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

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 2806 137862-53-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diovan
  • cardopan
  • valsartanin
  • valsartan
  • CGP 48933
  • CGP-48933
A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.
  • Molecular weight: 435.53
  • Formula: C24H29N5O3
  • CLOGP: 4.86
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 112.07
  • ALOGS: -4.28
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
80 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.18 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 13 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.50 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 23 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.49 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 1996 FDA

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
Hypotension 503.80 9.84 1678 137230 230911 46316243
Blood pressure increased 353.14 9.84 999 137909 125667 46421487
Blood pressure inadequately controlled 344.66 9.84 195 138713 4211 46542943
Cardiac failure 325.05 9.84 728 138180 79220 46467934
Completed suicide 272.34 9.84 52 138856 145868 46401286
Hyponatraemia 243.06 9.84 758 138150 100574 46446580
Dizziness 240.91 9.84 1784 137124 338630 46208524
Hypertension 222.43 9.84 1162 137746 195194 46351960
Hyperkalaemia 204.01 9.84 460 138448 50249 46496905
Rheumatoid arthritis 189.53 9.84 263 138645 239952 46307202
Product prescribing error 188.50 9.84 264 138644 19783 46527371
Blood pressure decreased 183.28 9.84 475 138433 56684 46490470
Off label use 174.61 9.84 565 138343 379276 46167878
Myocardial infarction 169.73 9.84 656 138252 96872 46450282
Wrong technique in product usage process 169.11 9.84 447 138461 53975 46493179
Acute kidney injury 153.54 9.84 1213 137695 234642 46312512
Toxicity to various agents 149.51 9.84 250 138658 211516 46335638
Blood creatinine increased 146.30 9.84 530 138378 75873 46471281
Diabetes mellitus 127.84 9.84 383 138525 49682 46497472
Angioedema 127.17 9.84 328 138580 39014 46508140
Cardiac failure congestive 119.27 9.84 565 138343 91185 46455969
Oligohydramnios 114.68 9.84 109 138799 5356 46541798
Cardiac failure chronic 113.99 9.84 90 138818 3434 46543720
Atrial fibrillation 104.88 9.84 595 138313 102995 46444159
Oedema peripheral 104.66 9.84 823 138085 158883 46388271
Cerebrovascular accident 102.72 9.84 581 138327 100458 46446696
Drug ineffective 102.03 9.84 1414 137494 676424 45870730
Hypertensive crisis 101.72 9.84 161 138747 13454 46533700
Blood potassium increased 99.38 9.84 180 138728 16787 46530367
Drug hypersensitivity 98.88 9.84 382 138526 243443 46303711
Infusion related reaction 97.85 9.84 94 138814 101114 46446040
Renal failure 97.50 9.84 625 138283 112969 46434185
Cerebral infarction 93.96 9.84 212 138696 23154 46524000
Pemphigus 91.36 9.84 13 138895 45261 46501893
Syncope 88.93 9.84 575 138333 104228 46442926
Cough 87.83 9.84 1059 137849 229190 46317964
Exposure during pregnancy 86.68 9.84 117 138791 108095 46439059
Treatment failure 83.70 9.84 92 138816 92995 46454159
Maternal exposure during pregnancy 83.03 9.84 110 138798 102439 46444715
Dyspnoea 82.37 9.84 2060 136848 513488 46033666
Renal impairment 79.79 9.84 434 138474 73938 46473216
Colitis microscopic 79.72 9.84 98 138810 6458 46540696
Coronary artery disease 79.43 9.84 251 138657 33501 46513653
Blood glucose increased 79.13 9.84 423 138485 71590 46475564
Glaucoma 78.54 9.84 157 138751 15764 46531390
Pain 76.60 9.84 981 137927 475967 46071187
Angina pectoris 76.21 9.84 213 138695 26562 46520592
Drug abuse 73.67 9.84 49 138859 63359 46483795
Neutropenia 72.75 9.84 203 138705 143001 46404153
Glossodynia 72.46 9.84 21 138887 44352 46502802
Glomerular filtration rate decreased 69.68 9.84 125 138783 11569 46535585
Hand deformity 69.59 9.84 10 138898 34564 46512590
Ejection fraction decreased 67.99 9.84 159 138749 17778 46529376
Blood urea increased 66.64 9.84 196 138712 25156 46521998
Febrile neutropenia 66.41 9.84 112 138796 94515 46452639
Arrhythmia 64.37 9.84 239 138669 34602 46512552
Abortion spontaneous 63.71 9.84 25 138883 43621 46503533
Therapeutic product effect decreased 62.48 9.84 93 138815 82508 46464646
Malaise 60.51 9.84 1349 137559 329883 46217271
Systemic lupus erythematosus 60.16 9.84 63 138845 65117 46482037
Cardiac disorder 55.43 9.84 268 138640 43590 46503564
Injection site pain 55.07 9.84 151 138757 107001 46440153
Blood pressure abnormal 54.98 9.84 116 138792 12101 46535053
Thyroid disorder 54.74 9.84 115 138793 11961 46535193
Condition aggravated 53.87 9.84 468 138440 244584 46302570
Mitral valve incompetence 53.67 9.84 150 138758 18702 46528452
Disease progression 52.88 9.84 121 138787 91179 46455975
Intentional overdose 52.21 9.84 70 138838 64874 46482280
Blood pressure diastolic decreased 50.65 9.84 123 138785 14088 46533066
Fall 50.29 9.84 1308 137600 327789 46219365
Pregnancy 49.87 9.84 10 138898 27127 46520027
Product use issue 49.67 9.84 132 138776 94512 46452642
N-terminal prohormone brain natriuretic peptide increased 49.63 9.84 41 138867 1670 46545484
Feeling abnormal 47.93 9.84 576 138332 124484 46422670
Injection site reaction 47.92 9.84 43 138865 47806 46499348
Injection site erythema 47.82 9.84 93 138815 74334 46472820
Asthenia 47.70 9.84 1237 137671 309838 46237316
Renal disorder 45.94 9.84 179 138729 26507 46520647
Product impurity 44.54 9.84 14 138894 59 46547095
Joint swelling 42.59 9.84 304 138604 165769 46381385
Tachyarrhythmia 42.05 9.84 60 138848 4572 46542582
Infection 41.76 9.84 230 138678 133362 46413792
Diabetes mellitus inadequate control 41.48 9.84 109 138799 13105 46534049
Infarction 41.04 9.84 42 138866 2259 46544895
Recalled product administered 40.95 9.84 18 138890 220 46546934
Arthropathy 40.13 9.84 124 138784 84576 46462578
Hospitalisation 40.03 9.84 80 138828 63305 46483849
Migraine 39.58 9.84 94 138814 69932 46477222
Ejection fraction abnormal 39.35 9.84 24 138884 598 46546556
General physical health deterioration 39.15 9.84 521 138387 115248 46431906
Alopecia 38.92 9.84 303 138605 162111 46385043
Concomitant disease aggravated 38.00 9.84 77 138831 7805 46539349
Pyrexia 37.65 9.84 772 138136 348030 46199124
Pulmonary hypoplasia 37.37 9.84 18 138890 275 46546879
Total lung capacity increased 36.92 9.84 25 138883 749 46546405
Sinusitis 36.53 9.84 231 138677 129537 46417617
Blood uric acid increased 36.07 9.84 53 138855 4148 46543006
Labile hypertension 35.77 9.84 21 138887 487 46546667
Suicidal ideation 35.74 9.84 71 138837 56311 46490843
Chest pain 35.61 9.84 729 138179 175595 46371559
Fear of disease 35.56 9.84 28 138880 1064 46546090
Memory impairment 35.44 9.84 369 138539 76968 46470186
