46321010
Headache 11.50 9.89 3449 361264 474903 45846446
Hyperhidrosis 11.50 9.89 575 364138 88733 46232616
Vertigo 11.50 9.89 507 364206 51541 46269808
Intestinal ischaemia 11.49 9.89 93 364620 6832 46314517
Clostridium difficile infection 11.47 9.89 133 364580 24970 46296379
Ectopic pregnancy 11.45 9.89 3 364710 2579 46318770
Protein urine present 11.45 9.89 74 364639 5057 46316292
Mitral valve incompetence 11.44 9.89 209 364504 18643 46302706
Leukaemic infiltration renal 11.41 9.89 5 364708 20 46321329
Renal function test abnormal 11.38 9.89 47 364666 2692 46318657
Dialysis 11.35 9.89 125 364588 9991 46311358
Vasculitis 11.32 9.89 160 364553 13551 46307798
Disability 11.32 9.89 41 364672 10126 46311223
Neurosensory hypoacusis 11.30 9.89 13 364700 296 46321053
Hypertonic bladder 11.29 9.89 50 364663 2954 46318395
Cerebrovascular insufficiency 11.25 9.89 8 364705 94 46321255
Deformity 11.22 9.89 25 364688 7232 46314117
Central nervous system lesion 11.22 9.89 38 364675 9577 46311772
Acute graft versus host disease 11.21 9.89 9 364704 4021 46317328
Wrong drug 11.18 9.89 9 364704 129 46321220
Tracheo-oesophageal fistula 11.18 9.89 17 364696 512 46320837
Arterial occlusive disease 11.17 9.89 70 364643 4734 46316615
Fluid intake reduced 11.15 9.89 54 364659 3312 46318037
Purpura 11.15 9.89 123 364590 9835 46311514
Base excess decreased 11.12 9.89 7 364706 66 46321283
Coronary arterial stent insertion 11.11 9.89 48 364665 2805 46318544
Stress 11.10 9.89 312 364401 51239 46270110
Drug tolerance decreased 11.08 9.89 5 364708 3054 46318295
Small cell carcinoma 11.07 9.89 10 364703 169 46321180
Hyperlipidaemia 11.06 9.89 205 364508 18334 46303015
Internal haemorrhage 11.04 9.89 66 364647 4389 46316960
Upper gastrointestinal haemorrhage 11.02 9.89 188 364525 16550 46304799
Pulse abnormal 10.99 9.89 33 364680 1611 46319738
Head banging 10.97 9.89 15 364698 409 46320940
Product solubility abnormal 10.96 9.89 22 364691 830 46320519
Anti-erythropoietin antibody positive 10.94 9.89 15 364698 410 46320939
Pneumonia viral 10.93 9.89 22 364691 6602 46314747
Haemoglobin decreased 10.91 9.89 1159 363554 127790 46193559
Gastric pH increased 10.90 9.89 6 364707 43 46321306
Pericardial effusion 10.90 9.89 269 364444 25274 46296075
Dystonia 10.88 9.89 48 364665 11209 46310140
Blood sodium decreased 10.88 9.89 234 364479 21492 46299857
Acquired porphyria 10.87 9.89 5 364708 23 46321326
Porphyrins urine increased 10.87 9.89 5 364708 23 46321326
Hand dermatitis 10.87 9.89 7 364706 69 46321280
Trichoglossia 10.84 9.89 9 364704 135 46321214
Renal cyst infection 10.84 9.89 8 364705 100 46321249
Blood sodium increased 10.80 9.89 44 364669 2505 46318844
Renal aneurysm 10.80 9.89 4 364709 9 46321340
Mixed dementia 10.80 9.89 4 364709 9 46321340
Heat illness 10.79 9.89 10 364703 175 46321174
Ventricular internal diameter abnormal 10.78 9.89 6 364707 44 46321305
Disease progression 10.78 9.89 593 364120 90707 46230642
Essential hypertension 10.78 9.89 64 364649 4246 46317103
Aphasia 10.78 9.89 296 364417 28271 46293078
Dermatitis bullous 10.77 9.89 99 364614 7544 46313805
Optic nerve injury 10.76 9.89 16 364697 472 46320877
Ventricular extrasystoles 10.76 9.89 133 364580 10930 46310419
Reduced facial expression 10.65 9.89 27 364686 1193 46320156
Drug abuser 10.63 9.89 6 364707 3227 46318122
Granuloma skin 10.63 9.89 7 364706 3463 46317886
Depression 10.58 9.89 1165 363548 168939 46152410
Injection site discolouration 10.53 9.89 24 364689 6886 46314463
Skin discolouration 10.52 9.89 332 364381 32348 46289001
Hepatocellular carcinoma 10.48 9.89 47 364666 2792 46318557
Surgery 10.42 9.89 160 364553 28625 46292724
Neurofibrosarcoma 10.42 9.89 9 364704 143 46321206
Nephrotic syndrome 10.40 9.89 70 364643 4851 46316498
Asymptomatic bacteriuria 10.38 9.89 7 364706 75 46321274
Pigmentation disorder 10.36 9.89 57 364656 3676 46317673
Metastases to fallopian tube 10.35 9.89 6 364707 48 46321301
Rales 10.34 9.89 118 364595 9513 46311836
Haemorrhagic erosive gastritis 10.34 9.89 12 364701 276 46321073
Pelvic pain 10.31 9.89 51 364662 11551 46309798
Blood iron abnormal 10.26 9.89 6 364707 3164 46318185
Laryngeal obstruction 10.23 9.89 5 364708 27 46321322
Cardiac valve sclerosis 10.23 9.89 5 364708 27 46321322
Embedded device 10.20 9.89 5 364708 2911 46318438
Cerebellar haemorrhage 10.16 9.89 28 364685 1301 46320048
Pernicious anaemia 10.15 9.89 19 364694 680 46320669
Sleep disorder 10.13 9.89 283 364430 46512 46274837
Lip disorder 10.10 9.89 25 364688 1088 46320261
Cell marker increased 10.09 9.89 13 364700 334 46321015
Urate nephropathy 10.09 9.89 8 364705 112 46321237
Pelvi-ureteric obstruction 10.09 9.89 8 364705 112 46321237
Oesophageal carcinoma recurrent 10.08 9.89 5 364708 28 46321321
