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

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 2583 144701-48-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • telmisartan
  • tolura
  • micardis
  • pritor
A biphenyl compound and benzimidazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION.
  • Molecular weight: 514.63
  • Formula: C33H30N4O2
  • CLOGP: 7.29
  • LIPINSKI: 2
  • HAC: 6
  • HDO: 1
  • TPSA: 72.94
  • ALOGS: -5.17
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.22 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 5.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 12, 1998 EMA KRKA, D.D., NOVO MESTO
Nov. 10, 1998 FDA BOEHRINGER INGELHEIM

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
Hyponatraemia 186.88 10.62 303 43928 111597 63333194
Blood pressure increased 117.47 10.62 311 43920 161751 63283040
Pemphigus 103.80 10.62 6 44225 183720 63261071
Alopecia 86.90 10.62 65 44166 337471 63107320
Hypertensive crisis 86.03 10.62 77 44154 15209 63429582
Bradycardia 85.80 10.62 170 44061 73057 63371734
Maternal exposure during pregnancy 79.60 10.62 27 44204 220035 63224756
Blood pressure systolic increased 75.85 10.62 126 44105 47271 63397520
Renal impairment 71.66 10.62 177 44054 88178 63356613
Glossodynia 68.15 10.62 20 44211 178856 63265935
Abdominal discomfort 67.99 10.62 74 44157 320811 63123980
Hypoglycaemia 63.90 10.62 134 44097 59931 63384860
Anti-cyclic citrullinated peptide antibody positive 62.10 10.62 5 44226 116207 63328584
Systemic lupus erythematosus 60.81 10.62 35 44196 208883 63235908
Fall 60.74 10.62 474 43757 391860 63052931
Endometriosis 58.88 10.62 40 44191 5280 63439511
Acute kidney injury 58.51 10.62 348 43883 263067 63181724
Hepatic function abnormal 55.79 10.62 96 44135 37046 63407745
Labile hypertension 53.86 10.62 18 44213 468 63444323
Labelled drug-drug interaction medication error 53.69 10.62 56 44175 13343 63431448
Head discomfort 53.63 10.62 56 44175 13359 63431432
Hyperkalaemia 53.15 10.62 117 44114 54086 63390705
Hemiplegia 52.53 10.62 47 44184 9276 63435515
Lactic acidosis 52.40 10.62 95 44136 38192 63406599
Glaucoma 51.97 10.62 65 44166 18840 63425951
Drug ineffective 51.74 10.62 473 43758 1044292 62400499
Arthritis 50.90 10.62 187 44044 115734 63329057
Drug specific antibody 50.27 10.62 27 44204 2328 63442463
Off label use 49.63 10.62 272 43959 674190 62770601
Wound 49.46 10.62 26 44205 163237 63281554
Completed suicide 49.08 10.62 20 44211 145653 63299138
Cerebral infarction 48.67 10.62 71 44160 23822 63420969
Listless 48.00 10.62 28 44203 2832 63441959
Pericarditis 47.80 10.62 16 44215 131563 63313228
Isosthenuria 47.69 10.62 12 44219 108 63444683
Fatigue 47.01 10.62 395 43836 887633 62557158
Carcinoid tumour pulmonary 46.29 10.62 16 44215 462 63444329
Hand deformity 45.98 10.62 27 44204 159430 63285361
Blood pressure decreased 45.23 10.62 123 44108 64899 63379892
Rhabdomyolysis 44.37 10.62 96 44135 43855 63400936
Carotid artery thrombosis 43.35 10.62 26 44205 2768 63442023
Reduced facial expression 43.26 10.62 23 44208 1943 63442848
Death 42.63 10.62 127 44104 374254 63070537
Breath sounds abnormal 42.43 10.62 45 44186 10928 63433863
Altered state of consciousness 41.60 10.62 68 44163 25162 63419629
Atrial fibrillation 41.38 10.62 176 44055 116460 63328331
Chronic kidney disease 41.16 10.62 95 44136 45303 63399488
Inappropriate antidiuretic hormone secretion 40.66 10.62 52 44179 15410 63429381
Pyelitis 40.37 10.62 12 44219 210 63444581
Affect lability 40.08 10.62 44 44187 11107 63433684
Exposure during pregnancy 39.91 10.62 30 44201 155517 63289274
Carotid arteriosclerosis 39.49 10.62 18 44213 1088 63443703
Bladder hypertrophy 39.45 10.62 12 44219 228 63444563
Product dose omission issue 38.50 10.62 65 44166 234248 63210543
Pain 38.42 10.62 331 43900 740297 62704494
Irritable bowel syndrome 37.89 10.62 6 44225 82406 63362385
Swelling 37.78 10.62 85 44146 275293 63169498
Postprandial hypoglycaemia 37.76 10.62 9 44222 63 63444728
Electrocardiogram PR shortened 37.50 10.62 12 44219 271 63444520
Toxic epidermal necrolysis 37.41 10.62 65 44166 25269 63419522
Infusion site streaking 37.40 10.62 14 44217 511 63444280
Chloropsia 36.73 10.62 8 44223 35 63444756
Duodenal ulcer perforation 36.57 10.62 8 44223 87201 63357590
Hypotension 35.51 10.62 317 43914 272287 63172504
Creatinine renal clearance increased 34.72 10.62 14 44217 625 63444166
Blood creatinine increased 34.67 10.62 137 44094 87707 63357084
Sleep apnoea syndrome 34.54 10.62 68 44163 29065 63415726
Administration site abscess 34.45 10.62 7 44224 20 63444771
Blood pressure inadequately controlled 33.96 10.62 28 44203 4950 63439841
Apathy 33.89 10.62 36 44195 8758 63436033
Neurologic neglect syndrome 33.83 10.62 22 44209 2699 63442092
Administration site induration 33.72 10.62 7 44224 23 63444768
Blood pressure abnormal 33.65 10.62 47 44184 15151 63429640
Administration site discharge 32.64 10.62 7 44224 28 63444763
Helicobacter infection 32.47 10.62 12 44219 92773 63352018
Muscle injury 31.82 10.62 4 44227 65341 63379450
Impaired healing 31.53 10.62 16 44215 102526 63342265
Oliguria 31.14 10.62 35 44196 9066 63435725
Hypokalaemia 31.09 10.62 149 44082 103655 63341136
Arthropathy 30.97 10.62 74 44157 234718 63210073
Skin necrosis 30.68 10.62 43 44188 13907 63430884
Asthma 30.53 10.62 172 44059 127389 63317402
Drug eruption 30.49 10.62 64 44167 28630 63416161
Cardiac failure 30.45 10.62 133 44098 89009 63355782
Administration site odour 30.44 10.62 7 44224 41 63444750
Myalgia 30.21 10.62 190 44041 146339 63298452
Granuloma skin 29.82 10.62 33 44198 8404 63436387
Product packaging confusion 29.74 10.62 9 44222 168 63444623
Arterial occlusive disease 29.61 10.62 28 44203 5930 63438861
Therapeutic product effect decreased 28.68 10.62 57 44174 193130 63251661
Psoriasis 28.38 10.62 128 44103 86829 63357962
Blood thyroid stimulating hormone normal 28.38 10.62 8 44223 115 63444676
Ill-defined disorder 27.89 10.62 11 44220 81744 63363047
Injection site cyst 27.52 10.62 7 44224 66 63444725
Ureteral disorder 27.25 10.62 10 44221 345 63444446
Albuminuria 26.93 10.62 9 44222 234 63444557