Nervousness 35.26 9.84 173 138735 28302 46518852
Therapeutic product effect incomplete 34.54 9.84 118 138790 78035 46469119
Seizure 34.15 9.84 220 138688 122834 46424320
Gout 33.96 9.84 92 138816 11264 46535890
Musculoskeletal stiffness 33.84 9.84 163 138745 97830 46449324
Macular degeneration 33.10 9.84 69 138839 7136 46540018
Cardiomegaly 32.35 9.84 120 138788 17362 46529792
Multiple sclerosis relapse 32.26 9.84 47 138861 42078 46505076
Basilar artery occlusion 32.24 9.84 13 138895 126 46547028
Nausea 32.15 9.84 1696 137212 685758 45861396
Cardiac failure acute 32.14 9.84 73 138835 8005 46539149
Brain natriuretic peptide increased 32.02 9.84 53 138855 4597 46542557
Injection site swelling 31.87 9.84 44 138864 40283 46506871
Product dose omission issue 31.81 9.84 334 138574 168186 46378968
Arthralgia 30.71 9.84 838 138070 363765 46183389
Inappropriate schedule of product administration 30.64 9.84 312 138596 64701 46482453
Bone marrow failure 30.51 9.84 26 138882 29643 46517511
Psoriatic arthropathy 30.48 9.84 38 138870 36341 46510813
Glycosylated haemoglobin increased 30.43 9.84 86 138822 10790 46536364
Chronic kidney disease 30.31 9.84 217 138691 40654 46506500
Anaphylactic reaction 30.25 9.84 71 138837 53041 46494113
Hypoglycaemia 29.14 9.84 268 138640 54081 46493073
Loss of personal independence in daily activities 29.05 9.84 81 138827 57102 46490052
Pancreatic steatosis 28.98 9.84 24 138884 981 46546173
Drug resistance 28.76 9.84 8 138900 17360 46529794
Ischaemic stroke 28.65 9.84 112 138796 16610 46530544
Diverticulitis 28.43 9.84 182 138726 32857 46514297
Blood sodium decreased 28.34 9.84 134 138774 21592 46525562
Psychotic disorder 28.33 9.84 16 138892 22605 46524549
Blood pressure systolic increased 28.20 9.84 164 138744 28623 46518531
Device dislocation 27.91 9.84 15 138893 21787 46525367
Rheumatoid factor positive 27.82 9.84 13 138895 20448 46526706
Intentional product misuse 27.65 9.84 62 138846 47066 46500088
Vascular resistance pulmonary decreased 27.62 9.84 10 138898 70 46547084
Blood pressure fluctuation 27.62 9.84 170 138738 30278 46516876
Palpitations 27.51 9.84 417 138491 94842 46452312
Cardiovascular disorder 27.18 9.84 89 138819 12098 46535056
Adverse drug reaction 27.15 9.84 57 138851 44305 46502849
Brain stem stroke 26.53 9.84 14 138894 262 46546892
Polyuria 26.42 9.84 63 138845 7132 46540022
Hyperuricaemia 26.30 9.84 49 138859 4668 46542486
Breast cancer 26.22 9.84 228 138680 45290 46501864
Therapeutic drug monitoring analysis not performed 26.21 9.84 17 138891 473 46546681
Cardiogenic shock 25.88 9.84 107 138801 16277 46530877
Transient ischaemic attack 25.70 9.84 185 138723 34718 46512436
Malignant neoplasm progression 25.43 9.84 103 138805 64823 46482331
Lymphatic fistula 24.97 9.84 21 138887 877 46546277
Femoral hernia incarcerated 24.75 9.84 21 138887 888 46546266
Pericarditis 24.56 9.84 21 138887 23906 46523248
Overdose 24.53 9.84 190 138718 101789 46445365
Thrombocytopenia 24.24 9.84 250 138658 126331 46420823
Product contamination chemical 24.10 9.84 5 138903 0 46547154
Throat clearing 23.66 9.84 15 138893 401 46546753
Tricuspid valve incompetence 23.60 9.84 92 138816 13625 46533529
Skin reaction 23.58 9.84 79 138829 10867 46536287
Diverticulum intestinal 23.38 9.84 54 138854 5987 46541167
Device stimulation issue 23.30 9.84 9 138899 77 46547077
Cutaneous lymphoma 23.26 9.84 11 138897 161 46546993
Left-to-right cardiac shunt 23.14 9.84 10 138898 117 46547037
Intentional product use issue 23.10 9.84 80 138828 52700 46494454
Arterial haemorrhage 23.05 9.84 27 138881 1691 46545463
Hypertensive cardiomyopathy 22.67 9.84 12 138896 226 46546928
Antinuclear antibody negative 22.57 9.84 12 138896 228 46546926
Hemiplegia 22.57 9.84 58 138850 6880 46540274
Thrombotic stroke 22.54 9.84 16 138892 518 46546636
Neuropathy peripheral 22.50 9.84 168 138740 90725 46456429
Cytomegalovirus infection 22.48 9.84 13 138895 18131 46529023
Forced expiratory volume decreased 22.43 9.84 48 138860 5056 46542098
Clostridium difficile infection 22.34 9.84 25 138883 25078 46522076
Acute myocardial infarction 22.24 9.84 167 138741 31757 46515397
Atrioventricular block complete 22.02 9.84 61 138847 7566 46539588
Rash 21.54 9.84 855 138053 355657 46191497
Lip swelling 21.30 9.84 139 138769 25256 46521898
Hypochloraemia 21.18 9.84 27 138881 1846 46545308
Acral lentiginous melanoma 21.18 9.84 5 138903 4 46547150
Hepatic cyst 21.15 9.84 45 138863 4721 46542433
Bronchial haemorrhage 21.03 9.84 13 138895 332 46546822
Product odour abnormal 20.74 9.84 21 138887 1115 46546039
Pancytopenia 20.68 9.84 158 138750 84900 46462254
Impaired work ability 20.59 9.84 6 138902 12630 46534524
Renal artery stenosis 20.57 9.84 26 138882 1762 46545392
Therapeutic response decreased 20.54 9.84 63 138845 43082 46504072
Ventricular extrasystoles 20.52 9.84 76 138832 10987 46536167
Angina unstable 20.45 9.84 59 138849 7489 46539665
Caesarean section 20.42 9.84 12 138896 16591 46530563
Status epilepticus 20.41 9.84 8 138900 13971 46533183
Urine albumin/creatinine ratio increased 20.29 9.84 10 138898 161 46546993
Transitional cell cancer of the renal pelvis and ureter 20.18 9.84 5 138903 6 46547148
Therapy cessation 20.11 9.84 30 138878 26599 46520555
Orthopnoea 20.00 9.84 50 138858 5830 46541324
Metastatic bronchial carcinoma 19.98 9.84 9 138899 117 46547037
Device issue 19.95 9.84 18 138890 19962 46527192
Cardio-respiratory arrest 19.85 9.84 101 138807 59768 46487386
Hypokalaemia 19.79 9.84 370 138538 87654 46459500
Gastritis haemorrhagic 19.75 9.84 22 138886 1304 46545850
N-terminal prohormone brain natriuretic peptide abnormal 19.71 9.84 7 138901 46 46547108
Ischaemic cardiomyopathy 19.68 9.84 31 138877 2579 46544575
Left atrial enlargement 19.67 9.84 11 138897 232 46546922
Hypoacusis 19.60 9.84 118 138790 20851 46526303
Coombs positive haemolytic anaemia 19.57 9.84 13 138895 377 46546777
Apparent death 19.43 9.84 22 138886 1328 46545826
Bronchial neoplasm 19.42 9.84 11 138897 238 46546916
Prescribed underdose 19.26 9.84 79 138829 11974 46535180
Ophthalmic vein thrombosis 18.89 9.84 9 138899 134 46547020
Near death experience 18.73 9.84 12 138896 327 46546827
Pollakiuria 18.68 9.84 130 138778 24131 46523023
White blood cell count decreased 18.59 9.84 229 138679 112002 46435152
Hypertensive heart disease 18.59 9.84 30 138878 2548 46544606
Premature delivery 18.54 9.84 23 138885 22046 46525108
Hip arthroplasty 18.47 9.84 16 138892 18096 46529058
Gait disturbance 18.11 9.84 563 138345 144700 46402454
Aortic valve stenosis 18.11 9.84 33 138875 3091 46544063
Wound infection pseudomonas 18.10 9.84 22 138886 1433 46545721
Lymphocyte stimulation test positive 18.07 9.84 15 138893 615 46546539
Herpes simplex reactivation 18.07 9.84 12 138896 348 46546806