Grip strength decreased 10.05 9.89 34 364679 8572 46312777
Albumin urine present 10.04 9.89 11 364702 237 46321112
Graft versus host disease in skin 10.04 9.89 3 364710 2364 46318985
Blood lactic acid 10.03 9.89 8 364705 113 46321236
Synovial cyst 10.03 9.89 27 364686 7319 46314030
Pneumothorax traumatic 10.02 9.89 9 364704 151 46321198
Forced vital capacity decreased 10.01 9.89 22 364691 885 46320464
Cerebrovascular disorder 10.01 9.89 47 364666 2847 46318502
Temperature regulation disorder 10.00 9.89 7 364706 3353 46317996
Stomatitis 9.94 9.89 434 364279 67863 46253486

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
Completed suicide 429.95 10.78 2051 297353 97441 29555633
Drug abuse 381.95 10.78 171 299233 81901 29571173
Gingival hypertrophy 376.44 10.78 223 299181 1410 29651664
Blood pressure inadequately controlled 256.96 10.78 210 299194 2360 29650714
Drug ineffective 247.39 10.78 2196 297208 338191 29314883
Hypertension 243.57 10.78 2057 297347 119297 29533777
Off label use 199.43 10.78 1567 297837 247723 29405351
Hypertensive crisis 190.72 10.78 318 299086 8039 29645035
Shock 177.91 10.78 568 298836 22291 29630783
Oedema peripheral 177.07 10.78 1725 297679 104107 29548967
Death 174.19 10.78 2521 296883 354762 29298312
Neutropenia 170.25 10.78 684 298720 127856 29525218
Blood pressure increased 155.27 10.78 1240 298164 70688 29582386
Febrile neutropenia 154.73 10.78 547 298857 106146 29546928
Foetal exposure during pregnancy 153.23 10.78 89 299315 36782 29616292
Angioedema 141.12 10.78 699 298705 33685 29619389
Bradycardia 139.98 10.78 1127 298277 64399 29588675
Acute kidney injury 137.56 10.78 3645 295759 270197 29382877
Non-cardiogenic pulmonary oedema 132.99 10.78 84 299320 605 29652469
Product use in unapproved indication 130.95 10.78 344 299060 73349 29579725
Intentional overdose 125.21 10.78 776 298628 40705 29612369
Treatment failure 115.15 10.78 106 299298 34573 29618501
Hypotension 113.65 10.78 2714 296690 197851 29455223
Cerebral infarction 113.12 10.78 543 298861 25830 29627244
Syncope 102.11 10.78 1297 298107 83606 29569468
Angina pectoris 92.72 10.78 558 298846 28960 29624114
Rheumatoid arthritis 87.14 10.78 175 299229 41022 29612052
Hypokalaemia 82.77 10.78 816 298588 49376 29603698
Thrombocytopenia 81.59 10.78 926 298478 136118 29516956
Swollen tongue 77.69 10.78 299 299105 12893 29640181
Blood creatinine increased 77.16 10.78 1313 298091 90062 29563012
Hyperkalaemia 76.21 10.78 1001 298403 65009 29588065
Drug resistance 74.94 10.78 55 299349 20078 29632996
Pancytopenia 74.23 10.78 521 298883 84531 29568543
Lip swelling 72.73 10.78 286 299118 12458 29640616
Aggression 72.03 10.78 164 299240 36743 29616331
Immune reconstitution inflammatory syndrome 71.48 10.78 5 299399 9096 29643978
Drug dependence 70.79 10.78 65 299339 21230 29631844
Pyrexia 70.29 10.78 2327 297077 292162 29360912
Cerebrovascular accident 68.12 10.78 1193 298211 82284 29570790
Blood pressure systolic increased 66.16 10.78 313 299091 14797 29638277
Premature baby 64.22 10.78 44 299360 16647 29636427
Renal impairment 63.03 10.78 1187 298217 82997 29570077
Seizure 59.90 10.78 662 298742 97813 29555261
Rhabdomyolysis 58.60 10.78 927 298477 62653 29590421
Metabolic acidosis 58.36 10.78 602 298802 36859 29616215
Dizziness 57.58 10.78 2439 296965 192470 29460604
Distributive shock 56.76 10.78 49 299355 597 29652477
Infective pulmonary exacerbation of cystic fibrosis 56.41 10.78 9 299395 8563 29644511
Sepsis 55.53 10.78 1080 298324 145315 29507759
Pathogen resistance 54.97 10.78 9 299395 8401 29644673
Exposure during pregnancy 54.06 10.78 13 299391 9248 29643826
Agitation 53.38 10.78 319 299085 53754 29599320
Mucosal inflammation 52.88 10.78 144 299260 30350 29622724
Infusion related reaction 51.63 10.78 219 299185 40345 29612729
Lactic acidosis 51.21 10.78 507 298897 30706 29622368
Leukopenia 47.04 10.78 348 299056 55811 29597263
Chronic kidney disease 46.69 10.78 581 298823 37257 29615817
Glycosylated haemoglobin increased 46.31 10.78 203 299201 9288 29643786
Pemphigoid 46.29 10.78 173 299231 7355 29645719
Interstitial lung disease 46.14 10.78 852 298552 59345 29593729
Chronic pigmented purpura 45.02 10.78 22 299382 88 29652986
Progressive multifocal leukoencephalopathy 44.75 10.78 17 299387 8996 29644078
Palmar-plantar erythrodysaesthesia syndrome 43.48 10.78 276 299128 14594 29638480
Cardiac failure congestive 42.53 10.78 1125 298279 83282 29569792
Nephrotic syndrome 42.14 10.78 158 299246 6727 29646347
Myalgia 41.60 10.78 1032 298372 75635 29577439
Septic shock 41.32 10.78 421 298983 63186 29589888
Acute graft versus host disease 41.31 10.78 5 299399 5859 29647215
Pulmonary oedema 41.20 10.78 643 298761 43332 29609742
Abnormal behaviour 40.07 10.78 127 299277 25496 29627578
