losartan ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 1610 114798-26-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • losartan
  • allisartan
  • lortaan
  • losartan potassium
  • losartan monopotassium
  • losartan monopotassium salt
An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.
  • Molecular weight: 422.92
  • Formula: C22H23ClN6O
  • CLOGP: 3.85
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 92.51
  • ALOGS: -4.97
  • ROTB: 8

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.05 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 12 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.95 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 35 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.37 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.20 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) 1.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 14, 1995 FDA MERCK SHARP DOHME

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
Pemphigus 460.02 9.62 4 166732 183722 63138564
Synovitis 377.68 9.62 30 166706 186888 63135398
Systemic lupus erythematosus 365.59 9.62 56 166680 208862 63113424
Hand deformity 364.64 9.62 12 166724 159445 63162841
Maternal exposure during pregnancy 328.82 9.62 86 166650 219976 63102310
Contraindicated product administered 299.69 9.62 99 166637 217549 63104737
Glossodynia 284.75 9.62 61 166675 178815 63143471
Wound 259.19 9.62 56 166680 163207 63159079
Drug intolerance 244.66 9.62 270 166466 308391 63013895
Infusion related reaction 242.23 9.62 175 166561 245346 63076940
Drug ineffective 228.47 9.62 1710 165026 1043055 62279231
Treatment failure 222.24 9.62 123 166613 198920 63123366
Arthropathy 218.04 9.62 178 166558 234614 63087672
Duodenal ulcer perforation 213.18 9.62 3 166733 87206 63235080
Cardiac failure congestive 202.67 9.62 618 166118 91815 63230471
Rheumatoid factor positive 197.85 9.62 5 166731 84401 63237885
Helicobacter infection 173.82 9.62 20 166716 92765 63229521
Pericarditis 170.53 9.62 66 166670 131513 63190773
Hepatic enzyme increased 168.01 9.62 170 166566 202158 63120128
Acute kidney injury 167.63 9.62 1225 165511 262190 63060096
Off label use 159.41 9.62 1078 165658 673384 62648902
Exposure during pregnancy 158.43 9.62 107 166629 155440 63166846
Folliculitis 158.20 9.62 6 166730 70311 63251975
Blood pressure increased 157.91 9.62 841 165895 161221 63161065
Therapeutic product effect decreased 148.55 9.62 173 166563 193014 63129272
Lower respiratory tract infection 145.84 9.62 83 166653 132224 63190062
Discomfort 145.47 9.62 135 166601 167239 63155047
Dizziness 144.04 9.62 1743 164993 428182 62894104
Joint swelling 138.41 9.62 422 166314 327244 62995042
Swelling 130.85 9.62 335 166401 275043 63047243
Muscle injury 130.47 9.62 11 166725 65334 63256952
Rheumatoid arthritis 129.89 9.62 297 166439 253522 63068764
Blood glucose increased 128.32 9.62 497 166239 83259 63239027
Hyponatraemia 121.00 9.62 598 166138 111302 63210984
Myocardial infarction 119.00 9.62 549 166187 99344 63222942
Sleep disorder due to general medical condition, insomnia type 112.41 9.62 6 166730 52211 63270075
Product substitution issue 111.11 9.62 171 166565 15825 63306461
Cough 110.92 9.62 1216 165520 291527 63030759
Diarrhoea 106.36 9.62 2541 164195 712825 62609461
Product use issue 102.62 9.62 271 166465 220249 63102037
Feeling abnormal 95.90 9.62 693 166043 147699 63174587
Drug abuse 94.55 9.62 36 166700 72482 63249804
Hypersensitivity 93.97 9.62 422 166314 292263 63030023
Blood pressure inadequately controlled 92.89 9.62 88 166648 4890 63317396
General physical health deterioration 89.58 9.62 253 166483 201149 63121137
Irritable bowel syndrome 88.94 9.62 53 166683 82359 63239927
Hyperkalaemia 88.25 9.62 328 166408 53875 63268411
Cerebrovascular accident 85.12 9.62 530 166206 107494 63214792
Product dose omission issue 80.88 9.62 956 165780 233357 63088929
Transient ischaemic attack 78.59 9.62 248 166488 37505 63284781
Impaired healing 78.58 9.62 92 166644 102450 63219836
Muscle spasms 78.31 9.62 688 166048 155462 63166824
Atrial fibrillation 75.50 9.62 545 166191 116091 63206195
Infection 73.77 9.62 330 166406 228843 63093443
Loss of employment 73.75 9.62 55 166681 2189 63320097
C-reactive protein increased 72.54 9.62 85 166651 94622 63227664
Febrile neutropenia 70.40 9.62 127 166609 118322 63203964
Malaise 68.86 9.62 1501 165235 414453 62907833
Abortion spontaneous 65.70 9.62 21 166715 47174 63275112
Blister 65.44 9.62 153 166583 129661 63192625
Acute myocardial infarction 65.01 9.62 209 166527 31915 63290371
Palpitations 64.58 9.62 512 166224 112258 63210028
COVID-19 63.95 9.62 512 166224 112591 63209695
Cardiospasm 63.25 9.62 47 166689 1860 63320426
Chest pain 62.53 9.62 853 165883 215106 63107180
Anosmia 61.82 9.62 83 166653 6777 63315509
Pruritus genital 61.50 9.62 53 166683 2601 63319685
Palmoplantar keratoderma 61.11 9.62 47 166689 1960 63320326
Pregnancy 59.72 9.62 12 166724 36824 63285462
Fall 59.66 9.62 1399 165337 390935 62931351
Sleep terror 59.04 9.62 52 166684 2628 63319658
Dyspnoea 59.02 9.62 2206 164530 659107 62663179
Dry skin 58.62 9.62 300 166436 56587 63265699
Coronary artery disease 56.99 9.62 201 166535 32176 63290110
Vision blurred 56.32 9.62 424 166312 91500 63230786
Liver injury 55.94 9.62 46 166690 60474 63261812
Chronic kidney disease 55.88 9.62 252 166484 45146 63277140
Oligohydramnios 55.81 9.62 76 166660 6290 63315996
Tension headache 54.97 9.62 68 166668 5118 63317168
Alopecia 54.90 9.62 594 166142 336942 62985344
Pain 54.87 9.62 1504 165232 739124 62583162
Pyrexia 53.95 9.62 890 165846 469588 62852698
Musculoskeletal stiffness 53.47 9.62 276 166460 184342 63137944
Inappropriate antidiuretic hormone secretion 52.84 9.62 122 166614 15340 63306946
Hypertensive crisis 52.66 9.62 121 166615 15165 63307121
Bradycardia 52.57 9.62 351 166385 72876 63249410
Renal failure 52.19 9.62 505 166231 117147 63205139
Carotid artery occlusion 52.11 9.62 63 166673 4631 63317655
Myalgia 51.45 9.62 600 166136 145929 63176357
Fibromyalgia 50.73 9.62 83 166653 80337 63241949
Gastrointestinal disorder 50.46 9.62 176 166560 131063 63191223
Memory impairment 49.99 9.62 455 166281 103803 63218483
Blood creatinine increased 49.83 9.62 398 166338 87446 63234840
Lactic acidosis 49.75 9.62 216 166520 38071 63284215
Hip arthroplasty 49.52 9.62 32 166704 47614 63274672
Asthenia 49.16 9.62 1337 165399 382267 62940019
Intestinal angioedema 49.06 9.62 27 166709 628 63321658
Psoriasis 48.25 9.62 392 166344 86565 63235721
Product taste abnormal 47.33 9.62 41 166695 2026 63320260
Abdominal discomfort 46.99 9.62 578 166158 320307 63001979
Angioedema 46.01 9.62 248 166488 47717 63274569
Skin discolouration 45.08 9.62 208 166528 37620 63284666
Live birth 44.48 9.62 7 166729 25623 63296663
Toxicity to various agents 44.35 9.62 425 166311 246825 63075461
Malignant mediastinal neoplasm 44.33 9.62 34 166702 1412 63320874
Condition aggravated 44.08 9.62 767 165969 401450 62920836
Atrial tachycardia 43.99 9.62 55 166681 4185 63318101
Blood pressure abnormal 42.46 9.62 111 166625 15087 63307199
Body height decreased 41.82 9.62 86 166650 9992 63312294
Mobility decreased 41.69 9.62 170 166566 120989 63201297
Hypomagnesaemia 41.14 9.62 167 166569 28570 63293716
Ill-defined disorder 40.68 9.62 97 166639 81658 63240628
Therapeutic product effect incomplete 40.25 9.62 180 166556 124876 63197410
Dehydration 39.38 9.62 657 166079 172697 63149589
Product odour abnormal 38.70 9.62 30 166706 1266 63321020
Hypoglycaemia 37.89 9.62 279 166457 59786 63262500
Urinary tract infection 37.79 9.62 936 165800 263748 63058538
Eye pruritus 37.35 9.62 121 166615 18550 63303736
Cardiac disorder 36.72 9.62 244 166492 50572 63271714
Pain of skin 36.72 9.62 89 166647 11545 63310741
Therapy cessation 36.68 9.62 168 166568 30289 63291997
Hypotension 35.69 9.62 953 165783 271651 63050635
Anti-neutrophil cytoplasmic antibody positive vasculitis 35.65 9.62 41 166695 2858 63319428
Abdominal pain upper 35.35 9.62 749 165987 205695 63116591
Pancytopenia 35.27 9.62 133 166603 96800 63225486
Neutropenia 34.78 9.62 293 166443 174712 63147574
Immunisation 34.29 9.62 27 166709 1166 63321120
Oedema peripheral 34.22 9.62 693 166043 188818 63133468
Glycosylated haemoglobin increased 34.08 9.62 90 166646 12308 63309978
Subarachnoid haemorrhage 33.64 9.62 98 166638 14185 63308101
Visual impairment 33.37 9.62 354 166382 84092 63238194
Loss of personal independence in daily activities 33.16 9.62 137 166599 97153 63225133
Dermatitis atopic 32.43 9.62 76 166660 9648 63312638
Drug interaction 32.31 9.62 809 165927 228322 63093964
Myelosuppression 32.19 9.62 11 166725 23692 63298594
Type 2 diabetes mellitus 31.59 9.62 76 166660 63792 63258494
Rheumatoid nodule 31.37 9.62 4 166732 17151 63305135
Injury 31.08 9.62 94 166642 73153 63249133