Renin decreased 18.04 9.84 8 138900 100 46547054
Wound 17.98 9.84 66 138842 42736 46504418
Pneumothorax traumatic 17.93 9.84 9 138899 151 46547003
Septic shock 17.89 9.84 100 138808 57793 46489361
Orthostatic hypotension 17.75 9.84 130 138778 24528 46522626
Multiple sclerosis 17.70 9.84 29 138879 24762 46522392
Coronary arterial stent insertion 17.64 9.84 31 138877 2822 46544332
Product colour issue 17.64 9.84 15 138893 636 46546518
Lipoedema 17.52 9.84 9 138899 159 46546995
Herpes zoster 17.49 9.84 124 138784 67748 46479406
Ear infection 17.30 9.84 26 138882 22987 46524167
Dehydration 17.24 9.84 608 138300 158932 46388222
Oedema 17.24 9.84 288 138620 66783 46480371
Mydriasis 17.22 9.84 5 138903 10548 46536606
Gastric ulcer haemorrhage 17.20 9.84 42 138866 4826 46542328
Staphylococcal infection 17.20 9.84 52 138856 35719 46511435
Hepatotoxicity 17.17 9.84 30 138878 24979 46522175
Drug intolerance 17.16 9.84 321 138587 146728 46400426
Frustration tolerance decreased 17.15 9.84 44 138864 5213 46541941
Respiratory arrest 17.10 9.84 48 138860 33768 46513386
Blood lactate dehydrogenase increased 17.07 9.84 112 138796 20388 46526766
Suicide attempt 17.04 9.84 95 138813 54941 46492213
Injection site bruising 16.99 9.84 52 138856 35584 46511570
Forced vital capacity decreased 16.99 9.84 17 138891 890 46546264
Injection site pruritus 16.88 9.84 61 138847 39682 46507472
Concomitant disease progression 16.75 9.84 26 138882 2136 46545018
Neutrophil function disorder 16.74 9.84 5 138903 17 46547137
Live birth 16.66 9.84 5 138903 10325 46536829
Swollen tongue 16.61 9.84 146 138762 29086 46518068
Bladder transitional cell carcinoma recurrent 16.52 9.84 4 138904 4 46547150
Synovitis 16.52 9.84 110 138798 60965 46486189
Cardiac pacemaker insertion 16.50 9.84 35 138873 3664 46543490
Bradycardia 16.43 9.84 283 138625 66015 46481139
Ventricular internal diameter abnormal 16.33 9.84 6 138902 44 46547110
Sinus node dysfunction 16.23 9.84 38 138870 4251 46542903
Nasal turbinate hypertrophy 16.17 9.84 12 138896 417 46546737
Infusion site pain 16.10 9.84 5 138903 10102 46537052
Incorrect route of product administration 16.07 9.84 15 138893 16368 46530786
Liver function test increased 16.02 9.84 27 138881 22799 46524355
Anuria 16.01 9.84 72 138836 11359 46535795
Withdrawal hypertension 16.00 9.84 8 138900 133 46547021
Metastases to bone 16.00 9.84 17 138891 17459 46529695
Coronary artery stenosis 15.95 9.84 40 138868 4673 46542481
Diabetic nephropathy 15.91 9.84 20 138888 1348 46545806
Gastric cancer 15.80 9.84 30 138878 2899 46544255
Progressive multifocal leukoencephalopathy 15.75 9.84 7 138901 11339 46535815
Lung diffusion test decreased 15.68 9.84 14 138894 634 46546520
Accidental exposure to product 15.67 9.84 24 138884 21057 46526097
Altered state of consciousness 15.62 9.84 121 138787 23227 46523927
Device related infection 15.60 9.84 24 138884 21017 46526137
Sepsis 15.54 9.84 298 138610 135716 46411438
Carotid artery disease 15.39 9.84 22 138886 1679 46545475
Deafness 15.39 9.84 91 138817 15977 46531177
Fluid retention 15.33 9.84 225 138683 50821 46496333
Gamma-glutamyltransferase increased 15.27 9.84 153 138755 31587 46515567
Neutrophil count decreased 15.12 9.84 72 138836 43354 46503800
Sudden cardiac death 15.09 9.84 25 138883 2170 46544984
Somnolence 14.94 9.84 353 138555 156168 46390986
Intentional self-injury 14.83 9.84 31 138877 24135 46523019
Blood pressure systolic decreased 14.83 9.84 42 138866 5276 46541878
Adverse reaction 14.83 9.84 3 138905 8087 46539067
Myocardial ischaemia 14.75 9.84 76 138832 12673 46534481
Dementia Alzheimer's type 14.75 9.84 18 138890 1177 46545977
Hypertensive emergency 14.75 9.84 21 138887 1597 46545557
Therapeutic drug monitoring analysis incorrectly performed 14.73 9.84 8 138900 159 46546995
Vomiting 14.71 9.84 1154 137754 451640 46095514
Small intestinal obstruction 14.50 9.84 16 138892 16156 46530998
Seroma 14.49 9.84 24 138884 2083 46545071
Carcinogenicity 14.46 9.84 3 138905 0 46547154
Kidney malrotation 14.46 9.84 3 138905 0 46547154
Mouth ulceration 14.39 9.84 37 138871 26795 46520359
Retinopathy hypertensive 14.18 9.84 9 138899 241 46546913
Nocturia 14.08 9.84 50 138858 7082 46540072
Platelet count decreased 14.07 9.84 211 138697 99813 46447341
Peak expiratory flow rate decreased 13.96 9.84 13 138895 622 46546532
Respiration abnormal 13.89 9.84 37 138871 4484 46542670
Aortic arteriosclerosis 13.87 9.84 43 138865 5678 46541476
Fear 13.86 9.84 89 138819 16083 46531071
Angiotensin converting enzyme inhibitor foetopathy 13.81 9.84 5 138903 35 46547119
Neuroleptic malignant syndrome 13.74 9.84 8 138900 11114 46536040
Acute myeloid leukaemia 13.73 9.84 16 138892 15762 46531392
Hypoxia 13.70 9.84 94 138814 51744 46495410
Neutropenic sepsis 13.68 9.84 10 138898 12314 46534840
Prerenal failure 13.62 9.84 19 138889 1418 46545736
Mood swings 13.59 9.84 17 138891 16235 46530919
Post-anoxic myoclonus 13.57 9.84 5 138903 37 46547117
Low density lipoprotein increased 13.55 9.84 44 138864 5956 46541198
Blood potassium abnormal 13.45 9.84 23 138885 2049 46545105
Bronchial disorder 13.45 9.84 16 138892 1019 46546135
Arteriosclerosis 13.41 9.84 61 138847 9672 46537482
Faecaloma 13.34 9.84 52 138856 7700 46539454
Lacunar infarction 13.32 9.84 31 138877 3454 46543700
Blood antidiuretic hormone increased 13.31 9.84 4 138904 14 46547140
Transplant rejection 13.19 9.84 6 138902 9590 46537564
Left ventricular dysfunction 13.19 9.84 63 138845 10192 46536962
Amenorrhoea 13.14 9.84 5 138903 8890 46538264
Plasma cell myeloma 13.11 9.84 78 138830 44400 46502754
Bezold-Jarisch reflex 13.09 9.84 4 138904 15 46547139
Loss of consciousness 13.09 9.84 418 138490 107820 46439334
Cardiac dysfunction 13.08 9.84 19 138889 1472 46545682
Therapy interrupted 12.99 9.84 8 138900 10783 46536371
Neurotoxicity 12.94 9.84 13 138895 13704 46533450
Liver function test abnormal 12.94 9.84 83 138825 46404 46500750
Prohormone brain natriuretic peptide increased 12.94 9.84 7 138901 138 46547016
Body height decreased 12.93 9.84 60 138848 9592 46537562
Injection site urticaria 12.91 9.84 10 138898 11957 46535197
Marasmus 12.91 9.84 11 138897 468 46546686
Constipation 12.89 9.84 407 138501 173690 46373464
Monocyte count abnormal 12.85 9.84 8 138900 207 46546947
Atrioventricular block 12.81 9.84 47 138861 6764 46540390
Dementia 12.69 9.84 82 138826 14848 46532306
Arterial occlusive disease 12.49 9.84 37 138871 4767 46542387
Carotid arteriosclerosis 12.49 9.84 15 138893 965 46546189
Glycosylated haemoglobin decreased 12.42 9.84 11 138897 493 46546661
Papilloma 12.39 9.84 8 138900 221 46546933
Dyschezia 12.35 9.84 19 138889 1549 46545605
Duodenal ulcer perforation 12.19 9.84 5 138903 8497 46538657