Suicidal ideation 40.04 10.78 205 299199 35909 29617165
Myocardial depression 39.96 10.78 16 299388 34 29653040
Renal artery stenosis 39.34 10.78 68 299336 1771 29651303
Multiple organ dysfunction syndrome 39.29 10.78 425 298979 63062 29590012
Depression 39.04 10.78 652 298752 89785 29563289
Product use issue 38.60 10.78 285 299119 45731 29607343
Hypoglycaemia 37.15 10.78 716 298688 50265 29602809
Gingival swelling 37.07 10.78 54 299350 1210 29651864
Hypomagnesaemia 36.77 10.78 288 299116 16310 29636764
Synovitis 36.05 10.78 27 299377 9756 29643318
Diabetic nephropathy 35.98 10.78 66 299338 1803 29651271
Suicide attempt 35.69 10.78 540 298864 36157 29616917
Atrioventricular block complete 35.23 10.78 173 299231 8304 29644770
Hyponatraemia 34.80 10.78 899 298505 66303 29586771
Bone marrow failure 34.20 10.78 167 299237 29618 29623456
5-hydroxyindolacetic acid in urine increased 34.16 10.78 23 299381 187 29652887
Aspergillus infection 34.16 10.78 31 299373 10183 29642891
Psychotic disorder 34.09 10.78 106 299298 21409 29631665
Proteinuria 34.05 10.78 277 299127 15868 29637206
Infection 33.98 10.78 562 298842 77512 29575562
Suspected suicide 33.74 10.78 88 299316 3073 29650001
Pseudolymphoma 33.46 10.78 33 299371 482 29652592
Cytomegalovirus infection 33.18 10.78 123 299281 23551 29629523
Febrile bone marrow aplasia 32.99 10.78 20 299384 8077 29644997
Bronchopulmonary aspergillosis 32.63 10.78 45 299359 12239 29640835
Sedation 32.56 10.78 72 299332 16301 29636773
Drug withdrawal syndrome 32.53 10.78 96 299308 19713 29633361
Multiple sclerosis 32.44 10.78 16 299388 7251 29645823
Haemophagocytic lymphohistiocytosis 32.41 10.78 30 299374 9761 29643313
Sinus bradycardia 32.31 10.78 214 299190 11481 29641593
Cytokine release syndrome 32.21 10.78 31 299373 9902 29643172
Peripheral swelling 31.62 10.78 817 298587 60257 29592817
Plasma cell myeloma 30.68 10.78 364 299040 53098 29599976
Gingival bleeding 30.51 10.78 136 299268 6268 29646806
Tachycardia 30.40 10.78 536 298868 73203 29579871
Periodontitis 30.03 10.78 58 299346 1649 29651425
Thalamus haemorrhage 29.67 10.78 42 299362 916 29652158
Coma 29.56 10.78 260 299144 40189 29612885
Substance abuse 29.23 10.78 17 299387 7023 29646051
Graft versus host disease 29.22 10.78 35 299369 10115 29642959
Eczema 29.08 10.78 231 299173 13138 29639936
Gastrointestinal tract mucosal pigmentation 28.99 10.78 22 299382 220 29652854
Injection site pain 28.76 10.78 181 299223 30129 29622945
Contraindicated product administered 28.66 10.78 83 299321 17148 29635926
Alcohol abuse 28.47 10.78 9 299395 5344 29647730
Post transplant lymphoproliferative disorder 28.08 10.78 9 299395 5297 29647777
Heart rate decreased 27.92 10.78 327 299077 20667 29632407
Chronic graft versus host disease 27.85 10.78 4 299400 4115 29648959
Vertebral osteophyte 27.80 10.78 13 299391 46 29653028
Respiratory depression 27.78 10.78 45 299359 11458 29641616
Plasmapheresis 27.54 10.78 25 299379 327 29652747
Vasoplegia syndrome 27.19 10.78 47 299357 1224 29651850
Palpitations 27.06 10.78 479 298925 33094 29619980
Transient ischaemic attack 26.94 10.78 377 299027 24823 29628251
Staphylococcal infection 26.90 10.78 184 299220 30040 29623034
Diabetes mellitus inadequate control 26.40 10.78 218 299186 12544 29640530
Renal cell carcinoma 26.38 10.78 121 299283 5645 29647429
Intentional product use issue 26.29 10.78 235 299169 36205 29616869
Mucormycosis 26.05 10.78 10 299394 5258 29647816
Myelodysplastic syndrome 26.03 10.78 98 299306 18680 29634394
Nocturia 26.01 10.78 157 299247 8155 29644919
Intentional self-injury 25.70 10.78 61 299343 13471 29639603
Candida infection 25.55 10.78 74 299330 15288 29637786
Polymyositis 25.52 10.78 49 299355 1387 29651687
C-reactive protein abnormal 25.45 10.78 12 299392 5581 29647493
Psoriatic arthropathy 25.43 10.78 77 299327 15684 29637390
Dyskinesia 25.31 10.78 122 299282 21712 29631362
Hyperplasia 25.11 10.78 29 299375 512 29652562
Acute hepatic failure 24.35 10.78 51 299353 11776 29641298
Haematotoxicity 24.09 10.78 16 299388 6154 29646920
Primary hyperaldosteronism 24.00 10.78 12 299392 51 29653023
Pelvic mass 23.97 10.78 16 299388 128 29652946
Pain 23.96 10.78 1447 297957 171194 29481880
Dystonia 23.54 10.78 38 299366 9689 29643385
Venoocclusive liver disease 23.42 10.78 19 299385 6594 29646480
Carotid sinus syndrome 23.09 10.78 10 299394 28 29653046
Aortic dissection 23.07 10.78 65 299339 2377 29650697
Maternal drugs affecting foetus 23.06 10.78 7 299397 4266 29648808
Prerenal failure 23.03 10.78 55 299349 1816 29651258
Atrioventricular block first degree 22.87 10.78 115 299289 5573 29647501
Lipodystrophy acquired 22.85 10.78 4 299400 3556 29649518
Hyperuricaemia 22.71 10.78 139 299265 7255 29645819
Diffuse large B-cell lymphoma 22.61 10.78 27 299377 7814 29645260