White blood cell count abnormal 26.66 10.62 27 44204 6215 63438576
Joint noise 26.46 10.62 23 44208 4369 63440422
Interstitial lung disease 26.43 10.62 99 44132 61809 63382982
Panniculitis 26.40 10.62 36 44195 11349 63433442
Vascular purpura 26.21 10.62 15 44216 1463 63443328
Dementia 26.18 10.62 47 44184 18747 63426044
Hypersensitivity 26.12 10.62 110 44121 292575 63152216
Blood parathyroid hormone decreased 25.85 10.62 33 44198 9758 63435033
Hypertensive angiopathy 25.84 10.62 7 44224 86 63444705
Vertigo 25.76 10.62 96 44135 59791 63385000
Gouty arthritis 25.73 10.62 11 44220 570 63444221
Disease progression 25.20 10.62 29 44202 122729 63322062
Infection 25.15 10.62 79 44152 229094 63215697
Oxygen saturation decreased 24.98 10.62 125 44106 88460 63356331
Gastric pH increased 24.93 10.62 6 44225 44 63444747
Staphylococcus test positive 24.68 10.62 21 44210 3875 63440916
Administration site haemorrhage 24.56 10.62 7 44224 105 63444686
Foreign body 24.50 10.62 17 44214 2321 63442470
Loss of consciousness 24.23 10.62 153 44078 117968 63326823
Prescription drug used without a prescription 24.19 10.62 17 44214 2369 63442422
Muscle atrophy 23.99 10.62 27 44204 7006 63437785
Haemoglobin increased 23.81 10.62 20 44211 3626 63441165
Renal function test abnormal 23.78 10.62 20 44211 3633 63441158
Electrocardiogram PR prolongation 23.41 10.62 11 44220 713 63444078
Tender joint count 23.41 10.62 8 44223 223 63444568
Blood pressure diastolic decreased 23.37 10.62 50 44181 22656 63422135
Contraindicated product administered 23.20 10.62 76 44155 217572 63227219
Product use in unapproved indication 23.16 10.62 57 44174 179023 63265768
Scoliosis 23.09 10.62 28 44203 7860 63436931
Urinary retention 22.77 10.62 59 44172 30242 63414549
Porphyrins urine increased 22.75 10.62 5 44226 23 63444768
Acquired porphyria 22.75 10.62 5 44226 23 63444768
Sinus congestion 22.33 10.62 43 44188 18080 63426711
Treatment failure 22.27 10.62 68 44163 198975 63245816
Endophthalmitis 22.02 10.62 19 44212 3573 63441218
Product monitoring error 22.02 10.62 21 44210 4495 63440296
Gangrene 21.73 10.62 24 44207 6099 63438692
Porphyrins stool increased 21.64 10.62 5 44226 30 63444761
Blood creatine phosphokinase increased 21.59 10.62 58 44173 30372 63414419
Stomatitis 21.40 10.62 40 44191 138685 63306106
Fibromyalgia 21.28 10.62 15 44216 80405 63364386
Carbohydrate antigen 15-3 increased 21.24 10.62 13 44218 1435 63443356
Non-small cell lung cancer recurrent 21.05 10.62 6 44225 90 63444701
Cerebrovascular accident 20.98 10.62 138 44093 107886 63336905
Renal failure 20.88 10.62 147 44084 117505 63327286
Cystitis 20.28 10.62 84 44147 54907 63389884
Allergy to metals 20.23 10.62 10 44221 725 63444066
Hypercalcaemia 20.11 10.62 54 44177 28268 63416523
Delirium 20.07 10.62 79 44152 50462 63394329
Hypertension 20.00 10.62 289 43942 279014 63165777
Blood pressure diastolic abnormal 19.78 10.62 36 44195 14506 63430285
Urine calcium/creatinine ratio increased 19.73 10.62 6 44225 114 63444677
Product use issue 19.58 10.62 83 44148 220437 63224354
Discomfort 19.57 10.62 56 44175 167318 63277473
Tracheal pain 19.49 10.62 5 44226 49 63444742
Iodine allergy 19.38 10.62 10 44221 794 63443997
Carcinoid tumour 19.31 10.62 8 44223 383 63444408
Personality disorder 19.29 10.62 22 44209 5789 63439002
Cerebral haemorrhage 19.27 10.62 56 44175 30673 63414118
Menopausal symptoms 19.25 10.62 15 44216 2446 63442345
Insulin-like growth factor decreased 19.21 10.62 8 44223 388 63444403
Left ventricular hypertrophy 19.15 10.62 21 44210 5294 63439497
Angina pectoris 19.04 10.62 55 44176 30023 63414768
Buttock injury 19.03 10.62 7 44224 243 63444548
Osteocalcin decreased 18.96 10.62 5 44226 55 63444736
Carcinoembryonic antigen increased 18.89 10.62 13 44218 1752 63443039
Eczema impetiginous 18.86 10.62 4 44227 15 63444776
Sensory loss 18.81 10.62 29 44202 10209 63434582
Paralysis recurrent laryngeal nerve 18.80 10.62 5 44226 57 63444734
Diabetic nephropathy 18.68 10.62 12 44219 1442 63443349
Skin dystrophy 18.42 10.62 5 44226 62 63444729
Pemphigoid 18.22 10.62 24 44207 7320 63437471
Retinal infarction 18.20 10.62 5 44226 65 63444726
Dizziness 18.08 10.62 409 43822 429516 63015275
Alanine aminotransferase increased 18.03 10.62 129 44102 103641 63341150
Rheumatic fever 17.98 10.62 4 44227 43107 63401684
Porphyria non-acute 17.86 10.62 7 44224 290 63444501
Bronchiolitis 17.80 10.62 15 44216 2732 63442059
Liver injury 17.79 10.62 10 44221 60510 63384281
Aphasia 17.76 10.62 57 44174 32943 63411848
Thalamus haemorrhage 17.62 10.62 9 44222 700 63444091
Cough 17.56 10.62 294 43937 292449 63152342
Basal cell carcinoma 17.54 10.62 51 44180 27940 63416851
Proteinuria 17.28 10.62 40 44191 19105 63425686
Urethral caruncle 17.01 10.62 5 44226 84 63444707
Vasoplegia syndrome 16.98 10.62 12 44219 1687 63443104
Product used for unknown indication 16.95 10.62 8 44223 524 63444267
Dehydration 16.47 10.62 189 44042 173165 63271626
Lower respiratory tract infection 16.42 10.62 43 44188 132264 63312527
Thyroid disorder 16.32 10.62 34 44197 15128 63429663
Blister 16.25 10.62 42 44189 129772 63315019
Blood potassium increased 16.25 10.62 38 44193 18271 63426520
Aspartate aminotransferase increased 16.13 10.62 113 44118 90164 63354627
Electrocardiogram T wave peaked 16.08 10.62 6 44225 217 63444574
Left atrial dilatation 16.00 10.62 12 44219 1849 63442942
Drug interaction 15.97 10.62 236 43995 228895 63215896
Fluid retention 15.97 10.62 11 44220 59675 63385116
Swollen joint count increased 15.75 10.62 3 44228 36051 63408740
Blood pressure fluctuation 15.73 10.62 69 44162 46248 63398543
Immobile 15.64 10.62 20 44211 5923 63438868
Blood pressure systolic abnormal 15.57 10.62 31 44200 13355 63431436
Myocardial infarction 15.55 10.62 121 44110 99772 63345019
Pulse abnormal 15.51 10.62 13 44218 2351 63442440
Hyperaldosteronism 15.51 10.62 6 44225 240 63444551
Dry gangrene 15.31 10.62 8 44223 652 63444139
Eating disorder 15.30 10.62 38 44193 18978 63425813
Angioedema 15.19 10.62 70 44161 47895 63396896
Hemiparesis 15.15 10.62 43 44188 23239 63421552
Clubbing 15.12 10.62 7 44224 439 63444352
Acute myocardial infarction 15.08 10.62 53 44178 32071 63412720