Lower respiratory tract infection 12.16 9.84 105 138803 54984 46492170
Ventricular hypokinesia 12.15 9.84 33 138875 4045 46543109
Blood creatine phosphokinase increased 12.09 9.84 131 138777 27593 46519561
C-reactive protein increased 12.05 9.84 243 138665 58347 46488807
Injection site warmth 11.94 9.84 14 138894 13758 46533396
Renal cancer 11.91 9.84 28 138880 3140 46544014
Drug ineffective for unapproved indication 11.90 9.84 19 138889 16394 46530760
Bundle branch block left 11.90 9.84 44 138864 6355 46540799
Foetal exposure during pregnancy 11.90 9.84 49 138859 30698 46516456
Tooth abscess 11.89 9.84 12 138896 12621 46534533
Laboratory test abnormal 11.87 9.84 32 138876 22815 46524339
Arrhythmogenic right ventricular dysplasia 11.86 9.84 4 138904 22 46547132
Haematotoxicity 11.85 9.84 3 138905 6930 46540224
Blood aldosterone increased 11.82 9.84 7 138901 165 46546989
Gastroenteritis 11.77 9.84 117 138791 24102 46523052
Asthmatic crisis 11.77 9.84 18 138890 1460 46545694
Candida infection 11.67 9.84 31 138877 22209 46524945
Multiple injuries 11.67 9.84 21 138887 1948 46545206
Febrile bone marrow aplasia 11.67 9.84 3 138905 6859 46540295
Atrial flutter 11.62 9.84 56 138852 9092 46538062
Encephalopathy 11.51 9.84 56 138852 33533 46513621
Brain contusion 11.49 9.84 11 138897 545 46546609
Heart valve incompetence 11.48 9.84 23 138885 2312 46544842
Epstein-Barr virus infection 11.47 9.84 3 138905 6781 46540373
Haematoma 11.41 9.84 145 138763 31727 46515427
Coronary angioplasty 11.33 9.84 6 138902 113 46547041
Colon cancer 11.25 9.84 56 138852 9213 46537941
Pneumonia aspiration 11.24 9.84 52 138856 31553 46515601
Blood sodium increased 11.23 9.84 24 138884 2525 46544629
Multiple organ dysfunction syndrome 11.22 9.84 99 138809 51611 46495543
Weight fluctuation 11.20 9.84 44 138864 6540 46540614
Pyometra 11.19 9.84 6 138902 116 46547038
Lymphostasis 11.18 9.84 3 138905 6 46547148
Rhabdomyolysis 11.15 9.84 181 138727 41728 46505426
Accident 11.14 9.84 37 138871 5067 46542087
Complication associated with device 11.08 9.84 18 138890 15423 46531731
Disease recurrence 11.08 9.84 24 138884 18447 46528707
Diarrhoea 11.05 9.84 1478 137430 558124 45989030
Nodal rhythm 11.00 9.84 19 138889 1706 46545448
Ulcer 10.93 9.84 22 138886 17370 46529784
Dizziness postural 10.90 9.84 43 138865 6403 46540751
Myocardial calcification 10.87 9.84 3 138905 7 46547147
Visual acuity reduced 10.83 9.84 107 138801 22006 46525148
Nephrogenic anaemia 10.83 9.84 20 138888 1893 46545261
Gingival hypertrophy 10.81 9.84 17 138891 1412 46545742
Contraindicated product administered 10.78 9.84 170 138738 79777 46467377
Upper respiratory tract infection 10.78 9.84 129 138779 63427 46483727
Gestational diabetes 10.76 9.84 4 138904 7215 46539939
Prosthesis implantation 10.71 9.84 5 138903 71 46547083
Visual impairment 10.70 9.84 267 138641 66422 46480732
Mucosal inflammation 10.64 9.84 70 138838 38906 46508248
Cranial sutures widening 10.59 9.84 4 138904 32 46547122
Cerebral arteriosclerosis 10.53 9.84 8 138900 288 46546866
Inappropriate antidiuretic hormone secretion 10.52 9.84 75 138833 14027 46533127
Glucose tolerance impaired 10.52 9.84 35 138873 4796 46542358
Joint range of motion decreased 10.51 9.84 18 138890 15106 46532048
Premature baby 10.48 9.84 24 138884 18088 46529066
Rash maculo-papular 10.43 9.84 45 138863 27829 46519325
Skin infection 10.41 9.84 11 138897 11328 46535826
Lymphocyte count decreased 10.40 9.84 40 138868 25549 46521605
Perihepatic discomfort 10.33 9.84 3 138905 9 46547145
Myelosuppression 10.31 9.84 5 138903 7698 46539456
Eructation 10.26 9.84 46 138862 7249 46539905
Drug dependence 10.25 9.84 28 138880 19873 46527281
Hepatocellular injury 10.24 9.84 49 138859 29473 46517681
Hepatic cancer 10.19 9.84 26 138882 3071 46544083
Bradyarrhythmia 10.15 9.84 20 138888 1986 46545168
Duodenal polyp 10.12 9.84 5 138903 81 46547073
Intestinal polyp 10.09 9.84 14 138894 1039 46546115
Fabry's disease 10.09 9.84 3 138905 10 46547144
Subclavian vein thrombosis 10.07 9.84 19 138889 1827 46545327
Cardiac myxoma 10.04 9.84 7 138901 220 46546934
Oxygen saturation decreased 10.04 9.84 145 138763 69019 46478135
Movement disorder 10.02 9.84 85 138823 16764 46530390
Ear pain 10.00 9.84 33 138875 22059 46525095
Injection site rash 9.94 9.84 20 138888 15793 46531361
Pigmentation disorder 9.94 9.84 29 138879 3704 46543450
Renal cell carcinoma 9.92 9.84 28 138880 3510 46543644
Coronary artery occlusion 9.87 9.84 49 138859 8053 46539101

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
Hypotension 1121.56 10.53 2542 123114 198023 29628799
Cardiac failure 730.73 10.53 1278 124378 82140 29744682
Dizziness 498.20 10.53 1869 123787 193040 29633782
Wrong technique in product usage process 476.88 10.53 620 125036 30535 29796287
Ejection fraction decreased 315.64 10.53 353 125303 14822 29812000
Product prescribing error 308.93 10.53 366 125290 16367 29810455
Blood creatinine increased 293.16 10.53 946 124710 90429 29736393
Off label use 281.87 10.53 381 125275 248909 29577913
Blood pressure decreased 276.11 10.53 610 125046 46465 29780357
Drug abuse 262.21 10.53 22 125634 82050 29744772
Toxicity to various agents 250.51 10.53 225 125431 176958 29649864
Hyperkalaemia 243.76 10.53 718 124938 65292 29761530
Dyspnoea 222.50 10.53 2252 123404 331043 29495779
Blood potassium increased 222.42 10.53 306 125350 15907 29810915
Cardiac failure chronic 191.11 10.53 174 125482 5689 29821133
Prescribed underdose 184.96 10.53 194 125462 7565 29819257
Completed suicide 183.68 10.53 94 125562 99398 29727424
Blood pressure inadequately controlled 182.40 10.53 121 125535 2449 29824373
Angioedema 182.06 10.53 428 125228 33956 29792866
Cough 180.13 10.53 1018 124638 124624 29702198
Neutropenia 171.25 10.53 172 125484 128368 29698454
Blood pressure increased 165.94 10.53 669 124987 71259 29755563
Renal impairment 149.44 10.53 724 124932 83460 29743362
Febrile neutropenia 144.10 10.53 141 125515 106552 29720270
N-terminal prohormone brain natriuretic peptide increased 140.40 10.53 81 125575 1265 29825557
Hypoacusis 134.40 10.53 225 125431 13914 29812908
Syncope 134.38 10.53 707 124949 84196 29742626
Glomerular filtration rate decreased 130.30 10.53 197 125459 11165 29815657
Myocardial infarction 127.00 10.53 932 124724 124693 29702129
Blood pressure systolic decreased 118.83 10.53 109 125547 3598 29823224
Weight increased 117.96 10.53 623 125033 74290 29752532
Pyrexia 117.67 10.53 739 124917 293750 29533072
Inappropriate schedule of product administration 110.13 10.53 392 125264 39336 29787486
Fluid retention 108.96 10.53 289 125367 24709 29802113
No adverse event 106.89 10.53 230 125426 17189 29809633
Blood urea increased 100.50 10.53 325 125331 31056 29795766
