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 ┬ÁM/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
Rheumatoid arthritis 847.28 9.82 659 395717 313872 52638818
Drug ineffective 814.17 9.82 3229 393147 814016 52138674
Maternal exposure during pregnancy 650.26 9.82 176 396200 155463 52797227
Pemphigus 636.56 9.82 33 396343 103998 52848692
Completed suicide 569.20 9.82 2282 394094 135919 52816771
Systemic lupus erythematosus 552.52 9.82 127 396249 125287 52827403
Contraindicated product administered 546.85 9.82 164 396212 135465 52817225
Hypotension 495.93 9.82 3408 392968 250668 52702022
Treatment failure 484.70 9.82 174 396202 128229 52824461
Glossodynia 457.08 9.82 94 396282 100197 52852493
Hand deformity 454.12 9.82 50 396326 84799 52867891
Synovitis 441.21 9.82 127 396249 107766 52844924
Hyponatraemia 424.50 9.82 1765 394611 106842 52845848
Anti-cyclic citrullinated peptide antibody positive 407.15 9.82 3 396373 57169 52895521
Drug intolerance 405.29 9.82 561 395815 204932 52747758
Acute kidney injury 404.67 9.82 3246 393130 250622 52702068
Blood pressure inadequately controlled 398.44 9.82 314 396062 4597 52948093
Infusion related reaction 396.59 9.82 345 396031 155612 52797078
Shock 392.01 9.82 654 395722 22485 52930205
Off label use 377.19 9.82 2018 394358 470194 52482496
Hypertension 375.97 9.82 2913 393463 222518 52730172
Blood pressure increased 375.45 9.82 2045 394331 138434 52814256
Therapeutic product effect decreased 370.92 9.82 238 396138 125417 52827273
Gingival hypertrophy 364.40 9.82 192 396184 1319 52951371
Pericarditis 360.22 9.82 32 396344 64374 52888316
Arthropathy 322.30 9.82 345 396031 141108 52811582
Oedema peripheral 322.20 9.82 2273 394103 168514 52784176
Alopecia 297.46 9.82 831 395545 233752 52718938
Exposure during pregnancy 296.36 9.82 294 396082 124566 52828124
Non-cardiogenic pulmonary oedema 282.17 9.82 122 396254 499 52952191
Cerebrovascular accident 273.44 9.82 1520 394856 103654 52849036
Fall 272.37 9.82 3950 392426 354490 52598200
Bradycardia 268.31 9.82 1143 395233 69913 52882777
Pain 247.53 9.82 2992 393384 585406 52367284
Rheumatoid factor positive 240.06 9.82 17 396359 41181 52911509
Wound 228.45 9.82 206 396170 91351 52861339
Hepatic enzyme increased 226.79 9.82 367 396009 125828 52826862
Hypersensitivity 217.11 9.82 818 395558 209847 52742843
Orthostatic hypotension 213.38 9.82 593 395783 29160 52923530
Hyperkalaemia 202.66 9.82 870 395506 53386 52899304
Dizziness 201.79 9.82 3883 392493 368376 52584314
Product use issue 197.11 9.82 468 395908 139116 52813574
Vasoplegia syndrome 191.09 9.82 118 396258 1134 52951556
Lactic acidosis 189.64 9.82 659 395717 36594 52916096
Angioedema 186.04 9.82 711 395665 41365 52911325
Renal impairment 185.39 9.82 1156 395220 82162 52870528
Folliculitis 184.99 9.82 13 396363 31696 52920994
Discomfort 184.66 9.82 264 396112 95208 52857482
Duodenal ulcer perforation 182.57 9.82 23 396353 35160 52917530
Abortion spontaneous 181.38 9.82 60 396316 46575 52906115
Therapeutic product effect incomplete 167.63 9.82 264 396112 91520 52861170
C-reactive protein abnormal 165.45 9.82 6 396370 25864 52926826
Cardiac failure congestive 162.30 9.82 1213 395163 91544 52861146
Abdominal discomfort 162.18 9.82 970 395406 220092 52732598
Pregnancy 157.34 9.82 23 396353 31418 52921272
Intentional overdose 156.78 9.82 944 395432 66261 52886429
Metabolic acidosis 156.69 9.82 676 395700 41566 52911124
Sinusitis 154.48 9.82 685 395691 167879 52784811
Lower respiratory tract infection 153.85 9.82 275 396101 90706 52861984
Helicobacter infection 152.41 9.82 50 396326 39019 52913671
Sleep disorder due to general medical condition, insomnia type 151.18 9.82 7 396369 24342 52928348
Arthralgia 147.34 9.82 2340 394036 437443 52515247
Hypokalaemia 145.18 9.82 1219 395157 95298 52857392
Swelling 143.08 9.82 833 395543 190272 52762418
Toxicity to various agents 141.14 9.82 2354 394022 217244 52735446
Infection 140.77 9.82 729 395647 171476 52781214
Device expulsion 139.85 9.82 26 396350 29787 52922903
Hypoglycaemia 137.05 9.82 828 395548 58185 52894505
Muscle injury 131.27 9.82 30 396346 29736 52922954
Hypertensive crisis 129.60 9.82 314 396062 14192 52938498
Distributive shock 126.26 9.82 81 396295 837 52951853
Injection site reaction 125.37 9.82 117 396259 51049 52901641
Atrial fibrillation 117.92 9.82 1309 395067 110343 52842347
Injection site erythema 117.15 9.82 249 396127 77000 52875690
Myocardial infarction 114.30 9.82 1185 395191 98169 52854521
Impaired healing 113.16 9.82 189 396187 64016 52888674
Syncope 111.95 9.82 1299 395077 110694 52841996
Drug abuse 111.72 9.82 197 396179 65329 52887361
Neurologic neglect syndrome 110.41 9.82 82 396294 1093 52951597
Condition aggravated 109.65 9.82 1551 394825 295583 52657107
Joint swelling 108.77 9.82 1166 395210 233472 52719218
Blood creatinine increased 107.28 9.82 1011 395365 81651 52871039
Decreased appetite 104.37 9.82 2207 394169 212767 52739923
Creatinine renal clearance decreased 104.34 9.82 239 396137 10412 52942278
Rash 103.21 9.82 2526 393850 443665 52509025
Musculoskeletal stiffness 103.18 9.82 518 395858 122850 52829840
Balance disorder 102.93 9.82 911 395465 72296 52880394
Depressed level of consciousness 102.18 9.82 724 395652 53704 52898986
Injection site pain 98.94 9.82 469 395907 112922 52839768
Carotid artery thrombosis 98.28 9.82 78 396298 1154 52951536
Irritable bowel syndrome 97.53 9.82 108 396268 43524 52909166
Ill-defined disorder 96.29 9.82 136 396240 49308 52903382
Cerebral infarction 95.93 9.82 398 395978 24046 52928644
Atrioventricular block complete 95.88 9.82 195 396181 7820 52944870
Swollen tongue 94.29 9.82 469 395907 30611 52922079
Sedation complication 92.52 9.82 180 396196 6986 52945704
Pyrexia 88.49 9.82 2300 394076 400893 52551797
Rhabdomyolysis 87.60 9.82 593 395783 43330 52909360
Product prescribing error 85.72 9.82 369 396007 22662 52930028
Live birth 85.50 9.82 7 396369 15052 52937638
Blood pressure decreased 82.92 9.82 762 395614 61107 52891583
Sinus bradycardia 82.89 9.82 268 396108 14333 52938357
Migraine 82.87 9.82 312 396064 80105 52872585
Asthenia 81.01 9.82 3220 393156 340370 52612320
Renal failure 80.90 9.82 1283 395093 117169 52835521
Foetal exposure during pregnancy 80.86 9.82 83 396293 34632 52918058
Product use in unapproved indication 79.48 9.82 498 395878 111791 52840899
Hypertensive emergency 77.65 9.82 79 396297 1642 52951048
Sprue-like enteropathy 76.60 9.82 47 396329 446 52952244
Subacute cutaneous lupus erythematosus 76.14 9.82 91 396285 2277 52950413
Overdose 74.73 9.82 1170 395206 106566 52846124
Intentional self-injury 73.03 9.82 49 396327 25235 52927455
Febrile neutropenia 72.92 9.82 468 395908 104468 52848222
Cardiac failure 72.54 9.82 965 395411 84879 52867811
Atrioventricular block first degree 72.33 9.82 154 396222 6381 52946309
Anuria 72.13 9.82 230 396146 12210 52940480
Coronary artery disease 70.65 9.82 458 395918 32979 52919711
Adjustment disorder 70.39 9.82 79 396297 1844 52950846
Injection site swelling 70.11 9.82 131 396245 42497 52910193
Hemiplegia 69.84 9.82 169 396207 7631 52945059
Drug interaction 69.50 9.82 2127 394249 217202 52735488
Cardiogenic shock 68.09 9.82 284 396092 17198 52935492
Angina pectoris 67.28 9.82 404 395972 28321 52924369
Infective pulmonary exacerbation of cystic fibrosis 66.77 9.82 4 396372 11152 52941538
Blood urea increased 64.71 9.82 374 396002 25857 52926833
Dehydration 64.44 9.82 1673 394703 166737 52785953
Fibromyalgia 64.39 9.82 145 396231 43930 52908760
Circulatory collapse 62.80 9.82 334 396042 22380 52930310
Drug resistance 62.79 9.82 35 396341 19927 52932763
Acute myocardial infarction 61.73 9.82 441 395935 32794 52919896
Chronic kidney disease 61.61 9.82 541 395835 42829 52909861
Hip arthroplasty 61.14 9.82 70 396306 27792 52924898
Loss of personal independence in daily activities 60.15 9.82 290 396086 69525 52883165
Linear IgA disease 60.09 9.82 64 396312 1406 52951284
Renin increased 59.92 9.82 29 396347 162 52952528
Psoriatic arthropathy 59.25 9.82 173 396203 48017 52904673
Gastrointestinal disorder 59.21 9.82 408 395968 89596 52863094
Palpitations 57.36 9.82 1074 395302 101274 52851416
Stomatitis 56.94 9.82 461 395915 97697 52854993
Blood calcium decreased 56.06 9.82 293 396083 19501 52933189
Injection site pruritus 55.85 9.82 143 396233 41446 52911244
Pulmonary oedema 55.83 9.82 628 395748 53095 52899595
Intentional product use issue 55.79 9.82 313 396063 72181 52880509
Transient ischaemic attack 55.70 9.82 455 395921 35270 52917420
Hyperglycaemia 54.87 9.82 496 395880 39588 52913102