Skin haemorrhage 15.03 10.62 26 44205 10068 63434723
Rash 15.00 10.62 288 43943 560583 62884208
XIth nerve injury 14.85 10.62 4 44227 48 63444743
Neutropenia 14.84 10.62 67 44164 174938 63269853
Uraemic encephalopathy 14.82 10.62 6 44225 271 63444520
Suicidal ideation 14.80 10.62 13 44218 62408 63382383
Haemorrhage subcutaneous 14.79 10.62 14 44217 2969 63441822
Exposure keratitis 14.78 10.62 4 44227 49 63444742
Renal tubular acidosis 14.75 10.62 11 44220 1681 63443110
Hypokinesia 14.70 10.62 31 44200 13905 63430886
Bite 14.61 10.62 7 44224 474 63444317
Rheumatoid nodule 14.57 10.62 35 44196 17120 63427671
Gastrointestinal disorder 14.55 10.62 45 44186 131194 63313597
Confusional state 14.39 10.62 238 43993 236142 63208649
Febrile neutropenia 14.31 10.62 39 44192 118410 63326381
Glomerular filtration rate decreased 14.30 10.62 30 44201 13411 63431380
Subacute cutaneous lupus erythematosus 14.25 10.62 13 44218 2630 63442161
Pregnancy 14.23 10.62 4 44227 36832 63407959
Meningioma surgery 14.22 10.62 4 44227 57 63444734
Adjustment disorder 14.04 10.62 14 44217 3164 63441627
Catecholamine crisis 13.99 10.62 3 44228 12 63444779
Drug specific antibody present 13.93 10.62 16 44215 4243 63440548
Sleep disorder due to a general medical condition 13.91 10.62 28 44203 12160 63432631
Motor dysfunction 13.84 10.62 26 44205 10735 63434056
Coordination abnormal 13.80 10.62 30 44201 13743 63431048
Skin ulcer 13.77 10.62 63 44168 42982 63401809
Phlebitis 13.72 10.62 20 44211 6704 63438087
Protein urine present 13.66 10.62 19 44212 6101 63438690
Palpitations 13.56 10.62 129 44102 112641 63332150
Injection site paraesthesia 13.48 10.62 7 44224 563 63444228
Hepatic steatosis 13.11 10.62 47 44184 28722 63416069
Visual acuity reduced 12.95 10.62 39 44192 21787 63423004
Bradypnoea 12.74 10.62 14 44217 3536 63441255
Base excess decreased 12.73 10.62 4 44227 85 63444706
HLA-B*27 positive 12.71 10.62 5 44226 209 63444582
Haemophilia 12.64 10.62 4 44227 87 63444704
Gamma-glutamyltransferase increased 12.56 10.62 52 44179 33979 63410812
Forced expiratory flow decreased 12.43 10.62 4 44227 92 63444699
Arrhythmia 12.33 10.62 56 44175 38084 63406707
Knee deformity 12.30 10.62 9 44222 1336 63443455
Compensatory sweating 12.24 10.62 3 44228 24 63444767
Vocal cord paralysis 12.21 10.62 11 44220 2190 63442601
Pelvic fracture 12.17 10.62 28 44203 13320 63431471
Influenza like illness 12.15 10.62 84 44147 66740 63378051
Drug tolerance decreased 12.09 10.62 33 44198 17440 63427351
Intentional product use issue 12.06 10.62 47 44184 127845 63316946
Breast cancer recurrent 12.05 10.62 15 44216 4326 63440465
Blood glucose decreased 12.02 10.62 37 44194 20915 63423876
Rash pruritic 11.97 10.62 77 44154 59722 63385069
No adverse event 11.94 10.62 7 44224 41398 63403393
Accelerated hypertension 11.91 10.62 6 44225 453 63444338
Face oedema 11.88 10.62 36 44195 20176 63424615
Sinusitis 11.81 10.62 101 44130 226552 63218239
Malaise 11.80 10.62 376 43855 415578 63029213
BRASH syndrome 11.79 10.62 6 44225 463 63444328
Rubber sensitivity 11.67 10.62 11 44220 2320 63442471
Multiple sclerosis relapse 11.61 10.62 10 44221 48468 63396323
Near drowning 11.55 10.62 3 44228 31 63444760
Sneezing 11.23 10.62 33 44198 18185 63426606
Hip arthroplasty 11.20 10.62 10 44221 47636 63397155
Pericardial effusion 11.15 10.62 46 44185 30012 63414779
Haemorrhagic infarction 11.13 10.62 5 44226 292 63444499
Hospitalisation 11.06 10.62 27 44204 85054 63359737
Idiosyncratic drug reaction 11.05 10.62 7 44224 821 63443970
Mental status changes 10.99 10.62 7 44224 39592 63405199
Abortion spontaneous 10.98 10.62 10 44221 47185 63397606
Gastrointestinal bacterial infection 10.85 10.62 7 44224 847 63443944
Injection site bruising 10.85 10.62 8 44223 41902 63402889
Gastrointestinal endoscopic therapy 10.78 10.62 3 44228 41 63444750
C-reactive protein increased 10.73 10.62 107 44124 94600 63350191
Carotid sinus syndrome 10.71 10.62 4 44227 145 63444646
Respiratory tract congestion 10.71 10.62 32 44199 17800 63426991
Thyroid mass 10.69 10.62 14 44217 4244 63440547
Atrioventricular block complete 10.69 10.62 20 44211 8231 63436560
Bradyarrhythmia 10.62 10.62 10 44221 2105 63442686

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
Cerebral infarction 110.66 11.63 124 28427 27331 34901049
Interstitial lung disease 90.17 11.63 178 28373 65104 34863276
Pericardial disease 60.31 11.63 20 28531 430 34927950
Cardiac failure 59.78 11.63 187 28364 91061 34837319
Death 58.07 11.63 152 28399 397897 34530483
Hepatic function abnormal 57.67 11.63 118 28433 44245 34884135
Pulmonary valve disease 57.22 11.63 18 28533 325 34928055
Hyperkalaemia 55.79 11.63 153 28398 69236 34859144
Completed suicide 53.83 11.63 8 28543 98160 34830220
Altered state of consciousness 50.74 11.63 77 28474 22816 34905564
Blood creatine phosphokinase increased 48.78 11.63 111 28440 44746 34883634
Blood pressure increased 44.88 11.63 166 28385 87936 34840444
Growth hormone deficiency 43.16 11.63 14 28537 280 34928100
Physical examination abnormal 42.00 11.63 14 28537 306 34928074
Acute kidney injury 37.52 11.63 397 28154 304591 34623789
Rales 37.02 11.63 43 28508 9840 34918540
Hyponatraemia 36.55 11.63 149 28402 82542 34845838
Cardiac discomfort 36.43 11.63 15 28536 601 34927779
Platelet distribution width increased 34.55 11.63 10 28541 134 34928246
Dyslalia 34.36 11.63 14 28537 546 34927834
Chronic kidney disease 34.23 11.63 92 28459 41118 34887262
Electrocardiogram Q wave abnormal 33.76 11.63 13 28538 436 34927944
Neutropenia 33.06 11.63 48 28503 156730 34771650
Product dose omission issue 32.41 11.63 30 28521 119681 34808699
Dyspnoea at rest 32.21 11.63 26 28525 3802 34924578
Stenosis 31.91 11.63 18 28533 1455 34926925
Liver disorder 31.89 11.63 78 28473 32919 34895461
Toxicity to various agents 31.06 11.63 74 28477 200288 34728092
Diabetic nephropathy 30.60 11.63 20 28531 2108 34926272
Renal impairment 30.35 11.63 155 28396 94358 34834022
Lactic acidosis 30.27 11.63 79 28472 34693 34893687
Hepatojugular reflux 30.09 11.63 13 28538 588 34927792
Post micturition dribble 29.76 11.63 6 28545 13 34928367
Ventricular arrhythmia 29.46 11.63 29 28522 5499 34922881