Hypertension 98.38 10.53 856 124800 120498 29706324
Ventricular tachycardia 98.11 10.53 270 125386 23592 29803230
Renal failure 95.51 10.53 892 124764 128074 29698748
Cerebrovascular accident 95.22 10.53 638 125018 82839 29743983
Drug ineffective 92.55 10.53 948 124708 339439 29487383
Concomitant disease aggravated 91.03 10.53 110 125546 5019 29821803
Ventricular arrhythmia 87.85 10.53 99 125557 4189 29822633
Blood pressure abnormal 84.03 10.53 124 125532 6875 29819947
Pancytopenia 83.24 10.53 143 125513 84909 29741913
Contraindicated product administered 83.14 10.53 207 125449 17024 29809798
Pneumonia 78.60 10.53 962 124694 333344 29493478
Sepsis 76.42 10.53 335 125321 146060 29680762
Mitral valve incompetence 75.81 10.53 170 125486 13064 29813758
Disease progression 75.71 10.53 137 125519 79737 29747085
Thrombocytopenia 74.97 10.53 308 125348 136736 29690086
Treatment failure 74.77 10.53 26 125630 34653 29792169
Ejection fraction abnormal 74.28 10.53 43 125613 676 29826146
Hospitalisation 71.66 10.53 49 125607 44270 29782552
Cardiac failure acute 70.09 10.53 133 125523 9076 29817746
Throat clearing 69.46 10.53 29 125627 211 29826611
Acute kidney injury 68.65 10.53 1566 124090 272276 29554546
Plasma cell myeloma 67.22 10.53 75 125581 53387 29773435
Infusion related reaction 66.72 10.53 44 125612 40520 29786302
Arrhythmia 66.67 10.53 296 125360 32873 29793949
Angina pectoris 64.38 10.53 270 125386 29248 29797574
Malignant neoplasm progression 64.11 10.53 129 125527 72158 29754664
Seizure 63.25 10.53 207 125449 98268 29728554
Cardiac failure congestive 61.50 10.53 582 125074 83825 29742997
Deep vein thrombosis 58.92 10.53 102 125554 60399 29766423
Oedema peripheral 58.89 10.53 691 124965 105141 29721681
Orthopnoea 58.24 10.53 83 125573 4457 29822365
Cerebral infarction 58.11 10.53 242 125414 26131 29800691
Left ventricular dilatation 57.97 10.53 35 125621 597 29826225
Vomiting 54.81 10.53 624 125032 219194 29607628
Atrial fibrillation 53.26 10.53 690 124966 107434 29719388
Malaise 52.97 10.53 989 124667 165973 29660849
Rheumatoid arthritis 52.66 10.53 57 125599 41140 29785682
Intentional overdose 52.35 10.53 58 125598 41423 29785399
Brain natriuretic peptide increased 52.10 10.53 74 125582 3961 29822861
Drug dependence 51.30 10.53 13 125643 21282 29805540
Aggression 50.66 10.53 48 125608 36859 29789963
Mucosal inflammation 50.25 10.53 33 125623 30461 29796361
Dizziness postural 48.59 10.53 85 125571 5445 29821377
Renal disorder 48.55 10.53 212 125444 23372 29803450
Neuropathy peripheral 48.16 10.53 144 125512 70331 29756491
Foetal exposure during pregnancy 47.14 10.53 51 125605 36820 29790002
Diabetes mellitus 47.09 10.53 319 125337 41546 29785276
Cardiac disorder 46.70 10.53 307 125349 39586 29787236
Agitation 46.66 10.53 98 125558 53975 29772847
Leukopenia 46.62 10.53 104 125552 56055 29770767
Suicidal ideation 46.12 10.53 50 125606 36064 29790758
Feeling abnormal 45.19 10.53 399 125257 56357 29770465
Intentional product use issue 44.84 10.53 52 125604 36388 29790434
Left ventricular dysfunction 44.68 10.53 107 125549 8584 29818238
Blood uric acid increased 44.62 10.53 86 125570 5937 29820885
Neutrophil count decreased 43.72 10.53 69 125587 42385 29784437
Brain natriuretic peptide abnormal 43.55 10.53 19 125637 156 29826666
Product impurity 42.98 10.53 14 125642 44 29826778
Hypertensive crisis 42.01 10.53 102 125554 8255 29818567
Blood glucose increased 41.72 10.53 418 125238 61112 29765710
Sudden cardiac death 41.52 10.53 64 125592 3688 29823134
Cardiogenic shock 41.36 10.53 160 125496 16701 29810121
Constipation 41.03 10.53 291 125365 112615 29714207
Intentional product misuse 41.03 10.53 51 125605 34616 29792206
Underdose 39.99 10.53 127 125529 12014 29814808
Cytomegalovirus infection 39.85 10.53 25 125631 23649 29803173
Jugular vein distension 39.72 10.53 26 125630 514 29826308
Nausea 39.46 10.53 947 124709 296010 29530812
Oedema 39.42 10.53 312 125344 42681 29784141
Blood pressure diastolic decreased 39.05 10.53 83 125573 6148 29820674
Weight fluctuation 38.35 10.53 62 125594 3722 29823100
Weight decreased 38.27 10.53 865 124791 150056 29676766
Abnormal behaviour 37.97 10.53 31 125625 25592 29801230
Tricuspid valve incompetence 37.87 10.53 100 125556 8523 29818299
Ischaemic cardiomyopathy 37.31 10.53 82 125574 6215 29820607
Bone marrow failure 37.19 10.53 42 125614 29743 29797079
N-terminal prohormone brain natriuretic peptide abnormal 37.16 10.53 15 125641 99 29826723
Drug resistance 37.13 10.53 19 125637 20114 29806708
Device inappropriate shock delivery 36.31 10.53 12 125644 40 29826782
Fear of disease 35.20 10.53 18 125638 218 29826604
White blood cell count decreased 34.73 10.53 208 125448 83739 29743083
Lung diffusion disorder 34.61 10.53 9 125647 8 29826814
Pulmonary embolism 34.25 10.53 190 125466 77945 29748877
Sedation 34.06 10.53 13 125643 16360 29810462
Overdose 33.83 10.53 211 125445 84126 29742696
Hepatojugular reflux 33.44 10.53 20 125636 335 29826487
Bundle branch block left 33.40 10.53 70 125586 5134 29821688
Ventricular hypokinesia 33.39 10.53 62 125594 4161 29822661
Left ventricular hypertrophy 33.03 10.53 78 125578 6200 29820622
Eosinophilic colitis 32.95 10.53 16 125640 172 29826650
Left atrial enlargement 32.74 10.53 22 125634 455 29826367
Heart rate decreased 32.58 10.53 174 125482 20820 29806002
Injection site pain 32.42 10.53 48 125608 30262 29796560
Type 2 diabetes mellitus 32.39 10.53 128 125528 13494 29813328
Septic shock 32.26 10.53 147 125509 63460 29763362
Cardiorenal syndrome 31.52 10.53 26 125630 742 29826080
Drug hypersensitivity 31.48 10.53 164 125492 68355 29758467
Lip swelling 31.31 10.53 121 125535 12623 29814199
Generalised tonic-clonic seizure 31.08 10.53 22 125634 19529 29807293
Sudden death 30.93 10.53 138 125518 15354 29811468
Respiratory arrest 30.65 10.53 47 125609 29211 29797611
Clostridium difficile infection 30.47 10.53 14 125642 15769 29811053
Cardiac dysfunction 30.45 10.53 31 125625 1166 29825656
Pulmonary oedema 30.40 10.53 300 125356 43675 29783147
Hallucination 30.19 10.53 105 125551 48954 29777868
Cardio-respiratory arrest 29.92 10.53 131 125525 57175 29769647
Neutropenic sepsis 29.41 10.53 6 125650 11403 29815419
Fatigue 29.31 10.53 1634 124022 319039 29507783
Diastolic dysfunction 29.24 10.53 59 125597 4212 29822610
Weight loss poor 29.03 10.53 14 125642 148 29826674
Nephrogenic anaemia 28.76 10.53 40 125616 2099 29824723
Orthostatic intolerance 28.59 10.53 24 125632 702 29826120
Tremor 28.46 10.53 192 125464 75171 29751651
Cytokine release syndrome 28.30 10.53 4 125652 9929 29816893
Ventricular extrasystoles 28.24 10.53 109 125547 11365 29815457
Neurotoxicity 28.21 10.53 10 125646 13172 29813650
Status epilepticus 28.18 10.53 6 125650 11066 29815756