Cardiogenic shock 22.58 10.78 263 299141 16598 29636476
Blood mercury abnormal 22.56 10.78 17 299387 168 29652906
Osteonecrosis 22.50 10.78 84 299320 16051 29637023
Sinusitis 22.35 10.78 219 299185 33126 29619948
Pneumonia 22.20 10.78 2966 296438 331340 29321734
Atrioventricular block 21.81 10.78 136 299268 7146 29645928
Blood pressure diastolic decreased 21.64 10.78 121 299283 6110 29646964
Wrong technique in product usage process 21.57 10.78 203 299201 30952 29622122
Loss of consciousness 21.52 10.78 985 298419 78390 29574684
Intentional product misuse 21.47 10.78 232 299172 34435 29618639
Device issue 21.40 10.78 28 299376 7788 29645286
Product monitoring error 21.24 10.78 51 299353 1690 29651384
Peripheral arterial occlusive disease 21.14 10.78 105 299299 5063 29648011
Brain contusion 20.80 10.78 32 299372 754 29652320
Mouth swelling 20.77 10.78 48 299356 1551 29651523
Orthostatic hypotension 20.72 10.78 346 299058 23633 29629441
Multiple sclerosis relapse 20.60 10.78 49 299355 10813 29642261
Leukaemoid reaction 20.54 10.78 13 299391 94 29652980
Electrocardiogram QRS complex prolonged 20.50 10.78 91 299313 4186 29648888
No adverse event 20.38 10.78 97 299307 17322 29635752
Renal disorder 20.27 10.78 340 299064 23244 29629830
Chills 20.26 10.78 559 298845 71779 29581295
Disease progression 20.17 10.78 626 298778 79248 29573826
Neutrophil count decreased 20.00 10.78 301 299103 42153 29610921
Drug ineffective for unapproved indication 19.91 10.78 50 299354 10830 29642244
Dermatomyositis 19.86 10.78 37 299367 1023 29652051
Lacunar infarction 19.81 10.78 73 299331 3082 29649992
Tongue oedema 19.76 10.78 67 299337 2713 29650361
Ischaemic stroke 19.68 10.78 249 299155 16026 29637048
Adenovirus infection 19.66 10.78 9 299395 4259 29648815
Hypertensive heart disease 19.61 10.78 61 299343 2359 29650715
Multiple-drug resistance 19.55 10.78 3 299401 2938 29650136
Irritability 19.21 10.78 143 299261 22907 29630167
Hypertensive nephropathy 19.20 10.78 23 299381 423 29652651
Drug eruption 19.06 10.78 263 299141 17263 29635811
Arthropathy 19.04 10.78 125 299279 20602 29632472
Brain stem infarction 18.98 10.78 41 299363 1265 29651809
Disease recurrence 18.92 10.78 75 299329 14086 29638988
Gout 18.89 10.78 260 299144 17055 29636019
Eyelid oedema 18.89 10.78 100 299304 4945 29648129
Apparent death 18.76 10.78 6 299398 3536 29649538
Accelerated hypertension 18.75 10.78 17 299387 222 29652852
Pericardial haemorrhage 18.73 10.78 68 299336 2850 29650224
Ventricular septal defect 18.65 10.78 6 299398 3523 29649551
Melaena 18.59 10.78 440 298964 31997 29621077
Guillain-Barre syndrome 18.52 10.78 100 299304 4983 29648091
Left ventricular enlargement 18.47 10.78 26 299378 564 29652510
Hydronephrosis 18.34 10.78 153 299251 8830 29644244
Renal failure 18.32 10.78 1512 297892 127454 29525620
Epiglottic oedema 18.25 10.78 15 299389 170 29652904
Hyperammonaemia 18.17 10.78 17 299387 5503 29647571
Hepatic neoplasm 18.07 10.78 50 299354 1809 29651265
Lymphocele 18.06 10.78 43 299361 1417 29651657
Ventricular tachycardia 18.05 10.78 152 299252 23710 29629364
Respiratory arrest 18.03 10.78 196 299208 29062 29624012
Hepatic failure 17.94 10.78 236 299168 33807 29619267
Acute myeloid leukaemia 17.88 10.78 106 299298 17900 29635174
Therapeutic product effect decreased 17.83 10.78 195 299209 28881 29624193
Condition aggravated 17.81 10.78 1163 298241 136703 29516371
Schizophrenia 17.81 10.78 40 299364 9008 29644066
Somnolence 17.79 10.78 788 298616 95975 29557099
Fibrillary glomerulonephritis 17.69 10.78 9 299395 40 29653034
Hypersensitivity vasculitis 17.68 10.78 79 299325 3644 29649430
Diastolic dysfunction 17.63 10.78 87 299317 4184 29648890
Acute myocardial infarction 17.54 10.78 671 298733 52268 29600806
Drug intolerance 17.47 10.78 333 299071 44958 29608116
Pulmonary embolism 17.46 10.78 622 298782 77513 29575561
Zoonotic bacterial infection 17.43 10.78 10 299394 59 29653015
Akathisia 17.38 10.78 20 299384 5884 29647190
Myelosuppression 17.35 10.78 29 299375 7293 29645781
Carotid artery stenosis 17.26 10.78 92 299312 4562 29648512
Acute graft versus host disease in skin 17.25 10.78 12 299392 4504 29648570
Status epilepticus 17.22 10.78 55 299349 11017 29642057
Dyspnoea exertional 17.19 10.78 470 298934 34960 29618114
Anxiety 17.12 10.78 729 298675 89142 29563932
Pseudomonas infection 17.06 10.78 51 299353 10431 29642643
Paranoia 17.00 10.78 49 299355 10139 29642935
Atheroembolism 16.99 10.78 16 299388 220 29652854
Acute coronary syndrome 16.99 10.78 209 299195 13364 29639710
Product substitution issue 16.94 10.78 164 299240 9871 29643203
Clear cell renal cell carcinoma 16.83 10.78 32 299372 899 29652175
Graft versus host disease in skin 16.82 10.78 6 299398 3301 29649773