IgA nephropathy 28.90 11.63 16 28535 1247 34927133
Off label use 28.20 11.63 214 28337 419310 34509070
Carotid artery stenosis 28.00 11.63 27 28524 4992 34923388
Daydreaming 27.67 11.63 12 28539 548 34927832
Mitral valve disease 27.16 11.63 16 28535 1403 34926977
Blood pressure decreased 26.99 11.63 98 28453 51417 34876963
Narrow anterior chamber angle 26.75 11.63 8 28543 121 34928259
Accident at work 26.32 11.63 13 28538 801 34927579
Tricuspid valve incompetence 26.26 11.63 36 28515 9724 34918656
Hypoglycaemia 26.18 11.63 101 28450 54539 34873841
Haematuria 26.02 11.63 95 28456 49971 34878409
Bundle branch block left 25.79 11.63 28 28523 5951 34922429
Occult blood 25.53 11.63 13 28538 855 34927525
Syncope 25.30 11.63 144 28407 91307 34837073
Mitral valve incompetence 24.65 11.63 44 28507 14899 34913481
Blood pressure inadequately controlled 24.51 11.63 19 28532 2621 34925759
Drug intolerance 24.49 11.63 9 28542 59561 34868819
Drug abuse 24.35 11.63 27 28524 99069 34829311
Staring 24.08 11.63 15 28536 1455 34926925
Drug ineffective 24.07 11.63 248 28303 456503 34471877
Loss of consciousness 23.42 11.63 131 28420 82536 34845844
Echocardiogram abnormal 23.05 11.63 13 28538 1050 34927330
Labile blood pressure 22.73 11.63 11 28540 648 34927732
Anaemia macrocytic 22.23 11.63 19 28532 3007 34925373
Petit mal epilepsy 21.95 11.63 19 28532 3059 34925321
Atrioventricular block complete 21.58 11.63 32 28519 9287 34919093
Hypoglycaemic coma 21.49 11.63 17 28534 2414 34925966
Helicobacter gastritis 21.23 11.63 13 28538 1223 34927157
Incontinence 21.17 11.63 25 28526 5822 34922558
Blood urea increased 20.56 11.63 63 28488 30301 34898079
Drug eruption 20.25 11.63 48 28503 19850 34908530
Myocardial rupture 20.15 11.63 7 28544 174 34928206
Oropharyngeal oedema 19.86 11.63 6 28545 94 34928286
Product packaging confusion 19.60 11.63 5 28546 40 34928340
Hyperuricaemia 19.17 11.63 28 28523 8015 34920365
Face oedema 19.11 11.63 34 28517 11482 34916898
Renal artery restenosis 18.91 11.63 4 28547 12 34928368
Anaplastic astrocytoma 18.79 11.63 6 28545 114 34928266
Carotid arteriosclerosis 18.63 11.63 14 28537 1844 34926536
Rhabdomyolysis 18.63 11.63 107 28444 68056 34860324
Pain 18.57 11.63 95 28456 204580 34723800
Diastolic dysfunction 18.33 11.63 24 28527 6203 34922177
Chylothorax 18.16 11.63 10 28541 771 34927609
Diabetes mellitus 18.02 11.63 81 28470 46792 34881588
Arrhythmia 17.81 11.63 67 28484 35741 34892639
Upper respiratory tract inflammation 17.17 11.63 13 28538 1731 34926649
Nodal arrhythmia 17.07 11.63 10 28541 868 34927512
Foetal exposure during pregnancy 16.99 11.63 5 28546 38096 34890284
Postrenal failure 16.93 11.63 8 28543 447 34927933
Anxiety 16.79 11.63 35 28516 99393 34828987
Left ventricle outflow tract obstruction 16.63 11.63 6 28545 167 34928213
Bradyarrhythmia 16.59 11.63 14 28537 2177 34926203
Blood creatinine increased 16.33 11.63 133 28418 94843 34833537
Treatment failure 16.16 11.63 9 28542 46688 34881692
Left ventricular hypertrophy 16.14 11.63 26 28525 8104 34920276
Drug-induced liver injury 16.08 11.63 56 28495 28776 34899604
Blood testosterone free increased 16.03 11.63 4 28547 29 34928351
Sprue-like enteropathy 16.02 11.63 8 28543 505 34927875
Gastric ulcer haemorrhage 15.99 11.63 21 28530 5445 34922935
Pneumonitis chemical 15.96 11.63 6 28545 188 34928192
Left ventricular dysfunction 15.91 11.63 29 28522 9978 34918402
Haemorrhage subcutaneous 15.88 11.63 14 28537 2310 34926070
Pericoronitis 15.80 11.63 3 28548 4 34928376
Drug hypersensitivity 15.67 11.63 26 28525 80503 34847877
Renal artery arteriosclerosis 15.57 11.63 4 28547 33 34928347
Product use in unapproved indication 15.46 11.63 47 28504 117452 34810928
Tender joint count increased 15.42 11.63 6 28545 207 34928173
Ejection fraction decreased 15.14 11.63 42 28509 19112 34909268
Gastric ulcer 15.12 11.63 37 28514 15613 34912767
Lens dislocation 15.10 11.63 5 28546 107 34928273
Hypertensive crisis 14.73 11.63 26 28525 8725 34919655
Aortic valve incompetence 14.72 11.63 21 28530 5883 34922497
Gastric cancer 14.67 11.63 22 28529 6447 34921933
Cerebral haemorrhage 14.67 11.63 62 28489 34875 34893505
Tubulointerstitial nephritis 14.59 11.63 44 28507 20980 34907400
Bulbar palsy 14.51 11.63 6 28545 243 34928137
Decreased appetite 14.44 11.63 203 28348 166189 34762191
Blindness transient 14.39 11.63 13 28538 2213 34926167
Cardiomegaly 14.39 11.63 36 28515 15402 34912978
Neuropathy peripheral 14.32 11.63 29 28522 83234 34845146
Hypocalcaemia 14.27 11.63 48 28503 24241 34904139
Haemorrhagic transformation stroke 14.22 11.63 11 28540 1512 34926868
Coronary artery stenosis 14.20 11.63 27 28524 9589 34918791
Swollen joint count increased 14.17 11.63 6 28545 258 34928122
Blood pressure systolic increased 14.05 11.63 46 28505 22906 34905474
Systolic dysfunction 14.05 11.63 14 28537 2694 34925686
Prostatism 14 11.63 6 28545 266 34928114
Progesterone increased 13.94 11.63 3 28548 10 34928370
Pharyngitis 13.89 11.63 24 28527 7920 34920460
Pemphigoid 13.63 11.63 25 28526 8641 34919739
Blood cholinesterase decreased 13.57 11.63 5 28546 148 34928232
Sinus node dysfunction 13.49 11.63 17 28534 4232 34924148
Blood thyroid stimulating hormone increased 13.47 11.63 17 28534 4238 34924142
Ventricular tachycardia 13.44 11.63 50 28501 26529 34901851
Hospitalisation 13.43 11.63 16 28535 56886 34871494
Dissociation 13.40 11.63 11 28540 1647 34926733
Hepatitis acute 13.34 11.63 23 28528 7578 34920802
Calculus bladder 13.32 11.63 9 28542 1003 34927377
Febrile neutropenia 13.28 11.63 62 28489 136787 34791593
Target skin lesion 13.14 11.63 3 28548 14 34928366
Congenital brain damage 12.97 11.63 3 28548 15 34928365
Jaundice 12.94 11.63 56 28495 31826 34896554
Diverticulum intestinal haemorrhagic 12.93 11.63 13 28538 2529 34925851
Alkalosis hypochloraemic 12.85 11.63 6 28545 326 34928054
Vitamin B12 deficiency 12.59 11.63 16 28535 4015 34924365
Acute myocardial infarction 12.56 11.63 81 28470 53638 34874742
Dizziness 12.48 11.63 249 28302 218272 34710108
Colon cancer 12.48 11.63 24 28527 8597 34919783
Trigemino-cardiac reflex 12.44 11.63 5 28546 188 34928192
Electrocardiogram QRS complex shortened 12.44 11.63 5 28546 188 34928192
Hypertonic bladder 12.28 11.63 11 28540 1853 34926527
Blood pressure abnormal 12.27 11.63 23 28528 8083 34920297
Choroidal haemorrhage 12.24 11.63 4 28547 82 34928298
Angiopathy 12.15 11.63 16 28535 4157 34924223
Bradycardia 12.10 11.63 104 28447 75314 34853066
Melaena 12.03 11.63 59 28492 35321 34893059
Coronary artery disease 12.02 11.63 74 28477 48231 34880149
Ocular pemphigoid 11.85 11.63 4 28547 91 34928289
Transient aphasia 11.72 11.63 6 28545 399 34927981
Agitation 11.67 11.63 18 28533 57381 34870999

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
Cerebral infarction 153.84 10.19 184 62043 45492 79636669
Hyponatraemia 151.22 10.19 389 61838 177459 79504702
Completed suicide 118.13 10.19 24 62203 245743 79436418
Blood pressure increased 114.46 10.19 394 61833 210966 79471195
Hepatic function abnormal 91.01 10.19 186 62041 72921 79609240
Death 85.52 10.19 198 62029 566316 79115845
Altered state of consciousness 83.29 10.19 134 62093 43688 79638473
Interstitial lung disease 83.24 10.19 234 61993 112366 79569795
Hypertensive crisis 82.26 10.19 91 62136 20679 79661482
Hyperkalaemia 80.94 10.19 234 61993 114164 79567997
Acute kidney injury 76.74 10.19 678 61549 518726 79163435
Bradycardia 75.34 10.19 255 61972 135302 79546859
Chronic kidney disease 74.99 10.19 162 62065 65992 79616169
Cardiac failure 73.01 10.19 276 61951 154566 79527595
Blood pressure systolic increased 72.49 10.19 161 62066 66825 79615336
Renal impairment 70.10 10.19 276 61951 157507 79524654
Hypoglycaemia 69.17 10.19 205 62022 101389 79580772
Lactic acidosis 66.13 10.19 160 62067 70199 79611962
Off label use 65.70 10.19 427 61800 906788 78775373
Pulmonary valve disease 59.93 10.19 18 62209 290 79681871
Blood pressure decreased 58.71 10.19 191 62036 99275 79582886
Maternal exposure during pregnancy 56.60 10.19 18 62209 136520 79545641
Pericardial disease 55.99 10.19 20 62207 567 79681594
Endometriosis 55.50 10.19 35 62192 3633 79678528
Diabetic nephropathy 54.56 10.19 32 62195 2915 79679246
Product dose omission issue 54.29 10.19 68 62159 247469 79434692
Labile hypertension 53.48 10.19 19 62208 530 79681631
Blood creatine phosphokinase increased 51.45 10.19 140 62087 65950 79616211
Alopecia 50.27 10.19 64 62163 231291 79450870
Pemphigus 49.34 10.19 9 62218 99573 79582588
Carcinoid tumour pulmonary 47.95 10.19 16 62211 368 79681793
Physical examination abnormal 47.20 10.19 15 62212 294 79681867
Glaucoma 46.87 10.19 67 62160 19694 79662467
Isosthenuria 46.04 10.19 12 62215 111 79682050
Product packaging confusion 45.64 10.19 14 62213 243 79681918
Hemiplegia 45.14 10.19 57 62170 14882 79667279
Anti-cyclic citrullinated peptide antibody positive 44.62 10.19 6 62221 83137 79599024
Fall 44.04 10.19 577 61650 487052 79195109
Rhabdomyolysis 43.85 10.19 178 62049 102953 79579208
Drug specific antibody 42.09 10.19 26 62201 2602 79679559
Listless 41.97 10.19 30 62197 3831 79678330
Carotid arteriosclerosis 41.84 10.19 26 62201 2630 79679531
Head discomfort 41.72 10.19 54 62173 14448 79667713
Drug eruption 40.30 10.19 99 62128 43836 79638325
Toxicity to various agents 39.99 10.19 181 62046 421359 79260802
Neutropenia 39.83 10.19 105 62122 287605 79394556
Pain 39.60 10.19 355 61872 703447 78978714
Drug ineffective 38.57 10.19 603 61624 1080310 78601851
Growth hormone deficiency 38.54 10.19 14 62213 417 79681744
Arthritis 38.03 10.19 184 62043 114696 79567465
Pericarditis 36.22 10.19 18 62209 104218 79577943
Infusion site streaking 35.77 10.19 14 62213 514 79681647
Glossodynia 35.68 10.19 18 62209 103319 79578842
Oliguria 35.35 10.19 53 62174 16256 79665905
Abdominal discomfort 35.08 10.19 91 62136 250636 79431525
Postprandial hypoglycaemia 35.05 10.19 9 62218 78 79682083
Platelet distribution width increased 34.93 10.19 10 62217 135 79682026
Product use in unapproved indication 34.93 10.19 91 62136 250268 79431893
Electrocardiogram PR shortened 34.90 10.19 12 62215 303 79681858
Irritable bowel syndrome 34.60 10.19 4 62223 62237 79619924
Creatinine renal clearance increased 34.50 10.19 16 62211 897 79681264
Affect lability 34.08 10.19 43 62184 11216 79670945
Pyelitis 33.90 10.19 12 62215 331 79681830
Blood creatinine increased 33.82 10.19 222 62005 154835 79527326
Administration site abscess 33.66 10.19 7 62220 20 79682141
Infection 33.61 10.19 88 62139 241624 79440537
Electrocardiogram Q wave abnormal 33.38 10.19 14 62213 616 79681545
Hypertension 32.97 10.19 399 61828 330593 79351568
Dyslalia 32.06 10.19 16 62211 1056 79681105
Breath sounds abnormal 31.91 10.19 50 62177 15934 79666227
Administration site discharge 31.85 10.19 7 62220 28 79682133
Carotid artery thrombosis 31.54 10.19 23 62204 3030 79679131
Administration site induration 31.28 10.19 7 62220 31 79682130
Reduced facial expression 31.25 10.19 22 62205 2743 79679418
Liver disorder 30.79 10.19 125 62102 72292 79609869
Blood pressure abnormal 30.58 10.19 51 62176 17118 79665043
Administration site odour 30.42 10.19 7 62220 36 79682125
Neurologic neglect syndrome 30.26 10.19 22 62205 2885 79679276
Haematuria 30.21 10.19 120 62107 68716 79613445
Exposure during pregnancy 30.14 10.19 21 62206 101111 79581050
Sleep apnoea syndrome 30.13 10.19 79 62148 36399 79645762
Hepatojugular reflux 29.72 10.19 13 62214 635 79681526
Pemphigoid 29.32 10.19 47 62180 15268 79666893
Inappropriate antidiuretic hormone secretion 29.31 10.19 64 62163 26249 79655912
Fatigue 29.08 10.19 531 61696 929196 78752965
Cerebral haemorrhage 28.99 10.19 105 62122 57568 79624593
Atrial fibrillation 28.42 10.19 257 61970 197629 79484532
Disease progression 28.08 10.19 64 62163 184298 79497863
Systemic lupus erythematosus 27.90 10.19 32 62195 121117 79561044
Loss of consciousness 27.74 10.19 225 62002 167718 79514443
Myalgia 27.64 10.19 243 61984 185398 79496763
Folliculitis 27.44 10.19 5 62222 55375 79626786
Blood thyroid stimulating hormone normal 27.35 10.19 8 62219 117 79682044
C-reactive protein abnormal 27.16 10.19 3 62224 48364 79633797
Stenosis 26.74 10.19 19 62208 2403 79679758
Arterial occlusive disease 26.72 10.19 33 62194 8423 79673738
Administration site haemorrhage 26.55 10.19 7 62220 68 79682093
Atrioventricular block complete 26.52 10.19 47 62180 16563 79665598
Impaired healing 26.39 10.19 18 62209 87637 79594524
Bladder hypertrophy 26.32 10.19 12 62215 647 79681514
Diabetes mellitus 26.25 10.19 126 62101 78264 79603897
Blood pressure inadequately controlled 26.09 10.19 28 62199 6149 79676012
Drug abuse 25.99 10.19 55 62172 162636 79519525
White blood cell count abnormal 25.97 10.19 27 62200 5718 79676443
Swelling 25.69 10.19 85 62142 216626 79465535
Hand deformity 25.54 10.19 26 62201 103893 79578268
Endophthalmitis 25.17 10.19 28 62199 6400 79675761
Staphylococcus test positive 24.98 10.19 28 62199 6453 79675708
Muscle injury 24.91 10.19 4 62223 48557 79633604
Therapeutic product effect decreased 24.86 10.19 57 62170 163806 79518355
Injection site cyst 24.69 10.19 7 62220 91 79682070
Hypersensitivity 24.60 10.19 113 62114 262126 79420035
IgA nephropathy 24.59 10.19 16 62211 1752 79680409
Haemoglobin increased 24.51 10.19 27 62200 6105 79676056
Narrow anterior chamber angle 24.39 10.19 8 62219 174 79681987
Bundle branch block left 24.36 10.19 37 62190 11476 79670685
Haemorrhage subcutaneous 24.29 10.19 24 62203 4785 79677376
Hypertensive angiopathy 24.02 10.19 7 62220 101 79682060
Drug interaction 23.99 10.19 456 61771 414727 79267434
Labelled drug-drug interaction medication error 23.99 10.19 61 62166 27589 79654572
Arrhythmia 23.88 10.19 103 62124 61169 79620992
Cardiac discomfort 23.88 10.19 14 62213 1274 79680887
Febrile neutropenia 23.83 10.19 96 62131 230903 79451258
Gastric pH increased 23.37 10.19 6 62221 52 79682109
Tender joint count 23.31 10.19 8 62219 201 79681960
Granuloma skin 23.08 10.19 32 62195 9142 79673019
Accident at work 22.81 10.19 13 62214 1122 79681039
Helicobacter infection 22.80 10.19 13 62214 69691 79612470
Urinary retention 22.69 10.19 96 62131 56534 79625627
Rales 22.68 10.19 49 62178 19952 79662209
Blood parathyroid hormone decreased 22.49 10.19 34 62193 10502 79671659
Apathy 22.39 10.19 38 62189 12939 79669222
Daydreaming 22.36 10.19 12 62215 921 79681240
Carbohydrate antigen 15-3 increased 22.35 10.19 13 62214 1166 79680995
Product monitoring error 22.31 10.19 31 62196 8875 79673286
Joint noise 22.27 10.19 21 62206 3953 79678208
Blood urea increased 22.17 10.19 86 62141 48704 79633457
Duodenal ulcer perforation 22.16 10.19 12 62215 66199 79615962
Bradyarrhythmia 21.52 10.19 21 62206 4125 79678036
Porphyrins urine increased 21.22 10.19 5 62222 29 79682132
Vertigo 20.98 10.19 108 62119 68974 79613187
Left ventricular hypertrophy 20.95 10.19 34 62193 11157 79671004
Menopausal symptoms 20.76 10.19 15 62212 1948 79680213
Buttock injury 20.70 10.19 7 62220 168 79681993
Cardiomegaly 20.68 10.19 56 62171 26296 79655865
Hypokalaemia 20.64 10.19 187 62040 143853 79538308
Drug resistance 20.51 10.19 4 62223 42209 79639952
Serotonin syndrome 20.39 10.19 5 62222 45022 79637139
Hyperaldosteronism 20.36 10.19 9 62218 451 79681710
Scoliosis 20.24 10.19 27 62200 7437 79674724
Acquired porphyria 20.17 10.19 5 62222 37 79682124
Hypotension 20.03 10.19 467 61760 439850 79242311
Arthropathy 19.95 10.19 71 62156 177040 79505121
Mitral valve incompetence 19.77 10.19 58 62169 28507 79653654
Carotid artery stenosis 19.75 10.19 29 62198 8729 79673432
Panniculitis 19.74 10.19 35 62192 12336 79669825
Ventricular arrhythmia 19.55 10.19 29 62198 8811 79673350
Porphyrins stool increased 19.41 10.19 5 62222 44 79682117
Agitation 19.24 10.19 30 62197 99685 79582476
Carcinoembryonic antigen increased 19.18 10.19 15 62212 2194 79679967
Dyspnoea at rest 19.17 10.19 26 62201 7276 79674885
Asthma 19.16 10.19 175 62052 134920 79547241
Product used for unknown indication 19.13 10.19 13 62214 1531 79680630
Hypoglycaemic coma 19.10 10.19 21 62206 4739 79677422
Renal artery restenosis 19.09 10.19 4 62223 12 79682149
Gastric ulcer haemorrhage 19.09 10.19 29 62198 8998 79673163
Syncope 19.02 10.19 219 62008 179230 79502931
Albuminuria 18.98 10.19 10 62217 739 79681422
Product substitution issue 18.95 10.19 46 62181 20210 79661951
Labile blood pressure 18.92 10.19 15 62212 2238 79679923
Dizziness 18.88 10.19 541 61686 525900 79156261
Osteocalcin decreased 18.83 10.19 5 62222 50 79682111
Staring 18.83 10.19 16 62211 2629 79679532
Psoriasis 18.76 10.19 127 62100 89460 79592701
Non-small cell lung cancer recurrent 18.67 10.19 6 62221 122 79682039
Sprue-like enteropathy 18.51 10.19 12 62215 1306 79680855
Ureteral disorder 18.47 10.19 9 62218 564 79681597
Drug-induced liver injury 18.46 10.19 101 62126 66016 79616145
Diverticulum intestinal haemorrhagic 18.40 10.19 19 62208 3992 79678169
Muscle atrophy 18.21 10.19 32 62195 11200 79670961
Renal tubular acidosis 18.19 10.19 18 62209 3596 79678565
Renal failure 18.16 10.19 238 61989 200730 79481431
Mitral valve disease 18.12 10.19 17 62210 3180 79678981
Prescription drug used without a prescription 18.11 10.19 19 62208 4066 79678095
Skin necrosis 17.92 10.19 42 62185 18045 79664116
Occult blood 17.84 10.19 13 62214 1710 79680451
Urine calcium/creatinine ratio increased 17.82 10.19 6 62221 142 79682019
Suicidal ideation 17.75 10.19 20 62207 76320 79605841
Bronchiolitis 17.72 10.19 19 62208 4169 79677992
Hypercalcaemia 17.67 10.19 68 62159 38362 79643799
Melaena 17.66 10.19 94 62133 60796 79621365
Drug ineffective for unapproved indication 17.57 10.19 9 62218 51229 79630932
Thalamus haemorrhage 17.45 10.19 13 62214 1769 79680392
Gouty arthritis 17.39 10.19 12 62215 1449 79680712
Fibromyalgia 17.10 10.19 15 62212 64325 79617836
Urethral caruncle 17.04 10.19 5 62222 74 79682087
Skin dystrophy 17.04 10.19 5 62222 74 79682087
Echocardiogram abnormal 16.94 10.19 14 62213 2214 79679947
Anaplastic astrocytoma 16.94 10.19 6 62221 166 79681995
Renal function test abnormal 16.60 10.19 20 62207 4978 79677183
Stomatitis 16.42 10.19 59 62168 146698 79535463
Mucosal inflammation 16.30 10.19 21 62206 75559 79606602
Treatment failure 16.25 10.19 73 62154 170413 79511748
Drug tolerance decreased 16.11 10.19 33 62194 12945 79669216
Neurotoxicity 15.97 10.19 3 62224 32515 79649646
Colon cancer 15.81 10.19 35 62192 14488 79667673
Helicobacter gastritis 15.79 10.19 14 62213 2435 79679726
Angina pectoris 15.79 10.19 81 62146 51651 79630510
Carcinoid tumour 15.74 10.19 8 62219 549 79681612
Rash 15.70 10.19 338 61889 578020 79104141
Face oedema 15.67 10.19 53 62174 28083 79654078
Foreign body 15.66 10.19 15 62212 2879 79679282
Tricuspid valve incompetence 15.58 10.19 42 62185 19670 79662491
Pulse abnormal 15.47 10.19 16 62211 3368 79678793
Insulin-like growth factor decreased 15.37 10.19 8 62219 577 79681584
Sinus congestion 15.33 10.19 42 62185 19854 79662307
Breast cancer recurrent 15.30 10.19 15 62212 2962 79679199
Toxic epidermal necrolysis 15.17 10.19 72 62155 44509 79637652
HLA-B*27 positive 15.15 10.19 5 62222 111 79682050
Gangrene 15.13 10.19 26 62201 8938 79673223
Hospitalisation 14.92 10.19 32 62195 94204 79587957
Upper respiratory tract inflammation 14.82 10.19 17 62210 4018 79678143
Personality disorder 14.81 10.19 21 62206 6125 79676036
Vascular purpura 14.80 10.19 15 62212 3083 79679078
Chronic gastritis 14.70 10.19 17 62210 4051 79678110
Cardiac failure chronic 14.64 10.19 29 62198 11106 79671055
Myocardial rupture 14.64 10.19 6 62221 249 79681912
Intentional product use issue 14.58 10.19 65 62162 152047 79530114
Cytokine release syndrome 14.47 10.19 5 62222 35993 79646168
Product use issue 14.46 10.19 100 62127 209722 79472439
Petit mal epilepsy 14.44 10.19 20 62207 5707 79676454
Coronary artery disease 14.42 10.19 94 62133 65380 79616781
Hyperlipidaemia 14.40 10.19 49 62178 26044 79656117
Neuropathy peripheral 14.39 10.19 59 62168 141246 79540915
Injection site bruising 14.36 10.19 7 62220 40995 79641166
Paralysis recurrent laryngeal nerve 14.33 10.19 5 62222 132 79682029
Blood pressure diastolic decreased 14.33 10.19 54 62173 30162 79651999
Renal artery arteriosclerosis 14.33 10.19 4 62223 49 79682112
Electrocardiogram PR prolongation 14.29 10.19 11 62216 1572 79680589
Postrenal failure 14.27 10.19 8 62219 669 79681492
Dementia 14.22 10.19 47 62180 24612 79657549
Bulbar palsy 14.22 10.19 6 62221 268 79681893
Drug level increased 14.20 10.19 65 62162 39586 79642575
Glycosylated haemoglobin increased 14.19 10.19 40 62187 19220 79662941
Nodal arrhythmia 14.16 10.19 12 62215 1966 79680195
Blood cholinesterase decreased 14.08 10.19 6 62221 275 79681886
Tender joint count increased 14.05 10.19 6 62221 276 79681885
Accelerated hypertension 14.00 10.19 8 62219 694 79681467
Blood pressure fluctuation 13.94 10.19 95 62132 67050 79615111
Clubbing 13.86 10.19 8 62219 707 79681454
Cystitis 13.69 10.19 79 62148 52653 79629508
Hypertensive nephropathy 13.67 10.19 9 62218 1005 79681156
Psoriatic arthropathy 13.63 10.19 25 62202 77974 79604187
Palpitations 13.63 10.19 155 62072 126455 79555706
Blood potassium increased 13.62 10.19 52 62175 29223 79652938
Lens dislocation 13.58 10.19 5 62222 155 79682006
Hyperuricaemia 13.48 10.19 29 62198 11770 79670391
Hypokinesia 13.47 10.19 39 62188 19021 79663140
Wound 13.47 10.19 46 62181 116133 79566028
Calculus bladder 13.42 10.19 10 62217 1362 79680799
Drug hypersensitivity 13.37 10.19 159 62068 298757 79383404
Anaemia macrocytic 13.30 10.19 19 62208 5578 79676583
Acute myocardial infarction 13.14 10.19 104 62123 76932 79605229
Memory impairment 13.11 10.19 44 62183 111690 79570471
Dehydration 13.10 10.19 269 61958 247918 79434243
Bite 13.04 10.19 7 62220 537 79681624
Hypersensitivity vasculitis 12.87 10.19 21 62206 6922 79675239
Respiratory distress 12.80 10.19 16 62211 58323 79623838
Drug intolerance 12.79 10.19 138 62089 263981 79418180
Aortic dissection 12.72 10.19 16 62211 4159 79678002
Peripheral arterial occlusive disease 12.71 10.19 23 62204 8235 79673926
Delirium 12.70 10.19 111 62116 84516 79597645
Pancreatitis acute 12.67 10.19 74 62153 49530 79632631
Respiratory depression 12.65 10.19 3 62224 27627 79654534
Sinusitis 12.59 10.19 95 62132 195406 79486755
C-reactive protein increased 12.58 10.19 155 62072 128872 79553289
Tubulointerstitial nephritis 12.47 10.19 61 62166 38174 79643987
Retinal infarction 12.35 10.19 5 62222 201 79681960
Gamma-glutamyltransferase increased 12.34 10.19 79 62148 54601 79627560
Injection site paraesthesia 12.31 10.19 7 62220 602 79681559
Leukopenia 12.27 10.19 48 62179 116465 79565696
Multiple sclerosis relapse 12.18 10.19 11 62216 46522 79635639
Mental status changes 12.12 10.19 21 62206 66938 79615223
Liver injury 11.93 10.19 16 62211 56598 79625563
Knee deformity 11.75 10.19 9 62218 1276 79680885
Basal cell carcinoma 11.74 10.19 59 62168 37316 79644845
Diastolic dysfunction 11.70 10.19 26 62201 10785 79671376
Gastric cancer 11.61 10.19 25 62202 10154 79672007
Oropharyngeal oedema 11.43 10.19 6 62221 440 79681721
Rheumatic fever 11.40 10.19 4 62223 28521 79653640
Jaundice 11.39 10.19 76 62151 53273 79628888
Orthostatic hypotension 11.38 10.19 79 62148 56085 79626076
Lower respiratory tract infection 11.34 10.19 57 62170 129163 79552998
Haemophilia 11.31 10.19 4 62223 110 79682051
Bile duct cancer 11.23 10.19 8 62219 1016 79681145
Sinus arrest 11.23 10.19 14 62213 3608 79678553
Joint range of motion decreased 11.18 10.19 6 62221 33276 79648885
Guttate psoriasis 11.17 10.19 6 62221 461 79681700
Thyroid disorder 11.13 10.19 30 62197 14049 79668112
Pneumonitis chemical 11.11 10.19 6 62221 466 79681695
Trigemino-cardiac reflex 11.06 10.19 5 62222 264 79681897
Transient aphasia 11.02 10.19 6 62221 474 79681687
Porphyria non-acute 10.97 10.19 7 62220 742 79681419
Depressed mood 10.95 10.19 13 62214 48467 79633694
Hyperglycaemia 10.94 10.19 93 62134 70242 79611919
Coordination abnormal 10.89 10.19 34 62193 17278 79664883
Spinal epidural haematoma 10.89 10.19 9 62218 1423 79680738
Alkalosis hypochloraemic 10.74 10.19 6 62221 498 79681663
Muscle twitching 10.74 10.19 3 62224 24761 79657400
Systolic dysfunction 10.71 10.19 14 62213 3781 79678380
Gastrointestinal disorder 10.67 10.19 54 62173 122151 79560010
Pelvic fracture 10.66 10.19 27 62200 12177 79669984
Blood pressure diastolic abnormal 10.54 10.19 36 62191 19166 79662995
Hyperplasia adrenal 10.51 10.19 3 62224 40 79682121
Erythema multiforme 10.50 10.19 34 62193 17617 79664544
Device issue 10.49 10.19 4 62223 27104 79655057
Bile duct stone 10.49 10.19 17 62210 5572 79676589
Neutropenic sepsis 10.47 10.19 4 62223 27060 79655101
Unevaluable event 10.46 10.19 17 62210 55568 79626593
COVID-19 10.44 10.19 76 62151 157598 79524563
Knee arthroplasty 10.42 10.19 11 62216 43237 79638924
Aortic valve incompetence 10.41 10.19 23 62204 9507 79672654
Diabetes mellitus inadequate control 10.40 10.19 42 62185 24222 79657939
Abortion spontaneous 10.39 10.19 5 62222 29502 79652659
Immobilisation syndrome 10.38 10.19 6 62221 532 79681629
Dihydrotestosterone increased 10.38 10.19 3 62224 42 79682119
Anaemia 10.32 10.19 435 61792 444580 79237581
Glomerular filtration rate decreased 10.30 10.19 40 62187 22662 79659499
Coronary artery stenosis 10.27 10.19 27 62200 12457 79669704
Platelet count decreased 10.27 10.19 211 62016 194453 79487708
Hypercreatinaemia 10.26 10.19 5 62222 313 79681848
Cerebellar haemorrhage 10.22 10.19 12 62215 2908 79679253
Immobile 10.20 10.19 19 62208 6954 79675207

FDA Adverse Event Reporting System (Pediatric)

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
Renal vein thrombosis 23.65 20.13 3 11 0 89778

Pharmacologic Action:

SourceCodeDescription
ATC C09CA07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
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 C09DX08 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
MeSH PA D057911 Angiotensin Receptor Antagonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
CHEBI has role CHEBI:35457 ACE inhibitor
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:61016 angiotensin receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Cerebrovascular accident indication 230690007
Disorder due to type 2 diabetes mellitus indication 422014003
History of myocardial infarction due to atherothrombotic coronary artery disease indication 387786000000000000
Myocardial Infarction Prevention indication
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Diabetic renal disease off-label use 127013003
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
Obstruction of bile duct contraindication 30144000
Cholestasis contraindication 33688009 DOID:13580
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Third trimester pregnancy contraindication 41587001
Severe renal impairment contraindication 42399005 DOID:1074
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Second trimester pregnancy contraindication 59466002
Hepatic failure contraindication 59927004
Severe hepatic impairment 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
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Systemic hypertension Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Semintra Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.65 acidic
pKa2 5.79 Basic
pKa3 5.13 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 9.31 CHEMBL CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 4.77 CHEMBL
Glycine receptor subunit alpha-1 Ion channel EC50 5.49 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor EC50 5.82 CHEMBL
Type-2 angiotensin II receptor GPCR IC50 9.48 CHEMBL
Angiotensin-converting enzyme Enzyme Ki 5.22 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 4.75 CHEMBL
Type-1B angiotensin II receptor GPCR IC50 8.52 CHEMBL
Type-1A angiotensin II receptor GPCR Ki 9.64 CHEMBL

External reference:

IDSource
4021146 VUID
N0000148599 NUI
D00627 KEGG_DRUG
4021146 VANDF
C0248719 UMLSCUI
CHEBI:9434 CHEBI
TLS PDB_CHEM_ID
CHEMBL1017 ChEMBL_ID
D000077333 MESH_DESCRIPTOR_UI
DB00966 DRUGBANK_ID
592 IUPHAR_LIGAND_ID
7144 INN_ID
U5SYW473RQ UNII
65999 PUBCHEM_CID
218353 RXNORM
13913 MMSL
53287 MMSL
7789 MMSL
d04364 MMSL
007683 NDDF
129487008 SNOMEDCT_US
387069000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
telmisartan and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0545 TABLET 40 mg ORAL NDA authorized generic 27 sections
telmisartan and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0546 TABLET 80 mg ORAL NDA authorized generic 27 sections
telmisartan and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0054-0547 TABLET 80 mg ORAL NDA authorized generic 27 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1075 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1076 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1077 TABLET 80 mg ORAL ANDA 28 sections
Telmisartan and Amlodipine HUMAN PRESCRIPTION DRUG LABEL 2 0378-1078 TABLET 80 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2920 TABLET 20 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2920 TABLET 20 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2921 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2921 TABLET 40 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2922 TABLET 80 mg ORAL ANDA 28 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-2922 TABLET 80 mg ORAL ANDA 28 sections
Micardis HUMAN PRESCRIPTION DRUG LABEL 1 0597-0039 TABLET 20 mg ORAL NDA 26 sections
Micardis HUMAN PRESCRIPTION DRUG LABEL 1 0597-0039 TABLET 20 mg ORAL NDA 26 sections
Micardis HUMAN PRESCRIPTION DRUG LABEL 1 0597-0040 TABLET 40 mg ORAL NDA 26 sections
Micardis HUMAN PRESCRIPTION DRUG LABEL 1 0597-0040 TABLET 40 mg ORAL NDA 26 sections
Micardis HUMAN PRESCRIPTION DRUG LABEL 1 0597-0041 TABLET 80 mg ORAL NDA 26 sections
Micardis HUMAN PRESCRIPTION DRUG LABEL 1 0597-0041 TABLET 80 mg ORAL NDA 26 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0042 TABLET 80 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0042 TABLET 80 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0043 TABLET 40 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0043 TABLET 40 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0044 TABLET 80 mg ORAL NDA 30 sections
Micardis HCT HUMAN PRESCRIPTION DRUG LABEL 2 0597-0044 TABLET 80 mg ORAL NDA 30 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0781-5372 TABLET 20 mg ORAL ANDA 26 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0781-5374 TABLET 40 mg ORAL ANDA 26 sections
Telmisartan HUMAN PRESCRIPTION DRUG LABEL 1 0781-5378 TABLET 80 mg ORAL ANDA 26 sections
TELMISARTAN HUMAN PRESCRIPTION DRUG LABEL 1 13668-156 TABLET 20 mg ORAL ANDA 18 sections
TELMISARTAN HUMAN PRESCRIPTION DRUG LABEL 1 13668-156 TABLET 20 mg ORAL ANDA 18 sections