Inappropriate antidiuretic hormone secretion 53.70 9.82 237 396139 14714 52937976
Blood pressure systolic increased 53.22 9.82 445 395931 34732 52917958
Left ventricular hypertrophy 52.04 9.82 118 396258 5105 52947585
Blood glucose increased 51.69 9.82 835 395541 76526 52876164
Renal artery stenosis 50.57 9.82 66 396310 1810 52950880
Rheumatoid nodule 50.27 9.82 13 396363 11851 52940839
Cognitive disorder 50.01 9.82 531 395845 44247 52908443
Personality disorder 50.00 9.82 101 396275 4030 52948660
Melaena 49.81 9.82 379 395997 28750 52923940
Abortion induced 49.59 9.82 10 396366 10816 52941874
Dysarthria 49.07 9.82 489 395887 40079 52912611
Neutropenia 48.82 9.82 860 395516 158325 52794365
Atrioventricular block 47.95 9.82 139 396237 7001 52945689
Diabetes mellitus inadequate control 47.78 9.82 222 396154 14088 52938602
Proteinuria 46.79 9.82 261 396115 17807 52934883
Pemphigoid 46.75 9.82 129 396247 6315 52946375
Malaise 46.23 9.82 3166 393210 354451 52598239
Hepatic function abnormal 46.21 9.82 448 395928 36451 52916239
Anaemia 45.67 9.82 2503 393873 274215 52678475
Glomerular filtration rate decreased 45.56 9.82 202 396174 12565 52940125
Oedema 45.47 9.82 791 395585 73555 52879135
Vasodilatation 45.12 9.82 73 396303 2444 52950246
Renal disorder 44.82 9.82 370 396006 28769 52923921
Drug level increased 44.54 9.82 282 396094 20139 52932551
Caesarean section 44.34 9.82 38 396338 17282 52935408
Injection site warmth 44.11 9.82 25 396351 14103 52938587
Hypomagnesaemia 43.65 9.82 325 396051 24486 52928204
Anti-neutrophil cytoplasmic antibody positive vasculitis 43.26 9.82 69 396307 2282 52950408
Suicide attempt 43.12 9.82 639 395737 57529 52895161
Injection site bruising 42.84 9.82 140 396236 37506 52915184
Oliguria 42.38 9.82 158 396218 9080 52943610
Device dislocation 41.99 9.82 69 396307 23528 52929162
Drug dependence 41.86 9.82 59 396317 21413 52931277
Body temperature increased 41.60 9.82 116 396260 32683 52920007
Foot deformity 41.45 9.82 46 396330 18522 52934168
Carotid artery stenosis 41.01 9.82 109 396267 5218 52947472
Dyspnoea 40.98 9.82 4963 391413 581269 52371421
Haemorrhage subcutaneous 40.34 9.82 78 396298 3013 52949677
Tenosynovitis 40.05 9.82 12 396364 9927 52942763
Septic shock 39.98 9.82 284 396092 61945 52890745
Premature labour 39.87 9.82 21 396355 12341 52940349
Suspected suicide 39.50 9.82 95 396281 4273 52948417
Ischaemic stroke 38.34 9.82 247 396129 17746 52934944
Knee arthroplasty 38.08 9.82 125 396251 33444 52919246
Altered state of consciousness 38.00 9.82 315 396061 24521 52928169
Drug withdrawal syndrome 37.90 9.82 96 396280 27926 52924764
Multiple sclerosis relapse 37.66 9.82 188 396188 44665 52908025
Glomerulonephritis rapidly progressive 37.46 9.82 38 396338 787 52951903
Blood creatine phosphokinase increased 37.32 9.82 354 396022 28631 52924059
Blood potassium decreased 37.19 9.82 462 395914 39998 52912692
Gastrointestinal haemorrhage 35.49 9.82 814 395562 79516 52873174
Urticaria 35.29 9.82 755 395621 135130 52817560
Aortic dissection 35.17 9.82 53 396323 1667 52951023
Atrioventricular block second degree 34.90 9.82 85 396291 3854 52948836
Supraventricular extrasystoles 34.86 9.82 91 396285 4309 52948381
Lacunar infarction 34.79 9.82 80 396296 3494 52949196
Weight increased 34.57 9.82 1208 395168 203359 52749331
Chest pain 34.30 9.82 1735 394641 188450 52764240
Eating disorder 34.30 9.82 222 396154 15975 52936715
Nodal rhythm 34.25 9.82 53 396323 1707 52950983
Bladder irritation 34.25 9.82 21 396355 199 52952491
Premature baby 34.22 9.82 59 396317 19742 52932948
Premature delivery 34.10 9.82 91 396285 26013 52926677
Haematochezia 34.05 9.82 472 395904 41886 52910804
Gingival swelling 34.01 9.82 88 396288 4144 52948546
Hyperdynamic left ventricle 33.98 9.82 19 396357 149 52952541
Metastases to bone 33.95 9.82 57 396319 19271 52933419
Unintended pregnancy 33.85 9.82 3 396373 6050 52946640
Colitis ulcerative 33.51 9.82 66 396310 20995 52931695
Lip swelling 33.44 9.82 329 396047 26872 52925818
Loss of consciousness 33.34 9.82 1097 395279 113115 52839575
Drug tolerance decreased 33.28 9.82 7 396369 7351 52945339
Red blood cell sedimentation rate increased 32.86 9.82 103 396273 27954 52924736
Glycosylated haemoglobin increased 31.96 9.82 171 396205 11484 52941206
Stillbirth 31.72 9.82 6 396370 6791 52945899
Uterine perforation 31.68 9.82 8 396368 7411 52945279
Ear pain 31.29 9.82 114 396262 29559 52923131
Arrhythmia 31.28 9.82 414 395962 36365 52916325
Pulmonary renal syndrome 31.10 9.82 25 396351 377 52952313
Hepatotoxicity 30.82 9.82 105 396271 27775 52924915
Intestinal malrotation 30.78 9.82 25 396351 383 52952307
Injury 30.65 9.82 237 396139 50734 52901956
Urine output decreased 30.17 9.82 168 396208 11455 52941235
Ovarian cyst 29.72 9.82 42 396334 15227 52937463
Psychotic disorder 29.64 9.82 88 396288 24297 52928393
Therapeutic response decreased 29.64 9.82 219 396157 47350 52905340
Sedation 29.52 9.82 344 396032 29331 52923359
Allergic reaction to excipient 29.48 9.82 24 396352 369 52952321
Hyperuricaemia 29.41 9.82 96 396280 5160 52947530
Heavy menstrual bleeding 28.92 9.82 53 396323 17323 52935367
Hyperaldosteronism 28.71 9.82 21 396355 273 52952417
Injection site urticaria 28.39 9.82 31 396345 12576 52940114
Loose tooth 28.30 9.82 71 396305 3280 52949410
Hypocalcaemia 28.27 9.82 338 396038 28999 52923691
Muscle spasms 28.19 9.82 1248 395128 133547 52819143
Product monitoring error 28.07 9.82 65 396311 2852 52949838
Blood pressure abnormal 28.06 9.82 184 396192 13299 52939391
Angina unstable 28.05 9.82 120 396256 7348 52945342
Bundle branch block right 28.04 9.82 93 396283 5040 52947650
Nocturia 28.03 9.82 122 396254 7528 52945162
Fatigue 27.81 9.82 4891 391485 725615 52227075
Pollakiuria 27.73 9.82 304 396072 25535 52927155
Hypoglycaemic coma 27.55 9.82 61 396315 2597 52950093
Gingival bleeding 27.49 9.82 171 396205 12137 52940553
Parkinsonism 27.33 9.82 136 396240 8877 52943813
Aphasia 27.24 9.82 349 396027 30429 52922261
Sinus arrest 27.15 9.82 49 396327 1795 52950895
Schizophrenia 27.00 9.82 22 396354 10257 52942433
Constipation 26.71 9.82 1763 394613 196649 52756041
Blister 26.57 9.82 418 395958 78335 52874355
Haematemesis 26.51 9.82 348 396028 30509 52922181
Nasopharyngitis 26.49 9.82 1163 395213 191132 52761558
Nephrosclerosis 26.48 9.82 35 396341 972 52951718
Immunodeficiency 26.41 9.82 44 396332 14923 52937767
Ischaemia 26.35 9.82 86 396290 4622 52948068
Pathogen resistance 26.29 9.82 8 396368 6552 52946138
Feeling abnormal 25.98 9.82 1242 395134 134059 52818631
Seizure 25.91 9.82 748 395628 128761 52823929
Panniculitis 25.61 9.82 13 396363 7801 52944889
Motor dysfunction 25.56 9.82 126 396250 8192 52944498
Leukopenia 25.09 9.82 389 395987 73074 52879616
Blood potassium increased 25.05 9.82 222 396154 17619 52935071
Respiratory failure 25.01 9.82 948 395428 99564 52853126
Device difficult to use 25.00 9.82 24 396352 10335 52942355
Accidental exposure to product 24.93 9.82 91 396285 23583 52929107
Anaphylactic reaction 24.93 9.82 295 396081 58031 52894659
Product label on wrong product 24.89 9.82 7 396369 3 52952687
Confusional state 24.77 9.82 1718 394658 192503 52760187
Mucosal inflammation 24.77 9.82 201 396175 42583 52910107
Affect lability 24.66 9.82 136 396240 9239 52943451
Cholecystitis chronic 24.66 9.82 25 396351 10493 52942197
Unintentional medical device removal 24.62 9.82 5 396371 5381 52947309
Haematotoxicity 24.62 9.82 14 396362 7883 52944807
Foetal death 24.55 9.82 20 396356 9327 52943363
Acute myeloid leukaemia 24.48 9.82 56 396320 16876 52935814
Bone erosion 24.48 9.82 28 396348 11124 52941566
Faeces discoloured 24.28 9.82 219 396157 17467 52935223
Enthesopathy 24.24 9.82 9 396367 6502 52946188
Dyspnoea exertional 24.19 9.82 557 395819 54443 52898247
Labile hypertension 24.17 9.82 24 396352 484 52952206
Product substitution issue 24.15 9.82 201 396175 15665 52937025
Fear of injection 23.92 9.82 6 396370 5583 52947107
BRASH syndrome 23.88 9.82 16 396360 179 52952511
Multiple sclerosis 23.84 9.82 112 396264 27041 52925649
Joint effusion 23.80 9.82 39 396337 13313 52939377
Ageusia 23.78 9.82 168 396208 12446 52940244
Schizoaffective disorder 23.74 9.82 51 396325 2126 52950564
Gangrene 23.71 9.82 85 396291 4792 52947898
Scleral discolouration 23.40 9.82 21 396355 371 52952319
Myocardial depression 23.40 9.82 23 396353 458 52952232
Generalised oedema 23.37 9.82 192 396184 14907 52937783
Amenorrhoea 23.34 9.82 21 396355 9328 52943362
Chronic pigmented purpura 23.32 9.82 12 396364 78 52952612