Left ventricular hypertrophy 16.81 10.78 114 299290 6164 29646910
Metastatic renal cell carcinoma 16.79 10.78 59 299345 2433 29650641
Retinopathy hypertensive 16.57 10.78 17 299387 261 29652813
Polypectomy 16.54 10.78 23 299381 493 29652581
Swelling face 16.54 10.78 301 299103 20903 29632171
Hospitalisation 16.44 10.78 328 299076 43991 29609083
Thrombotic stroke 16.42 10.78 17 299387 264 29652810
Encephalopathy 16.34 10.78 225 299179 31980 29621094
Neurotoxicity 16.26 10.78 72 299332 13110 29639964
Coronary artery stenosis 16.19 10.78 150 299254 8920 29644154
Vomiting 16.18 10.78 1937 297467 217881 29435193
Blood pressure decreased 16.15 10.78 599 298805 46476 29606598
Deep vein thrombosis 16.05 10.78 471 298933 60030 29593044
Small for dates baby 16.01 10.78 6 299398 3202 29649872
Haemorrhage subcutaneous 15.97 10.78 54 299350 2183 29650891
Atrioventricular block second degree 15.96 10.78 68 299336 3072 29650002
Lymphadenopathy 15.96 10.78 161 299243 24215 29628859
Psoriasis 15.95 10.78 314 299090 42192 29610882
Diabetic neuropathy 15.89 10.78 80 299324 3879 29649195
Pharyngeal oedema 15.86 10.78 115 299289 6356 29646718
Mydriasis 15.82 10.78 23 299381 6120 29646954
Milk-alkali syndrome 15.77 10.78 23 299381 516 29652558
Lacrimal disorder 15.75 10.78 18 299386 314 29652760
Aortic aneurysm 15.74 10.78 114 299290 6299 29646775
Nipple inflammation 15.72 10.78 10 299394 73 29653001
Hallucination 15.63 10.78 372 299032 48687 29604387
Angina unstable 15.60 10.78 190 299214 12120 29640954
Blood creatine phosphokinase increased 15.54 10.78 560 298844 43288 29609786
Presyncope 15.50 10.78 236 299168 15820 29637254
Tremor 15.49 10.78 606 298798 74757 29578317
Crying 15.45 10.78 20 299384 5589 29647485
Cognitive disorder 15.29 10.78 157 299247 23533 29629541
Lymphoma 15.24 10.78 51 299353 10070 29643004
Drug screen positive 15.19 10.78 13 299391 4394 29648680
Tricuspid valve calcification 15.18 10.78 5 299399 4 29653070
Hair colour changes 15.12 10.78 42 299362 1523 29651551
Embolic stroke 15.11 10.78 74 299330 3548 29649526
Neuroleptic malignant syndrome 15.10 10.78 98 299306 16197 29636877
Neuropathy peripheral 15.07 10.78 564 298840 69911 29583163
Discomfort 15.03 10.78 214 299190 14142 29638932
White blood cell count decreased 14.95 10.78 686 298718 83261 29569813
Band neutrophil percentage decreased 14.91 10.78 6 299398 13 29653061
Left atrial enlargement 14.90 10.78 21 299383 456 29652618
Chest pain 14.83 10.78 1367 298037 116260 29536814
Pruritus 14.79 10.78 1373 298031 116831 29536243
Dermatitis infected 14.74 10.78 11 299393 107 29652967
Skin toxicity 14.74 10.78 7 299397 3242 29649832
Drug use disorder 14.73 10.78 7 299397 3241 29649833
Osteoporosis 14.55 10.78 56 299348 10607 29642467
Nasal crusting 14.51 10.78 20 299384 425 29652649
Intervertebral disc displacement 14.51 10.78 13 299391 167 29652907
Ventricular compliance decreased 14.46 10.78 4 299400 0 29653074
Hypoinsulinaemia 14.46 10.78 4 299400 0 29653074
Mucosal membrane hyperplasia 14.46 10.78 4 299400 0 29653074
Blood aldosterone decreased 14.46 10.78 4 299400 0 29653074
Non-compaction cardiomyopathy 14.46 10.78 4 299400 0 29653074
Vertebrobasilar stroke 14.46 10.78 4 299400 0 29653074
Kidney small 14.46 10.78 9 299395 63 29653011
Polymyalgia rheumatica 14.41 10.78 33 299371 1060 29652014
Coronary artery disease 14.37 10.78 621 298783 49091 29603983
Malabsorption 14.22 10.78 48 299356 1939 29651135
Blood pressure abnormal 14.18 10.78 119 299285 6880 29646194
Hyperbilirubinaemia 14.17 10.78 105 299299 16837 29636237
Large intestine polyp 14.09 10.78 115 299289 6594 29646480
Hepatitis 14.09 10.78 149 299255 22207 29630867
Clostridium difficile infection 14.08 10.78 96 299308 15687 29637387
Blood aldosterone increased 14.06 10.78 6 299398 16 29653058
Toxic nodular goitre 14.06 10.78 6 299398 16 29653058
Hypertensive emergency 14.03 10.78 28 299376 816 29652258
Body temperature decreased 14.02 10.78 153 299251 9502 29643572
Device related infection 13.97 10.78 106 299298 16909 29636165
Drug abuser 13.96 10.78 14 299390 4387 29648687
Immune-mediated myositis 13.95 10.78 36 299368 1249 29651825
Gastric cancer 13.93 10.78 91 299313 4859 29648215
Tenosynovitis 13.88 10.78 9 299395 3506 29649568
Maternal exposure during pregnancy 13.86 10.78 11 299393 3860 29649214
Post-traumatic amnestic disorder 13.84 10.78 8 299396 48 29653026
Sinonasal obstruction 13.80 10.78 6 299398 17 29653057
Cardio-respiratory arrest 13.77 10.78 452 298952 56854 29596220
Surfactant protein increased 13.77 10.78 5 299399 7 29653067
Epstein-Barr virus infection 13.74 10.78 29 299375 6677 29646397
High density lipoprotein decreased 13.69 10.78 66 299338 3144 29649930
Cystic fibrosis 13.66 10.78 3 299401 2271 29650803