Therapeutic product effect incomplete 27.79 10.53 63 125593 33771 29793051
Synovitis 27.73 10.53 4 125652 9779 29817043
Respiratory failure 27.71 10.53 279 125377 100363 29726459
Pain 27.67 10.53 534 125122 172107 29654715
Sinus arrest 27.63 10.53 33 125623 1487 29825335
Immune reconstitution inflammatory syndrome 27.55 10.53 3 125653 9098 29817724
Drug ineffective for unapproved indication 27.48 10.53 6 125650 10874 29815948
Therapy non-responder 27.45 10.53 51 125605 29402 29797420
Memory impairment 27.37 10.53 257 125399 36917 29789905
Schizophrenia 27.35 10.53 3 125653 9045 29817777
Congestive cardiomyopathy 27.24 10.53 75 125581 6552 29820270
Blood lactic acid 27.23 10.53 18 125638 362 29826460
Orthostatic hypotension 27.13 10.53 183 125473 23796 29803026
Hypoxia 27.10 10.53 106 125550 47748 29779074
Graft versus host disease 26.88 10.53 5 125651 10145 29816677
Near death experience 26.75 10.53 10 125646 52 29826770
Infection 26.54 10.53 205 125451 77869 29748953
Hypertensive heart disease 26.39 10.53 41 125615 2379 29824443
Left ventricular enlargement 26.38 10.53 21 125635 569 29826253
Fractured coccyx 26.28 10.53 13 125643 146 29826676
Intentional self-injury 26.13 10.53 12 125644 13520 29813302
Blood triglycerides increased 25.86 10.53 122 125534 13895 29812927
Blood pressure fluctuation 25.76 10.53 143 125513 17360 29809462
Glycosylated haemoglobin increased 25.72 10.53 93 125563 9398 29817424
Atrioventricular block 25.67 10.53 78 125578 7204 29819618
Palpitations 25.67 10.53 234 125422 33339 29793483
Right hemisphere deficit syndrome 25.61 10.53 8 125648 21 29826801
Chest pain 25.50 10.53 660 124996 116967 29709855
Dystonia 25.32 10.53 5 125651 9722 29817100
Blood thyroid stimulating hormone abnormal 25.17 10.53 13 125643 161 29826661
Vertigo 25.16 10.53 172 125484 22463 29804359
Liver function test abnormal 25.12 10.53 58 125598 30892 29795930
Psychotic disorder 25.09 10.53 32 125624 21483 29805339
Loss of consciousness 25.04 10.53 470 125186 78905 29747917
Pulmonary arterial pressure abnormal 24.75 10.53 13 125643 167 29826655
Drug withdrawal syndrome 24.65 10.53 28 125628 19781 29807041
Chronic kidney disease 24.65 10.53 255 125401 37583 29789239
Chest discomfort 24.39 10.53 295 125361 45185 29781637
Mitral valve thickening 24.30 10.53 14 125642 218 29826604
Blood creatine increased 24.23 10.53 56 125600 4389 29822433
Visual impairment 24.22 10.53 214 125442 30224 29796598
Stomatitis 24.16 10.53 78 125578 37201 29789621
Loss of personal independence in daily activities 24.12 10.53 33 125623 21502 29805320
Pemphigoid 24.11 10.53 78 125578 7450 29819372
Peripheral swelling 24.11 10.53 375 125281 60699 29766123
Hypochromasia 23.98 10.53 16 125640 327 29826495
Therapeutic response unexpected 23.93 10.53 87 125569 8816 29818006
Diabetic nephropathy 23.72 10.53 34 125622 1835 29824987
Serotonin syndrome 23.70 10.53 24 125632 17867 29808955
Confusional state 23.48 10.53 411 125245 134423 29692399
Pruritus 23.27 10.53 655 125001 117549 29709273
Aspergillus infection 23.17 10.53 7 125649 10207 29816615
Condition aggravated 23.14 10.53 423 125233 137443 29689379
Hyperuricaemia 23.13 10.53 76 125580 7318 29819504
Right atrial enlargement 23.12 10.53 14 125642 240 29826582
Exercise tolerance decreased 22.99 10.53 50 125606 3762 29823060
Aortic aneurysm 22.90 10.53 69 125587 6344 29820478
Bacteraemia 22.84 10.53 19 125637 15541 29811281
Drug reaction with eosinophilia and systemic symptoms 22.63 10.53 54 125602 28434 29798388
Encephalopathy 22.57 10.53 65 125591 32140 29794682
Infarction 22.56 10.53 40 125616 2590 29824232
Laziness 22.50 10.53 15 125641 306 29826516
Colitis 22.49 10.53 61 125595 30759 29796063
Nasal pruritus 22.48 10.53 9 125647 58 29826764
Dyspnoea paroxysmal nocturnal 22.35 10.53 26 125630 1139 29825683
Oxygen saturation increased 22.20 10.53 13 125643 209 29826613
Chest injury 22.18 10.53 28 125628 1336 29825486
Extrasystoles 22.12 10.53 49 125607 3733 29823089
Low density lipoprotein abnormal 22.05 10.53 14 125642 262 29826560
Bronchopulmonary aspergillosis 22.05 10.53 12 125644 12272 29814550
Electrocardiogram QRS complex abnormal 21.73 10.53 14 125642 269 29826553
Adverse drug reaction 21.64 10.53 40 125616 23105 29803717
Therapeutic product effect decreased 21.63 10.53 57 125599 29019 29797803
Aortic valve incompetence 21.52 10.53 57 125599 4866 29821956
Pneumocystis jirovecii pneumonia 21.52 10.53 24 125632 17096 29809726
Transplant rejection 21.45 10.53 6 125650 9200 29817622
Blood cholesterol increased 21.33 10.53 133 125523 16837 29809985
Pancreatic neoplasm 21.12 10.53 23 125633 936 29825886
Pulmonary valve stenosis congenital 21.10 10.53 11 125645 139 29826683
Candida infection 21.05 10.53 20 125636 15342 29811480
Microalbuminuria 21.05 10.53 19 125637 614 29826208
Psoriatic arthropathy 21.04 10.53 21 125635 15740 29811082
Gouty arthritis 21.00 10.53 24 125632 1031 29825791
Product dose omission issue 20.89 10.53 265 125391 91366 29735456
Cardiac aneurysm 20.71 10.53 19 125637 627 29826195
Gout 20.71 10.53 134 125522 17181 29809641
Epilepsy 20.55 10.53 33 125623 20136 29806686
Pathogen resistance 20.52 10.53 5 125651 8405 29818417
Urine albumin/creatinine ratio increased 20.39 10.53 10 125646 110 29826712
Swollen tongue 20.24 10.53 109 125547 13083 29813739
Hallucination, auditory 19.99 10.53 8 125648 9781 29817041
Renal artery stenosis 19.83 10.53 31 125625 1808 29825014
Mental status changes 19.82 10.53 84 125572 36995 29789827
Acute myeloid leukaemia 19.76 10.53 28 125628 17978 29808844
Product use issue 19.56 10.53 113 125543 45903 29780919
Hemiplegia 19.54 10.53 67 125589 6594 29820228
Abdominal pain 19.51 10.53 427 125229 135227 29691595
Mean platelet volume increased 19.44 10.53 15 125641 388 29826434
Acute myocardial infarction 19.37 10.53 321 125335 52618 29774204
Thrombotic microangiopathy 19.35 10.53 6 125650 8604 29818218
Respiratory distress 19.33 10.53 72 125584 32900 29793922
Hepatotoxicity 19.14 10.53 29 125627 18116 29808706
Lymphocyte stimulation test positive 19.14 10.53 21 125635 862 29825960
Ventricular hyperkinesia 19.12 10.53 12 125644 220 29826602
Cell marker increased 19.12 10.53 16 125640 466 29826356
Dyspnoea at rest 19.04 10.53 37 125619 2569 29824253
N-terminal prohormone brain natriuretic peptide decreased 18.95 10.53 5 125651 5 29826817
Hyponatraemia 18.86 10.53 391 125265 66811 29760011
Conduction disorder 18.47 10.53 31 125625 1920 29824902
Device malfunction 18.31 10.53 75 125581 8036 29818786
Paranoia 18.22 10.53 10 125646 10178 29816644
Respiratory depression 18.21 10.53 13 125643 11490 29815332
Cerebellar ischaemia 18.20 10.53 9 125647 101 29826721
Venoocclusive liver disease 18.07 10.53 3 125653 6610 29820212
Cachexia 18.07 10.53 3 125653 6608 29820214
Lymphocyte count abnormal 18.04 10.53 17 125639 581 29826241
Coronary artery disease 18.03 10.53 301 125355 49411 29777411
Suicide attempt 17.89 10.53 86 125570 36611 29790211
Poisoning 17.84 10.53 13 125643 11369 29815453
Hypophagia 17.78 10.53 42 125614 22194 29804628
Blood cholesterol decreased 17.73 10.53 21 125635 938 29825884
Platelet count decreased 17.68 10.53 326 125330 105803 29721019
Myoglobin blood increased 17.66 10.53 29 125627 1764 29825058
Disease recurrence 17.64 10.53 20 125636 14141 29812681
Cerebral vasoconstriction 17.56 10.53 11 125645 201 29826621
Musculoskeletal stiffness 17.55 10.53 84 125572 35797 29791025
Headache 17.40 10.53 608 125048 181698 29645124
Gamma-glutamyltransferase increased 17.35 10.53 194 125462 29156 29797666
Left ventricular failure 17.16 10.53 53 125603 4938 29821884
Ischaemic stroke 17.10 10.53 122 125534 16153 29810669
Multiple organ dysfunction syndrome 17.05 10.53 177 125479 63310 29763512
Unevaluable event 16.99 10.53 72 125584 31713 29795109
Sprue-like enteropathy 16.92 10.53 13 125643 334 29826488
Accidental overdose 16.72 10.53 32 125624 18243 29808579
Myelosuppression 16.64 10.53 5 125651 7317 29819505
Lower respiratory tract infection 16.55 10.53 57 125599 26657 29800165
Tachycardia 16.53 10.53 214 125442 73525 29753297
Miosis 16.47 10.53 6 125650 7770 29819052
Multiple sclerosis 16.45 10.53 5 125651 7262 29819560
Laboratory test abnormal 16.43 10.53 30 125626 17412 29809410
Intestinal obstruction 16.41 10.53 35 125621 19177 29807645
Subacute hepatic failure 16.39 10.53 8 125648 87 29826735
Posterior reversible encephalopathy syndrome 16.38 10.53 8 125648 8699 29818123
Illness 16.34 10.53 40 125616 3254 29823568
Breast discomfort 16.32 10.53 5 125651 12 29826810
Fungal infection 16.09 10.53 20 125636 13580 29813242
Urinary tract infection 16.06 10.53 215 125441 73444 29753378
Chills 15.82 10.53 211 125445 72127 29754695
Extrapyramidal disorder 15.76 10.53 13 125643 10680 29816142
Hypocalvaria 15.69 10.53 4 125652 3 29826819
Painful respiration 15.67 10.53 23 125633 1269 29825553
Substance abuse 15.66 10.53 5 125651 7035 29819787
Arteriosclerosis 15.60 10.53 88 125568 10745 29816077
Delirium 15.59 10.53 103 125553 40528 29786294
Hypocapnia 15.56 10.53 8 125648 98 29826724
Atrial enlargement 15.49 10.53 8 125648 99 29826723
Neuroleptic malignant syndrome 15.37 10.53 28 125628 16267 29810555
Atrial thrombosis 15.35 10.53 28 125628 1853 29824969
Goitre 15.34 10.53 25 125631 1511 29825311
Pain in jaw 15.33 10.53 17 125639 12139 29814683
Chronic pigmented purpura 15.28 10.53 8 125648 102 29826720
Oscillopsia 15.21 10.53 6 125650 37 29826785
Peripheral arterial occlusive disease 15.18 10.53 52 125604 5116 29821706
Impaired reasoning 15.12 10.53 7 125649 67 29826755
Diffuse large B-cell lymphoma 15.07 10.53 7 125649 7834 29818988
Walking aid user 15.06 10.53 24 125632 1423 29825399
Osteonecrosis of jaw 15.02 10.53 35 125621 18583 29808239
Dyspnoea exertional 14.93 10.53 220 125436 35210 29791612
Lymphopenia 14.91 10.53 20 125636 13143 29813679
Rhythm idioventricular 14.68 10.53 11 125645 272 29826550
Bile duct cancer 14.62 10.53 16 125640 655 29826167
Tonic clonic movements 14.61 10.53 20 125636 1034 29825788
Pericarditis 14.60 10.53 9 125647 8597 29818225
Rales 14.59 10.53 60 125596 6440 29820382
Anaphylactic reaction 14.58 10.53 64 125592 27918 29798904
Rash erythematous 14.53 10.53 47 125609 22405 29804417
Progressive multifocal leukoencephalopathy 14.51 10.53 10 125646 9003 29817819
Adrenal adenoma 14.51 10.53 11 125645 277 29826545
Pulmonary hypoplasia 14.45 10.53 13 125643 418 29826404
Death 14.40 10.53 1710 123946 355573 29471249
Joint stiffness 14.28 10.53 11 125645 9350 29817472
Pyonephrosis 14.28 10.53 7 125649 77 29826745
Miscarriage of partner 14.27 10.53 4 125652 6 29826816
Aspiration 14.15 10.53 14 125642 10537 29816285
Osteonecrosis 14.11 10.53 29 125627 16106 29810716
Neoplasm malignant 14.04 10.53 125 125531 17689 29809133
Unresponsive to stimuli 14.02 10.53 60 125596 26359 29800463
Prostate cancer 14.00 10.53 158 125498 23799 29803023
Leukocytosis 13.92 10.53 45 125611 21457 29805365
Dependence on oxygen therapy 13.92 10.53 8 125648 124 29826698
Adrenal insufficiency 13.90 10.53 14 125642 10449 29816373
Cardiovascular somatic symptom disorder 13.89 10.53 6 125650 48 29826774
Presyncope 13.88 10.53 115 125541 15941 29810881
Heart rate increased 13.87 10.53 234 125422 38487 29788335
Gastric cancer 13.84 10.53 49 125607 4901 29821921
Heart valve incompetence 13.83 10.53 20 125636 1088 29825734
Acute coronary syndrome 13.83 10.53 101 125555 13472 29813350
Penile oedema 13.82 10.53 11 125645 298 29826524
Hypertrophic osteoarthropathy 13.82 10.53 7 125649 83 29826739
Splenomegaly 13.79 10.53 22 125634 13458 29813364
Paraesthesia oral 13.65 10.53 40 125616 3621 29823201
Surfactant protein increased 13.55 10.53 4 125652 8 29826814
Staphylococcal infection 13.50 10.53 73 125583 30151 29796671
Melaena 13.50 10.53 201 125455 32236 29794586
Blepharochalasis 13.43 10.53 3 125653 0 29826822
Superinfection mycobacterial 13.43 10.53 3 125653 0 29826822
Alcohol abuse 13.42 10.53 3 125653 5350 29821472
Second primary malignancy 13.30 10.53 5 125651 6351 29820471
Somnolence 13.22 10.53 307 125349 96456 29730366
Electrocardiogram QT prolonged 13.17 10.53 92 125564 35743 29791079
Product monitoring error 13.07 10.53 25 125631 1716 29825106
Adverse event 13.06 10.53 28 125628 15313 29811509
Urticaria chronic 13.06 10.53 7 125649 94 29826728
Low cardiac output syndrome 13.01 10.53 11 125645 325 29826497
Acquired C1 inhibitor deficiency 12.94 10.53 4 125652 10 29826812
Coma 12.91 10.53 108 125548 40341 29786481
Failure to thrive 12.88 10.53 9 125647 8045 29818777
Cytomegalovirus viraemia 12.86 10.53 4 125652 5725 29821097
Multiple sclerosis relapse 12.83 10.53 16 125640 10846 29815976
Asthenia 12.79 10.53 1086 124570 220204 29606618
Liver function test increased 12.75 10.53 17 125639 11199 29815623
Drug interaction 12.72 10.53 696 124960 198872 29627950
Atrial tachycardia 12.66 10.53 28 125628 2131 29824691
Osteitis deformans 12.65 10.53 5 125651 31 29826791
Stevens-Johnson syndrome 12.62 10.53 35 125621 17521 29809301
Heart rate abnormal 12.58 10.53 23 125633 1525 29825297
Thrombotic stroke 12.56 10.53 10 125646 271 29826551
Pollakiuria 12.50 10.53 117 125539 16789 29810033
Mania 12.45 10.53 12 125644 9142 29817680
Blood pressure systolic increased 12.42 10.53 107 125549 15003 29811819
Body mass index increased 12.37 10.53 15 125641 687 29826135
Polyuria 12.33 10.53 62 125594 7244 29819578
Cellulitis 12.32 10.53 131 125525 46653 29780169
Peritonitis 12.32 10.53 47 125609 21328 29805494
Renal dysplasia 12.27 10.53 8 125648 157 29826665
Product substitution issue 12.21 10.53 78 125578 9957 29816865
Creatinine urine increased 12.18 10.53 8 125648 159 29826663
Neoplasm progression 12.17 10.53 37 125619 17986 29808836
Hypertensive nephropathy 12.17 10.53 12 125644 434 29826388
Blood potassium decreased 12.16 10.53 115 125541 16547 29810275
Device issue 12.16 10.53 9 125647 7807 29819015
Nipple pain 12.13 10.53 14 125642 608 29826214
Decreased activity 12.04 10.53 38 125618 3583 29823239
Toxic epidermal necrolysis 12.00 10.53 37 125619 17903 29808919
Injection site erythema 11.99 10.53 25 125631 13809 29813013
Klebsiella infection 11.97 10.53 7 125649 6880 29819942
Dyskinesia 11.95 10.53 49 125607 21785 29805037
Myocardial ischaemia 11.89 10.53 118 125538 17199 29809623
Withdrawal syndrome 11.85 10.53 18 125638 11232 29815590
Genital candidiasis 11.78 10.53 6 125650 72 29826750
Renal pain 11.75 10.53 31 125625 2641 29824181
Hypoparathyroidism 11.69 10.53 12 125644 456 29826366
Exposure during pregnancy 11.62 10.53 13 125643 9248 29817574
Full blood count decreased 11.55 10.53 31 125625 15686 29811136
Gallbladder hypofunction 11.54 10.53 4 125652 16 29826806
Anxiety 11.48 10.53 288 125368 89583 29737239
Device related infection 11.44 10.53 35 125621 16980 29809842
Gait disturbance 11.43 10.53 402 125254 74375 29752447
Congenital inguinal hernia 11.41 10.53 7 125649 123 29826699
Epstein-Barr virus infection 11.40 10.53 7 125649 6699 29820123
Chromophobe renal cell carcinoma 11.37 10.53 3 125653 3 29826819
Aortic valve thickening 11.37 10.53 3 125653 3 29826819
Coronary artery stenosis 11.34 10.53 71 125585 8999 29817823
Cardiac output decreased 11.27 10.53 16 125640 856 29825966
Peritonitis bacterial 11.23 10.53 19 125637 11359 29815463
Renal failure neonatal 11.23 10.53 6 125650 80 29826742
Squamous cell carcinoma of skin 11.16 10.53 13 125643 9082 29817740
Coagulopathy 11.08 10.53 40 125616 18447 29808375
Incorrect route of product administration 11.08 10.53 19 125637 11296 29815526
Lipid metabolism disorder 11.02 10.53 9 125647 253 29826569
Inferior vena cava dilatation 10.95 10.53 8 125648 190 29826632
Psychomotor hyperactivity 10.93 10.53 11 125645 8213 29818609
Cardiac discomfort 10.93 10.53 10 125646 329 29826493
Renal function test abnormal 10.87 10.53 28 125628 2351 29824471
Shock 10.86 10.53 145 125511 22714 29804108
Heart valve stenosis 10.83 10.53 4 125652 20 29826802
Ventricular dyssynchrony 10.83 10.53 4 125652 20 29826802
Colon cancer 10.76 10.53 66 125590 8306 29818516
Bronchitis 10.76 10.53 227 125429 38898 29787924
Intestinal perforation 10.65 10.53 12 125644 8507 29818315
Atrial flutter 10.64 10.53 99 125557 14182 29812640
Bladder cancer 10.61 10.53 70 125586 9032 29817790
Pseudohyponatraemia 10.61 10.53 6 125650 90 29826732
Retinopathy 10.60 10.53 25 125631 1985 29824837
Injection site reaction 10.59 10.53 18 125638 10742 29816080
Febrile bone marrow aplasia 10.57 10.53 11 125645 8086 29818736
Angioplasty 10.56 10.53 17 125639 1017 29825805

Pharmacologic Action:

SourceCodeDescription
ATC C09CA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB08 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX05 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX10 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
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:35674 antihypertensive
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:61016 angiotensin receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Left ventricular cardiac dysfunction indication 429589006
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
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
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
Neutropenic disorder contraindication 303011007 DOID:1227
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.8 acidic
pKa2 4.44 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Jan. 7, 2021 PEDIATRIC EXCLUSIVITY
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Jan. 7, 2021 PEDIATRIC EXCLUSIVITY
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Jan. 7, 2021 PEDIATRIC EXCLUSIVITY
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
160MG DIOVAN NOVARTIS N021283 July 18, 2001 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION
40MG DIOVAN NOVARTIS N021283 Aug. 14, 2002 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION
80MG DIOVAN NOVARTIS N021283 July 18, 2001 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST Ki 5.33 CHEMBL CHEMBL
Type-1B angiotensin II receptor GPCR IC50 8.72 CHEMBL
Type-1A angiotensin II receptor GPCR IC50 8.47 CHEMBL
Angiotensin II receptor (AT-1) type-1 GPCR IC50 8.57 CHEMBL

External reference:

IDSource
D00400 KEGG_DRUG
4020986 VANDF
C0527644 UMLSCUI
CHEBI:9927 CHEBI
CHEMBL1069 ChEMBL_ID
D000068756 MESH_DESCRIPTOR_UI
60846 PUBCHEM_CID
7016 INN_ID
DB00177 DRUGBANK_ID
80M03YXJ7I UNII
3937 IUPHAR_LIGAND_ID
216652 RXNORM
53010 MMSL
5663 MMSL
8844 MMSL
d04113 MMSL
006279 NDDF
108581009 SNOMEDCT_US
386876001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 80 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0358 TABLET 80 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0359 TABLET 160 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0360 TABLET 320 mg ORAL NDA 33 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0423 TABLET 40 mg ORAL NDA 33 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0561 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0562 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0563 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
ENTRESTO HUMAN PRESCRIPTION DRUG LABEL 2 0078-0659 TABLET, FILM COATED 26 mg ORAL NDA 34 sections
ENTRESTO HUMAN PRESCRIPTION DRUG LABEL 2 0078-0696 TABLET, FILM COATED 103 mg ORAL NDA 34 sections
ENTRESTO HUMAN PRESCRIPTION DRUG LABEL 2 0078-0777 TABLET, FILM COATED 51 mg ORAL NDA 34 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1721 TABLET, FILM COATED 160 mg ORAL ANDA 27 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1722 TABLET, FILM COATED 160 mg ORAL ANDA 27 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1723 TABLET, FILM COATED 320 mg ORAL ANDA 27 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1724 TABLET, FILM COATED 320 mg ORAL ANDA 27 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5807 TABLET, FILM COATED 40 mg ORAL ANDA 29 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5813 TABLET, FILM COATED 80 mg ORAL ANDA 29 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5814 TABLET, FILM COATED 160 mg ORAL ANDA 29 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5815 TABLET, FILM COATED 320 mg ORAL ANDA 29 sections
Valsartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-6321 TABLET, FILM COATED 80 mg ORAL ANDA 28 sections