Listless 23.26 9.82 56 396320 2520 52950170
Hemiparesis 23.20 9.82 253 396123 21222 52931468
Swelling face 23.03 9.82 572 395804 56596 52896094
Myocardial ischaemia 23.02 9.82 169 396207 12675 52940015
Arteriosclerosis 22.91 9.82 141 396235 9970 52942720
Mood swings 22.81 9.82 61 396315 17425 52935265
Subdural haematoma 22.65 9.82 178 396198 13635 52939055
Gastric ulcer haemorrhage 22.55 9.82 86 396290 4996 52947694
Dysgeusia 22.50 9.82 446 395930 42485 52910205
Metabolic alkalosis 22.46 9.82 61 396315 2958 52949732
Bradyarrhythmia 22.44 9.82 48 396328 1995 52950695
Hypertensive heart disease 22.24 9.82 55 396321 2518 52950172
Tongue oedema 22.15 9.82 76 396300 4191 52948499
Conjoined twins 22.15 9.82 18 396358 276 52952414
Acute coronary syndrome 22.15 9.82 143 396233 10281 52942409
Myalgia 22.07 9.82 1208 395168 132283 52820407
Ear infection 22.06 9.82 108 396268 25792 52926898
Multiple drug therapy 21.89 9.82 39 396337 1414 52951276
Prescription drug used without a prescription 21.88 9.82 44 396332 1750 52950940
Fibromuscular dysplasia 21.88 9.82 16 396360 208 52952482
Lymphocyte stimulation test positive 21.86 9.82 25 396351 596 52952094
Harlequin syndrome 21.78 9.82 9 396367 32 52952658
Premature rupture of membranes 21.74 9.82 5 396371 4935 52947755
Lichen nitidus 21.69 9.82 11 396365 69 52952621
Device issue 21.67 9.82 85 396291 21573 52931117
Injection site rash 21.50 9.82 58 396318 16521 52936169
Staphylococcal infection 21.45 9.82 183 396193 38365 52914325
Retinal ischaemia 21.43 9.82 19 396357 330 52952360
Bone marrow failure 21.06 9.82 134 396242 29981 52922709
Carotid arteriosclerosis 21.04 9.82 32 396344 1015 52951675
Irritability 21 9.82 139 396237 30814 52921876
Aortic aneurysm 20.94 9.82 66 396310 3482 52949208
Lymphocele 20.92 9.82 29 396347 844 52951846
Therapy partial responder 20.58 9.82 10 396366 6153 52946537
Status epilepticus 20.55 9.82 52 396324 15132 52937558
Cerebral haemorrhage 20.49 9.82 325 396051 29671 52923019
Urinary retention 20.43 9.82 311 396065 28155 52924535
Urine albumin/creatinine ratio increased 20.37 9.82 16 396360 233 52952457
Presyncope 20.29 9.82 290 396086 25904 52926786
Gestational diabetes 20.14 9.82 18 396358 8021 52944669
Wrong technique in product usage process 20.12 9.82 319 396057 59713 52892977
Heart rate decreased 20.09 9.82 386 395990 36561 52916129
Tubulointerstitial nephritis 19.99 9.82 199 396177 16305 52936385
Hypoperfusion 19.98 9.82 37 396339 1383 52951307
No adverse event 19.85 9.82 191 396185 39074 52913616
Dementia 19.82 9.82 201 396175 16549 52936141
Galactorrhoea 19.81 9.82 3 396373 3992 52948698
Blood aldosterone increased 19.80 9.82 14 396362 172 52952518
Sensory loss 19.68 9.82 113 396263 7792 52944898
Gingival atrophy 19.67 9.82 8 396368 27 52952663
Haemodynamic instability 19.57 9.82 120 396256 8474 52944216
Retinopathy hypertensive 19.54 9.82 16 396360 248 52952442
Hypoglossal nerve paralysis 19.46 9.82 7 396369 15 52952675
Grip strength decreased 19.41 9.82 36 396340 11713 52940977
Head discomfort 19.40 9.82 151 396225 11533 52941157
Vertigo 19.38 9.82 550 395826 55531 52897159
Haemodialysis 19.36 9.82 128 396248 9276 52943414
Acute motor-sensory axonal neuropathy 19.21 9.82 18 396358 337 52952353
Disability 19.17 9.82 40 396336 12458 52940232
Suicidal ideation 19.14 9.82 325 396051 60186 52892504
Protein urine present 19.08 9.82 88 396288 5566 52947124
Osteopenia 19.04 9.82 71 396305 18284 52934406
Disorientation 19.01 9.82 404 395972 38955 52913735
Diabetic nephropathy 18.94 9.82 37 396339 1440 52951250
C-reactive protein increased 18.85 9.82 373 396003 67513 52885177
Gallbladder adenocarcinoma 18.79 9.82 11 396365 95 52952595
Oral discharge 18.64 9.82 13 396363 156 52952534
Putamen haemorrhage 18.52 9.82 14 396362 192 52952498
Mydriasis 18.45 9.82 35 396341 11291 52941399
Pseudolymphoma 18.27 9.82 23 396353 608 52952082
Rectourethral fistula 18.26 9.82 8 396368 34 52952656
Blood uric acid increased 18.23 9.82 72 396304 4252 52948438
Nephrogenic systemic fibrosis 18.22 9.82 77 396299 4690 52948000
Tendonitis 18.15 9.82 65 396311 16941 52935749
Post transplant lymphoproliferative disorder 18.12 9.82 5 396371 4366 52948324
Interstitial lung disease 18.12 9.82 567 395809 58055 52894635
Cytomegalovirus infection 18.11 9.82 79 396297 19460 52933230
Electrocardiogram abnormal 18.03 9.82 113 396263 8040 52944650
Inflammation 18.03 9.82 307 396069 56829 52895861
Gingivitis 17.80 9.82 111 396265 7884 52944806
Acute hepatic failure 17.79 9.82 64 396312 16656 52936034
Gravitational oedema 17.68 9.82 33 396343 1241 52951449
Device adhesion issue 17.65 9.82 3 396373 3667 52949023
Diarrhoea 17.64 9.82 5056 391320 620490 52332200
Venoocclusive liver disease 17.57 9.82 6 396370 4566 52948124
Pulse abnormal 17.54 9.82 41 396335 1810 52950880
Skin tightness 17.52 9.82 68 396308 3983 52948707
Hypernatraemia 17.41 9.82 100 396276 6897 52945793
Dysphoria 17.38 9.82 9 396367 5340 52947350
Diabetes mellitus 17.37 9.82 524 395852 53375 52899315
Pancreatic toxicity 17.35 9.82 7 396369 23 52952667
Sinus rhythm 17.32 9.82 24 396352 698 52951992
Sickle cell anaemia with crisis 17.29 9.82 6 396370 4521 52948169
Vitello-intestinal duct remnant 17.24 9.82 8 396368 40 52952650
Medication error 17.16 9.82 372 396004 35993 52916697
Suspected product quality issue 17.15 9.82 13 396363 179 52952511
Hyperkaliuria 17.12 9.82 10 396366 86 52952604
Injection site haemorrhage 17.07 9.82 95 396281 21956 52930734
Nephrogenic anaemia 17.07 9.82 42 396334 1917 52950773
Fryns syndrome 17.06 9.82 9 396367 62 52952628
Crohn's disease 17.05 9.82 15 396361 6735 52945955
Haemoglobin decreased 17.05 9.82 1212 395164 136095 52816595
Product storage error 16.98 9.82 46 396330 13084 52939606
Intestinal villi atrophy 16.97 9.82 13 396363 182 52952508
Complication of device insertion 16.93 9.82 12 396364 6005 52946685
Blood glucose decreased 16.89 9.82 225 396151 19791 52932899
Transcription medication error 16.81 9.82 15 396361 263 52952427
Thirst 16.80 9.82 145 396231 11421 52941269
Blood sodium decreased 16.76 9.82 253 396123 22863 52929827
Upper respiratory tract infection 16.76 9.82 388 395988 68709 52883981
Taste disorder 16.74 9.82 109 396267 7859 52944831
Rectal ulcer haemorrhage 16.68 9.82 13 396363 187 52952503
Anorexia nervosa 16.62 9.82 13 396363 188 52952502
Congenital bladder anomaly 16.62 9.82 13 396363 188 52952502
Blood lactic acid increased 16.59 9.82 88 396288 5890 52946800
Hypothermia 16.58 9.82 159 396217 12897 52939793
Crush syndrome 16.57 9.82 11 396365 121 52952569
Hypertensive encephalopathy 16.55 9.82 23 396353 671 52952019
Aggression 16.43 9.82 104 396272 23299 52929391
Urachal abnormality 16.40 9.82 13 396363 192 52952498
Dermatosis 16.34 9.82 16 396360 317 52952373
Blood loss anaemia 16.34 9.82 117 396259 8706 52943984
Benign neoplasm of adrenal gland 16.31 9.82 7 396369 28 52952662
Granuloma skin 16.26 9.82 9 396367 5145 52947545
Generalised tonic-clonic seizure 16.24 9.82 136 396240 28622 52924068
Cytokine release syndrome 16.18 9.82 22 396354 8107 52944583
Neurotoxicity 16.16 9.82 59 396317 15290 52937400
Ankylosing spondylitis 16.16 9.82 22 396354 8103 52944587
Hallucination, gustatory 16.16 9.82 9 396367 70 52952620
Vaginal haemorrhage 16.04 9.82 125 396251 26716 52925974
Periodontitis 16.02 9.82 59 396317 3370 52949320
Agitation 16.01 9.82 323 396053 58303 52894387
Ventricular failure 15.94 9.82 18 396358 423 52952267
Hyperlipidaemia 15.90 9.82 218 396158 19297 52933393
Intermenstrual bleeding 15.88 9.82 25 396351 8673 52944017
Sleep disorder 15.88 9.82 325 396051 58545 52894145
Febrile bone marrow aplasia 15.84 9.82 18 396358 7171 52945519
Hyperplastic cholecystopathy 15.78 9.82 10 396366 101 52952589
Bursitis 15.77 9.82 100 396276 22392 52930298
CD30 expression 15.76 9.82 7 396369 31 52952659
Reduced facial expression 15.70 9.82 38 396338 1716 52950974
Maternal drugs affecting foetus 15.68 9.82 11 396365 5535 52947155
Drug hypersensitivity 15.68 9.82 1728 394648 263514 52689176
Autoimmune enteropathy 15.65 9.82 5 396371 6 52952684
Hypergastrinaemia 15.61 9.82 10 396366 103 52952587
Upper gastrointestinal haemorrhage 15.57 9.82 198 396178 17232 52935458
Device deployment issue 15.55 9.82 4 396372 3660 52949030
Full blood count decreased 15.53 9.82 258 396118 23771 52928919
Lichen planus 15.52 9.82 42 396334 2032 52950658
Gastrointestinal toxicity 15.49 9.82 8 396368 4754 52947936
Substance abuse 15.45 9.82 7 396369 4487 52948203
Persistent cloaca 15.44 9.82 13 396363 210 52952480
Renal cell carcinoma 15.42 9.82 60 396316 3519 52949171
Haemorrhagic erosive gastritis 15.41 9.82 15 396361 295 52952395
Cystic fibrosis 15.38 9.82 5 396371 3926 52948764
Mental status changes 15.36 9.82 394 395982 39177 52913513
Gout 15.25 9.82 150 396226 12249 52940441
Cardiac disorder 15.24 9.82 457 395919 46509 52906181
Lymphocyte count decreased 15.24 9.82 134 396242 27918 52924772
Nodule 15.24 9.82 72 396304 17357 52935333
Peripheral arterial occlusive disease 15.21 9.82 64 396312 3890 52948800
Blood cholinesterase decreased 15.17 9.82 11 396365 141 52952549
Duodenal ulcer 15.16 9.82 103 396273 7533 52945157
Cerebral ischaemia 15.13 9.82 93 396283 6572 52946118
Dystonia 15.11 9.82 48 396328 12973 52939717
Infected dermal cyst 15.10 9.82 18 396358 449 52952241
Electrolyte imbalance 15.00 9.82 210 396166 18674 52934016
Device malfunction 14.94 9.82 64 396312 15844 52936846
Diverticulum intestinal haemorrhagic 14.88 9.82 31 396345 1265 52951425
Adenoma benign 14.85 9.82 24 396352 803 52951887
Blood parathyroid hormone decreased 14.83 9.82 15 396361 6303 52946387
Burn oesophageal 14.82 9.82 12 396364 183 52952507
Retroperitoneal oedema 14.81 9.82 6 396370 20 52952670
Neovascularisation 14.77 9.82 21 396355 626 52952064
Skin discolouration 14.73 9.82 354 396022 34838 52917852
Pleural effusion 14.72 9.82 802 395574 87777 52864913
Albuminuria 14.70 9.82 13 396363 225 52952465
Purpura 14.70 9.82 134 396242 10719 52941971
Dialysis 14.68 9.82 129 396247 10213 52942477
Insulin-like growth factor decreased 14.65 9.82 17 396359 412 52952278
Ventricular septal defect 14.61 9.82 7 396369 4343 52948347
Mitral valve incompetence 14.57 9.82 215 396161 19336 52933354
Cardiac failure chronic 14.56 9.82 64 396312 3966 52948724
Saliva discolouration 14.48 9.82 7 396369 39 52952651
Apical granuloma 14.48 9.82 7 396369 39 52952651
Hypertensive angiopathy 14.44 9.82 9 396367 88 52952602
Dermatitis bullous 14.40 9.82 107 396269 8056 52944634
Soft tissue disorder 14.26 9.82 7 396369 4283 52948407
Organ failure 14.24 9.82 48 396328 2623 52950067
Menstruation irregular 14.19 9.82 19 396357 7047 52945643
Facial nerve disorder 14.15 9.82 20 396356 593 52952097
Bromhidrosis 14.13 9.82 5 396371 10 52952680
Body tinea 14.10 9.82 29 396347 1172 52951518
Genital haemorrhage 14.09 9.82 19 396357 7025 52945665
Sinus node dysfunction 14.08 9.82 67 396309 4294 52948396
Exercise tolerance decreased 14.05 9.82 77 396299 5218 52947472
Renal tubular necrosis 13.98 9.82 138 396238 11281 52941409
Congenital acrochordon 13.97 9.82 8 396368 66 52952624
Skin induration 13.92 9.82 53 396323 3077 52949613
Immune reconstitution inflammatory syndrome 13.86 9.82 16 396360 6330 52946360
Pulmonary hypoplasia 13.84 9.82 14 396362 289 52952401
Pericardial effusion 13.83 9.82 282 396094 26996 52925694
Haemorrhage intracranial 13.83 9.82 156 396220 13196 52939494
Restlessness 13.79 9.82 289 396087 27798 52924892
Platelet aggregation decreased 13.79 9.82 6 396370 25 52952665
Carcinoid tumour of the caecum 13.79 9.82 6 396370 25 52952665
Arterial occlusive disease 13.79 9.82 74 396302 4975 52947715
Temperature regulation disorder 13.78 9.82 7 396369 4200 52948490
Lymphadenopathy 13.77 9.82 188 396188 36067 52916623
Humerus fracture 13.75 9.82 107 396269 8172 52944518
Normal newborn 13.72 9.82 20 396356 7159 52945531
Norepinephrine increased 13.68 9.82 8 396368 69 52952621
Internal haemorrhage 13.63 9.82 70 396306 4626 52948064
Skin weeping 13.61 9.82 15 396361 343 52952347
Breast cancer metastatic 13.59 9.82 63 396313 15265 52937425
Congenital nail disorder 13.56 9.82 9 396367 99 52952591
Wrong drug 13.48 9.82 10 396366 133 52952557
Labelled drug-drug interaction medication error 13.48 9.82 132 396244 10767 52941923
Gastrointestinal ischaemia 13.46 9.82 12 396364 210 52952480
Oropharyngeal swelling 13.43 9.82 24 396352 872 52951818
Joint stiffness 13.39 9.82 152 396224 30131 52922559
Hypomania 13.39 9.82 10 396366 4872 52947818
Cardiomegaly 13.37 9.82 196 396180 17604 52935086
Hyperprolactinaemia 13.36 9.82 4 396372 3311 52949379
Heat illness 13.30 9.82 11 396365 173 52952517
Secondary hypertension 13.30 9.82 10 396366 136 52952554
Microalbuminuria 13.27 9.82 15 396361 353 52952337
Electrocardiogram U wave present 13.26 9.82 9 396367 103 52952587
Stomatitis haemorrhagic 13.26 9.82 6 396370 28 52952662
Bowel movement irregularity 13.25 9.82 64 396312 4127 52948563
Vision blurred 13.24 9.82 770 395606 84834 52867856
Candida infection 13.17 9.82 122 396254 25151 52927539
Ischaemic cardiomyopathy 13.15 9.82 46 396330 2562 52950128
Yellow skin 12.98 9.82 41 396335 2165 52950525
Osteoporosis 12.98 9.82 255 396121 46205 52906485
Device use error 12.97 9.82 13 396363 5486 52947204
Jaundice hepatocellular 12.93 9.82 6 396370 30 52952660
Femoral artery dissection 12.93 9.82 6 396370 30 52952660
Venous aneurysm 12.90 9.82 4 396372 4 52952686
Multiple-drug resistance 12.86 9.82 4 396372 3231 52949459
Abnormal loss of weight 12.86 9.82 76 396300 5296 52947394
Capillary disorder 12.86 9.82 8 396368 78 52952612
Transplant rejection 12.80 9.82 36 396340 10115 52942575
Finger deformity 12.74 9.82 14 396362 5663 52947027
Psychogenic visual disorder 12.73 9.82 5 396371 15 52952675
Renal aneurysm 12.73 9.82 5 396371 15 52952675
Lung diffusion test abnormal 12.69 9.82 8 396368 80 52952610
Kidney fibrosis 12.62 9.82 34 396342 1641 52951049
Ventricular extrasystoles 12.61 9.82 138 396238 11586 52941104
Hand dermatitis 12.61 9.82 8 396368 81 52952609
Hypoacusis 12.60 9.82 237 396139 22362 52930328
Deformity 12.59 9.82 25 396351 7929 52944761
Coordination abnormal 12.54 9.82 140 396236 11811 52940879
Sinus arrhythmia 12.53 9.82 32 396344 1495 52951195
Blood cholinesterase increased 12.49 9.82 5 396371 16 52952674
Intestinal ischaemia 12.48 9.82 97 396279 7405 52945285
Fluid intake reduced 12.46 9.82 55 396321 3414 52949276
Biopsy kidney 12.43 9.82 9 396367 115 52952575
Acral lentiginous melanoma 12.43 9.82 4 396372 5 52952685
Myelosuppression 12.42 9.82 51 396325 12777 52939913
Duodenal ulcer repair 12.40 9.82 7 396369 56 52952634
Aspergillus infection 12.36 9.82 23 396353 7473 52945217
Atrial pressure increased 12.27 9.82 5 396371 17 52952673
Bacteriuria 12.25 9.82 21 396355 738 52951952
Adverse drug reaction 12.21 9.82 304 396072 53321 52899369
Oxalosis 12.19 9.82 6 396370 35 52952655
Renal transplant 12.18 9.82 30 396346 1370 52951320
Drug-disease interaction 12.17 9.82 14 396362 336 52952354
Femoral neck fracture 12.12 9.82 105 396271 8278 52944412
Blood sodium increased 12.12 9.82 46 396330 2666 52950024
Synovial cyst 12.12 9.82 28 396348 8408 52944282
Thalamus haemorrhage 12.10 9.82 19 396357 620 52952070
Inhibitory drug interaction 12.08 9.82 41 396335 2249 52950441
Pigmentation disorder 12.07 9.82 61 396315 4006 52948684
Acute respiratory failure 12.07 9.82 311 396065 30947 52921743
Hyperparathyroidism secondary 12.03 9.82 31 396345 1456 52951234
Product solubility abnormal 12.03 9.82 23 396353 881 52951809
Hypereosinophilic syndrome 11.98 9.82 13 396363 292 52952398
Ectopic pregnancy 11.91 9.82 3 396373 2784 52949906
Enterochromaffin cell hyperplasia 11.91 9.82 7 396369 61 52952629
Gingival pain 11.90 9.82 86 396290 6417 52946273
Dysphagia 11.90 9.82 753 395623 83644 52869046
Drug screen positive 11.88 9.82 7 396369 3865 52948825
Bifascicular block 11.87 9.82 9 396367 124 52952566
Neurosensory hypoacusis 11.84 9.82 13 396363 296 52952394
Rheumatoid factor negative 11.81 9.82 18 396358 572 52952118
Acne 11.77 9.82 103 396273 21483 52931207
Coeliac disease 11.75 9.82 30 396346 8705 52943985
Type 2 diabetes mellitus 11.75 9.82 165 396211 31505 52921185
Typical aura without headache 11.73 9.82 3 396373 0 52952690
Blood pressure difference of extremities 11.73 9.82 3 396373 0 52952690
Tongue abscess 11.73 9.82 3 396373 0 52952690
Carbohydrate metabolism disorder 11.73 9.82 3 396373 0 52952690
Morganella test positive 11.73 9.82 3 396373 0 52952690
Adrenal gland cancer metastatic 11.73 9.82 3 396373 0 52952690
Cardiac index increased 11.73 9.82 3 396373 0 52952690
Ventricular drainage 11.73 9.82 3 396373 0 52952690
Tachypnoea 11.68 9.82 174 396202 15680 52937010
Leukaemic infiltration renal 11.65 9.82 5 396371 20 52952670
Gastric cancer 11.64 9.82 52 396324 3245 52949445
Pernicious anaemia 11.62 9.82 20 396356 705 52951985
Coronary arterial stent insertion 11.61 9.82 47 396329 2807 52949883
Anti-erythropoietin antibody positive 11.59 9.82 15 396361 408 52952282
Adrenal neoplasm 11.56 9.82 13 396363 304 52952386
Cerebrovascular insufficiency 11.54 9.82 8 396368 95 52952595
Influenza like illness 11.54 9.82 354 396022 60505 52892185
Congenital diaphragmatic hernia 11.52 9.82 11 396365 211 52952479
Bladder sphincter atony 11.51 9.82 10 396366 169 52952521
Diffuse large B-cell lymphoma refractory 11.50 9.82 25 396351 1051 52951639
Cerebral atrophy 11.47 9.82 70 396306 4934 52947756
Retroperitoneal haematoma 11.47 9.82 47 396329 2823 52949867
Cerebellar haemorrhage 11.43 9.82 30 396346 1425 52951265
Brain stem infarction 11.43 9.82 22 396354 847 52951843
Phrenic nerve paralysis 11.41 9.82 6 396370 41 52952649
Rib deformity 11.41 9.82 10 396366 171 52952519
Product administration error 11.39 9.82 224 396152 21307 52931383
Joint injury 11.38 9.82 107 396269 21993 52930697
Hypertonic bladder 11.24 9.82 51 396325 3204 52949486
Embedded device 11.22 9.82 5 396371 3236 52949454
Small for dates baby 11.20 9.82 7 396369 3745 52948945
Tonsillar inflammation 11.20 9.82 8 396368 100 52952590
Cerebrovascular disorder 11.20 9.82 48 396328 2942 52949748
Hepatocellular carcinoma 11.19 9.82 49 396327 3031 52949659
Hospice care 11.18 9.82 81 396295 6049 52946641
Gastric pH increased 11.18 9.82 6 396370 43 52952647
Renal function test abnormal 11.13 9.82 50 396326 3127 52949563
Sensorimotor disorder 11.13 9.82 16 396360 482 52952208
Oesophageal food impaction 11.13 9.82 10 396366 177 52952513
Acquired porphyria 11.11 9.82 5 396371 23 52952667
Porphyrins urine increased 11.11 9.82 5 396371 23 52952667
Head banging 11.10 9.82 15 396361 426 52952264
Sudden hearing loss 11.07 9.82 27 396349 1225 52951465
Fluid overload 11.07 9.82 278 396098 27553 52925137
Cytotoxic oedema 11.02 9.82 9 396367 139 52952551
Vasculitis 11.02 9.82 164 396212 14776 52937914
Mixed dementia 10.99 9.82 4 396372 9 52952681
Rales 10.97 9.82 126 396250 10706 52941984
Accelerated hypertension 10.91 9.82 15 396361 433 52952257
Gingival disorder 10.91 9.82 53 396323 3426 52949264
Essential hypertension 10.88 9.82 67 396309 4738 52947952
Lethargy 10.85 9.82 496 395880 53264 52899426
Muscular weakness 10.79 9.82 881 395495 100111 52852579
Graft versus host disease 10.75 9.82 23 396353 7099 52945591
Intestinal angioedema 10.74 9.82 18 396358 621 52952069
Pneumonia viral 10.71 9.82 23 396353 7089 52945601
Lip oedema 10.63 9.82 54 396322 3553 52949137
Cardiac valve sclerosis 10.62 9.82 5 396371 26 52952664
Dyslalia 10.62 9.82 17 396359 564 52952126
Cell marker increased 10.58 9.82 13 396363 335 52952355
Aortic stenosis 10.57 9.82 64 396312 4499 52948191
Nephrotic syndrome 10.55 9.82 72 396304 5273 52947417
Disease recurrence 10.54 9.82 102 396274 20844 52931846
Ventricular internal diameter abnormal 10.53 9.82 6 396370 49 52952641
Cholestatic liver injury 10.49 9.82 41 396335 2410 52950280
Scleritis 10.47 9.82 6 396370 3364 52949326
Acute graft versus host disease 10.42 9.82 10 396366 4307 52948383
Forced vital capacity decreased 10.41 9.82 24 396352 1050 52951640
Psychomotor retardation 10.40 9.82 54 396322 3584 52949106
Blood lactic acid 10.39 9.82 8 396368 113 52952577
Respiratory tract infection 10.33 9.82 179 396197 33045 52919645
Oesophageal carcinoma recurrent 10.32 9.82 5 396371 28 52952662
Neurofibrosarcoma 10.31 9.82 9 396367 153 52952537
Hyperhidrosis 10.31 9.82 601 395775 96192 52856498
Renal cyst infection 10.27 9.82 8 396368 115 52952575
Infusion site streaking 10.27 9.82 14 396362 401 52952289
Pneumothorax traumatic 10.26 9.82 9 396367 154 52952536
Skin necrosis 10.26 9.82 42 396334 10530 52942160
Tracheo-oesophageal fistula 10.23 9.82 17 396359 582 52952108
Small cell carcinoma 10.22 9.82 10 396366 198 52952492
Congenital uterine anomaly 10.21 9.82 8 396368 116 52952574
Transplant dysfunction 10.20 9.82 13 396363 4925 52947765
Orthopnoea 10.20 9.82 79 396297 6025 52946665
Nephropathy 10.13 9.82 72 396304 5345 52947345
Myoglobin blood increased 10.12 9.82 29 396347 1451 52951239
Tuberculosis 10.12 9.82 45 396331 11026 52941664
Carcinoid tumour of the stomach 10.07 9.82 9 396367 158 52952532
Porphyrins stool increased 10.04 9.82 5 396371 30 52952660
Blood chloride decreased 10.04 9.82 73 396303 5458 52947232
Mesenteric arterial occlusion 10.04 9.82 7 396369 84 52952606
Hyperparathyroidism primary 10.00 9.82 13 396363 355 52952335
Injection site induration 9.99 9.82 32 396344 8626 52944064
Incorrect route of product administration 9.98 9.82 93 396283 19151 52933539
Iliac artery occlusion 9.98 9.82 9 396367 160 52952530
Pelvic pain 9.98 9.82 52 396324 12221 52940469
Therapeutic drug monitoring analysis not performed 9.97 9.82 19 396357 726 52951964
Urine flow decreased 9.96 9.82 11 396365 252 52952438
Malignant hypertension 9.94 9.82 24 396352 1082 52951608
Trichoglossia 9.94 9.82 10 396366 205 52952485
Skin infection 9.93 9.82 55 396321 12727 52939963
Interstitial granulomatous dermatitis 9.91 9.82 5 396371 31 52952659
Fibrosis 9.90 9.82 57 396319 3935 52948755
Adams-Stokes syndrome 9.86 9.82 6 396370 56 52952634
End stage renal disease 9.83 9.82 79 396297 6092 52946598
Gastric cyst 9.83 9.82 8 396368 123 52952567

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 556.36 11.26 2100 320938 90417 32100071
Gingival hypertrophy 395.55 11.26 233 322805 1466 32189022
Drug abuse 336.78 11.26 189 322849 80054 32110434
Drug ineffective 280.68 11.26 2451 320587 381026 31809462
Blood pressure inadequately controlled 276.68 11.26 224 322814 2498 32187990
Hypertension 267.25 11.26 2228 320810 129522 32060966
Off label use 265.30 11.26 1869 321169 304451 31886037
Shock 197.08 11.26 607 322431 23507 32166981
Hypertensive crisis 192.72 11.26 328 322710 8489 32181999
Intentional overdose 178.64 11.26 853 322185 40748 32149740
Foetal exposure during pregnancy 177.97 11.26 94 322944 41207 32149281
Neutropenia 175.39 11.26 771 322267 141404 32049084
Oedema peripheral 170.82 11.26 1809 321229 112282 32078206
Death 163.82 11.26 2746 320292 379771 31810717
Angioedema 160.12 11.26 750 322288 35539 32154949
Acute kidney injury 157.51 11.26 3920 319118 289548 31900940
Febrile neutropenia 153.81 11.26 638 322400 118928 32071560
Product use in unapproved indication 151.48 11.26 408 322630 86796 32103692
Blood pressure increased 151.20 11.26 1324 321714 78030 32112458
Bradycardia 144.21 11.26 1209 321829 70353 32120135
Hypotension 140.43 11.26 2966 320072 213144 31977344
Non-cardiogenic pulmonary oedema 139.19 11.26 86 322952 597 32189891
Treatment failure 139.00 11.26 111 322927 39052 32151436
Cerebral infarction 118.36 11.26 566 322472 27048 32163440
Syncope 116.19 11.26 1388 321650 88736 32101752
Angina pectoris 100.38 11.26 594 322444 30832 32159656
Rheumatoid arthritis 98.06 11.26 183 322855 44361 32146127
Distributive shock 94.48 11.26 76 322962 839 32189649
Hypokalaemia 89.68 11.26 889 322149 54205 32136283
Blood creatinine increased 85.47 11.26 1386 321652 94746 32095742
Hyperkalaemia 85.41 11.26 1064 321974 68686 32121802
Drug resistance 82.85 11.26 64 322974 22901 32167587
Thrombocytopenia 81.21 11.26 1013 322025 147286 32043202
Metabolic acidosis 81.08 11.26 686 322352 40013 32150475
Cerebrovascular accident 79.15 11.26 1251 321787 85069 32105419
Swollen tongue 77.18 11.26 304 322734 13335 32177153
Drug dependence 75.54 11.26 73 322965 23411 32167077
Premature baby 74.25 11.26 46 322992 18472 32172016
Lip swelling 74.04 11.26 302 322736 13463 32177025
Immune reconstitution inflammatory syndrome 72.42 11.26 6 323032 9553 32180935
Blood pressure systolic increased 71.26 11.26 352 322686 17044 32173444
Pyrexia 70.35 11.26 2537 320501 317431 31873057
Rhabdomyolysis 69.88 11.26 996 322042 66269 32124219
Renal impairment 69.49 11.26 1292 321746 90680 32099808
Pancytopenia 69.45 11.26 576 322462 90659 32099829
Sepsis 68.66 11.26 1137 321901 157697 32032791
Aggression 65.58 11.26 188 322850 39201 32151287
Pathogen resistance 64.34 11.26 9 323029 9501 32180987
Dizziness 61.73 11.26 2608 320430 207010 31983478
Infusion related reaction 59.37 11.26 242 322796 45357 32145131
Infective pulmonary exacerbation of cystic fibrosis 57.79 11.26 9 323029 8770 32181718
Chronic kidney disease 57.45 11.26 629 322409 39346 32151142
Seizure 57.33 11.26 708 322330 103146 32087342
Suspected suicide 56.34 11.26 105 322933 2923 32187565
Exposure during pregnancy 53.31 11.26 13 323025 9216 32181272
Mucosal inflammation 53.18 11.26 163 322875 33271 32157217
Interstitial lung disease 51.13 11.26 919 322119 64082 32126406
Leukopenia 50.68 11.26 369 322669 59753 32130735
Septic shock 50.49 11.26 440 322598 68549 32121939
Multiple organ dysfunction syndrome 50.03 11.26 448 322590 69406 32121082
Agitation 49.84 11.26 348 322690 56888 32133600
Lactic acidosis 49.72 11.26 531 322507 33005 32157483
Product use issue 49.42 11.26 314 322724 52463 32138025
Glycosylated haemoglobin increased 48.98 11.26 219 322819 10170 32180318
Chronic pigmented purpura 47.39 11.26 23 323015 91 32190397
Progressive multifocal leukoencephalopathy 46.82 11.26 18 323020 9513 32180975
Suicide attempt 46.61 11.26 583 322455 37661 32152827
Renal artery stenosis 46.38 11.26 75 322963 1858 32188630
Cardiac failure congestive 46.29 11.26 1137 321901 83715 32106773
Pemphigoid 45.30 11.26 185 322853 8251 32182237
Depression 44.83 11.26 686 322352 96374 32094114
Palmar-plantar erythrodysaesthesia syndrome 44.81 11.26 289 322749 15460 32175028
Nephrotic syndrome 43.62 11.26 166 322872 7163 32183325
Cytokine release syndrome 43.61 11.26 42 322996 13493 32176995
Acute graft versus host disease 43.16 11.26 6 323032 6364 32184124
Proteinuria 43.13 11.26 308 322730 17047 32173441
Abnormal behaviour 42.83 11.26 128 322910 26338 32164150
Myalgia 41.22 11.26 1078 321960 80152 32110336
Aspergillus infection 40.81 11.26 33 323005 11541 32178947
Infection 40.06 11.26 596 322442 84119 32106369
Pulmonary oedema 39.56 11.26 663 322375 45604 32144884
Suicidal ideation 39.12 11.26 220 322818 37863 32152625
Gingival swelling 37.96 11.26 55 322983 1234 32189254
Haemophagocytic lymphohistiocytosis 37.91 11.26 34 323004 11301 32179187
Myocardial depression 37.76 11.26 16 323022 42 32190446
Sedation 37.42 11.26 80 322958 18446 32172042
Atrioventricular block complete 37.35 11.26 182 322856 8762 32181726
Synovitis 37.14 11.26 32 323006 10846 32179642
Bronchopulmonary aspergillosis 36.98 11.26 49 322989 13638 32176850
5-hydroxyindolacetic acid in urine increased 36.90 11.26 25 323013 207 32190281
Cytomegalovirus infection 36.46 11.26 130 322908 25334 32165154
Hypoglycaemia 36.33 11.26 750 322288 53632 32136856
Bone marrow failure 36.13 11.26 167 322871 30237 32160251
Vasoplegia syndrome 35.69 11.26 57 322981 1397 32189091
Plasma cell myeloma 35.57 11.26 383 322655 57231 32133257
Thalamus haemorrhage 35.50 11.26 47 322991 966 32189522
Gastrointestinal tract mucosal pigmentation 34.85 11.26 29 323009 337 32190151
Hypomagnesaemia 34.84 11.26 312 322726 18493 32171995
Diabetic nephropathy 34.25 11.26 70 322968 2089 32188399
Peripheral swelling 34.08 11.26 905 322133 67440 32123048
Gingival bleeding 33.54 11.26 148 322890 6833 32183655
Tachycardia 33.51 11.26 568 322470 78520 32111968
Diastolic dysfunction 33.33 11.26 121 322917 5103 32185385
Psychotic disorder 33.31 11.26 117 322921 22903 32167585
Graft versus host disease 33.14 11.26 35 323003 10771 32179717
Transient ischaemic attack 32.63 11.26 396 322642 25398 32165090
Drug ineffective for unapproved indication 32.55 11.26 55 322983 13857 32176631
Myelosuppression 32.37 11.26 41 322997 11635 32178853
Febrile bone marrow aplasia 32.24 11.26 22 323016 8393 32182095
Nocturia 31.83 11.26 179 322859 9115 32181373
Dyskinesia 31.51 11.26 124 322914 23479 32167009
Pseudolymphoma 31.31 11.26 33 323005 527 32189961
Orthostatic hypotension 31.24 11.26 391 322647 25259 32165229
C-reactive protein abnormal 31.23 11.26 12 323026 6344 32184144
Injection site pain 30.77 11.26 197 322841 32861 32157627
Palpitations 30.59 11.26 515 322523 35454 32155034
Chronic graft versus host disease 30.51 11.26 4 323034 4436 32186052
Drug withdrawal syndrome 30.51 11.26 101 322937 20130 32170358
Post transplant lymphoproliferative disorder 30.40 11.26 10 323028 5824 32184664
Hyponatraemia 30.11 11.26 961 322077 73552 32116936
Staphylococcal infection 29.34 11.26 195 322843 32244 32158244
Renal cell carcinoma 29.01 11.26 127 322911 5843 32184645
Mucormycosis 28.92 11.26 10 323028 5644 32184844
Dermatomyositis 28.90 11.26 47 322991 1170 32189318
Psoriatic arthropathy 28.45 11.26 87 322951 17773 32172715
Sinus bradycardia 28.41 11.26 223 322815 12715 32177773
Haematotoxicity 28.34 11.26 16 323022 6760 32183728
Contraindicated product administered 28.24 11.26 96 322942 18980 32171508
Myelodysplastic syndrome 28.22 11.26 103 322935 19935 32170553
Periodontitis 28.03 11.26 60 322978 1851 32188637
Substance abuse 28.01 11.26 18 323020 7089 32183399
Acute hepatic failure 27.90 11.26 54 322984 12915 32177573
Candida infection 27.38 11.26 81 322957 16722 32173766
Sinusitis 27.26 11.26 232 322806 36328 32154160
Pelvic mass 26.96 11.26 20 323018 194 32190294
Multiple-drug resistance 26.93 11.26 3 323035 3772 32186716
Vertebral osteophyte 26.87 11.26 13 323025 51 32190437
Polymyositis 26.50 11.26 51 322987 1455 32189033
Plasmapheresis 26.49 11.26 25 323013 347 32190141
Electrocardiogram QRS complex prolonged 25.91 11.26 102 322936 4472 32186016
Intentional product use issue 25.89 11.26 281 322757 41930 32148558
Loss of consciousness 25.85 11.26 1036 322002 81671 32108817
Primary hyperaldosteronism 25.76 11.26 13 323025 57 32190431
Accelerated hypertension 25.66 11.26 21 323017 238 32190250
Atrioventricular block first degree 25.62 11.26 120 322918 5683 32184805
Cytomegalovirus chorioretinitis 25.44 11.26 3 323035 3609 32186879
Blood mercury abnormal 25.30 11.26 19 323019 188 32190300
Stenosis 25.26 11.26 41 322997 1019 32189469
Myocardial infarction 25.16 11.26 1507 321531 124169 32066319
Device issue 25.02 11.26 31 323007 8881 32181607
Dystonia 24.85 11.26 42 322996 10581 32179907
Coronary artery disease 24.72 11.26 658 322380 49048 32141440
Neutrophil count decreased 24.63 11.26 325 322713 46814 32143674
No adverse event 24.51 11.26 109 322929 19944 32170544
Erectile dysfunction 24.41 11.26 303 322735 19536 32170952
Multiple sclerosis 24.30 11.26 24 323014 7620 32182868
Respiratory depression 24.30 11.26 60 322978 13151 32177337
Hyperdynamic left ventricle 24.29 11.26 14 323024 84 32190404
Diabetes mellitus inadequate control 24.27 11.26 226 322812 13542 32176946
Wrong technique in product usage process 24.15 11.26 227 322811 34832 32155656
Product monitoring error 24.08 11.26 68 322970 2506 32187982
Lipodystrophy acquired 23.73 11.26 4 323034 3678 32186810
Disease progression 23.71 11.26 669 322369 86193 32104295
Orbital myositis 23.66 11.26 16 323022 132 32190356
Akathisia 23.58 11.26 21 323017 7004 32183484
Eczema 23.52 11.26 240 322798 14740 32175748
Irritability 23.42 11.26 146 322892 24508 32165980
Renal failure 23.18 11.26 1592 321446 132886 32057602
Pneumonia 23.17 11.26 3135 319903 352117 31838371
Carotid sinus syndrome 23.14 11.26 10 323028 28 32190460
Acute myocardial infarction 22.99 11.26 714 322324 54435 32136053
Prerenal failure 22.98 11.26 58 322980 1997 32188491
Hospitalisation 22.97 11.26 345 322693 48626 32141862
Adenovirus infection 22.91 11.26 9 323029 4695 32185793
Maternal drugs affecting foetus 22.87 11.26 7 323031 4270 32186218
Aortic dissection 22.85 11.26 67 322971 2523 32187965
Tongue oedema 22.82 11.26 72 322966 2824 32187664
Hyperplasia 22.79 11.26 30 323008 613 32189875
Atrioventricular block 22.72 11.26 142 322896 7513 32182975
Venoocclusive liver disease 22.42 11.26 24 323014 7341 32183147
Hypertensive nephropathy 22.39 11.26 26 323012 465 32190023
Hyperuricaemia 22.31 11.26 148 322890 7993 32182495
Diffuse large B-cell lymphoma 22.15 11.26 31 323007 8431 32182057
Pseudomonas infection 21.98 11.26 55 322983 12001 32178487
Chills 21.93 11.26 599 322439 77485 32113003
Clear cell renal cell carcinoma 21.66 11.26 38 323000 1008 32189480
Lacunar infarction 21.35 11.26 75 322963 3111 32187377
Brain stem infarction 21.34 11.26 43 322995 1270 32189218
Embolic stroke 21.25 11.26 84 322954 3690 32186798
Melaena 21.18 11.26 472 322566 34193 32156295
Osteonecrosis 21.14 11.26 89 322949 16533 32173955
Heart rate decreased 21.13 11.26 360 322678 24840 32165648
Schizophrenia 21.11 11.26 42 322996 9942 32180546
Coma 21.10 11.26 297 322741 42315 32148173
Alcohol abuse 21.06 11.26 9 323029 4463 32186025
Disease recurrence 21.06 11.26 85 322953 15979 32174509
Carotid arteriosclerosis 20.96 11.26 38 323000 1035 32189453
Status epilepticus 20.95 11.26 56 322982 11950 32178538
Hypertensive heart disease 20.91 11.26 63 322975 2409 32188079
Renal disorder 20.84 11.26 359 322679 24824 32165664
Carotid artery stenosis 20.82 11.26 100 322938 4786 32185702
Leukaemoid reaction 20.72 11.26 13 323025 93 32190395
Lymphadenopathy 20.57 11.26 171 322867 26911 32163577
Arthropathy 20.43 11.26 135 322903 22354 32168134
Ventricular septal defect 20.36 11.26 6 323032 3751 32186737
Atheroembolism 20.32 11.26 18 323020 229 32190259
Vomiting 20.30 11.26 2040 320998 233517 31956971
Brain contusion 20.28 11.26 33 323005 822 32189666
Neurotoxicity 20.23 11.26 79 322959 14991 32175497
Therapeutic product effect decreased 20.03 11.26 204 322834 30813 32159675
Angina unstable 19.91 11.26 199 322839 12156 32178332
Dyspnoea exertional 19.73 11.26 517 322521 38444 32152044
Overdose 19.71 11.26 1056 321982 86021 32104467
Acute myeloid leukaemia 19.56 11.26 111 322927 19063 32171425
Macroglossia 19.56 11.26 21 323017 343 32190145
Pain 19.53 11.26 1601 321437 185955 32004533
Therapeutic product effect incomplete 19.47 11.26 291 322747 41050 32149438
Haemorrhage subcutaneous 19.32 11.26 60 322978 2333 32188155
Pericardial haemorrhage 19.28 11.26 71 322967 3015 32187473
Blood pressure diastolic decreased 19.22 11.26 130 322908 7067 32183421
Intentional self-injury 19.21 11.26 72 322966 13828 32176660
Apparent death 19.18 11.26 6 323032 3609 32186879
Graft versus host disease in skin 19.09 11.26 6 323032 3598 32186890
Cytomegalovirus infection reactivation 19.05 11.26 5 323033 3374 32187114
Skin toxicity 19.01 11.26 7 323031 3799 32186689
Hepatic failure 19.00 11.26 245 322793 35435 32155053
Acute coronary syndrome 18.94 11.26 217 322821 13724 32176764
Ischaemic stroke 18.93 11.26 262 322776 17314 32173174
Peripheral arterial occlusive disease 18.92 11.26 109 322929 5600 32184888
Eyelid oedema 18.87 11.26 103 322935 5186 32185302
Hydronephrosis 18.68 11.26 160 322878 9363 32181125
Lymphocele 18.58 11.26 44 322994 1454 32189034
Blood creatine phosphokinase increased 18.49 11.26 587 322451 44889 32145599
Immune-mediated myositis 18.44 11.26 47 322991 1628 32188860
Mouth swelling 18.38 11.26 48 322990 1688 32188800
Condition aggravated 18.36 11.26 1315 321723 154346 32036142
Epiglottic oedema 18.12 11.26 15 323023 173 32190315
Fungal infection 18.00 11.26 84 322954 15171 32175317
Duodenal ulcer haemorrhage 17.84 11.26 97 322941 4877 32185611
Product substitution issue 17.75 11.26 170 322868 10266 32180222
Dysphagia 17.67 11.26 470 322568 61006 32129482
Hypersensitivity vasculitis 17.65 11.26 78 322960 3603 32186885
Paranoia 17.63 11.26 52 322986 10747 32179741
Cardiogenic shock 17.62 11.26 296 322742 20366 32170122
Left ventricular hypertrophy 17.62 11.26 123 322915 6757 32183731
Bone erosion 17.60 11.26 3 323035 2736 32187752
Encephalopathy 17.60 11.26 237 322801 34020 32156468
Neuropathy peripheral 17.58 11.26 607 322431 76375 32114113
Mydriasis 17.49 11.26 23 323015 6423 32184065
Zoonotic bacterial infection 17.49 11.26 10 323028 59 32190429
Obsessive-compulsive disorder 17.48 11.26 14 323024 4920 32185568
Presyncope 17.47 11.26 255 322783 17046 32173442
Ear infection 17.46 11.26 36 323002 8412 32182076
Neuroleptic malignant syndrome 17.46 11.26 102 322936 17393 32173095
Blood pressure abnormal 17.39 11.26 132 322906 7448 32183040
Putamen haemorrhage 17.29 11.26 17 323021 249 32190239
Breath sounds abnormal 17.24 11.26 111 322927 5934 32184554
Colitis ulcerative 17.24 11.26 99 322939 16952 32173536
Maternal exposure during pregnancy 17.22 11.26 11 323027 4346 32186142
Blood glucose increased 17.20 11.26 803 322235 64438 32126050
Lung diffusion test decreased 17.10 11.26 27 323011 655 32189833
Fibrillary glomerulonephritis 17.07 11.26 9 323029 44 32190444
Deep vein thrombosis 17.06 11.26 492 322546 63221 32127267
Pulmonary embolism 17.01 11.26 669 322369 82990 32107498
Tremor 16.95 11.26 648 322390 80629 32109859
Blood uric acid increased 16.91 11.26 118 322920 6481 32184007
Osteoporosis 16.90 11.26 63 322975 12119 32178369
Cognitive disorder 16.85 11.26 170 322868 25724 32164764
Chest pain 16.80 11.26 1442 321596 122695 32067793
Muscle rigidity 16.76 11.26 56 322982 11130 32179358
Prescription drug used without a prescription 16.72 11.26 39 322999 1276 32189212
Hepatic neoplasm 16.68 11.26 52 322986 2026 32188462
Product dose omission issue 16.61 11.26 841 322197 101734 32088754
Retinopathy hypertensive 16.60 11.26 17 323021 262 32190226
Gout 16.60 11.26 270 322768 18458 32172030
Diffuse large B-cell lymphoma recurrent 16.57 11.26 3 323035 2619 32187869
Fall 16.55 11.26 2208 320830 193993 31996495
Guillain-Barre syndrome 16.53 11.26 102 322936 5372 32185116
Cerebral haemorrhage 16.43 11.26 457 322581 34290 32156198
Drug intolerance 16.35 11.26 377 322661 49858 32140630
Hyperbilirubinaemia 16.32 11.26 106 322932 17624 32172864
Milk-alkali syndrome 16.32 11.26 24 323014 546 32189942
Cytomegalovirus viraemia 16.29 11.26 26 323012 6701 32183787
Left ventricular enlargement 16.29 11.26 26 323012 637 32189851
Somnolence 16.24 11.26 854 322184 102943 32087545
Metastatic renal cell carcinoma 16.23 11.26 59 322979 2490 32187998
Intentional product misuse 16.22 11.26 256 322782 35795 32154693
Thrombotic stroke 16.15 11.26 17 323021 271 32190217
Dermatitis infected 16.12 11.26 12 323026 117 32190371
Drug use disorder 15.95 11.26 8 323030 3613 32186875
Swelling face 15.89 11.26 313 322725 22192 32168296
Tenosynovitis 15.87 11.26 9 323029 3794 32186694
Polymyalgia rheumatica 15.87 11.26 38 323000 1265 32189223
Lacrimal disorder 15.84 11.26 18 323020 314 32190174
Nipple inflammation 15.78 11.26 10 323028 73 32190415
Hallucination 15.73 11.26 400 322638 52219 32138269
Small for dates baby 15.71 11.26 7 323031 3386 32187102
Epstein-Barr virus infection 15.71 11.26 29 323009 7061 32183427
Liver carcinoma ruptured 15.63 11.26 13 323025 151 32190337
Microalbuminuria 15.56 11.26 27 323011 710 32189778
Lymphoma 15.55 11.26 55 322983 10745 32179743
Blood pressure decreased 15.53 11.26 638 322400 50442 32140046
Hyperammonaemia 15.49 11.26 22 323016 5947 32184541
Hypertensive emergency 15.42 11.26 30 323008 863 32189625
Drug eruption 15.42 11.26 272 322766 18894 32171594
Aortic aneurysm 15.41 11.26 117 322921 6602 32183886
Pharyngeal oedema 15.40 11.26 114 322924 6382 32184106
Hair colour changes 15.39 11.26 44 322994 1633 32188855
Low density lipoprotein decreased 15.37 11.26 33 323005 1020 32189468
Migraine 15.35 11.26 79 322959 13906 32176582
White blood cell count decreased 15.30 11.26 745 322293 90453 32100035
Intervertebral disc displacement 15.29 11.26 13 323025 156 32190332
Tricuspid valve calcification 15.21 11.26 5 323033 4 32190484
Atrioventricular block second degree 15.20 11.26 71 322967 3359 32187129
Anxiety 15.19 11.26 789 322249 95216 32095272
Bundle branch block 15.17 11.26 31 323007 925 32189563
Arteriosclerosis 15.10 11.26 172 322866 10862 32179626
Kidney small 15.10 11.26 9 323029 58 32190430
Polypectomy 15.08 11.26 23 323015 541 32189947
Therapy partial responder 15.08 11.26 16 323022 4914 32185574
Crying 15.04 11.26 22 323016 5874 32184614
Gastric cancer 15.00 11.26 99 322939 5338 32185150
Thrombotic cerebral infarction 14.95 11.26 18 323020 335 32190153
Band neutrophil percentage decreased 14.94 11.26 6 323032 13 32190475
Ventricular tachycardia 14.93 11.26 172 322866 25384 32165104
Nausea 14.90 11.26 2886 320152 317963 31872525
Euphoric mood 14.86 11.26 18 323020 5209 32185279
Pruritus 14.84 11.26 1478 321560 127224 32063264
Diabetic neuropathy 14.83 11.26 81 322957 4079 32186409
Prostatic specific antigen increased 14.79 11.26 198 322840 12989 32177499
Musculoskeletal stiffness 14.73 11.26 288 322750 38976 32151512
Coronary arterial stent insertion 14.73 11.26 82 322956 4160 32186328
Device related infection 14.65 11.26 111 322927 17822 32172666
Graft versus host disease in gastrointestinal tract 14.57 11.26 8 323030 3433 32187055
High density lipoprotein decreased 14.57 11.26 69 322969 3283 32187205
Psoriasis 14.50 11.26 348 322690 45775 32144713
Generalised bullous fixed drug eruption 14.49 11.26 4 323034 0 32190488
Non-compaction cardiomyopathy 14.49 11.26 4 323034 0 32190488
Ventricular compliance decreased 14.49 11.26 4 323034 0 32190488
Mucosal membrane hyperplasia 14.49 11.26 4 323034 0 32190488
Blood aldosterone decreased 14.49 11.26 4 323034 0 32190488
Vertebrobasilar stroke 14.49 11.26 4 323034 0 32190488
Hypoinsulinaemia 14.49 11.26 4 323034 0 32190488
Prostate cancer recurrent 14.46 11.26 30 323008 905 32189583
Cutaneous lupus erythematosus 14.42 11.26 26 323012 705 32189783
Delusion 14.41 11.26 74 322964 13034 32177454
Hepatic enzyme increased 14.40 11.26 270 322768 36767 32153721
Nasal crusting 14.40 11.26 20 323018 431 32190057
Cataract 14.37 11.26 328 322710 23855 32166633
Cystic fibrosis 14.33 11.26 3 323035 2363 32188125
Hepatic function abnormal 14.31 11.26 563 322475 44277 32146211
Freezing phenomenon 14.31 11.26 3 323035 2360 32188128
Myopathy 14.29 11.26 174 322864 11167 32179321
Enterococcal infection 14.25 11.26 45 322993 9102 32181386
Hyperglycaemia 14.18 11.26 490 322548 37901 32152587
Thirst 14.16 11.26 123 322915 7227 32183261
Oxygen consumption decreased 14.15 11.26 13 323025 174 32190314
Respiratory arrest 14.13 11.26 202 322836 28706 32161782
Blood aldosterone increased 14.09 11.26 6 323032 16 32190472
Viral infection 14.04 11.26 99 322939 16151 32174337
Pollakiuria 14.02 11.26 263 322775 18481 32172007
Coronary artery stenosis 14.02 11.26 154 322884 9639 32180849
Cardiomegaly 14.01 11.26 219 322819 14852 32175636
Bacteraemia 14.01 11.26 110 322928 17523 32172965
Post-traumatic amnestic disorder 13.88 11.26 8 323030 48 32190440
Respiratory failure 13.87 11.26 898 322140 106284 32084204
Suspected suicide attempt 13.85 11.26 11 323027 119 32190369
Drug screen positive 13.85 11.26 13 323025 4228 32186260
Left atrial enlargement 13.80 11.26 24 323014 632 32189856
Surfactant protein increased 13.80 11.26 5 323033 7 32190481
Hypovolaemic shock 13.76 11.26 116 322922 6756 32183732
Haemodynamic instability 13.75 11.26 141 322897 8670 32181818
Pericardial disease 13.69 11.26 17 323021 327 32190161
Clostridium difficile infection 13.68 11.26 112 322926 17684 32172804
Peripheral artery occlusion 13.59 11.26 41 322997 1569 32188919
Large intestine polyp 13.57 11.26 120 322918 7086 32183402
Needle fatigue 13.56 11.26 19 323019 413 32190075
Mycobacterium avium complex infection 13.53 11.26 6 323032 2911 32187577
Blood cholinesterase decreased 13.49 11.26 11 323027 124 32190364
Pelvic cyst 13.48 11.26 7 323031 33 32190455
Sex hormone binding globulin increased 13.41 11.26 5 323033 8 32190480
Crohn's disease 13.41 11.26 14 323024 4331 32186157
Faeces discoloured 13.38 11.26 215 322823 14662 32175826
Toxic nodular goitre 13.36 11.26 6 323032 19 32190469
Unintentional medical device removal 13.35 11.26 4 323034 2474 32188014
Cachexia 13.30 11.26 32 323006 7077 32183411
Haemodialysis 13.28 11.26 168 322870 10878 32179610
Sinus node dysfunction 13.27 11.26 77 322961 3967 32186521
Body temperature increased 13.26 11.26 97 322941 15694 32174794
Neonatal respiratory distress syndrome 13.21 11.26 13 323025 4134 32186354
Nodal rhythm 13.18 11.26 39 322999 1476 32189012
Seronegative arthritis 13.15 11.26 30 323008 967 32189521
Device leakage 13.14 11.26 16 323022 4620 32185868
Hepatitis B 13.13 11.26 27 323011 6314 32184174
Wrong strength 13.07 11.26 10 323028 102 32190386
Malaise 13.06 11.26 1978 321060 175160 32015328
Bradykinesia 13.01 11.26 14 323024 4272 32186216
Generalised oedema 13.01 11.26 185 322853 12298 32178190
Bundle branch block left 12.90 11.26 100 322938 5679 32184809
Tuberculosis 12.87 11.26 44 322994 8685 32181803
Histology abnormal 12.80 11.26 16 323022 310 32190178
Albumin urine present 12.79 11.26 18 323020 393 32190095
Giant cell arteritis 12.78 11.26 27 323011 825 32189663
Thromboangiitis obliterans 12.71 11.26 6 323032 22 32190466
Low birth weight baby 12.68 11.26 32 323006 6962 32183526
Fracture displacement 12.67 11.26 8 323030 58 32190430
Product administered to patient of inappropriate age 12.66 11.26 6 323032 2800 32187688
Antipsychotic drug level increased 12.64 11.26 10 323028 3536 32186952
Acidosis 12.64 11.26 164 322874 10682 32179806
Body temperature decreased 12.61 11.26 166 322872 10848 32179640
Hypocalcaemia 12.57 11.26 309 322729 22745 32167743
Dysmorphism 12.56 11.26 6 323032 2787 32187701
Stomatitis 12.51 11.26 304 322734 39925 32150563
Sinonasal obstruction 12.51 11.26 6 323032 23 32190465
Hypertensive encephalopathy 12.50 11.26 17 323021 359 32190129
Malabsorption 12.45 11.26 49 322989 2148 32188340
Renal function test abnormal 12.40 11.26 54 322984 2479 32188009
Neuralgia 12.35 11.26 68 322970 11767 32178721
Drug abuser 12.34 11.26 14 323024 4170 32186318
On and off phenomenon 12.32 11.26 10 323028 3491 32186997
Kinematic imbalances due to suboccipital strain 12.31 11.26 6 323032 24 32190464
Strongyloidiasis 12.31 11.26 5 323033 2556 32187932
Macrophages increased 12.24 11.26 12 323026 175 32190313
Haematochezia 12.21 11.26 491 322547 38717 32151771
Multiple sclerosis relapse 12.12 11.26 68 322970 11713 32178775
Dysphonia 12.12 11.26 280 322758 20404 32170084
Atrial septal defect 12.08 11.26 33 323005 6992 32183496
Urogenital haemorrhage 12.07 11.26 20 323018 506 32189982
Lipoma 12.05 11.26 38 323000 1490 32188998
Large intestinal polypectomy 12.03 11.26 8 323030 64 32190424
Drug reaction with eosinophilia and systemic symptoms 11.96 11.26 239 322799 32246 32158242
Gastrointestinal ischaemia 11.93 11.26 13 323025 216 32190272
Tricuspid valve incompetence 11.93 11.26 143 322895 9144 32181344
Dyspnoea 11.91 11.26 3892 319146 358153 31832335
Incorrect route of product administration 11.90 11.26 68 322970 11658 32178830
Yellow skin 11.89 11.26 48 322990 2129 32188359
Dysgeusia 11.85 11.26 335 322703 25196 32165292
Physical deconditioning 11.83 11.26 26 323012 817 32189671
Serotonin syndrome 11.83 11.26 127 322911 18990 32171498
Pneumocystis jirovecii pneumonia 11.82 11.26 125 322913 18745 32171743
Hepatitis 11.78 11.26 165 322873 23528 32166960
Platelet count decreased 11.78 11.26 979 322059 113612 32076876
Lymphomatoid papulosis 11.77 11.26 12 323026 184 32190304
Intestinal villi atrophy 11.75 11.26 11 323027 151 32190337
Ventricular hypertrophy 11.75 11.26 87 322951 4871 32185617
Muscle necrosis 11.75 11.26 26 323012 821 32189667
Hepatotoxicity 11.75 11.26 129 322909 19208 32171280
Epilepsy 11.70 11.26 152 322886 21957 32168531
Hyperparathyroidism secondary 11.65 11.26 32 323006 1160 32189328
Palatal oedema 11.62 11.26 26 323012 827 32189661
Joint swelling 11.62 11.26 627 322411 51108 32139380
Herpes zoster 11.59 11.26 239 322799 32102 32158386
Portal hypertension 11.55 11.26 14 323024 4050 32186438
Fulminant type 1 diabetes mellitus 11.54 11.26 22 323016 623 32189865
Retinal vascular thrombosis 11.54 11.26 8 323030 69 32190419
Blood potassium decreased 11.53 11.26 239 322799 17099 32173389
Herbal interaction 11.51 11.26 16 323022 345 32190143
Intraventricular haemorrhage 11.49 11.26 62 322976 3108 32187380
Product solubility abnormal 11.46 11.26 21 323017 577 32189911
Arterial stenosis 11.43 11.26 33 323005 1232 32189256
Rhythm idioventricular 11.41 11.26 15 323023 306 32190182
Cytomegalovirus colitis 11.40 11.26 6 323032 2636 32187852
Acute biphenotypic leukaemia 11.36 11.26 8 323030 71 32190417
Oedema 11.33 11.26 553 322485 44594 32145894
Renal artery thrombosis 11.27 11.26 15 323023 310 32190178
Phaeochromocytoma malignant 11.27 11.26 8 323030 72 32190416

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE;14MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 10MG BASE;14MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 1MG BASE/ML NORLIQVA CMP DEV LLC N214439 Feb. 24, 2022 RX SOLUTION ORAL 11253474 Feb. 24, 2041 NORLIQVA IS INDICATED FOR THE SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA
EQ 1MG BASE/ML NORLIQVA CMP DEV LLC N214439 Feb. 24, 2022 RX SOLUTION ORAL 11253474 Feb. 24, 2041 NORLIQVA IS INDICATED FOR THE TREATMENT OF CONFIRMED OR SUSPECTED VASOSPASTIC ANGINA
EQ 1MG BASE/ML NORLIQVA CMP DEV LLC N214439 Feb. 24, 2022 RX SOLUTION ORAL 11253474 Feb. 24, 2041 NORLIQVA IS INDICATED FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel BLOCKER WOMBAT-PK CHEMBL
Voltage-dependent L-type calcium channel subunit alpha-1D Ion channel BLOCKER Ki 7 WOMBAT-PK CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 5.63 CHEMBL
Aldehyde oxidase Enzyme IC50 5.26 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 6.58 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.36 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR Ki 5.27 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 5.10 CHEMBL
Voltage-dependent calcium channel gamma-1 subunit Ion channel Ki 7.20 WOMBAT-PK
Carbonic anhydrase 1 Enzyme WOMBAT-PK
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel Ki 7.20 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1H Ion channel Ki 4.51 WOMBAT-PK
Potassium channel subfamily K member 2 Ion channel IC50 6.40 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 6.65 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.87 DRUG MATRIX
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel Ki 8.70 CHEMBL
Potassium channel subfamily K member 2 Ion channel IC50 6.37 CHEMBL

External reference:

IDSource
4020813 VUID
N0000148333 NUI
D00615 KEGG_DRUG
111470-99-6 SECONDARY_CAS_RN
104416 RXNORM
C0051696 UMLSCUI
CHEBI:2669 CHEBI
6UB PDB_CHEM_ID
CHEMBL1491 ChEMBL_ID
CHEMBL1200402 ChEMBL_ID
CHEMBL1200984 ChEMBL_ID
D017311 MESH_DESCRIPTOR_UI
DB00381 DRUGBANK_ID
2162 PUBCHEM_CID
6981 IUPHAR_LIGAND_ID
5729 INN_ID
1J444QC288 UNII
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