Macroglossia 13.64 10.78 14 299390 215 29652859
Crohn's disease 13.63 10.78 14 299390 4338 29648736
Blood uric acid increased 13.61 10.78 105 299299 5918 29647156
Generalised oedema 13.60 10.78 180 299224 11705 29641369
Sinus node dysfunction 13.60 10.78 75 299329 3768 29649306
Therapeutic product effect incomplete 13.60 10.78 247 299157 33587 29619487
Nodal rhythm 13.57 10.78 38 299366 1385 29651689
Seronegative arthritis 13.55 10.78 27 299377 786 29652288
Myocardial infarction 13.51 10.78 1444 297960 124181 29528893
Breath sounds abnormal 13.45 10.78 90 299314 4845 29648229
Albumin urine present 13.44 10.78 18 299386 372 29652702
Blood cholinesterase decreased 13.43 10.78 11 299393 124 29652950
Ear infection 13.40 10.78 34 299370 7340 29645734
Putamen haemorrhage 13.39 10.78 14 299390 220 29652854
Sex hormone binding globulin increased 13.38 10.78 5 299399 8 29653066
Hepatitis B reactivation 13.36 10.78 6 299398 2871 29650203
Low density lipoprotein decreased 13.35 10.78 30 299374 951 29652123
Wrong strength 13.34 10.78 10 299394 98 29652976
Delusion 13.31 10.78 68 299336 11921 29641153
Incorrect route of product administration 13.24 10.78 63 299341 11252 29641822
Liver carcinoma ruptured 13.22 10.78 11 299393 127 29652947
Haemodialysis 13.21 10.78 169 299235 10904 29642170
Duodenal ulcer haemorrhage 13.21 10.78 86 299318 4586 29648488
Arteriosclerosis 13.21 10.78 166 299238 10667 29642407
Peripheral artery occlusion 13.19 10.78 38 299366 1408 29651666
Thromboangiitis obliterans 13.10 10.78 6 299398 20 29653054
Fungal infection 13.01 10.78 81 299323 13519 29639555
Coronary arterial stent insertion 12.98 10.78 79 299325 4115 29648959
Acute biphenotypic leukaemia 12.97 10.78 8 299396 55 29653019
Macrophages increased 12.92 10.78 12 299392 162 29652912
Platelet count decreased 12.91 10.78 900 298504 105229 29547845
Rhythm idioventricular 12.85 10.78 15 299389 268 29652806
Yellow skin 12.78 10.78 48 299356 2045 29651029
Colitis ulcerative 12.78 10.78 88 299316 14346 29638728
Malaise 12.77 10.78 1879 297525 165083 29487991
Antipsychotic drug level increased 12.65 10.78 8 299396 3158 29649916
Serotonin syndrome 12.63 10.78 116 299288 17775 29635299
Fracture displacement 12.62 10.78 8 299396 58 29653016
Hypertensive encephalopathy 12.59 10.78 17 299387 354 29652720
Therapy partial responder 12.58 10.78 11 299393 3680 29649394
Musculoskeletal stiffness 12.58 10.78 268 299136 35613 29617461
Giant cell arteritis 12.56 10.78 24 299380 677 29652397
Suspected suicide attempt 12.55 10.78 11 299393 137 29652937
Dysphagia 12.51 10.78 452 298952 56246 29596828
Renin increased 12.51 10.78 8 299396 59 29653015
Gastrointestinal ischaemia 12.50 10.78 13 299391 203 29652871
Neonatal respiratory distress syndrome 12.46 10.78 13 299391 3999 29649075
Cataract 12.45 10.78 296 299108 21539 29631535
Nausea 12.45 10.78 2702 296702 294255 29358819
Cytomegalovirus viraemia 12.40 10.78 24 299380 5705 29647369
Cachexia 12.39 10.78 30 299374 6581 29646493
Lung diffusion test decreased 12.38 10.78 22 299382 586 29652488
Ureteric cancer 12.35 10.78 12 299392 172 29652902
Product dose omission issue 12.33 10.78 770 298634 90861 29562213
Prescription drug used without a prescription 12.33 10.78 34 299370 1228 29651846
Hypersensitivity 12.32 10.78 429 298975 53599 29599475
Dysgeusia 12.31 10.78 330 299074 24471 29628603
Kinematic imbalances due to suboccipital strain 12.28 10.78 6 299398 24 29653050
Viral infection 12.28 10.78 95 299309 15090 29637984
Obsessive-compulsive disorder 12.22 10.78 14 299390 4127 29648947
Prostatic specific antigen increased 12.19 10.78 178 299226 11826 29641248
Mycobacterium marinum infection 12.17 10.78 14 299390 246 29652828
Body temperature increased 12.17 10.78 92 299312 14688 29638386
Histology abnormal 12.15 10.78 15 299389 285 29652789
Migraine 12.15 10.78 77 299327 12797 29640277
Muscle rigidity 12.09 10.78 57 299347 10204 29642870
Mycobacterium avium complex infection 12.05 10.78 6 299398 2705 29650369
Enterococcal infection 12.00 10.78 42 299362 8182 29644892
Overdose 12.00 10.78 989 298415 83348 29569726
Intraventricular haemorrhage 12.00 10.78 61 299343 2969 29650105
On and off phenomenon 11.97 10.78 7 299397 2884 29650190
Herbal interaction 11.97 10.78 16 299388 330 29652744
Arterial stenosis 11.96 10.78 33 299371 1192 29651882
Thrombotic cerebral infarction 11.95 10.78 15 299389 290 29652784
Thirst 11.94 10.78 114 299290 6835 29646239
Graft versus host disease in gastrointestinal tract 11.93 10.78 8 299396 3061 29650013
Cerebral haemorrhage 11.90 10.78 421 298983 32466 29620608
Hepatitis B 11.83 10.78 27 299377 6045 29647029
Hepatic enzyme increased 11.80 10.78 250 299154 33244 29619830
Oliguria 11.79 10.78 120 299284 7319 29645755
Dysphonia 11.78 10.78 261 299143 18771 29634303