Lip swelling 30.74 9.62 162 166574 30901 63291385
Multi-organ disorder 30.66 9.62 28 166708 1484 63320802
Device expulsion 30.50 9.62 28 166708 34894 63287392
Bone erosion 30.38 9.62 5 166731 17712 63304574
Pulmonary oedema 30.23 9.62 247 166489 54626 63267660
Blindness 29.41 9.62 124 166612 21575 63300711
Gastrointestinal haemorrhage 29.19 9.62 334 166402 80842 63241444
Red blood cell sedimentation rate increased 29.06 9.62 44 166692 43938 63278348
Renal impairment 28.89 9.62 357 166379 87998 63234288
Full blood count decreased 28.75 9.62 140 166596 25884 63296402
Intentional product use issue 28.73 9.62 207 166529 127685 63194601
Sprue-like enteropathy 28.50 9.62 20 166716 723 63321563
Malignant neoplasm progression 28.39 9.62 115 166621 82006 63240280
Asthmatic crisis 28.16 9.62 29 166707 1784 63320502
Hyperglycaemia 27.86 9.62 197 166539 41670 63280616
Hepatic steatosis 27.76 9.62 149 166587 28620 63293666
Drug tolerance decreased 27.69 9.62 6 166730 17467 63304819
Suspected suicide 27.20 9.62 56 166680 6512 63315774
Leukopenia 26.86 9.62 108 166628 77182 63245104
Eye haemorrhage 26.82 9.62 65 166671 8431 63313855
Syncope 26.68 9.62 445 166291 116940 63205346
Flatulence 26.52 9.62 169 166567 34533 63287753
International normalised ratio increased 26.13 9.62 210 166526 46215 63276071
Cardiac failure 26.12 9.62 353 166383 88789 63233497
CD30 expression 26.02 9.62 8 166728 36 63322250
Dysgeusia 25.59 9.62 210 166526 46500 63275786
Hypoparathyroidism 25.42 9.62 18 166718 660 63321626
Ventricular tachycardia 25.41 9.62 112 166624 19867 63302419
Suicide attempt 25.26 9.62 79 166657 60839 63261447
Neuropathy peripheral 25.14 9.62 429 166307 113238 63209048
Glomerular filtration rate decreased 25.00 9.62 85 166651 13356 63308930
Bundle branch block left 24.45 9.62 56 166680 7003 63315283
Pruritus 24.45 9.62 1172 165564 360281 62962005
Hallucination 24.15 9.62 235 166501 54582 63267704
Knee arthroplasty 24.13 9.62 68 166668 54138 63268148
Haemorrhagic stroke 23.54 9.62 49 166687 5743 63316543
Mitral valve incompetence 23.54 9.62 108 166628 19486 63302800
Dysphonia 23.42 9.62 209 166527 47405 63274881
Glomerulonephritis rapidly progressive 23.32 9.62 20 166716 975 63321311
Primary hyperaldosteronism 23.19 9.62 8 166728 55 63322231
Back pain 23.14 9.62 880 165856 263265 63059021
Eye pain 22.94 9.62 160 166576 33694 63288592
Body temperature increased 22.88 9.62 39 166697 37153 63285133
Psoriatic arthropathy 22.61 9.62 144 166592 91376 63230910
Blood immunoglobulin E increased 22.43 9.62 38 166698 3811 63318475
Cutaneous T-cell dyscrasia 22.37 9.62 8 166728 62 63322224
Eye irritation 22.02 9.62 115 166621 21856 63300430
Intentional self-injury 21.96 9.62 21 166715 25666 63296620
Renal disorder 21.85 9.62 155 166581 32819 63289467
Facet joint syndrome 21.79 9.62 3 166733 12135 63310151
Nasopharyngitis 21.75 9.62 505 166231 253752 63068534
Papillary muscle rupture 21.27 9.62 5 166731 5 63322281
Insomnia 21.27 9.62 727 166009 214525 63107761
Blood glucose decreased 21.23 9.62 110 166626 20842 63301444
Blood pressure diastolic abnormal 21.09 9.62 6 166730 14536 63307750
Sedation 20.97 9.62 44 166692 38765 63283521
Blood potassium decreased 20.94 9.62 185 166551 41841 63280445
Diabetes mellitus inadequate control 20.93 9.62 87 166649 15039 63307247
Hepatotoxicity 20.86 9.62 41 166695 37000 63285286
Thyroid disorder 20.82 9.62 87 166649 15075 63307211
Drug hypersensitivity 20.59 9.62 640 166096 310047 63012239
Overweight 20.51 9.62 36 166700 3715 63318571
Tinnitus 20.51 9.62 162 166574 35466 63286820
Blood urea increased 20.49 9.62 129 166607 26250 63296036
Mouth swelling 20.32 9.62 41 166695 4699 63317587
Diplopia 20.31 9.62 119 166617 23609 63298677
Nausea 20.13 9.62 2549 164187 851922 62470364
Product quality issue 20.05 9.62 162 166574 35703 63286583
Noninfectious peritonitis 20.03 9.62 9 166727 133 63322153
Sodium retention 20.03 9.62 9 166727 133 63322153
Dopamine transporter scintigraphy abnormal 19.99 9.62 8 166728 87 63322199
Balance disorder 19.90 9.62 322 166414 84100 63238186
Oral pain 19.71 9.62 135 166601 28259 63294027
Muscle spasticity 19.60 9.62 17 166719 21777 63300509
Nervousness 19.59 9.62 144 166592 30835 63291451
Sialoadenitis 19.48 9.62 23 166713 1649 63320637
Ischaemic cardiomyopathy 19.38 9.62 28 166708 2449 63319837
Hyperlipidaemia 19.31 9.62 102 166634 19469 63302817
Facial pain 18.96 9.62 66 166670 10495 63311791
Hypertensive emergency 18.87 9.62 24 166712 1858 63320428
Anuria 18.81 9.62 74 166662 12477 63309809
Vasculitis 18.73 9.62 96 166640 18113 63304173
Bone marrow failure 18.68 9.62 30 166706 29260 63293026
Vitamin B6 deficiency 18.65 9.62 8 166728 105 63322181
Blood pressure systolic abnormal 18.55 9.62 6 166730 13380 63308906
Diabetes mellitus 18.46 9.62 226 166510 55584 63266702
Ageusia 18.25 9.62 78 166658 13650 63308636
Disability 18.16 9.62 13 166723 18334 63303952
Milk-alkali syndrome 18.11 9.62 16 166720 812 63321474
Bromhidrosis 18.09 9.62 5 166731 14 63322272
Product residue present 17.76 9.62 35 166701 3944 63318342
Premature baby 17.67 9.62 17 166719 20718 63301568
Haemorrhage intracranial 17.65 9.62 76 166660 13343 63308943
Myeloma cast nephropathy 17.58 9.62 8 166728 122 63322164
Scleroderma renal crisis 17.52 9.62 11 166725 329 63321957
Gait disturbance 17.42 9.62 616 166120 182562 63139724
Prescribed overdose 17.40 9.62 40 166696 34113 63288173
Rhinorrhoea 17.33 9.62 255 166481 65322 63256964
Disease progression 17.22 9.62 223 166513 122535 63199751
Venous occlusion 17.13 9.62 16 166720 873 63321413
Coma 17.09 9.62 99 166637 64265 63258021
Dengue fever 17.07 9.62 14 166722 641 63321645
Muscle twitching 17.07 9.62 99 166637 19569 63302717
Diabetic foot 17.02 9.62 20 166716 1427 63320859
Angina unstable 17.01 9.62 49 166687 7046 63315240
Diabetic ketoacidosis 17.01 9.62 102 166634 20403 63301883
Rash papular 17.01 9.62 84 166652 15618 63306668
Gastritis 16.96 9.62 161 166575 37142 63285144
Blood phosphorus increased 16.96 9.62 30 166706 3115 63319171
Vascular stenosis 16.94 9.62 11 166725 349 63321937
Cytomegalovirus infection 16.92 9.62 18 166718 20934 63301352
Nodular rash 16.89 9.62 9 166727 196 63322090
Blood pressure diastolic decreased 16.72 9.62 21 166715 22685 63299601
Injection site reaction 16.64 9.62 88 166648 58436 63263850
Tremor 16.62 9.62 460 166276 131779 63190507
Atrioventricular block 16.62 9.62 51 166685 7596 63314690
Near death experience 16.60 9.62 12 166724 455 63321831
Influenza 16.24 9.62 387 166349 108335 63213951
Swollen tongue 16.22 9.62 151 166585 34649 63287637
Headache 16.17 9.62 1899 164837 631342 62690944
Thymus disorder 16.17 9.62 10 166726 291 63321995
Thrombosis 16.02 9.62 249 166487 64506 63257780
Grip strength decreased 16.01 9.62 21 166715 22266 63300020
Stomatitis 15.97 9.62 262 166474 138463 63183823
Panniculitis 15.96 9.62 5 166731 11380 63310906
Urine albumin/creatinine ratio increased 15.93 9.62 10 166726 299 63321987
Electrocardiogram PR prolongation 15.85 9.62 14 166722 710 63321576
Premature delivery 15.81 9.62 35 166701 30246 63292040
Neuroleptic malignant syndrome 15.68 9.62 6 166730 12050 63310236
Spinal epidural haematoma 15.68 9.62 17 166719 1110 63321176
Blindness transient 15.60 9.62 32 166704 3712 63318574
Poisoning deliberate 15.60 9.62 5 166731 11213 63311073
Arrhythmia 15.59 9.62 161 166575 37979 63284307
Pulmonary toxicity 15.49 9.62 3 166733 9452 63312834
Pseudolymphoma 15.47 9.62 13 166723 616 63321670
Cardiorenal syndrome 15.44 9.62 15 166721 860 63321426
Renin decreased 15.42 9.62 7 166729 106 63322180
Hypokalaemia 15.35 9.62 369 166367 103435 63218851
Linear IgA disease 15.34 9.62 19 166717 1432 63320854
Blood pressure decreased 15.32 9.62 248 166488 64774 63257512
Blood magnesium decreased 15.30 9.62 72 166664 13126 63309160
Angina pectoris 15.30 9.62 133 166603 29945 63292341
Hyperhidrosis 15.25 9.62 381 166355 107455 63214831
Sinusitis 15.22 9.62 466 166270 226187 63096099
Norepinephrine increased 15.18 9.62 6 166730 63 63322223
Gout 15.10 9.62 72 166664 13199 63309087
Drug resistance 15.09 9.62 23 166713 22910 63299376
Foetal exposure during pregnancy 15.05 9.62 39 166697 31923 63290363
Diabetic retinopathy 14.94 9.62 24 166712 2303 63319983
Nasal congestion 14.94 9.62 249 166487 65411 63256875
Pain in extremity 14.89 9.62 1036 165700 330450 62991836
Lacrimation increased 14.86 9.62 99 166637 20532 63301754
Anaphylactic reaction 14.83 9.62 107 166629 65993 63256293
Eosinophilia myalgia syndrome 14.80 9.62 4 166732 10 63322276
Dystonia 14.75 9.62 9 166727 13810 63308476
Ascites 14.73 9.62 56 166680 40672 63281614
Choking 14.61 9.62 58 166678 9821 63312465
Haemophagocytic lymphohistiocytosis 14.31 9.62 5 166731 10622 63311664
Extradural haematoma 14.26 9.62 20 166716 1702 63320584
Joint range of motion decreased 14.20 9.62 41 166695 32387 63289899
Product dispensing error 14.05 9.62 59 166677 10246 63312040
Colitis microscopic 13.95 9.62 55 166681 9284 63313002
Upper gastrointestinal haemorrhage 13.91 9.62 91 166645 18761 63303525
Drug dependence 13.87 9.62 27 166709 24456 63297830
Blood sodium decreased 13.81 9.62 110 166626 24142 63298144
Otolithiasis 13.80 9.62 4 166732 14 63322272
Cholecystitis chronic 13.74 9.62 5 166731 10356 63311930
Dislocation of vertebra 13.61 9.62 3 166733 8632 63313654
Autoimmune disorder 13.60 9.62 15 166721 17162 63305124
Arrhythmia supraventricular 13.58 9.62 15 166721 1000 63321286
Acute myeloid leukaemia 13.55 9.62 15 166721 17132 63305154
Premature labour 13.54 9.62 8 166728 12496 63309790
Gastric disorder 13.54 9.62 154 166582 37215 63285071
Haemoglobin decreased 13.52 9.62 488 166248 144997 63177289
Recalled product administered 13.22 9.62 11 166725 514 63321772
Instillation site pain 13.22 9.62 14 166722 890 63321396
Rash 13.20 9.62 1281 165455 559590 62762696
Mucosal inflammation 13.10 9.62 71 166665 46857 63275429
Product packaging issue 13.08 9.62 16 166720 1190 63321096
Crystal urine 13.05 9.62 5 166731 48 63322238
Overdose 13.03 9.62 218 166518 114860 63207426
Left ventricular hypertrophy 13.03 9.62 37 166699 5278 63317008
Normal newborn 12.94 9.62 3 166733 8338 63313948
Hepatic failure 12.91 9.62 49 166687 35607 63286679
Eyelid pain 12.88 9.62 9 166727 323 63321963
Cardiac valve disease 12.86 9.62 32 166704 4220 63318066
Inflammation 12.85 9.62 146 166590 82127 63240159
Faeces discoloured 12.84 9.62 88 166648 18421 63303865
Haematoma 12.84 9.62 144 166592 34676 63287610
Head injury 12.83 9.62 119 166617 27277 63295009
Spider naevus 12.83 9.62 7 166729 160 63322126
Fear 12.81 9.62 78 166658 15688 63306598
Amenorrhoea 12.79 9.62 5 166731 9909 63312377
Rebound tachycardia 12.76 9.62 3 166733 3 63322283
Suicidal ideation 12.62 9.62 104 166632 62317 63259969
Product physical issue 12.53 9.62 35 166701 4945 63317341
Calciphylaxis 12.50 9.62 26 166710 3046 63319240
Pollakiuria 12.42 9.62 120 166616 27817 63294469
Leukaemoid reaction 12.23 9.62 7 166729 176 63322110
Ulcer 12.18 9.62 32 166704 26075 63296211
Patella fracture 12.12 9.62 21 166715 2145 63320141
Creatinine renal clearance decreased 12.09 9.62 15 166721 16293 63305993
Blindness unilateral 12.08 9.62 40 166696 6201 63316085
Swelling face 12.07 9.62 234 166502 63241 63259045
Poor quality product administered 12.01 9.62 26 166710 3130 63319156
Epilepsy 12.01 9.62 34 166702 27031 63295255
Cardiovascular disorder 11.96 9.62 62 166674 11750 63310536
Chromaturia 11.91 9.62 80 166656 16637 63305649
Decreased immune responsiveness 11.90 9.62 34 166702 4867 63317419
Chikungunya virus infection 11.89 9.62 7 166729 186 63322100
Hypoacusis 11.87 9.62 106 166630 24045 63298241
Sinus bradycardia 11.83 9.62 72 166664 14479 63307807
Suspiciousness 11.81 9.62 9 166727 370 63321916
Pancreatitis acute 11.74 9.62 116 166620 27050 63295236
Hiccups 11.67 9.62 21 166715 2210 63320076
Psychotic disorder 11.63 9.62 32 166704 25680 63296606
Device dislocation 11.62 9.62 32 166704 25673 63296613
Obstructive airways disorder 11.58 9.62 23 166713 20676 63301610
Blood aldosterone increased 11.56 9.62 7 166729 196 63322090
Haemorrhagic fever 11.55 9.62 3 166733 6 63322280
Transplant rejection 11.53 9.62 7 166729 10773 63311513
Myopathy 11.51 9.62 59 166677 11132 63311154
Device difficult to use 11.49 9.62 10 166726 12786 63309500
Agitation 11.43 9.62 101 166635 59656 63262630
Gastroenteritis aeromonas 11.42 9.62 4 166732 29 63322257
Blood glucose abnormal 11.40 9.62 46 166690 7846 63314440
Aortic stenosis 11.40 9.62 34 166702 4986 63317300
Hypertensive encephalopathy 11.38 9.62 11 166725 627 63321659
Blood cholesterol increased 11.35 9.62 176 166560 93856 63228430
Renal artery stenosis 11.33 9.62 19 166717 1890 63320396
End stage renal disease 11.30 9.62 41 166695 6652 63315634
Neutropenic sepsis 11.29 9.62 16 166720 16422 63305864
Bone pain 11.28 9.62 204 166532 54437 63267849
Familial periodic paralysis 11.24 9.62 5 166731 72 63322214
Nail bed tenderness 11.21 9.62 9 166727 400 63321886
Weight decreased 11.05 9.62 857 165879 275941 63046345
Weight increased 11.02 9.62 566 166170 260226 63062060
Arteriosclerosis 11.01 9.62 54 166682 10012 63312274
Blood parathyroid hormone decreased 10.98 9.62 6 166730 9785 63312501
Night sweats 10.96 9.62 79 166657 48735 63273551
Pneumonia aspiration 10.93 9.62 50 166686 34490 63287796
Affect lability 10.91 9.62 8 166728 11143 63311143
Ultrasound kidney abnormal 10.86 9.62 4 166732 34 63322252
Poisoning 10.81 9.62 12 166724 13688 63308598
Hypovolaemia 10.79 9.62 56 166680 10617 63311669
Laboratory test abnormal 10.71 9.62 113 166623 26799 63295487
Hypertension 10.70 9.62 862 165874 278441 63043845
Lip dry 10.68 9.62 15 166721 15455 63306831
Inferior vena cava dilatation 10.66 9.62 5 166731 82 63322204
Thrombocytopenia 10.58 9.62 309 166427 150848 63171438
Aspergillus infection 10.57 9.62 4 166732 8089 63314197
Infective pulmonary exacerbation of cystic fibrosis 10.49 9.62 5 166731 8812 63313474
Dysstasia 10.45 9.62 93 166643 21073 63301213
Hypersensitivity vasculitis 10.45 9.62 29 166707 4083 63318203
Sluggishness 10.40 9.62 34 166702 5235 63317051
Foreign body sensation in eyes 10.40 9.62 20 166716 2214 63320072
Blood loss anaemia 10.36 9.62 49 166687 8952 63313334
Caesarean section 10.35 9.62 18 166718 17014 63305272
Human herpesvirus 6 encephalitis 10.30 9.62 7 166729 240 63322046
Accelerated hypertension 10.30 9.62 9 166727 450 63321836
Heart rate increased 10.25 9.62 322 166414 93916 63228370
Heart valve calcification 10.24 9.62 3 166733 11 63322275
Mitral valve stenosis 10.24 9.62 14 166722 1163 63321123
Hypophosphataemia 10.23 9.62 58 166678 11368 63310918
Suffocation feeling 10.18 9.62 15 166721 1335 63320951
Thrombocytosis 10.13 9.62 36 166700 5782 63316504
Food allergy 10.13 9.62 9 166727 11392 63310894
Diabetic metabolic decompensation 10.12 9.62 17 166719 1693 63320593
Bronchopulmonary aspergillosis 10.12 9.62 5 166731 8630 63313656
Septic shock 10.11 9.62 119 166617 66510 63255776
Therapeutic response decreased 10.08 9.62 108 166628 61417 63260869
Pulmonary hypertension 10.06 9.62 145 166591 36978 63285308
Eructation 10.06 9.62 46 166690 8287 63313999
Carotid bruit 10.02 9.62 11 166725 728 63321558
Iron deficiency anaemia 10.00 9.62 88 166648 19881 63302405
Hypocalcaemia 9.87 9.62 127 166609 31586 63290700
Uterine perforation 9.86 9.62 3 166733 6960 63315326
Nail infection 9.85 9.62 21 166715 2502 63319784
Drug monitoring procedure not performed 9.81 9.62 10 166726 608 63321678
Eye swelling 9.79 9.62 101 166635 23817 63298469
Periorbital oedema 9.75 9.62 35 166701 5649 63316637
Depressed mood 9.73 9.62 154 166582 40037 63282249
Cardiotoxicity 9.72 9.62 5 166731 8433 63313853
Hiatus hernia 9.72 9.62 93 166643 21501 63300785
Platelet count decreased 9.71 9.62 385 166351 115737 63206549
Therapy interrupted 9.70 9.62 129 166607 32326 63289960
Atrial septal defect 9.68 9.62 40 166696 6898 63315388
Lower limb fracture 9.63 9.62 32 166704 24189 63298097
Chronic obstructive pulmonary disease 9.62 9.62 224 166512 62462 63259824

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
Angioedema 195.75 10.28 383 106137 36991 34813420
Drug abuse 189.73 10.28 36 106484 99060 34751351
Febrile neutropenia 119.18 10.28 145 106375 136704 34713707
Toxicity to various agents 115.14 10.28 277 106243 200085 34650326
Cardiospasm 111.31 10.28 66 106454 1522 34848889
Dizziness 105.12 10.28 1072 105448 217449 34632962
Off label use 103.53 10.28 802 105718 418722 34431689
Neutropenia 97.12 10.28 208 106312 156570 34693841
Palmoplantar keratoderma 96.37 10.28 65 106455 1888 34848523
Myocardial infarction 95.53 10.28 664 105856 120421 34729990
Tension headache 91.10 10.28 75 106445 2967 34847444
Pruritus genital 89.28 10.28 65 106455 2139 34848272
Sleep terror 88.57 10.28 66 106454 2252 34848159
Carotid artery occlusion 79.67 10.28 76 106444 3661 34846750
Anosmia 78.60 10.28 78 106442 3946 34846465
Cardiac failure congestive 77.43 10.28 476 106044 82794 34767617
Immunisation 76.11 10.28 45 106475 1032 34849379
Atrial tachycardia 73.70 10.28 72 106448 3573 34846838
Foetal exposure during pregnancy 70.45 10.28 15 106505 38086 34812325
Facial pain 69.04 10.28 70 106450 3634 34846777
Hyperkalaemia 68.55 10.28 403 106117 68986 34781425
Drug ineffective 68.47 10.28 981 105539 455770 34394641
Fatigue 68.36 10.28 1542 104978 369111 34481300
General physical health deterioration 67.68 10.28 185 106335 128084 34722327
Eye pruritus 67.66 10.28 98 106422 7391 34843020
Transient ischaemic attack 67.20 10.28 211 106309 27402 34823009
Psoriasis 64.76 10.28 262 106258 38550 34811861
Leukopenia 63.14 10.28 59 106461 62797 34787614
Blood glucose increased 63.02 10.28 383 106137 66335 34784076
Palpitations 62.84 10.28 265 106255 39721 34810690
Acute myocardial infarction 61.71 10.28 325 106195 53394 34797017
Suicide attempt 58.40 10.28 23 106497 39093 34811318
Peripheral swelling 57.53 10.28 415 106105 76126 34774285
Feeling abnormal 51.11 10.28 349 106171 62886 34787525
Myalgia 49.98 10.28 432 106088 83678 34766733
Thrombocytopenia 49.27 10.28 277 106243 155970 34694441
Tinnitus 48.28 10.28 153 106367 19965 34830446
Pruritus 47.05 10.28 649 105871 141332 34709079
Pain of skin 46.76 10.28 74 106446 6035 34844376
Angina unstable 46.56 10.28 107 106413 11546 34838865
Visual impairment 46.31 10.28 224 106296 35578 34814833
Lip swelling 45.88 10.28 130 106390 15950 34834461
Sprue-like enteropathy 45.87 10.28 25 106495 488 34849923
Blindness 44.57 10.28 123 106397 14863 34835548
Overdose 43.88 10.28 137 106383 90922 34759489
Abdominal discomfort 43.56 10.28 322 106198 59513 34790898
Blood pressure increased 43.06 10.28 434 106086 87668 34762743
Product substitution issue 42.91 10.28 95 106425 10000 34840411
Pericarditis 41.21 10.28 102 106418 11543 34838868
Treatment failure 41.10 10.28 49 106471 46648 34803763
Serotonin syndrome 40.86 10.28 6 106514 19927 34830484
Cerebrovascular accident 39.64 10.28 414 106106 84397 34766014
Pyrexia 39.57 10.28 746 105774 332267 34518144
Intentional overdose 39.33 10.28 45 106475 43629 34806782
Dry skin 39.21 10.28 194 106326 31093 34819318
Coma 39.07 10.28 49 106471 45629 34804782
Hypertensive emergency 38.37 10.28 29 106491 1011 34849400
Multiple organ dysfunction syndrome 37.73 10.28 114 106406 76452 34773959
Product dose omission issue 37.54 10.28 542 105978 119169 34731242
Cytomegalovirus infection 36.40 10.28 17 106503 26118 34824293
Rash papular 36.34 10.28 90 106430 10188 34840223
Muscle twitching 36.22 10.28 90 106430 10208 34840203
Muscular weakness 36.04 10.28 360 106160 72537 34777874
Plasmapheresis 34.93 10.28 18 106502 312 34850099
Ventricular tachycardia 34.88 10.28 167 106353 26412 34823999
Atrial fibrillation 34.45 10.28 544 105976 121849 34728562
Condition aggravated 34.08 10.28 398 106122 191798 34658613
Pancytopenia 33.73 10.28 162 106358 94995 34755416
Malignant neoplasm progression 33.53 10.28 146 106374 87900 34762511
Septic shock 32.57 10.28 111 106409 71723 34778688
Mucosal inflammation 31.42 10.28 43 106477 38579 34811832
Coronary artery disease 31.28 10.28 253 106267 48052 34802359
Amnesia 30.00 10.28 160 106360 26403 34824008
Drug dispensed to wrong patient 29.65 10.28 19 106501 505 34849906
Dyspnoea 29.41 10.28 1416 105104 375366 34475045
Hypertensive crisis 29.24 10.28 75 106445 8676 34841735
Memory impairment 29.21 10.28 229 106291 43089 34807322
Hepatic cytolysis 28.29 10.28 5 106515 14491 34835920
Disease progression 28.18 10.28 203 106317 107874 34742537
Neuroleptic malignant syndrome 27.67 10.28 10 106510 17924 34832487
COVID-19 27.51 10.28 359 106161 77191 34773220
Cardiac disorder 25.85 10.28 222 106298 42904 34807507
Intestinal angioedema 25.83 10.28 13 106507 214 34850197
C-reactive protein increased 25.62 10.28 82 106438 54016 34796395
Epilepsy 25.58 10.28 17 106503 21478 34828933
Diarrhoea 25.10 10.28 1439 105081 388473 34461938
Back pain 24.63 10.28 514 106006 121275 34729136
Ascites 23.91 10.28 68 106452 46503 34803908
Vasculitis 23.61 10.28 82 106438 11214 34839197
Syncope 23.32 10.28 400 106120 91051 34759360
Therapeutic product effect incomplete 22.97 10.28 78 106442 50463 34799948
Drug dependence 22.85 10.28 24 106496 24193 34826218
Chest pain 22.77 10.28 526 105994 126236 34724175
Premature baby 22.73 10.28 16 106504 19617 34830794
Infusion related reaction 22.70 10.28 84 106436 52973 34797438
Cough 22.52 10.28 608 105912 149532 34700879
Subarachnoid haemorrhage 22.44 10.28 87 106433 12548 34837863
Cytokine release syndrome 22.35 10.28 22 106498 22855 34827556
Acute kidney injury 22.25 10.28 1139 105381 303849 34546562
Respiratory depression 21.96 10.28 11 106509 16234 34834177
Sedation 21.94 10.28 19 106501 20987 34829424
Alanine aminotransferase increased 21.94 10.28 150 106370 80665 34769746
Diabetic neuropathy 21.94 10.28 43 106477 4154 34846257
Status epilepticus 21.30 10.28 6 106514 12608 34837803
Product use in unapproved indication 20.92 10.28 243 106277 117256 34733155
Rash 20.81 10.28 853 105667 221899 34628512
Diplopia 20.79 10.28 104 106416 16739 34833672
Paraesthesia 20.67 10.28 292 106228 63880 34786531
Delirium 20.60 10.28 67 106453 43924 34806487
Skin discolouration 20.50 10.28 108 106412 17737 34832674
Chronic kidney disease 20.11 10.28 203 106317 41007 34809404
Cholestasis 19.97 10.28 32 106488 26916 34823495
Migraine 19.55 10.28 105 106415 17373 34833038
Paraplegia 19.23 10.28 33 106487 2878 34847533
Pathogen resistance 19.10 10.28 3 106517 9479 34840932
Blood pressure inadequately controlled 18.87 10.28 31 106489 2609 34847802
Bone marrow failure 18.75 10.28 38 106482 29215 34821196
Dengue fever 18.73 10.28 11 106509 249 34850162
Hallucination 18.50 10.28 239 106281 51259 34799152
Contraindicated product administered 18.41 10.28 23 106497 21458 34828953
Posterior reversible encephalopathy syndrome 18.23 10.28 4 106516 9950 34840461
Carcinogenicity 18.15 10.28 7 106513 58 34850353
Adverse drug reaction 18.09 10.28 152 106368 29190 34821221
Neurotoxicity 17.96 10.28 17 106503 17993 34832418
Abdominal pain upper 17.61 10.28 311 106209 71179 34779232
Product quality issue 17.49 10.28 100 106420 16935 34833476
Acute respiratory distress syndrome 17.28 10.28 33 106487 25936 34824475
Tenosynovitis stenosans 17.10 10.28 5 106515 15 34850396
Gamma-glutamyltransferase increased 17.06 10.28 40 106480 29191 34821220
C-reactive protein abnormal 17.00 10.28 3 106517 8707 34841704
Schizophrenia 16.88 10.28 3 106517 8663 34841748
Alopecia 16.55 10.28 129 106391 24226 34826185
High frequency ablation 16.54 10.28 9 106511 175 34850236
Abdominal wall haematoma 16.54 10.28 24 106496 1813 34848598
Transient aphasia 16.53 10.28 12 106508 393 34850018
Balance disorder 16.47 10.28 193 106327 40461 34809950
Blood creatinine increased 16.40 10.28 392 106128 94584 34755827
Cognitive disorder 16.31 10.28 146 106374 28547 34821864
Muscle spasms 16.29 10.28 320 106200 74681 34775730
Hyperthermia 16.15 10.28 6 106514 10571 34839840
Vitamin B1 deficiency 16.05 10.28 11 106509 328 34850083
Eosinophilia 16.02 10.28 35 106485 26187 34824224
Dermatitis atopic 16.01 10.28 44 106476 5303 34845108
Peri-implantitis 15.99 10.28 8 106512 130 34850281
Aspartate aminotransferase increased 15.93 10.28 131 106389 67652 34782759
Gastroenteritis eosinophilic 15.72 10.28 9 106511 194 34850217
Depressed level of consciousness 15.72 10.28 72 106448 42769 34807642
Febrile bone marrow aplasia 15.65 10.28 3 106517 8206 34842205
Pneumonia aspiration 15.63 10.28 70 106450 41833 34808578
Haematotoxicity 15.61 10.28 3 106517 8191 34842220
Antineutrophil cytoplasmic antibody increased 15.44 10.28 5 106515 23 34850388
Miosis 15.26 10.28 5 106515 9530 34840881
Headache 15.15 10.28 752 105768 199883 34650528
Sepsis 15.13 10.28 389 106131 166172 34684239
Vascular injury 15.12 10.28 10 106510 281 34850130
Product odour abnormal 15.08 10.28 15 106505 761 34849650
Obstructive airways disorder 15.02 10.28 15 106505 15479 34834932
Hepatocellular injury 14.98 10.28 28 106492 22183 34828228
Cardiac flutter 14.95 10.28 23 106497 1830 34848581
Abdominal pain 14.90 10.28 382 106138 163236 34687175
Psychotic disorder 14.64 10.28 33 106487 24419 34825992
Burning feet syndrome 14.61 10.28 7 106513 103 34850308
Aggression 14.58 10.28 65 106455 38899 34811512
Heart rate increased 14.57 10.28 210 106310 46133 34804278
Insomnia 14.50 10.28 417 106103 103490 34746921
Synovitis 14.36 10.28 13 106507 14053 34836358
Hyponatraemic seizure 14.07 10.28 6 106514 66 34850345
Diabetic foot 13.89 10.28 28 106492 2760 34847651
Respiratory failure 13.84 10.28 240 106280 108332 34742079
Coeliac disease 13.82 10.28 14 106506 726 34849685
Chikungunya virus infection 13.46 10.28 5 106515 37 34850374
Guillain-Barre syndrome 13.44 10.28 45 106475 6042 34844369
Blister 13.35 10.28 117 106403 22741 34827670
Shoshin beriberi 13.32 10.28 6 106514 76 34850335
Pneumocystis jirovecii pneumonia 13.15 10.28 25 106495 19685 34830726
Toxic epidermal necrolysis 13.14 10.28 29 106491 21617 34828794
Neutrophil count increased 13.05 10.28 20 106500 17126 34833285
Blood pressure abnormal 12.94 10.28 54 106466 8052 34842359
Asthenia 12.92 10.28 890 105630 244361 34606050
Eczema nummular 12.92 10.28 7 106513 135 34850276
Agranulocytosis 12.81 10.28 34 106486 23787 34826624
Renal pain 12.80 10.28 29 106491 3099 34847312
Hepatic function abnormal 12.71 10.28 81 106439 44282 34806129
Seizure 12.66 10.28 234 106286 104623 34745788
Progressive multifocal leukoencephalopathy 12.63 10.28 7 106513 9757 34840654
Blood pressure diastolic decreased 12.53 10.28 6 106514 9088 34841323
Blood glucose decreased 12.49 10.28 76 106444 13161 34837250
Fluid retention 12.42 10.28 131 106389 26756 34823655
Heat stroke 12.38 10.28 15 106505 950 34849461
Dystonia 12.34 10.28 9 106511 10836 34839575
B-cell small lymphocytic lymphoma stage IV 12.32 10.28 3 106517 3 34850408
Dysphonia 12.29 10.28 117 106403 23266 34827145
Ageusia 12.26 10.28 63 106457 10245 34840166
Application site haematoma 12.24 10.28 5 106515 49 34850362
Tendon rupture 12.22 10.28 48 106472 6964 34843447
Epstein-Barr virus infection 12.21 10.28 4 106516 7624 34842787
Plasma cell myeloma refractory 12.16 10.28 12 106508 603 34849808
Exposure during pregnancy 12.15 10.28 6 106514 8928 34841483
Neoplasm progression 11.97 10.28 34 106486 23266 34827145
Oral mucosal blistering 11.83 10.28 21 106499 1881 34848530
Atheroembolism 11.73 10.28 9 106511 321 34850090
Akathisia 11.72 10.28 5 106515 8104 34842307
Anhidrosis 11.70 10.28 6 106514 103 34850308
Ichthyosis 11.59 10.28 6 106514 105 34850306
Diffuse large B-cell lymphoma 11.56 10.28 4 106516 7366 34843045
Recalled product administered 11.53 10.28 11 106509 530 34849881
Food allergy 11.35 10.28 18 106502 1470 34848941
Granulocytopenia 11.32 10.28 3 106517 6564 34843847
Dysgeusia 11.27 10.28 127 106393 26370 34824041
Osteoarthritis 11.20 10.28 104 106416 20538 34829873
Product use issue 11.14 10.28 131 106389 63085 34787326
Cachexia 11.10 10.28 4 106516 7182 34843229
Blood osmolarity decreased 11.03 10.28 11 106509 560 34849851
Eye irritation 11.02 10.28 49 106471 7512 34842899
Carotid bruit 10.99 10.28 7 106513 184 34850227
Rash maculo-papular 10.93 10.28 47 106473 28404 34822007
Hypogammaglobulinaemia 10.83 10.28 5 106515 7735 34842676
Renal disorder 10.79 10.28 122 106398 25358 34825053
Haemorrhagic stroke 10.79 10.28 44 106476 6495 34843916
Hyphaema 10.77 10.28 11 106509 576 34849835
Coordination abnormal 10.74 10.28 49 106471 7595 34842816
Lymphopenia 10.66 10.28 21 106499 16314 34834097
Non-cardiac chest pain 10.60 10.28 33 106487 4264 34846147
Drug resistance 10.47 10.28 42 106478 25885 34824526
Cataract 10.47 10.28 124 106396 26062 34824349
Lichen planus 10.41 10.28 14 106506 985 34849426
Infection 10.33 10.28 205 106315 90710 34759701

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Synovitis 296.79 9.58 34 219819 150700 79373835
Cardiac failure congestive 263.56 9.58 928 218925 141474 79383061
Drug abuse 258.32 9.58 65 219788 162626 79361909
Maternal exposure during pregnancy 249.27 9.58 39 219814 136499 79388036
Drug ineffective 244.77 9.58 1863 217990 1079050 78445485
Hand deformity 239.82 9.58 11 219842 103908 79420627
Angioedema 229.45 9.58 589 219264 75446 79449089
Myocardial infarction 227.29 9.58 1058 218795 183071 79341464
Off label use 214.48 9.58 1544 218309 905671 78618864
Pemphigus 213.22 9.58 16 219837 99566 79424969
Infusion related reaction 198.48 9.58 205 219648 230032 79294503
Contraindicated product administered 189.20 9.58 99 219754 157439 79367096
Systemic lupus erythematosus 185.47 9.58 52 219801 121097 79403438
Cardiospasm 173.26 9.58 110 219743 3191 79521344
Blood glucose increased 171.09 9.58 699 219154 114276 79410259
Dizziness 169.42 9.58 2204 217649 524237 79000298
Acute kidney injury 165.65 9.58 2171 217682 517233 79007302
Treatment failure 160.71 9.58 140 219713 170346 79354189
Palmoplantar keratoderma 159.01 9.58 109 219744 3607 79520928
Febrile neutropenia 156.26 9.58 247 219606 230752 79293783
Drug intolerance 153.84 9.58 310 219543 263809 79260726
Sleep terror 152.23 9.58 114 219739 4344 79520191
Pruritus genital 147.17 9.58 112 219741 4374 79520161
Rheumatoid factor positive 146.16 9.58 4 219849 59835 79464700
Duodenal ulcer perforation 143.57 9.58 10 219843 66201 79458334
Anosmia 143.31 9.58 148 219705 8696 79515839
Tension headache 137.79 9.58 132 219721 7079 79517456
Carotid artery occlusion 133.08 9.58 133 219720 7514 79517021
General physical health deterioration 130.75 9.58 360 219493 274878 79249657
Wound 129.46 9.58 80 219773 116099 79408436
Transient ischaemic attack 128.86 9.58 378 219475 52317 79472218
Hepatic enzyme increased 127.55 9.58 191 219662 182419 79342116
Folliculitis 127.31 9.58 6 219847 55374 79469161
Hyperkalaemia 126.41 9.58 637 219216 113761 79410774
Cerebrovascular accident 125.47 9.58 795 219058 154497 79370038
Helicobacter infection 124.75 9.58 21 219832 69683 79454852
Atrial tachycardia 122.19 9.58 123 219730 7010 79517525
Toxicity to various agents 119.34 9.58 678 219175 420862 79103673
Arthropathy 119.15 9.58 190 219663 176921 79347614
Glossodynia 118.16 9.58 69 219784 103268 79421267
Blood pressure increased 116.21 9.58 987 218866 210373 79314162
Acute myocardial infarction 115.08 9.58 469 219384 76567 79447968
Exposure during pregnancy 113.56 9.58 69 219784 101063 79423472
Feeling abnormal 112.92 9.58 789 219064 158410 79366125
C-reactive protein abnormal 111.97 9.58 5 219848 48362 79476173
Immunisation 108.26 9.58 70 219783 2097 79522438
Atrial fibrillation 105.59 9.58 918 218935 196968 79327567
Lower respiratory tract infection 103.64 9.58 122 219731 129098 79395437
Sleep disorder due to general medical condition, insomnia type 99.22 9.58 5 219848 43551 79480984
Neutropenia 96.58 9.58 436 219417 287274 79237261
Palpitations 95.42 9.58 637 219216 125973 79398562
Product substitution issue 91.28 9.58 184 219669 20072 79504463
Therapeutic product effect decreased 89.76 9.58 199 219654 163664 79360871
Hyponatraemia 89.69 9.58 815 219038 177033 79347502
Joint swelling 86.69 9.58 455 219398 288191 79236344
Coronary artery disease 86.47 9.58 384 219469 65090 79459445
Muscle injury 86.08 9.58 15 219838 48546 79475989
Rheumatoid arthritis 85.19 9.58 292 219561 208178 79316357
Pain of skin 83.59 9.58 147 219706 14466 79510069
COVID-19 82.80 9.58 729 219124 156945 79367590
Product dose omission issue 82.15 9.58 1043 218810 246494 79278041
C-reactive protein increased 81.60 9.58 144 219709 128883 79395652
Myalgia 81.40 9.58 826 219027 184815 79339720
Diarrhoea 80.77 9.58 3076 216777 877413 78647122
Lip swelling 80.28 9.58 272 219581 40639 79483896
Chest pain 77.97 9.58 1151 218702 281153 79243382
Eye pruritus 76.69 9.58 173 219680 20397 79504138
Dry skin 76.05 9.58 380 219473 67615 79456920
Facial pain 75.57 9.58 128 219725 12222 79512313
Intestinal angioedema 74.41 9.58 40 219813 843 79523692
Dyspnoea 74.33 9.58 2976 216877 854049 78670486
Discomfort 73.44 9.58 147 219706 125470 79399065
Irritable bowel syndrome 73.39 9.58 40 219813 62201 79462334
Sprue-like enteropathy 71.88 9.58 45 219808 1273 79523262
Cough 69.98 9.58 1409 218444 365380 79159155
Infection 69.80 9.58 386 219467 241326 79283209
Pyrexia 69.11 9.58 1388 218465 677321 78847214
Memory impairment 68.49 9.58 535 219318 111199 79413336
Visual impairment 68.48 9.58 462 219391 91669 79432866
Blindness 66.91 9.58 201 219652 28182 79496353
Leukopenia 65.86 9.58 139 219714 116374 79408161
Ventricular tachycardia 64.76 9.58 258 219595 41677 79482858
Loss of employment 64.49 9.58 55 219798 2532 79522003
Hypertensive crisis 62.72 9.58 161 219692 20609 79503926
Tinnitus 61.57 9.58 264 219589 44069 79480466
Blood pressure inadequately controlled 60.80 9.58 80 219773 6097 79518438
Pancytopenia 60.60 9.58 243 219610 165502 79359033
Condition aggravated 60.32 9.58 995 218858 500129 79024406
Subarachnoid haemorrhage 60.28 9.58 176 219677 24289 79500246
Product use issue 59.52 9.58 337 219516 209485 79315050
Blood creatinine increased 59.14 9.58 671 219182 154386 79370149
Cardiac disorder 58.99 9.58 346 219507 65411 79459124
Myelosuppression 58.56 9.58 19 219834 40277 79484258
Rash papular 56.26 9.58 160 219693 21756 79502779
Muscle twitching 56.15 9.58 173 219680 24591 79499944
Therapeutic product effect incomplete 56.10 9.58 201 219652 141444 79383091
Lactic acidosis 56.03 9.58 359 219494 70000 79454535
Swelling 52.72 9.58 365 219488 216346 79308189
Chronic kidney disease 51.73 9.58 336 219517 65818 79458717
Muscle spasms 50.80 9.58 719 219134 174011 79350524
Coma 50.50 9.58 128 219725 100521 79424014
Fibromyalgia 50.24 9.58 62 219791 64278 79460257
Musculoskeletal stiffness 50.22 9.58 280 219573 174728 79349807
Hypersensitivity 49.86 9.58 472 219381 261767 79262768
Suicide attempt 49.37 9.58 96 219757 82836 79441699
Body height decreased 48.67 9.58 86 219767 8494 79516041
Vasculitis 48.46 9.58 166 219687 24936 79499599
Angina unstable 47.74 9.58 126 219727 16401 79508134
Syncope 46.53 9.58 724 219129 178725 79345810
Pregnancy 46.07 9.58 9 219844 26842 79497693
Red blood cell sedimentation rate abnormal 45.93 9.58 3 219850 20960 79503575
Hypertensive emergency 45.84 9.58 47 219806 2738 79521797
Fatigue 45.69 9.58 3059 216794 926668 78597867
Malaise 45.57 9.58 1715 218138 488154 79036381
Diplopia 45.48 9.58 198 219655 33268 79491267
Cytomegalovirus infection 45.26 9.58 31 219822 42613 79481922
Impaired healing 45.13 9.58 110 219743 87545 79436990
Malignant neoplasm progression 45.03 9.58 207 219646 135783 79388752
Dehydration 43.87 9.58 943 218910 247244 79277291
Product use in unapproved indication 42.88 9.58 462 219391 249897 79274638
Psoriasis 42.34 9.58 405 219448 89182 79435353
Skin discolouration 42.18 9.58 224 219629 40810 79483725
Overdose 41.54 9.58 317 219536 183889 79340646
Malignant mediastinal neoplasm 41.37 9.58 33 219820 1382 79523153
Neuroleptic malignant syndrome 40.04 9.58 13 219840 27546 79496989
Asthenia 39.89 9.58 1758 218095 509931 79014604
Abortion spontaneous 39.34 9.58 16 219837 29491 79495044
Fall 39.04 9.58 1680 218173 485949 79038586
Hypoglycaemia 38.88 9.58 440 219413 101154 79423381
Abdominal pain upper 38.77 9.58 848 219005 222971 79301564
Pruritus 38.70 9.58 1390 218463 393258 79131277
Haemophagocytic lymphohistiocytosis 38.15 9.58 7 219846 21830 79502705
Glomerular filtration rate decreased 37.76 9.58 143 219710 22559 79501976
Live birth 37.45 9.58 4 219849 18740 79505795
Drug resistance 36.99 9.58 37 219816 42176 79482359
Rheumatoid nodule 36.76 9.58 3 219850 17435 79507100
Back pain 36.40 9.58 1097 218756 303083 79221452
Vision blurred 36.27 9.58 449 219404 105449 79419086
Suspected suicide 36.19 9.58 86 219767 10490 79514045
Thrombocytopenia 36.17 9.58 514 219339 264745 79259790
Haemorrhagic stroke 35.84 9.58 88 219765 10958 79513577
Dermatitis atopic 35.74 9.58 83 219770 9973 79514562
Bone erosion 35.17 9.58 4 219849 17843 79506692
Mucosal inflammation 34.98 9.58 100 219753 75480 79449055
Blood pressure diastolic decreased 34.78 9.58 20 219833 30196 79494339
Product quality issue 34.69 9.58 185 219668 33755 79490780
Sedation 34.56 9.58 56 219797 51839 79472696
Amnesia 34.35 9.58 294 219559 62763 79461772
Liver injury 34.16 9.58 65 219788 56549 79467986
Blood pressure diastolic abnormal 33.88 9.58 6 219847 19196 79505339
Aspergillus infection 33.78 9.58 6 219847 19155 79505380
Pericarditis 33.71 9.58 160 219693 104076 79420459
Ill-defined disorder 33.64 9.58 83 219770 65792 79458743
Bundle branch block left 33.48 9.58 88 219765 11425 79513110
Drug dispensed to wrong patient 33.30 9.58 22 219831 684 79523851
Product taste abnormal 33.23 9.58 36 219817 2235 79522300
Poisoning deliberate 32.97 9.58 6 219847 18822 79505713
Therapy cessation 32.62 9.58 196 219657 37366 79487169
Hypotension 32.38 9.58 1504 218349 438813 79085722
Diabetic neuropathy 32.33 9.58 60 219793 6156 79518379
Septic shock 32.28 9.58 202 219651 122599 79401936
Hallucination 32.19 9.58 370 219483 85375 79439160
Insomnia 32.02 9.58 894 218959 244276 79280259
Muscular weakness 31.77 9.58 621 219232 160108 79364427
Loss of personal independence in daily activities 31.71 9.58 160 219693 102420 79422115
Inappropriate antidiuretic hormone secretion 31.52 9.58 150 219703 26163 79498372
Bone marrow failure 31.44 9.58 58 219795 51049 79473486
Epilepsy 31.25 9.58 40 219813 40820 79483715
Graft versus host disease 30.55 9.58 3 219850 15023 79509512
Product odour abnormal 30.33 9.58 27 219826 1317 79523218
Anti-neutrophil cytoplasmic antibody positive vasculitis 30.26 9.58 44 219809 3685 79520850
Red blood cell sedimentation rate increased 30.20 9.58 50 219803 45892 79478643
Ascites 30.06 9.58 107 219746 75455 79449080
Drug interaction 30.06 9.58 1416 218437 413767 79110768
Renal failure 29.45 9.58 744 219109 200224 79324311
Respiratory depression 29.44 9.58 20 219833 27610 79496925
Glycosylated haemoglobin increased 29.33 9.58 118 219735 19142 79505393
Premature delivery 29.27 9.58 14 219839 23453 79501082
Gastrointestinal disorder 29.12 9.58 207 219646 121998 79402537
Dengue fever 28.69 9.58 22 219831 869 79523666
Renal impairment 28.66 9.58 602 219251 157181 79367354
Oedema peripheral 28.61 9.58 904 218949 251384 79273151
Hepatic cytolysis 28.47 9.58 20 219833 27131 79497404
Drug dependence 28.09 9.58 43 219810 40726 79483809
Serotonin syndrome 27.78 9.58 51 219802 44976 79479559
Nasopharyngitis 27.31 9.58 514 219339 253367 79271168
Blister 27.21 9.58 205 219648 119271 79405264
Blood pressure systolic abnormal 27.14 9.58 7 219846 17240 79507295
Drug hypersensitivity 26.91 9.58 623 219230 298293 79226242
Dysphonia 26.81 9.58 257 219596 56615 79467920
Diabetic ketoacidosis 26.48 9.58 173 219680 33949 79490586
Mouth swelling 26.12 9.58 54 219799 5997 79518538
Sinusitis 25.53 9.58 382 219471 195119 79329416
Ageusia 25.41 9.58 102 219751 16530 79508005
Mobility decreased 25.34 9.58 215 219638 121960 79402575
Hip arthroplasty 25.33 9.58 37 219816 35719 79488816
Pneumonia aspiration 25.21 9.58 97 219756 66870 79457665
Bradycardia 25.20 9.58 519 219334 135038 79389497
Immune reconstitution inflammatory syndrome 25.14 9.58 4 219849 13837 79510698
Primary hyperaldosteronism 25.09 9.58 11 219842 145 79524390
Plasmapheresis 24.85 9.58 18 219835 651 79523884
Flatulence 24.76 9.58 202 219651 42522 79482013
Urinary tract infection 24.73 9.58 958 218895 273554 79250981
Hypomagnesaemia 24.65 9.58 217 219636 46694 79477841
Oral pain 24.55 9.58 161 219692 31637 79492898
Mydriasis 24.46 9.58 9 219844 17634 79506901
Blood pressure abnormal 24.42 9.58 103 219750 17066 79507469
Status epilepticus 24.26 9.58 20 219833 25021 79499514
Pathogen resistance 24.20 9.58 5 219848 14337 79510198
Diabetic foot 24.04 9.58 39 219814 3593 79520942
Intentional product use issue 23.94 9.58 286 219567 151826 79372709
Acute myeloid leukaemia 23.86 9.58 30 219823 30855 79493680
Poisoning 23.49 9.58 21 219832 25251 79499284
Gastrointestinal haemorrhage 23.48 9.58 553 219300 147166 79377369
Disease progression 23.47 9.58 362 219491 184000 79340535
CD30 expression 23.46 9.58 8 219845 50 79524485
Febrile bone marrow aplasia 23.12 9.58 4 219849 13016 79511519
Haematotoxicity 23.12 9.58 7 219846 15512 79509023
Posterior reversible encephalopathy syndrome 23.07 9.58 23 219830 26258 79498277
Balance disorder 23.05 9.58 392 219461 98465 79426070
Haemorrhage intracranial 22.95 9.58 137 219716 26056 79498479
Blood glucose decreased 22.85 9.58 137 219716 26097 79498438
Peripheral swelling 22.45 9.58 933 218920 268684 79255851
Cardiac valve disease 22.20 9.58 49 219804 5692 79518843
Dystonia 22.12 9.58 16 219837 21383 79503152
Headache 22.00 9.58 2090 217763 651682 78872853
Cutaneous T-cell dyscrasia 21.99 9.58 8 219845 62 79524473
Blood urea increased 21.79 9.58 218 219635 48572 79475963
Hepatotoxicity 21.59 9.58 71 219782 51281 79473254
Dysgeusia 21.58 9.58 247 219606 56930 79467605
Swollen tongue 21.38 9.58 195 219658 42375 79482160
Angiotensin converting enzyme inhibitor foetopathy 21.35 9.58 7 219846 38 79524497
Intentional overdose 21.29 9.58 188 219665 105772 79418763
Eye haemorrhage 21.05 9.58 67 219786 9690 79514845
Chikungunya virus infection 21.02 9.58 11 219842 219 79524316
Obstructive airways disorder 20.90 9.58 34 219819 31425 79493110
Abdominal pain 20.83 9.58 870 218983 388699 79135836
Full blood count decreased 20.83 9.58 136 219717 26683 79497852
Intentional self-injury 20.65 9.58 36 219817 32383 79492152
Paraplegia 20.54 9.58 44 219809 5009 79519526
Progressive multifocal leukoencephalopathy 20.53 9.58 16 219837 20584 79503951
Urine albumin/creatinine ratio increased 20.34 9.58 15 219838 558 79523977
Delirium 20.33 9.58 143 219710 84484 79440051
Carcinogenicity 20.30 9.58 8 219845 79 79524456
Multi-organ disorder 20.22 9.58 30 219823 2558 79521977
Diabetes mellitus inadequate control 20.05 9.58 125 219728 24139 79500396
Noninfectious peritonitis 19.88 9.58 11 219842 246 79524289
Hepatic failure 19.77 9.58 94 219759 61118 79463417
Sodium retention 19.67 9.58 10 219843 187 79524348
Hyperhidrosis 19.64 9.58 552 219301 150940 79373595
Schizophrenia 19.59 9.58 9 219844 15431 79509104
Cytokine release syndrome 19.46 9.58 44 219809 35954 79488581
Burning feet syndrome 19.34 9.58 10 219843 194 79524341
Post transplant lymphoproliferative disorder 19.34 9.58 4 219849 11460 79513075
Multiple organ dysfunction syndrome 19.34 9.58 225 219628 120021 79404514
Renal disorder 19.22 9.58 189 219664 41916 79482619
Hepatocellular injury 19.19 9.58 67 219786 47526 79477009
Oligohydramnios 19.10 9.58 34 219819 3378 79521157
Recalled product administered 19.08 9.58 17 219836 830 79523705
Device expulsion 19.08 9.58 26 219827 25835 79498700
Stomatitis 19.07 9.58 287 219566 146470 79378065
Drug tolerance decreased 19.07 9.58 6 219847 12972 79511563
Inflammation 18.99 9.58 166 219687 93587 79430948
Myopathy 18.95 9.58 109 219744 20454 79504081
Facet joint syndrome 18.95 9.58 4 219849 11298 79513237
Hyperlipidaemia 18.87 9.58 130 219723 25963 79498572
Miosis 18.82 9.58 10 219843 15779 79508756
Renal artery stenosis 18.60 9.58 34 219819 3448 79521087
Chromaturia 18.46 9.58 128 219725 25618 79498917
Cachexia 18.42 9.58 4 219849 11079 79513456
Atrioventricular block 18.26 9.58 82 219771 13959 79510576
Transplant rejection 18.25 9.58 16 219837 19421 79505114
High frequency ablation 18.19 9.58 11 219842 292 79524243
Eye irritation 18.01 9.58 108 219745 20573 79503962
Bromhidrosis 17.85 9.58 5 219848 14 79524521
Eye pain 17.80 9.58 170 219683 37408 79487127
Agranulocytosis 17.75 9.58 64 219789 44966 79479569
Autoimmune disorder 17.73 9.58 12 219841 16600 79507935
Gout 17.72 9.58 123 219730 24626 79499909
Panniculitis 17.68 9.58 6 219847 12365 79512170
Psoriatic arthropathy 17.68 9.58 134 219719 77865 79446670
Pseudolymphoma 17.46 9.58 19 219834 1186 79523349
Disability 17.44 9.58 13 219840 17107 79507428
Neurotoxicity 17.38 9.58 40 219813 32478 79492057
Glomerulonephritis rapidly progressive 17.25 9.58 22 219831 1626 79522909
Renal pain 17.02 9.58 56 219797 8240 79516295
Bronchopulmonary aspergillosis 16.86 9.58 22 219831 22272 79502263
Sialoadenitis 16.80 9.58 24 219829 1977 79522558
Disturbance in attention 16.79 9.58 214 219639 50587 79473948
Asthmatic crisis 16.76 9.58 24 219829 1982 79522553
Therapy partial responder 16.73 9.58 14 219839 17383 79507152
Alanine aminotransferase increased 16.60 9.58 332 219521 162238 79362297
Pseudomonas infection 16.47 9.58 20 219833 20883 79503652
Muscle spasticity 16.44 9.58 21 219832 21454 79503081
Blood pressure decreased 16.30 9.58 374 219479 99092 79425443
Body temperature increased 16.30 9.58 65 219788 44355 79480180
Blood potassium decreased 16.26 9.58 198 219655 46314 79478221
Decreased immune responsiveness 16.08 9.58 42 219811 5433 79519102
Hyperglycaemia 16.07 9.58 278 219575 70057 79454478
Epstein-Barr virus infection 15.95 9.58 10 219843 14406 79510129
Gamma-glutamyltransferase increased 15.94 9.58 87 219766 54593 79469942
Non-cardiac chest pain 15.84 9.58 60 219793 9464 79515071
Thymus disorder 15.84 9.58 10 219843 287 79524248
Neutrophil count decreased 15.82 9.58 174 219679 93785 79430750
Pneumocystis jirovecii pneumonia 15.80 9.58 42 219811 32466 79492069
Tumour lysis syndrome 15.78 9.58 26 219827 23913 79500622
Transient aphasia 15.78 9.58 12 219841 468 79524067
Spider naevus 15.72 9.58 8 219845 150 79524385
Accelerated hypertension 15.64 9.58 14 219839 688 79523847
Hepatic steatosis 15.60 9.58 166 219687 37572 79486963
Gastroenteritis eosinophilic 15.60 9.58 10 219843 295 79524240
Psychotic disorder 15.56 9.58 60 219793 41342 79483193
Extrapyramidal disorder 15.55 9.58 24 219829 22655 79501880
Neutropenic sepsis 15.53 9.58 32 219821 27032 79497503
Mitral valve incompetence 15.46 9.58 133 219720 28432 79496103
Aggression 15.45 9.58 80 219773 50878 79473657
Joint range of motion decreased 15.42 9.58 44 219809 33238 79491297
Product physical issue 15.38 9.58 35 219818 4150 79520385
Hypoparathyroidism 15.36 9.58 17 219836 1081 79523454
Injury 15.35 9.58 138 219715 77358 79447177
Thyroid disorder 15.25 9.58 78 219775 14001 79510534
Grip strength decreased 15.13 9.58 23 219830 21846 79502689
Erectile dysfunction 15.03 9.58 80 219773 14584 79509951
Ischaemic cardiomyopathy 14.95 9.58 51 219802 7644 79516891
Cardiomegaly 14.95 9.58 124 219729 26228 79498307
Respiratory arrest 14.95 9.58 95 219758 57455 79467080
Milk-alkali syndrome 14.93 9.58 19 219834 1401 79523134
Blood pressure fluctuation 14.91 9.58 116 219737 67029 79457506
Extravasation blood 14.83 9.58 11 219842 413 79524122
Hyperammonaemia 14.81 9.58 6 219847 11087 79513448
Linear IgA disease 14.77 9.58 29 219824 3103 79521432
Pancreatitis acute 14.75 9.58 205 219648 49399 79475136
Coronary artery occlusion 14.65 9.58 82 219771 15233 79509302
Product residue present 14.61 9.58 31 219822 3505 79521030
Oral candidiasis 14.61 9.58 38 219815 29590 79494945
Eosinophilia myalgia syndrome 14.60 9.58 4 219849 10 79524525
Enterococcal infection 14.57 9.58 13 219840 15647 79508888
Body temperature decreased 14.53 9.58 43 219810 32102 79492433
Generalised tonic-clonic seizure 14.43 9.58 67 219786 43843 79480692
Calciphylaxis 14.38 9.58 32 219821 3738 79520797
Renin decreased 14.37 9.58 7 219846 119 79524416
Hypersensitivity vasculitis 14.36 9.58 47 219806 6896 79517639
Depressed level of consciousness 14.35 9.58 184 219669 96468 79428067
Rash maculo-papular 14.34 9.58 93 219760 55985 79468550
Carotid bruit 14.33 9.58 14 219839 769 79523766
Papillary muscle rupture 14.33 9.58 4 219849 11 79524524
Cardiac failure 14.32 9.58 542 219311 154300 79370235
Hypocalvaria 14.31 9.58 5 219848 34 79524501
Ischaemic stroke 14.30 9.58 147 219706 32984 79491551
Weight increased 14.29 9.58 622 219231 276764 79247771
Angina pectoris 14.27 9.58 211 219642 51521 79473014
Pain 14.25 9.58 1711 218142 702091 78822444
Blood immunoglobulin E increased 14.19 9.58 42 219811 5840 79518695
Acute respiratory distress syndrome 14.04 9.58 68 219785 43999 79480536
Rhabdomyolysis 13.99 9.58 378 219475 102753 79421782
Shoshin beriberi 13.90 9.58 6 219847 76 79524459
Diabetic retinopathy 13.74 9.58 28 219825 3078 79521457
Photopsia 13.74 9.58 39 219814 5297 79519238
Agitation 13.65 9.58 193 219660 99522 79425013
Chronic obstructive pulmonary disease 13.63 9.58 320 219533 85099 79439436
Carotid artery stenosis 13.61 9.58 54 219799 8704 79515831
Haematuria 13.60 9.58 266 219587 68570 79455965
Oral mucosal blistering 13.55 9.58 43 219810 6208 79518327
Cardiac flutter 13.53 9.58 37 219816 4917 79519618
Heart rate increased 13.52 9.58 432 219421 120292 79404243
Bradyarrhythmia 13.42 9.58 33 219820 4113 79520422
Hypertensive encephalopathy 13.39 9.58 15 219838 967 79523568
Peri-implantitis 13.34 9.58 8 219845 209 79524326
Low density lipoprotein increased 13.27 9.58 53 219800 8569 79515966
Norepinephrine increased 13.24 9.58 6 219847 86 79524449
Venous occlusion 13.22 9.58 16 219837 1121 79523414
Rebound tachycardia 13.19 9.58 4 219849 16 79524519
Multiple-drug resistance 13.07 9.58 4 219849 8804 79515731
Therapeutic response unexpected 13.05 9.58 97 219756 19849 79504686
Tendon rupture 13.01 9.58 67 219786 12059 79512476
Sickle cell anaemia with crisis 12.89 9.58 3 219850 7919 79516616
Therapeutic response decreased 12.83 9.58 120 219733 66733 79457802
Dislocation of vertebra 12.79 9.58 3 219850 7877 79516658
Infective pulmonary exacerbation of cystic fibrosis 12.78 9.58 10 219843 12841 79511694
Nodular rash 12.76 9.58 9 219844 312 79524223
Near death experience 12.76 9.58 11 219842 514 79524021
Osteoporosis 12.72 9.58 92 219761 54020 79470515
Hypovolaemia 12.71 9.58 88 219765 17603 79506932
Diffuse large B-cell lymphoma 12.67 9.58 9 219844 12140 79512395
Poor venous access 12.64 9.58 19 219834 18130 79506405
B-cell small lymphocytic lymphoma stage IV 12.62 9.58 3 219850 3 79524532
Tubulointerstitial nephritis 12.61 9.58 161 219692 38074 79486461
Granulocytopenia 12.55 9.58 8 219845 11423 79513112
Cholestasis 12.54 9.58 88 219765 52021 79472514
Cerebellar haemorrhage 12.53 9.58 26 219827 2894 79521641
Blood pressure systolic increased 12.53 9.58 121 219732 66865 79457670
Faeces discoloured 12.46 9.58 129 219724 28998 79495537
Myeloma cast nephropathy 12.43 9.58 7 219846 162 79524373
Unintentional medical device removal 12.39 9.58 3 219850 7709 79516826
Blindness transient 12.39 9.58 35 219818 4741 79519794
Gait disturbance 12.38 9.58 695 219158 206811 79317724
Lymphocyte count decreased 12.31 9.58 78 219775 47211 79477324
Heat stroke 12.26 9.58 19 219834 1684 79522851
Aortic dissection 12.23 9.58 32 219821 4143 79520392
Atheroembolism 12.20 9.58 9 219844 335 79524200
Arrhythmia 12.19 9.58 237 219616 61035 79463500
Pseudoaldosteronism 12.17 9.58 7 219846 169 79524366
Oxygen saturation decreased 12.15 9.58 267 219586 128780 79395755
Blood parathyroid hormone decreased 12.09 9.58 7 219846 10529 79514006
Atrioventricular block first degree 12.03 9.58 67 219786 12424 79512111
Product dispensing error 12.03 9.58 70 219783 13193 79511342
Respiratory rate increased 12.01 9.58 26 219827 21574 79502961
Sleep disorder due to a general medical condition 11.96 9.58 13 219840 14264 79510271
Loss of consciousness 11.95 9.58 572 219281 167371 79357164
Drug level below therapeutic 11.93 9.58 6 219847 9764 79514771
Patella fracture 11.87 9.58 20 219833 1901 79522634
Cardiorenal syndrome 11.82 9.58 18 219835 1571 79522964
Eczema nummular 11.81 9.58 9 219844 352 79524183
Blood glucose abnormal 11.77 9.58 59 219794 10507 79514028
Spinal epidural haematoma 11.77 9.58 17 219836 1415 79523120
Hypogammaglobulinaemia 11.76 9.58 11 219842 12940 79511595
Fear 11.70 9.58 102 219751 21884 79502651
Blindness unilateral 11.69 9.58 49 219804 8097 79516438
Type 2 diabetes mellitus 11.63 9.58 101 219752 57021 79467514
Anuria 11.55 9.58 98 219755 20865 79503670
Injection site reaction 11.54 9.58 96 219757 54689 79469846
Instillation site pain 11.54 9.58 12 219841 711 79523824
Scleroderma renal crisis 11.48 9.58 11 219842 590 79523945
Device related infection 11.46 9.58 52 219801 34242 79490293
Knee arthroplasty 11.43 9.58 71 219782 43177 79481358
Pollakiuria 11.41 9.58 155 219698 37162 79487373
Parathyroid haemorrhage 11.41 9.58 3 219850 6 79524529
Diabetes mellitus 11.41 9.58 290 219563 78100 79446435
Vascular stenosis 11.40 9.58 11 219842 595 79523940
Guillain-Barre syndrome 11.40 9.58 52 219801 8913 79515622
Psychomotor hyperactivity 11.39 9.58 18 219835 16831 79507704
Overweight 11.34 9.58 31 219822 4119 79520416
Blood triglycerides abnormal 11.32 9.58 10 219843 483 79524052
Hepatic function abnormal 11.29 9.58 138 219715 72969 79451566
Fluid retention 11.29 9.58 262 219591 69547 79454988
Pancreatic carcinoma 11.25 9.58 70 219783 13507 79511028
Wrong product administered 11.25 9.58 52 219801 8960 79515575
Gastroenteritis aeromonas 11.23 9.58 4 219849 29 79524506
Depressed mood 11.21 9.58 192 219661 48288 79476247
Therapy interrupted 11.21 9.58 134 219719 31207 79493328
Eosinophilia 11.20 9.58 76 219777 45269 79479266
Orthopnoea 11.05 9.58 56 219797 10017 79514518
Lichen planus 11.00 9.58 24 219829 2767 79521768
Haemorrhagic fever 11.00 9.58 4 219849 31 79524504
Frequent bowel movements 10.98 9.58 43 219810 29496 79495039
Application site haematoma 10.95 9.58 5 219848 73 79524462
Nephrolithiasis 10.89 9.58 207 219646 53084 79471451
Device adhesion issue 10.89 9.58 3 219850 7072 79517463
Mitral valve stenosis 10.89 9.58 15 219838 1195 79523340
Normal newborn 10.88 9.58 3 219850 7069 79517466
Periorbital oedema 10.88 9.58 49 219804 8353 79516182
Lip dry 10.88 9.58 16 219837 15402 79509133
Anticoagulation drug level above therapeutic 10.87 9.58 28 219825 3592 79520943
Urethral haemorrhage 10.86 9.58 9 219844 398 79524137
Device dislocation 10.85 9.58 36 219817 25934 79498601
Essential hypertension 10.80 9.58 39 219814 6014 79518521
Hypokalaemia 10.76 9.58 493 219360 143547 79380988
Nail bed tenderness 10.73 9.58 9 219844 405 79524130
Pulmonary oedema 10.73 9.58 319 219534 87935 79436600
Nervousness 10.72 9.58 140 219713 33275 79491260
Application site scab 10.70 9.58 7 219846 214 79524321
Aortic stenosis 10.69 9.58 45 219808 7450 79517085
Blood magnesium decreased 10.63 9.58 80 219773 16432 79508103
Hyperthermia 10.63 9.58 21 219832 18016 79506519
Blood aldosterone increased 10.50 9.58 7 219846 221 79524314
Blood loss anaemia 10.50 9.58 76 219777 15422 79509113
Orbital oedema 10.48 9.58 9 219844 418 79524117
Electrocardiogram PR prolongation 10.48 9.58 17 219836 1566 79522969
Arrhythmia supraventricular 10.40 9.58 20 219833 2107 79522428
Blood potassium increased 10.40 9.58 125 219728 29150 79495385
Anhidrosis 10.39 9.58 7 219846 225 79524310
Product availability issue 10.31 9.58 29 219824 3918 79520617
Hyponatraemic seizure 10.30 9.58 10 219843 545 79523990
Microcytic anaemia 10.29 9.58 35 219818 5239 79519296
Drug ineffective for unapproved indication 10.25 9.58 91 219762 51147 79473388
Nasal congestion 10.22 9.58 280 219573 76272 79448263
Parathyroid tumour 10.21 9.58 5 219848 86 79524449
Nausea 10.21 9.58 2873 216980 954323 78570212
Clostridium difficile colitis 10.17 9.58 50 219803 32233 79492302
Extrasystoles 10.16 9.58 44 219809 7375 79517160
Cytopenia 10.16 9.58 26 219827 20357 79504178
Metastatic renal cell carcinoma 10.14 9.58 21 219832 2334 79522201
Gastric disorder 10.06 9.58 152 219701 37281 79487254
Umbilical hernia repair 10.06 9.58 5 219848 89 79524446
Fear of injection 10.05 9.58 4 219849 7470 79517065
Vasculitic rash 10.03 9.58 20 219833 2164 79522371
Myocardial ischaemia 9.97 9.58 111 219742 25408 79499127
Vitamin B6 deficiency 9.97 9.58 8 219845 338 79524197
Generalised anxiety disorder 9.95 9.58 20 219833 2177 79522358
Drug specific antibody present 9.91 9.58 3 219850 6649 79517886
Sputum discoloured 9.89 9.58 29 219824 21714 79502821
Colitis microscopic 9.87 9.58 57 219796 10711 79513824
Thrombotic microangiopathy 9.84 9.58 26 219827 20143 79504392
Blood urea abnormal 9.82 9.58 15 219838 1312 79523223
Encephalitis 9.76 9.58 16 219837 14744 79509791
Encephalopathy 9.74 9.58 129 219724 67268 79457267
Product supply issue 9.70 9.58 19 219834 2029 79522506
Creatinine renal clearance decreased 9.66 9.58 24 219829 18978 79505557
Lung disorder 9.63 9.58 160 219693 80397 79444138
Pneumonia fungal 9.62 9.58 10 219843 11200 79513335
Familial periodic paralysis 9.61 9.58 6 219847 169 79524366
Prescribed overdose 9.60 9.58 63 219790 37820 79486715

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09CA01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
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
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:51451 ERA
CHEBI has role CHEBI:61016 angiotensin receptor antagonists
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
MeSH PA D057911 Angiotensin Receptor Antagonists
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Diabetic renal disease indication 127013003
Hypertensive urgency indication 443482000
Hypertension with Left Ventricular Hypertrophy indication
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
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
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Azotemia contraindication 445009001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.5 acidic
pKa2 13.19 acidic
pKa3 3.89 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST IC50 9.48 CHEMBL CHEMBL
Angiotensin-converting enzyme Enzyme IC50 7.72 CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 4.46 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 5.54 DRUG MATRIX
Thromboxane A2 receptor GPCR IC50 4.70 CHEMBL
Type-2 angiotensin II receptor GPCR IC50 5 CHEMBL
Phosphodiesterase 3 Enzyme IC50 4.89 CHEMBL
Phosphodiesterase 4 Enzyme IC50 4.59 CHEMBL
Angiotensin II receptor GPCR Kd 8.43 CHEMBL
Multidrug resistance protein 1 Transporter Km 3.50 WOMBAT-PK
Platelet glycoprotein VI Unclassified IC50 4.98 CHEMBL
Type-1B angiotensin II receptor GPCR Ki 8.44 CHEMBL
Type-2 angiotensin II receptor GPCR IC50 5.13 CHEMBL
Type-1 angiotensin II receptor GPCR IC50 7.02 CHEMBL
Type-1A angiotensin II receptor GPCR Ki 7.84 CHEMBL
Type-1 angiotensin II receptor GPCR Kd 8.80 CHEMBL
Type-1 angiotensin II receptor GPCR IC50 7.74 CHEMBL
Angiotensin II receptor (AT-1) type-1 GPCR Ki 8.72 CHEMBL
Angiotensin II receptor GPCR IC50 8.34 CHEMBL

External reference:

IDSource
4020913 VUID
N0000148401 NUI
D00357 KEGG_DRUG
124750-99-8 SECONDARY_CAS_RN
4020913 VANDF
4020920 VANDF
C0126174 UMLSCUI
CHEBI:6541 CHEBI
LSN PDB_CHEM_ID
CHEMBL191 ChEMBL_ID
CHEMBL995 ChEMBL_ID
D019808 MESH_DESCRIPTOR_UI
DB00678 DRUGBANK_ID
3961 PUBCHEM_CID
590 IUPHAR_LIGAND_ID
6913 INN_ID
JMS50MPO89 UNII
203160 RXNORM
172424 MMSL
4996 MMSL
d03821 MMSL
004991 NDDF
004992 NDDF
108582002 SNOMEDCT_US
373567002 SNOMEDCT_US
96309000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0054-0123 TABLET 25 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0054-0124 TABLET 50 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0054-0125 TABLET 100 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7367 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7367 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7368 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7368 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7369 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0093-7369 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7958 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7959 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7960 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7047 TABLET, FILM COATED 25 mg ORAL ANDA 27 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7047 TABLET, FILM COATED 25 mg ORAL ANDA 27 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7048 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7048 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7049 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7049 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
LOSARTAN POTASSIUM Human Prescription Drug Label 1 13107-195 TABLET 25 mg ORAL ANDA 27 sections
LOSARTAN POTASSIUM Human Prescription Drug Label 1 13107-196 TABLET 50 mg ORAL ANDA 27 sections
LOSARTAN POTASSIUM Human Prescription Drug Label 1 13107-197 TABLET 100 mg ORAL ANDA 27 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 13668-113 TABLET 25 mg ORAL ANDA 28 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 13668-113 TABLET 25 mg ORAL ANDA 28 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 13668-115 TABLET 100 mg ORAL ANDA 28 sections
Losartan Potassium HUMAN PRESCRIPTION DRUG LABEL 1 13668-115 TABLET 100 mg ORAL ANDA 28 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 13668-116 TABLET 50 mg ORAL ANDA 25 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 13668-116 TABLET 50 mg ORAL ANDA 25 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 13668-116 TABLET 50 mg ORAL ANDA 25 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 13668-117 TABLET 100 mg ORAL ANDA 25 sections
Losartan Potassium and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 13668-117 TABLET 100 mg ORAL ANDA 25 sections