Acidosis 11.78 10.78 156 299248 10145 29642929
Ventricular hyperkinesia 11.73 10.78 13 299391 219 29652855
Mitral valve thickening 11.73 10.78 13 299391 219 29652855
Lymphomatoid papulosis 11.71 10.78 12 299392 184 29652890
Anuria 11.70 10.78 156 299248 10160 29642914
Physical deconditioning 11.67 10.78 22 299382 614 29652460
Hypocalcaemia 11.65 10.78 288 299116 21088 29631986
Gastric ulcer haemorrhage 11.65 10.78 92 299312 5222 29647852
Large intestinal polypectomy 11.59 10.78 8 299396 68 29653006
Blood glucose increased 11.57 10.78 738 298666 60792 29592282
Hyperparathyroidism secondary 11.56 10.78 32 299372 1158 29651916
Hypothyroidism 11.53 10.78 212 299192 14751 29638323
Stomatitis 11.51 10.78 284 299120 36995 29616079
Ventricular hypertrophy 11.49 10.78 86 299318 4801 29648273
Bacteraemia 11.37 10.78 100 299304 15460 29637614
Atrial septal defect 11.35 10.78 32 299372 6669 29646405
Respiratory failure 11.34 10.78 859 298545 99783 29553291
Noninfective gingivitis 11.34 10.78 14 299390 266 29652808
Prostate cancer recurrent 11.31 10.78 24 299380 731 29652343
Carotid arteriosclerosis 11.30 10.78 27 299377 892 29652182
Aortic valve stenosis 11.25 10.78 40 299364 1659 29651415
Faeces discoloured 11.24 10.78 199 299205 13747 29639327
Renal artery thrombosis 11.20 10.78 15 299389 310 29652764
Haemodynamic instability 11.17 10.78 126 299278 7889 29645185
Product solubility abnormal 11.17 10.78 20 299384 536 29652538
Hyperdynamic left ventricle 11.13 10.78 8 299396 73 29653001
Erectile dysfunction 11.13 10.78 248 299156 17854 29635220
Intercapillary glomerulosclerosis 11.13 10.78 7 299397 50 29653024
Inguinal hernia, obstructive 11.09 10.78 6 299398 31 29653043
Toxic skin eruption 11.06 10.78 163 299241 10852 29642222
Low birth weight baby 11.06 10.78 28 299376 6048 29647026
Hepatic function abnormal 11.03 10.78 519 298885 41426 29611648
Cerebellar haemorrhage 11.02 10.78 35 299369 1369 29651705
Diabetes mellitus 11.01 10.78 518 298886 41347 29611727
Cold sweat 11.00 10.78 139 299265 8943 29644131
Clostridial infection 10.98 10.78 12 299392 3613 29649461
Irregular breathing 10.94 10.78 10 299394 132 29652942
Coma scale 10.86 10.78 4 299400 6 29653068
Gingival hypoplasia 10.86 10.78 4 299400 6 29653068
Fracture pain 10.86 10.78 4 299400 6 29653068
Wernicke's encephalopathy 10.85 10.78 3 299401 0 29653074
Urostomy 10.85 10.78 3 299401 0 29653074
Benign anorectal neoplasm 10.85 10.78 3 299401 0 29653074
Lower gastrointestinal perforation 10.85 10.78 3 299401 0 29653074
Epinephrine increased 10.85 10.78 3 299401 0 29653074
Tissue injury 10.85 10.78 3 299401 0 29653074
Hypertrophy 10.84 10.78 15 299389 320 29652754
Oedema due to cardiac disease 10.84 10.78 5 299399 17 29653057
Angiogram 10.81 10.78 9 299395 104 29652970
Bundle branch block 10.80 10.78 26 299378 863 29652211
Pelvic cyst 10.79 10.78 6 299398 33 29653041

Pharmacologic Action:

SourceCodeDescription
ATC C08CA01 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
Dihydropyridine derivatives
ATC C07FB07 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C07FB12 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C07FB13 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C08CA51 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
Dihydropyridine derivatives
ATC C08GA02 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
CALCIUM CHANNEL BLOCKERS AND DIURETICS
Calcium channel blockers and diuretics
ATC C09BB03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BB07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09DB01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB05 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB09 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09XA53 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C09XA54 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C10BX03 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 C10BX11 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 C10BX18 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA CS M0006414 Dihydropyridines
FDA MoA N0000000069 Calcium Channel Antagonists
FDA EPC N0000175421 Dihydropyridine Calcium Channel Blocker
CHEBI has role CHEBI:35620 vasodilator
CHEBI has role CHEBI:35674 antihypertensive
CHEBI has role CHEBI:38215 calcium channel blockers
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D014665 Vasodilator Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Prinzmetal angina indication 87343002
Angina pectoris indication 194828000
Cerebrovascular accident indication 230690007
Primary Prevention of Coronary Heart Disease indication
Myocardial Infarction Prevention indication
Anuria contraindication 2472002 DOID:2983
Alcoholism contraindication 7200002
Hyperkalemia contraindication 14140009
Jaundice contraindication 18165001
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Obstruction of bile duct contraindication 30144000
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Hypothyroidism contraindication 40930008 DOID:1459
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Diabetes mellitus type 2 contraindication 44054006 DOID:9352
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Disorder of connective tissue contraindication 105969002 DOID:65
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Hemorrhagic cerebral infarction contraindication 230706003
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Surgical procedure contraindication 387713003
Breastfeeding (mother) contraindication 413712001
Traumatic injury contraindication 417746004
Azotemia contraindication 445009001
Head and Neck Angioedema contraindication
Hemodialysis with High-Flux Membrane contraindication
Severe Aortic Valve Stenosis contraindication
Intestinal Angioedema contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.0 Basic
pKa2 1.55 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10MG BASE;200MG CONSENSI COEPTIS N210045 May 31, 2018 RX TABLET ORAL May 31, 2021 NEW COMBINULLTION
EQ 2.5MG BASE;200MG CONSENSI COEPTIS N210045 May 31, 2018 RX TABLET ORAL May 31, 2021 NEW COMBINULLTION
EQ 5MG BASE;200MG CONSENSI COEPTIS N210045 May 31, 2018 RX TABLET ORAL May 31, 2021 NEW COMBINULLTION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Voltage-dependent L-type calcium channel subunit alpha-1D Ion channel BLOCKER Ki 7 WOMBAT-PK CHEMBL
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel BLOCKER WOMBAT-PK CHEMBL
Voltage-dependent calcium channel gamma-1 subunit Ion channel Ki 7.20 WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 6.65 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.87 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 6.58 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.36 DRUG MATRIX
Carbonic anhydrase 1 Enzyme WOMBAT-PK
Aldehyde oxidase Enzyme IC50 5.26 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1H Ion channel Ki 4.51 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 5.27 CHEMBL
Potassium channel subfamily K member 2 Ion channel IC50 6.40 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 5.63 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 5.10 CHEMBL
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel Ki 7.20 WOMBAT-PK
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel Ki 8.70 CHEMBL

External reference:

IDSource
1J444QC288 UNII
4020813 VUID
N0000148333 NUI
D00615 KEGG_DRUG
111470-99-6 SECONDARY_CAS_RN
C0051696 UMLSCUI
CHEBI:2669 CHEBI
6UB PDB_CHEM_ID
06X PDB_CHEM_ID
CHEMBL1491 ChEMBL_ID
CHEMBL1200402 ChEMBL_ID
CHEMBL1200984 ChEMBL_ID
DB00381 DRUGBANK_ID
D017311 MESH_DESCRIPTOR_UI
2162 PUBCHEM_CID
5729 INN_ID
6981 IUPHAR_LIGAND_ID
104416 RXNORM
108736 MMSL
173594 MMSL
23944 MMSL
27341 MMSL
4180 MMSL
d00689 MMSL
003672 NDDF
003673 NDDF
008599 NDDF
015579 NDDF
108537001 SNOMEDCT_US
384976003 SNOMEDCT_US
386864001 SNOMEDCT_US
421048000 SNOMEDCT_US
4020586 VANDF
4020813 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1520 TABLET 2.50 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1530 TABLET 5 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1540 TABLET 10 mg ORAL NDA 26 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2150 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2160 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2170 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2180 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2190 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2250 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2260 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2270 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2960 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2970 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2980 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Lotrel HUMAN PRESCRIPTION DRUG LABEL 2 0078-0364 CAPSULE 10 mg ORAL NDA 31 sections
Lotrel HUMAN PRESCRIPTION DRUG LABEL 2 0078-0379 CAPSULE 10 mg ORAL NDA 31 sections
Lotrel HUMAN PRESCRIPTION DRUG LABEL 2 0078-0405 CAPSULE 5 mg ORAL NDA 31 sections
Lotrel HUMAN PRESCRIPTION DRUG LABEL 2 0078-0406 CAPSULE 5 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0561 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0562 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0563 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5002 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5003 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 3 0093-5004 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections