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 2498.54 23.16 886 10026 31550 2315623
Dizziness 1686.35 23.16 791 10121 57874 2289299
Blood pressure increased 1433.89 23.16 499 10413 16487 2330686
Dyspnoea 1219.52 23.16 702 10210 78031 2269142
Malaise 1133.01 23.16 595 10317 54990 2292183
Cardiac failure 1021.38 23.16 356 10556 11738 2335435
Acute kidney injury 987.57 23.16 438 10474 27684 2319489
Cough 912.88 23.16 436 10476 32681 2314492
Hyperkalaemia 903.93 23.16 273 10639 5620 2341553
Hyponatraemia 872.29 23.16 325 10587 13000 2334173
Hypertension 832.85 23.16 386 10526 26975 2320198
Fall 754.37 23.16 431 10481 46668 2300505
Blood pressure decreased 733.48 23.16 260 10652 8976 2338197
Fatigue 686.19 23.16 505 10407 84368 2262805
Blood creatinine increased 685.44 23.16 256 10656 10277 2336896
Blood pressure inadequately controlled 658.59 23.16 145 10767 755 2346418
Angioedema 604.83 23.16 220 10692 8176 2338997
Oedema peripheral 590.44 23.16 292 10620 23471 2323702
Syncope 530.73 23.16 244 10668 16631 2330542
Feeling abnormal 507.35 23.16 263 10649 23318 2323855
Diabetes mellitus 490.21 23.16 183 10729 7312 2339861
Asthenia 488.80 23.16 327 10585 46599 2300574
Renal impairment 478.15 23.16 195 10717 9897 2337276
Death 469.72 23.16 398 10514 81070 2266103
Headache 458.68 23.16 390 10522 79789 2267384
Pruritus 429.53 23.16 293 10619 43047 2304126
Blood potassium increased 429.49 23.16 123 10789 2073 2345100
Atrial fibrillation 423.00 23.16 196 10716 13572 2333601
Renal failure 406.16 23.16 205 10707 17144 2330029
Drug ineffective 403.45 23.16 403 10509 101221 2245952
Wrong technique in product usage process 378.31 23.16 204 10708 19544 2327629
Chest pain 363.82 23.16 225 10687 27912 2319261
General physical health deterioration 348.25 23.16 173 10739 13966 2333207
Blood pressure fluctuation 344.24 23.16 100 10812 1775 2345398
Cerebrovascular accident 341.12 23.16 192 10720 19994 2327179
Product prescribing error 339.54 23.16 110 10802 2850 2344323
Nausea 333.76 23.16 382 10530 111807 2235366
Weight decreased 331.96 23.16 213 10699 28158 2319015
Gait disturbance 326.60 23.16 194 10718 22351 2324822
Weight increased 323.03 23.16 192 10720 22145 2325028
Blood urea increased 310.52 23.16 108 10804 3497 2343676
Dehydration 307.74 23.16 186 10726 22109 2325064
Rash 303.89 23.16 272 10640 59286 2287887
Myocardial infarction 302.75 23.16 174 10738 18839 2328334
Memory impairment 288.50 23.16 148 10764 12775 2334398
Peripheral swelling 277.33 23.16 160 10752 17437 2329736
Blood pressure diastolic decreased 271.98 23.16 74 10838 1021 2346152
Loss of consciousness 270.38 23.16 161 10751 18606 2328567
Angina pectoris 266.45 23.16 99 10813 3888 2343285
Diarrhoea 263.96 23.16 294 10618 83270 2263903
Blood glucose increased 260.64 23.16 136 10776 12154 2335019
Hypokalaemia 252.27 23.16 127 10785 10527 2336646
Pneumonia 241.03 23.16 220 10692 49076 2298097
Glomerular filtration rate decreased 240.60 23.16 72 10840 1421 2345752
Oligohydramnios 239.00 23.16 65 10847 895 2346278
Decreased appetite 238.42 23.16 175 10737 28716 2318457
Inappropriate schedule of product administration 230.41 23.16 125 10787 12079 2335094
Arrhythmia 226.82 23.16 99 10813 5929 2341244
Oedema 219.41 23.16 114 10798 10089 2337084
Vomiting 219.11 23.16 248 10664 71354 2275819
Palpitations 218.43 23.16 134 10778 16322 2330851
Blood pressure systolic increased 216.61 23.16 74 10838 2265 2344908
Pain in extremity 204.18 23.16 188 10724 42352 2304821
Fluid retention 199.70 23.16 95 10817 6951 2340222
Lip swelling 197.18 23.16 84 10828 4737 2342436
Contraindicated product administered 194.46 23.16 73 10839 2948 2344225
Asthma 191.87 23.16 108 10804 11206 2335967
Confusional state 190.73 23.16 143 10769 24201 2322972
Ejection fraction decreased 188.75 23.16 70 10842 2731 2344442
Insomnia 187.77 23.16 145 10767 25642 2321531
Cerebral infarction 187.07 23.16 79 10833 4358 2342815
No adverse event 186.51 23.16 100 10812 9428 2337745
Anaemia 185.09 23.16 163 10749 34629 2312544
Urinary tract infection 183.16 23.16 152 10760 29790 2317383
Pain 181.85 23.16 210 10702 61647 2285526
Orthostatic hypotension 179.61 23.16 68 10844 2811 2344362
Hypersensitivity 179.07 23.16 136 10776 23457 2323716
Cardiac disorder 175.50 23.16 90 10822 7743 2339430
Visual impairment 174.76 23.16 103 10809 11652 2335521
Drug intolerance 172.59 23.16 108 10804 13609 2333564
Heart rate increased 169.54 23.16 99 10813 11006 2336167
Abdominal discomfort 167.46 23.16 116 10796 17340 2329833
Swollen tongue 166.70 23.16 77 10835 5266 2341907
Cardiogenic shock 163.25 23.16 61 10851 2430 2344743
Blood pressure abnormal 161.99 23.16 55 10857 1650 2345523
Nervousness 159.45 23.16 74 10838 5115 2342058
Concomitant disease aggravated 159.38 23.16 48 10864 968 2346205
Swelling face 156.55 23.16 89 10823 9404 2337769
Chest discomfort 154.27 23.16 103 10809 14492 2332681
Renal disorder 153.63 23.16 69 10843 4419 2342754
Chronic kidney disease 149.57 23.16 66 10846 4052 2343121
Hypertensive crisis 148.29 23.16 57 10855 2456 2344717
Myalgia 147.93 23.16 121 10791 23212 2323961
Muscle spasms 147.68 23.16 117 10795 21449 2325724
Mitral valve incompetence 147.48 23.16 57 10855 2493 2344680
Heart rate decreased 143.54 23.16 62 10850 3614 2343559
Breast cancer 140.58 23.16 83 10829 9412 2337761
Cardiac failure chronic 138.35 23.16 36 10876 413 2346760
Nasopharyngitis 134.83 23.16 112 10800 21944 2325229
Tachycardia 134.25 23.16 99 10813 16310 2330863
C-reactive protein increased 131.84 23.16 69 10843 6186 2340987
Lymphatic fistula 131.62 23.16 21 10891 2 2347171
Bradycardia 131.62 23.16 81 10831 9900 2337273
Cardiac failure congestive 131.40 23.16 97 10815 16004 2331169
Anuria 128.09 23.16 47 10865 1777 2345396
Arthralgia 127.99 23.16 165 10747 54120 2293053
Femoral hernia incarcerated 126.76 23.16 21 10891 8 2347165
Somnolence 126.69 23.16 111 10801 23374 2323799
Left ventricular dysfunction 125.69 23.16 42 10870 1198 2345975
Blood sodium decreased 123.37 23.16 53 10859 3047 2344126
Interstitial lung disease 122.79 23.16 71 10841 7741 2339432
Gamma-glutamyltransferase increased 121.93 23.16 63 10849 5499 2341674
Blood potassium decreased 121.83 23.16 62 10850 5243 2341930
Pyrexia 121.55 23.16 160 10752 53548 2293625
Tricuspid valve incompetence 121.22 23.16 44 10868 1612 2345561
Back pain 119.89 23.16 123 10789 31536 2315637
Pancreatic steatosis 119.76 23.16 22 10890 33 2347140
Swelling 112.51 23.16 89 10823 16261 2330912
Abdominal pain upper 110.33 23.16 100 10812 22000 2325173
Coronary artery disease 109.66 23.16 60 10852 5879 2341294
Cataract 107.19 23.16 59 10853 5849 2341324
Hepatic cyst 106.90 23.16 32 10880 631 2346542
Erythema 106.74 23.16 104 10808 25055 2322118
Abdominal pain 106.32 23.16 120 10792 34254 2312919
Stress 106.23 23.16 62 10850 6876 2340297
Aspartate aminotransferase increased 105.17 23.16 77 10835 12535 2334638
Wound infection pseudomonas 103.97 23.16 21 10891 65 2347108
Anxiety 103.84 23.16 110 10802 29249 2317924
Dementia Alzheimer's type 103.32 23.16 33 10879 813 2346360
Urinary retention 102.49 23.16 49 10863 3618 2343555
Arterial haemorrhage 101.96 23.16 24 10888 175 2346998
Pollakiuria 101.37 23.16 49 10863 3707 2343466
Influenza 100.97 23.16 76 10836 12902 2334271
Chronic obstructive pulmonary disease 99.87 23.16 60 10852 7017 2340156
Blood cholesterol increased 99.68 23.16 54 10858 5187 2341986
Tachyarrhythmia 99.17 23.16 30 10882 614 2346559
Depression 97.00 23.16 104 10808 28028 2319145
Vision blurred 96.97 23.16 78 10834 14590 2332583
Gout 96.67 23.16 36 10876 1419 2345754
Aortic arteriosclerosis 95.52 23.16 29 10883 601 2346572
Condition aggravated 94.41 23.16 109 10803 31870 2315303
Inflammatory marker increased 93.83 23.16 28 10884 546 2346627
Aortic valve stenosis 93.78 23.16 25 10887 317 2346856
Alanine aminotransferase increased 93.57 23.16 75 10837 13957 2333216
Blood creatine phosphokinase increased 92.37 23.16 51 10861 5085 2342088
Cardiomegaly 92.17 23.16 40 10872 2356 2344817
Drug hypersensitivity 91.89 23.16 130 10782 46513 2300660
Tremor 90.60 23.16 87 10825 20574 2326599
Hemiplegia 90.56 23.16 34 10878 1371 2345802
Hypoacusis 90.37 23.16 44 10868 3381 2343792
Arthritis 90.28 23.16 64 10848 9904 2337269
Muscular weakness 89.63 23.16 75 10837 14822 2332351
Blood alkaline phosphatase increased 88.51 23.16 54 10858 6491 2340682
Hypoaesthesia 88.41 23.16 85 10827 20130 2327043
Glaucoma 87.26 23.16 37 10875 2058 2345115
Blood lactate dehydrogenase increased 86.68 23.16 43 10869 3441 2343732
Haematuria 86.34 23.16 46 10866 4272 2342901
Pleural effusion 85.62 23.16 66 10846 11602 2335571
Dementia 84.72 23.16 39 10873 2642 2344531
Weight fluctuation 84.57 23.16 27 10885 664 2346509
Speech disorder 84.02 23.16 52 10860 6412 2340761
Coma 83.99 23.16 59 10853 8997 2338176
Ventricular extrasystoles 82.81 23.16 35 10877 1931 2345242
Dysphagia 82.31 23.16 67 10845 12738 2334435
Drug interaction 82.05 23.16 97 10815 29066 2318107
Dyspepsia 81.82 23.16 60 10852 9784 2337389
Blood uric acid increased 81.61 23.16 26 10886 635 2346538
Diabetes mellitus inadequate control 80.84 23.16 34 10878 1853 2345320
Pulmonary oedema 80.23 23.16 53 10859 7310 2339863
Cardiovascular disorder 79.91 23.16 36 10876 2319 2344854
Seroma 79.75 23.16 21 10891 253 2346920
Haemarthrosis 79.37 23.16 23 10889 403 2346770
Infarction 79.00 23.16 25 10887 597 2346576
Urticaria 78.91 23.16 87 10825 24174 2322999
Glycosylated haemoglobin increased 78.42 23.16 33 10879 1801 2345372
Forced expiratory volume decreased 78.00 23.16 24 10888 521 2346652
N-terminal prohormone brain natriuretic peptide increased 77.74 23.16 18 10894 121 2347052
Faecaloma 77.13 23.16 27 10885 888 2346285
Diverticulum intestinal 76.74 23.16 25 10887 657 2346516
Pulmonary hypertension 76.39 23.16 45 10867 5073 2342100
Fear 76.29 23.16 36 10876 2580 2344593
Bronchitis 76.26 23.16 66 10846 13648 2333525
Dizziness postural 76.03 23.16 27 10885 927 2346246
Balance disorder 75.62 23.16 57 10855 9690 2337483
Rhabdomyolysis 74.85 23.16 49 10863 6655 2340518
Eructation 74.46 23.16 28 10884 1134 2346039
Blood pressure systolic decreased 74.24 23.16 25 10887 730 2346443
Neoplasm malignant 73.98 23.16 44 10868 5049 2342124
Depressed level of consciousness 73.93 23.16 51 10861 7553 2339620
Groin pain 73.88 23.16 29 10883 1321 2345852
Hypoglycaemia 73.87 23.16 53 10859 8354 2338819
Osteoarthritis 73.27 23.16 49 10863 6897 2340276
Transient ischaemic attack 72.43 23.16 46 10866 5932 2341241
Brain natriuretic peptide increased 71.38 23.16 23 10889 583 2346590
Vertigo 70.86 23.16 54 10858 9330 2337843
Maternal exposure during pregnancy 69.74 23.16 65 10847 14798 2332375
Heart rate irregular 69.55 23.16 33 10879 2394 2344779
Deafness 69.16 23.16 34 10878 2667 2344506
Cardiac failure acute 68.90 23.16 26 10886 1063 2346110
Product use in unapproved indication 68.62 23.16 57 10855 11143 2336030
Wound dehiscence 68.03 23.16 23 10889 680 2346493
Gait inability 67.64 23.16 44 10868 5911 2341262
Lower respiratory tract infection 66.37 23.16 42 10870 5382 2341791
Thrombotic stroke 66.23 23.16 16 10896 132 2347041
Suicide attempt 66.19 23.16 56 10856 11226 2335947
Tinnitus 65.94 23.16 41 10871 5094 2342079
Orthopnoea 65.80 23.16 22 10890 628 2346545
Urinary incontinence 65.23 23.16 38 10874 4195 2342978
Electrocardiogram QRS complex prolonged 65.01 23.16 25 10887 1077 2346096
Joint dislocation 64.94 23.16 27 10885 1429 2345744
Alopecia 64.89 23.16 75 10837 21926 2325247
Circulatory collapse 64.31 23.16 36 10876 3684 2343489
Head injury 64.25 23.16 37 10875 3997 2343176
Spinal pain 63.57 23.16 26 10886 1319 2345854
Dysstasia 63.56 23.16 33 10879 2906 2344267
Escherichia infection 63.52 23.16 26 10886 1322 2345851
Gastrointestinal haemorrhage 63.44 23.16 57 10855 12378 2334795
Total lung capacity increased 63.37 23.16 11 10901 9 2347164
Agitation 63.09 23.16 54 10858 10997 2336176
Joint swelling 62.95 23.16 65 10847 16754 2330419
Gastroenteritis 62.30 23.16 33 10879 3027 2344146
Limb discomfort 61.98 23.16 34 10878 3345 2343828
Dyspnoea exertional 61.89 23.16 41 10871 5679 2341494
Sudden death 61.73 23.16 28 10884 1832 2345341
Hyperglycaemia 60.20 23.16 38 10874 4847 2342326
Wheezing 60.13 23.16 42 10870 6342 2340831
Left ventricular hypertrophy 60.01 23.16 21 10891 690 2346483
Visual acuity reduced 59.82 23.16 39 10873 5259 2341914
Exposure during pregnancy 59.81 23.16 77 10835 25142 2322031
Labile hypertension 59.24 23.16 13 10899 66 2347107
Atrioventricular block complete 58.97 23.16 25 10887 1389 2345784
Haemoglobin decreased 58.84 23.16 65 10847 18086 2329087
Aplastic anaemia 58.71 23.16 22 10890 882 2346291
Hypochloraemia 58.55 23.16 17 10895 300 2346873
Presyncope 58.23 23.16 34 10878 3769 2343404
Toxicity to various agents 58.18 23.16 87 10825 32667 2314506
Osteopenia 57.56 23.16 27 10885 1908 2345265
Amnesia 57.55 23.16 43 10869 7210 2339963
Wound 57.19 23.16 30 10882 2698 2344475
Respiratory disorder 56.61 23.16 34 10878 3970 2343203
Polyuria 56.38 23.16 23 10889 1159 2346014
Device stimulation issue 56.28 23.16 9 10903 1 2347172
Apparent death 56.23 23.16 17 10895 347 2346826
Cerebral haemorrhage 56.06 23.16 38 10874 5466 2341707
Prescribed underdose 55.93 23.16 27 10885 2035 2345138
Accident 55.92 23.16 21 10891 847 2346326
Incorrect dose administered 54.57 23.16 47 10865 9648 2337525
Liver disorder 53.07 23.16 39 10873 6375 2340798
Postoperative wound infection 52.73 23.16 22 10890 1174 2345999
Hiatus hernia 52.66 23.16 26 10886 2058 2345115
Basilar artery occlusion 52.61 23.16 10 10902 20 2347153
Hepatic function abnormal 52.58 23.16 38 10874 6054 2341119
Gastritis 52.40 23.16 34 10878 4547 2342626
Renal artery stenosis 52.29 23.16 15 10897 253 2346920
Hip fracture 51.52 23.16 34 10878 4678 2342495
Constipation 51.21 23.16 66 10846 21563 2325610
Dysphonia 51.09 23.16 38 10874 6326 2340847
Movement disorder 50.61 23.16 28 10884 2800 2344373
Product dispensing error 50.59 23.16 27 10885 2514 2344659
Rales 50.49 23.16 21 10891 1112 2346061
Productive cough 50.10 23.16 35 10877 5286 2341887
Gastrointestinal disorder 49.72 23.16 43 10869 8874 2338299
Hyperhidrosis 49.58 23.16 55 10857 15367 2331806
Face oedema 49.37 23.16 31 10881 3917 2343256
Fibromyalgia 49.20 23.16 29 10883 3271 2343902
Dysarthria 49.19 23.16 37 10875 6265 2340908
Paraesthesia 48.58 23.16 65 10847 22023 2325150
Intentional overdose 48.32 23.16 47 10865 11274 2335899
Low density lipoprotein increased 48.24 23.16 21 10891 1245 2345928
Recalled product administered 48.04 23.16 9 10903 16 2347157
Pulmonary hypoplasia 48.02 23.16 11 10901 70 2347103
Abdominal distension 47.80 23.16 45 10867 10366 2336807
Altered state of consciousness 47.49 23.16 30 10882 3830 2343343
Eczema 47.35 23.16 28 10884 3177 2343996
Electrocardiogram abnormal 46.98 23.16 21 10891 1327 2345846
Blood glucose decreased 46.97 23.16 28 10884 3224 2343949
Thyroid disorder 46.95 23.16 22 10890 1551 2345622
Thrombosis 46.80 23.16 42 10870 9102 2338071
Lacunar infarction 46.63 23.16 17 10895 630 2346543
Disorientation 46.63 23.16 36 10876 6336 2340837
Obstructive airways disorder 46.61 23.16 21 10891 1352 2345821
Lethargy 46.47 23.16 41 10871 8689 2338484
Bundle branch block left 46.43 23.16 19 10893 965 2346208
Dry mouth 46.43 23.16 40 10872 8213 2338960
Generalised oedema 46.35 23.16 25 10887 2378 2344795
Drug-induced liver injury 46.14 23.16 29 10883 3670 2343503
Cardiac arrest 45.86 23.16 52 10860 14878 2332295
Atrioventricular block 45.77 23.16 20 10892 1197 2345976
Sinus node dysfunction 45.47 23.16 17 10895 677 2346496
Throat irritation 44.84 23.16 32 10880 4998 2342175
Respiratory failure 44.79 23.16 49 10863 13479 2333694
Dysuria 44.46 23.16 29 10883 3912 2343261
Surgery 44.32 23.16 33 10879 5502 2341671
Discomfort 44.11 23.16 32 10880 5127 2342046
Cardiac pacemaker insertion 44.10 23.16 17 10895 737 2346436
Eye swelling 43.97 23.16 30 10882 4360 2342813
Lower limb fracture 43.95 23.16 23 10889 2058 2345115
Underdose 43.73 23.16 34 10878 6044 2341129
Foetal exposure during pregnancy 43.60 23.16 32 10880 5220 2341953
Breast pain 43.48 23.16 20 10892 1351 2345822
Sleep apnoea syndrome 43.48 23.16 23 10889 2103 2345070
White blood cell count increased 43.29 23.16 36 10876 7042 2340131
Head discomfort 42.91 23.16 21 10891 1630 2345543
Arterial occlusive disease 42.61 23.16 16 10896 645 2346528
Nephropathy 42.51 23.16 17 10895 813 2346360
Hepatitis 42.48 23.16 34 10878 6303 2340870
Frustration tolerance decreased 42.45 23.16 17 10895 816 2346357
Myocardial ischaemia 42.14 23.16 23 10889 2239 2344934
Seizure 42.02 23.16 64 10848 24402 2322771
Metabolic acidosis 41.96 23.16 33 10879 5965 2341208
Arteriosclerosis 41.92 23.16 20 10892 1468 2345705
Acute pulmonary oedema 41.87 23.16 19 10893 1244 2345929
Urine output decreased 41.53 23.16 20 10892 1499 2345674
Choking 41.29 23.16 20 10892 1518 2345655
Aortic valve incompetence 41.27 23.16 17 10895 878 2346295
Creatinine renal clearance decreased 40.89 23.16 17 10895 899 2346274
Sinus bradycardia 40.77 23.16 22 10890 2094 2345079
Ophthalmic vein thrombosis 40.30 23.16 8 10904 22 2347151
Glucose tolerance impaired 40.25 23.16 15 10897 592 2346581
Acute myocardial infarction 40.16 23.16 30 10882 5025 2342148
Cardiomyopathy 40.10 23.16 24 10888 2783 2344390
Product substitution issue 40.09 23.16 30 10882 5039 2342134
Limb injury 39.91 23.16 23 10889 2487 2344686
Sleep disorder 39.68 23.16 33 10879 6456 2340717
Myelodysplastic syndrome 39.49 23.16 23 10889 2537 2344636
Depressed mood 39.42 23.16 30 10882 5168 2342005
Blindness 39.29 23.16 26 10886 3592 2343581
Eating disorder 39.22 23.16 22 10890 2259 2344914
General physical condition abnormal 38.68 23.16 15 10897 661 2346512
Cholelithiasis 38.61 23.16 31 10881 5772 2341401
Impaired healing 38.35 23.16 30 10882 5381 2341792
Ischaemic stroke 38.32 23.16 25 10887 3372 2343801
Brain stem stroke 38.06 23.16 9 10903 67 2347106
Joint injury 37.98 23.16 22 10890 2402 2344771
Parkinson's disease 37.90 23.16 18 10894 1308 2345865
Paralysis 37.86 23.16 20 10892 1824 2345349
Haematoma 37.61 23.16 29 10883 5092 2342081
Road traffic accident 37.46 23.16 27 10885 4281 2342892
Pulmonary thrombosis 37.40 23.16 17 10895 1117 2346056
Thrombocytopenia 37.10 23.16 53 10859 19078 2328095
Pulmonary congestion 36.66 23.16 20 10892 1945 2345228
Hyperuricaemia 36.65 23.16 14 10898 592 2346581
Lactic acidosis 36.59 23.16 29 10883 5301 2341872
Aphasia 36.40 23.16 28 10884 4900 2342273
Atrial flutter 36.25 23.16 17 10895 1200 2345973
Macular degeneration 36.17 23.16 17 10895 1206 2345967
Oral pain 35.90 23.16 24 10888 3373 2343800
Product colour issue 35.86 23.16 11 10901 236 2346937
Intervertebral disc protrusion 35.83 23.16 23 10889 3018 2344155
Premature labour 35.37 23.16 20 10892 2086 2345087
Labyrinthitis 35.32 23.16 12 10900 360 2346813
Haematocrit decreased 35.14 23.16 26 10886 4292 2342881
Product odour abnormal 35.10 23.16 12 10900 367 2346806
Musculoskeletal discomfort 35.08 23.16 20 10892 2118 2345055
Renal cancer 35.00 23.16 14 10898 670 2346503
Inflammation 34.71 23.16 30 10882 6183 2340990
Eye disorder 34.64 23.16 23 10889 3196 2343977
Osteoporosis 34.63 23.16 26 10886 4388 2342785
Blood bilirubin increased 34.39 23.16 28 10884 5317 2341856
Eosinophil count increased 34.27 23.16 16 10896 1118 2346055
Left ventricular failure 34.19 23.16 14 10898 712 2346461
Sepsis 34.08 23.16 50 10862 18438 2328735
Cholestasis 33.92 23.16 24 10888 3697 2343476
Infection 33.58 23.16 49 10863 17980 2329193
Hypovolaemia 33.37 23.16 16 10896 1187 2345986
Diabetic nephropathy 32.72 23.16 10 10902 212 2346961
Coronary artery stenosis 32.53 23.16 14 10898 807 2346366
Lipoedema 32.50 23.16 7 10905 32 2347141
Respiration abnormal 32.48 23.16 13 10899 623 2346550
Bladder spasm 32.07 23.16 10 10902 227 2346946
Ventricular fibrillation 31.91 23.16 19 10893 2182 2344991
Heart valve incompetence 31.70 23.16 11 10901 352 2346821
Hypercholesterolaemia 31.67 23.16 17 10895 1601 2345572
Lymphocyte stimulation test positive 31.67 23.16 10 10902 237 2346936
Gastric cancer 31.55 23.16 13 10899 672 2346501
Distributive shock 31.21 23.16 8 10904 86 2347087
Inappropriate antidiuretic hormone secretion 31.07 23.16 19 10893 2290 2344883
Platelet count decreased 30.94 23.16 44 10868 15769 2331404
Cardiac valve disease 30.82 23.16 13 10899 713 2346460
Sputum discoloured 30.81 23.16 15 10897 1151 2346022
Delirium 30.77 23.16 26 10886 5197 2341976
Normochromic normocytic anaemia 30.72 23.16 13 10899 719 2346454
Pharyngeal oedema 30.62 23.16 22 10890 3471 2343702
Hypokinesia 30.38 23.16 17 10895 1737 2345436
Facial paralysis 30.26 23.16 19 10893 2400 2344773
Anal incontinence 30.22 23.16 17 10895 1755 2345418
Cardio-respiratory arrest 30.04 23.16 33 10879 9113 2338060
Hepatic steatosis 29.93 23.16 21 10891 3192 2343981
Purpura 29.88 23.16 17 10895 1793 2345380
Cardiac myxoma 29.86 23.16 7 10905 50 2347123
Hepatic enzyme increased 29.86 23.16 34 10878 9768 2337405
Proteinuria 29.79 23.16 20 10892 2830 2344343
Malabsorption 29.61 23.16 12 10900 594 2346579
Normochromic anaemia 29.60 23.16 6 10906 19 2347154
Jaundice 29.57 23.16 26 10886 5482 2341691
Ejection fraction abnormal 29.54 23.16 8 10904 108 2347065
Sinus arrest 29.47 23.16 10 10902 299 2346874
Colon cancer 29.34 23.16 17 10895 1856 2345317
Respiratory distress 29.13 23.16 25 10887 5104 2342069
Blood sodium increased 28.77 23.16 11 10901 466 2346707
Cardiac murmur 28.59 23.16 16 10896 1635 2345538
Angina unstable 28.56 23.16 15 10897 1351 2345822
Gastrooesophageal reflux disease 28.47 23.16 32 10880 9063 2338110
Intracranial aneurysm 28.33 23.16 12 10900 665 2346508
Duodenal ulcer 28.22 23.16 14 10898 1119 2346054
Carpal tunnel syndrome 28.11 23.16 17 10895 2008 2345165
Lymphoedema 28.08 23.16 14 10898 1131 2346042
Incontinence 27.68 23.16 15 10897 1439 2345734
Spinal osteoarthritis 27.66 23.16 16 10896 1741 2345432
Dyslipidaemia 27.19 23.16 12 10900 735 2346438
Globulins increased 27.16 23.16 7 10905 77 2347096
Product use issue 27.02 23.16 36 10876 12133 2335040
Femur fracture 26.93 23.16 27 10885 6712 2340461
Lung disorder 26.89 23.16 26 10886 6186 2340987
Type 2 diabetes mellitus 26.86 23.16 17 10895 2177 2344996
Hypomagnesaemia 26.82 23.16 18 10894 2546 2344627
Post procedural complication 26.80 23.16 19 10893 2935 2344238
Urinary tract infection enterococcal 26.75 23.16 9 10903 262 2346911
Red blood cell count decreased 26.71 23.16 22 10890 4244 2342929
Electrocardiogram ST segment depression 26.65 23.16 11 10901 571 2346602
Haemorrhage 26.60 23.16 34 10878 11005 2336168
Acute coronary syndrome 26.54 23.16 15 10897 1562 2345611
Ankle fracture 26.36 23.16 17 10895 2248 2344925
Labelled drug-drug interaction medication error 26.32 23.16 14 10898 1294 2345879
Lung neoplasm malignant 26.30 23.16 19 10893 3023 2344150
Renal atrophy 26.29 23.16 8 10904 167 2347006
Pancreatitis 26.27 23.16 29 10883 8050 2339123
Red cell distribution width increased 26.27 23.16 11 10901 592 2346581
Azotaemia 26.24 23.16 11 10901 594 2346579
Agranulocytosis 26.19 23.16 20 10892 3462 2343711
Paraesthesia oral 26.16 23.16 17 10895 2277 2344896
Oxygen saturation decreased 26.01 23.16 28 10884 7558 2339615
Concomitant disease progression 25.90 23.16 10 10902 435 2346738
Upper limb fracture 25.83 23.16 18 10894 2705 2344468
Shock 25.81 23.16 21 10891 3983 2343190
Fracture 25.79 23.16 18 10894 2713 2344460
Contusion 25.58 23.16 36 10876 12774 2334399
Skin irritation 25.57 23.16 14 10898 1371 2345802
Endometrial cancer 25.53 23.16 11 10901 636 2346537
Premature baby 25.42 23.16 19 10893 3185 2343988
Electrocardiogram QT prolonged 25.33 23.16 28 10884 7786 2339387
Foetal growth restriction 25.22 23.16 13 10899 1127 2346046
Nocturia 25.18 23.16 12 10900 878 2346295
Stevens-Johnson syndrome 24.67 23.16 21 10891 4238 2342935
Blood chloride decreased 24.60 23.16 11 10901 695 2346478
Catheterisation cardiac 24.56 23.16 11 10901 698 2346475
Feeling hot 24.51 23.16 26 10886 6902 2340271
Angioplasty 24.42 23.16 8 10904 214 2346959
Rib fracture 24.32 23.16 17 10895 2568 2344605
Ventricular tachycardia 24.21 23.16 18 10894 2993 2344180
Body height decreased 24.18 23.16 13 10899 1228 2345945
Hemiparesis 24.17 23.16 19 10893 3431 2343742
Completed suicide 24.13 23.16 46 10866 20988 2326185
Multiple organ dysfunction syndrome 24.11 23.16 27 10885 7614 2339559
Eye pain 24.10 23.16 22 10890 4869 2342304
Eyelid oedema 24.08 23.16 17 10895 2609 2344564
Neck pain 23.95 23.16 27 10885 7670 2339503
Pulmonary embolism 23.85 23.16 42 10870 18041 2329132
Heart rate abnormal 23.84 23.16 10 10902 541 2346632
Hypophagia 23.74 23.16 20 10892 3980 2343193
Myelopathy 23.73 23.16 9 10903 373 2346800
Varicose vein 23.70 23.16 11 10901 758 2346415
Skin lesion 23.63 23.16 20 10892 4005 2343168
Blood glucose abnormal 23.63 23.16 13 10899 1285 2345888
Acidosis 23.61 23.16 14 10898 1596 2345577
Therapeutic drug monitoring analysis not performed 23.56 23.16 5 10907 21 2347152
Pigmentation disorder 23.54 23.16 11 10901 770 2346403
Thrombophlebitis 23.44 23.16 11 10901 778 2346395
Overdose 23.42 23.16 44 10868 19863 2327310
Ascites 23.35 23.16 23 10889 5597 2341576
Arthropathy 23.34 23.16 26 10886 7290 2339883
Faeces discoloured 23.33 23.16 16 10896 2343 2344830
Skin disorder 23.31 23.16 19 10893 3612 2343561
Dyspnoea at rest 23.30 23.16 9 10903 392 2346781
Flushing 23.17 23.16 33 10879 11838 2335335

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 4254.95 31.69 1576 13142 28078 1703985
Dizziness 2080.05 31.69 994 13724 33367 1698696
Cardiac failure 1906.60 31.69 702 14016 11900 1720163
Dyspnoea 1574.62 31.69 950 13768 51109 1680954
Blood creatinine increased 1293.21 31.69 546 14172 13400 1718663
Hyperkalaemia 1064.12 31.69 414 14304 8133 1723930
Acute kidney injury 1028.51 31.69 629 14089 34315 1697748
Blood pressure decreased 1025.33 31.69 391 14327 7255 1724808
Fatigue 918.11 31.69 675 14043 50106 1681957
Death 912.30 31.69 843 13875 86600 1645463
Cough 875.54 31.69 461 14257 18736 1713327
Renal failure 779.49 31.69 433 14285 19584 1712479
Blood pressure increased 705.28 31.69 331 14387 10422 1721641
Malaise 676.29 31.69 455 14263 29110 1702953
Blood potassium increased 653.04 31.69 211 14507 2319 1729744
Renal impairment 650.77 31.69 327 14391 11987 1720076
Syncope 647.08 31.69 341 14377 13828 1718235
Angioedema 616.65 31.69 292 14426 9372 1722691
Hypertension 600.28 31.69 362 14356 19086 1712977
Weight increased 598.23 31.69 301 14417 11056 1721007
Asthenia 533.56 31.69 420 14298 34250 1697813
Wrong technique in product usage process 504.64 31.69 262 14456 10273 1721790
Contraindicated product administered 483.51 31.69 147 14571 1297 1730766
Fall 475.96 31.69 356 14362 26858 1705205
Ejection fraction decreased 470.23 31.69 160 14558 2085 1729978
No adverse event 468.72 31.69 200 14518 4982 1727081
Blood urea increased 463.38 31.69 193 14525 4518 1727545
Product prescribing error 436.11 31.69 154 14564 2256 1729807
Oedema peripheral 404.68 31.69 260 14458 15290 1716773
Weight decreased 398.26 31.69 298 14420 22455 1709608
Inappropriate schedule of product administration 387.32 31.69 196 14522 7263 1724800
Pruritus 373.02 31.69 289 14429 22933 1709130
Chest pain 371.27 31.69 271 14447 19643 1712420
Atrial fibrillation 364.57 31.69 241 14477 14870 1717193
Feeling abnormal 351.89 31.69 211 14507 10955 1721108
Fluid retention 344.26 31.69 147 14571 3662 1728401
Loss of consciousness 334.19 31.69 227 14491 14648 1717415
Cardiac failure chronic 332.68 31.69 92 14626 556 1731507
Blood pressure inadequately controlled 328.43 31.69 90 14628 523 1731540
Diarrhoea 326.26 31.69 391 14327 53461 1678602
Blood glucose increased 320.55 31.69 195 14523 10389 1721674
Oedema 304.51 31.69 163 14555 6785 1725278
Prescribed underdose 298.23 31.69 103 14615 1405 1730658
Cerebrovascular accident 292.39 31.69 225 14493 17641 1714422
Peripheral swelling 283.56 31.69 163 14555 7808 1724255
Myocardial infarction 283.54 31.69 264 14454 26910 1705153
Blood pressure systolic decreased 281.59 31.69 82 14636 612 1731451
Ventricular tachycardia 273.53 31.69 125 14593 3673 1728390
Glomerular filtration rate decreased 270.72 31.69 95 14623 1362 1730701
Hyponatraemia 270.34 31.69 165 14553 8835 1723228
Diabetes mellitus 261.11 31.69 147 14571 6761 1725302
Rash 248.79 31.69 290 14428 38403 1693660
Hypoacusis 247.05 31.69 103 14615 2410 1729653
Blood pressure fluctuation 245.50 31.69 86 14632 1226 1730837
Orthostatic hypotension 237.90 31.69 110 14608 3321 1728742
Dehydration 224.53 31.69 192 14526 17466 1714597
Cardiogenic shock 222.60 31.69 95 14623 2359 1729704
Drug ineffective 220.90 31.69 354 14364 63447 1668616
Arrhythmia 219.17 31.69 125 14593 5891 1726172
Pulmonary oedema 219.12 31.69 129 14589 6457 1725606
Chronic kidney disease 208.12 31.69 108 14610 4209 1727854
Gait disturbance 203.66 31.69 158 14560 12512 1719551
Angina pectoris 198.32 31.69 110 14608 4908 1727155
Cerebral infarction 197.19 31.69 111 14607 5098 1726965
Nausea 194.97 31.69 297 14421 50899 1681164
Pneumonia 194.61 31.69 281 14437 45901 1686162
Heart rate decreased 194.53 31.69 90 14628 2719 1729344
Concomitant disease aggravated 190.80 31.69 62 14656 691 1731372
Mitral valve incompetence 185.50 31.69 78 14640 1864 1730199
Renal disorder 184.92 31.69 98 14620 3988 1728075
Cardiac disorder 183.54 31.69 122 14596 7569 1724494
Palpitations 177.02 31.69 114 14604 6700 1725363
C-reactive protein increased 174.31 31.69 107 14611 5778 1726285
Cardiac failure acute 172.93 31.69 65 14653 1144 1730919
Blood pressure abnormal 172.27 31.69 63 14655 1023 1731040
Haemoglobin decreased 171.90 31.69 163 14555 16951 1715112
Cardiac failure congestive 171.88 31.69 155 14563 15115 1716948
Lip swelling 170.33 31.69 82 14636 2713 1729350
Headache 165.27 31.69 223 14495 34153 1697910
Anaemia 164.84 31.69 206 14512 29251 1702812
Dizziness postural 163.93 31.69 57 14661 793 1731270
Chronic obstructive pulmonary disease 163.08 31.69 103 14615 5850 1726213
Blood pressure diastolic decreased 162.99 31.69 55 14663 695 1731368
Chest discomfort 157.53 31.69 109 14609 7222 1724841
Bradycardia 155.53 31.69 125 14593 10409 1721654
Hypokalaemia 154.21 31.69 102 14616 6272 1725791
Brain natriuretic peptide increased 152.77 31.69 49 14669 522 1731541
Gamma-glutamyltransferase increased 151.75 31.69 93 14625 5005 1727058
Swollen tongue 146.16 31.69 74 14644 2734 1729329
General physical health deterioration 145.31 31.69 132 14586 12986 1719077
Blood creatine phosphokinase increased 143.44 31.69 111 14607 8745 1723318
Blood uric acid increased 143.40 31.69 54 14664 955 1731108
Sudden death 142.95 31.69 74 14644 2866 1729197
Aspartate aminotransferase increased 140.73 31.69 119 14599 10637 1721426
Memory impairment 140.65 31.69 98 14620 6565 1725498
Insomnia 139.15 31.69 142 14576 16134 1715929
Cardiac arrest 138.04 31.69 140 14578 15790 1716273
Heart rate increased 135.66 31.69 95 14623 6415 1725648
Blood triglycerides increased 133.81 31.69 68 14650 2532 1729531
Product use in unapproved indication 133.14 31.69 109 14609 9313 1722750
Orthopnoea 132.46 31.69 45 14673 581 1731482
Pain in extremity 129.39 31.69 145 14573 18327 1713736
Tricuspid valve incompetence 128.94 31.69 53 14665 1193 1730870
Gout 127.62 31.69 66 14652 2550 1729513
Left ventricular hypertrophy 126.19 31.69 47 14671 805 1731258
Dyspnoea exertional 124.06 31.69 76 14642 4085 1727978
Pleural effusion 123.41 31.69 112 14606 10998 1721065
Alanine aminotransferase increased 121.40 31.69 116 14602 12162 1719901
Decreased appetite 120.92 31.69 159 14559 23712 1708351
Left ventricular dysfunction 120.20 31.69 50 14668 1161 1730902
Blood pressure systolic increased 119.18 31.69 55 14663 1650 1730413
Sudden cardiac death 118.71 31.69 45 14673 811 1731252
Acute myocardial infarction 118.51 31.69 98 14620 8489 1723574
Swelling face 116.38 31.69 75 14643 4408 1727655
N-terminal prohormone brain natriuretic peptide increased 116.18 31.69 28 14690 87 1731976
Drug intolerance 116.01 31.69 84 14634 5978 1726085
Myalgia 114.95 31.69 126 14592 15532 1716531
Haematocrit decreased 114.67 31.69 73 14645 4200 1727863
Nasopharyngitis 113.31 31.69 102 14616 9908 1722155
Somnolence 113.12 31.69 129 14589 16610 1715453
Interstitial lung disease 112.12 31.69 100 14618 9596 1722467
Blood sodium decreased 112.02 31.69 58 14660 2246 1729817
Visual impairment 111.85 31.69 83 14635 6135 1725928
Shock 108.96 31.69 70 14648 4091 1727972
Weight fluctuation 103.50 31.69 35 14683 445 1731618
Type 2 diabetes mellitus 102.15 31.69 51 14667 1827 1730236
Balance disorder 98.79 31.69 75 14643 5737 1726326
Vomiting 98.61 31.69 187 14531 38128 1693935
Blood creatine increased 98.19 31.69 38 14680 726 1731337
Glycosylated haemoglobin increased 95.96 31.69 49 14669 1842 1730221
Presyncope 95.34 31.69 55 14663 2643 1729420
Blood lactate dehydrogenase increased 94.19 31.69 61 14657 3614 1728449
Diastolic dysfunction 93.29 31.69 33 14685 484 1731579
Joint swelling 92.88 31.69 75 14643 6278 1725785
Heart rate irregular 92.17 31.69 46 14672 1646 1730417
Blood cholesterol increased 92.06 31.69 56 14662 2970 1729093
Underdose 91.17 31.69 61 14657 3819 1728244
Pollakiuria 90.86 31.69 55 14663 2891 1729172
Productive cough 90.55 31.69 59 14659 3532 1728531
Metabolic acidosis 90.24 31.69 69 14649 5333 1726730
Neoplasm malignant 89.62 31.69 63 14655 4276 1727787
Back pain 87.70 31.69 113 14605 16500 1715563
Device malfunction 87.19 31.69 47 14671 1977 1730086
Muscular weakness 86.75 31.69 89 14629 10160 1721903
Red blood cell count decreased 86.72 31.69 58 14660 3628 1728435
Vertigo 86.36 31.69 62 14656 4351 1727712
Ventricular extrasystoles 86.32 31.69 46 14672 1890 1730173
Hypoaesthesia 86.15 31.69 87 14631 9748 1722315
Cardiorenal syndrome 85.78 31.69 21 14697 71 1731992
Eosinophil count increased 85.02 31.69 41 14677 1360 1730703
Hypertensive crisis 84.62 31.69 42 14676 1485 1730578
Therapeutic response unexpected 84.55 31.69 49 14669 2375 1729688
Left atrial enlargement 84.44 31.69 19 14699 39 1732024
Acute pulmonary oedema 84.24 31.69 39 14679 1178 1730885
Ventricular fibrillation 83.83 31.69 51 14667 2705 1729358
Hemiplegia 83.61 31.69 40 14678 1303 1730760
Left ventricular dilatation 81.71 31.69 19 14699 48 1732015
Nephrogenic anaemia 81.47 31.69 24 14694 187 1731876
Hypertensive heart disease 81.38 31.69 29 14689 435 1731628
Cardiomegaly 80.93 31.69 47 14671 2287 1729776
Muscle spasms 79.21 31.69 90 14628 11531 1720532
Hypochromasia 78.73 31.69 17 14701 26 1732037
White blood cell count increased 77.81 31.69 72 14646 7240 1724823
Patent ductus arteriosus 77.52 31.69 31 14687 648 1731415
Urine output decreased 77.49 31.69 39 14679 1421 1730642
Urticaria 77.06 31.69 91 14627 12150 1719913
Swelling 76.61 31.69 70 14648 6926 1725137
Vision blurred 76.50 31.69 76 14642 8347 1723716
Hypoglycaemia 76.39 31.69 76 14642 8362 1723701
Arthralgia 75.10 31.69 126 14592 23318 1708745
Platelet count decreased 74.37 31.69 104 14614 16419 1715644
Brain natriuretic peptide abnormal 74.01 31.69 15 14703 13 1732050
Blood potassium decreased 73.76 31.69 44 14674 2251 1729812
Hyperglycaemia 73.43 31.69 60 14658 5105 1726958
Confusional state 73.06 31.69 118 14600 21160 1710903
Rhabdomyolysis 72.39 31.69 84 14634 11006 1721057
Pain 72.10 31.69 133 14585 26524 1705539
Hypervolaemia 71.03 31.69 20 14698 130 1731933
Abdominal pain 70.83 31.69 117 14601 21373 1710690
Left ventricular enlargement 70.10 31.69 16 14702 36 1732027
Abdominal pain upper 69.60 31.69 82 14636 10919 1721144
Depression 69.26 31.69 101 14617 16568 1715495
Apparent death 69.14 31.69 23 14695 277 1731786
Hypersensitivity 67.99 31.69 79 14639 10365 1721698
Ischaemic cardiomyopathy 67.89 31.69 33 14685 1114 1730949
Mitral valve thickening 66.65 31.69 13 14705 7 1732056
Ventricular arrhythmia 66.05 31.69 28 14690 682 1731381
Ventricular hypokinesia 65.79 31.69 28 14690 689 1731374
N-terminal prohormone brain natriuretic peptide abnormal 65.72 31.69 12 14706 1 1732062
Lethargy 65.56 31.69 65 14653 7119 1724944
Anuria 65.40 31.69 38 14680 1850 1730213
Blood alkaline phosphatase increased 64.87 31.69 56 14662 5139 1726924
Hepatic function abnormal 64.55 31.69 64 14654 7010 1725053
Hyperhidrosis 64.40 31.69 84 14634 12404 1719659
Condition aggravated 64.19 31.69 111 14607 21039 1711024
Pulmonary hypertension 64.15 31.69 43 14675 2699 1729364
Congestive cardiomyopathy 63.85 31.69 32 14686 1155 1730908
Ventricular hyperkinesia 63.76 31.69 13 14705 12 1732051
Speech disorder 62.90 31.69 52 14666 4496 1727567
Prostate cancer 62.13 31.69 52 14666 4574 1727489
Mean platelet volume increased 61.90 31.69 15 14703 48 1732015
Pharyngeal oedema 61.89 31.69 35 14683 1618 1730445
Right atrial enlargement 61.83 31.69 13 14705 16 1732047
Cardiomyopathy 61.62 31.69 42 14676 2710 1729353
Influenza 61.33 31.69 61 14657 6706 1725357
Blood glucose decreased 60.57 31.69 39 14679 2286 1729777
Myocardial ischaemia 60.50 31.69 44 14674 3149 1728914
Blood chloride increased 60.05 31.69 21 14697 297 1731766
Abdominal discomfort 59.62 31.69 69 14649 9012 1723051
Tachycardia 59.08 31.69 81 14637 12547 1719516
Liver disorder 58.99 31.69 55 14663 5581 1726482
Erythema 58.97 31.69 86 14632 14102 1717961
Bundle branch block left 58.79 31.69 27 14691 800 1731263
Bronchitis 58.78 31.69 54 14664 5378 1726685
Sepsis 55.08 31.69 99 14619 19339 1712724
Gastric cancer 54.64 31.69 28 14690 1060 1731003
Abdominal distension 54.58 31.69 56 14662 6388 1725675
Aortic aneurysm 53.58 31.69 27 14691 986 1731077
Fractured coccyx 53.53 31.69 12 14706 24 1732039
Eczema 53.29 31.69 36 14682 2288 1729775
Respiratory failure 53.28 31.69 83 14635 14422 1717641
Dementia Alzheimer's type 53.22 31.69 23 14695 588 1731475
Circulatory collapse 52.93 31.69 42 14676 3425 1728638
Renal artery stenosis 52.51 31.69 18 14700 239 1731824
Diabetic nephropathy 52.24 31.69 19 14699 303 1731760
Coronary artery disease 51.96 31.69 67 14651 9779 1722284
Dementia 51.76 31.69 34 14684 2062 1730001
Anxiety 51.75 31.69 85 14633 15442 1716621
Arterial occlusive disease 50.84 31.69 24 14694 758 1731305
Arteriosclerosis 50.64 31.69 32 14686 1815 1730248
Lymphocyte count decreased 50.29 31.69 34 14684 2164 1729899
Microalbuminuria 50.24 31.69 15 14703 123 1731940
Multiple organ dysfunction syndrome 48.94 31.69 63 14655 9179 1722884
Atrial septal defect 48.81 31.69 28 14690 1330 1730733
Pulmonary arterial pressure abnormal 48.74 31.69 11 14707 23 1732040
Oxygen saturation increased 48.74 31.69 11 14707 23 1732040
Dysphagia 48.73 31.69 66 14652 10102 1721961
Hyperuricaemia 48.55 31.69 25 14693 956 1731107
Aortic valve incompetence 48.41 31.69 23 14695 737 1731326
Sprue-like enteropathy 48.26 31.69 12 14706 44 1732019
Blood thyroid stimulating hormone abnormal 47.84 31.69 12 14706 46 1732017
Jugular vein distension 47.64 31.69 14 14704 108 1731955
Polyuria 47.06 31.69 27 14691 1283 1730780
Discomfort 46.95 31.69 35 14683 2601 1729462
Electrocardiogram QRS complex abnormal 46.30 31.69 12 14706 54 1732009
Lactic acidosis 46.04 31.69 46 14672 5083 1726980
Drug interaction 45.99 31.69 114 14604 27844 1704219
Premature baby 45.68 31.69 36 14682 2906 1729157
Disorientation 45.36 31.69 47 14671 5422 1726641
Lung neoplasm malignant 45.32 31.69 37 14681 3142 1728921
Pyrexia 45.31 31.69 157 14561 46243 1685820
High density lipoprotein decreased 45.27 31.69 21 14697 637 1731426
Paraesthesia oral 45.05 31.69 22 14696 750 1731313
Throat irritation 44.65 31.69 29 14689 1725 1730338
Ascites 44.53 31.69 47 14671 5539 1726524
Paraesthesia 44.36 31.69 64 14654 10387 1721676
Red cell distribution width increased 44.32 31.69 18 14700 392 1731671
Extrasystoles 44.28 31.69 22 14696 779 1731284
Amnesia 44.15 31.69 44 14674 4847 1727216
Peripheral arterial occlusive disease 44.10 31.69 22 14696 786 1731277
Dyspnoea paroxysmal nocturnal 44.07 31.69 14 14704 144 1731919
Device inappropriate shock delivery 43.51 31.69 8 14710 1 1732062
Rales 43.51 31.69 23 14695 929 1731134
Gait inability 43.50 31.69 37 14681 3326 1728737
Overdose 43.44 31.69 82 14636 16619 1715444
Head injury 42.70 31.69 35 14683 2989 1729074
Renal function test abnormal 42.55 31.69 18 14700 436 1731627
Stress 42.48 31.69 33 14685 2608 1729455
Limb discomfort 42.26 31.69 26 14692 1406 1730657
Cerebral haemorrhage 41.70 31.69 48 14670 6229 1725834
Jaundice 41.36 31.69 47 14671 6015 1726048
Weight loss poor 41.33 31.69 11 14707 56 1732007
Road traffic accident 41.20 31.69 37 14681 3576 1728487
Exercise tolerance decreased 41.12 31.69 19 14699 571 1731492
Dyslipidaemia 40.76 31.69 21 14697 804 1731259
Dysuria 40.69 31.69 37 14681 3635 1728428
Urinary retention 40.55 31.69 44 14674 5351 1726712
Wheezing 40.54 31.69 39 14679 4114 1727949
Hypovolaemia 40.43 31.69 24 14694 1216 1730847
Proteinuria 40.33 31.69 33 14685 2811 1729252
Benign prostatic hyperplasia 40.29 31.69 25 14693 1373 1730690
Infection 40.28 31.69 67 14651 12293 1719770
Infarction 40.18 31.69 20 14698 711 1731352
Lymphocyte stimulation test positive 39.94 31.69 15 14703 263 1731800
Coronary artery stenosis 39.88 31.69 26 14692 1556 1730507
Ejection fraction abnormal 39.50 31.69 12 14706 105 1731958
Sinus arrest 39.41 31.69 16 14702 348 1731715
Sleep disorder 39.37 31.69 38 14680 4025 1728038
Gouty arthritis 39.28 31.69 14 14704 210 1731853
Blood bilirubin increased 38.77 31.69 46 14672 6164 1725899
Goitre 38.73 31.69 15 14703 287 1731776
Blood iron decreased 38.68 31.69 18 14700 550 1731513
Dry mouth 38.68 31.69 37 14681 3876 1728187
Pseudomonal sepsis 38.55 31.69 16 14702 369 1731694
Hypokinesia 38.41 31.69 23 14695 1184 1730879
Pulmonary valve stenosis congenital 38.23 31.69 10 14708 47 1732016
Fluid overload 38.20 31.69 28 14690 2027 1730036
Atrioventricular block 38.20 31.69 24 14694 1347 1730716
Cardio-respiratory arrest 38.11 31.69 56 14662 9237 1722826
Chromaturia 38.10 31.69 31 14687 2619 1729444
Blood phosphorus increased 38.07 31.69 16 14702 381 1731682
Large intestine polyp 37.60 31.69 21 14697 947 1731116
Atrial flutter 37.33 31.69 27 14691 1915 1730148
Pancreatitis acute 37.31 31.69 37 14681 4050 1728013
Cold sweat 37.29 31.69 26 14692 1740 1730323
Pallor 37.07 31.69 34 14684 3377 1728686
Hepatocellular injury 36.67 31.69 33 14685 3198 1728865
Hepatic enzyme increased 36.41 31.69 46 14672 6575 1725488
Gastritis 35.70 31.69 32 14686 3085 1728978
Cell marker increased 35.66 31.69 12 14706 150 1731913
Electrocardiogram T wave inversion 35.57 31.69 16 14702 451 1731612
Obstructive airways disorder 35.57 31.69 21 14697 1053 1731010
Drug eruption 35.42 31.69 31 14687 2895 1729168
Superinfection 35.16 31.69 14 14704 289 1731774
Cerebral ischaemia 35.14 31.69 21 14697 1077 1730986
Sluggishness 35.01 31.69 18 14700 686 1731377
Deafness 34.78 31.69 26 14692 1940 1730123
Conduction disorder 34.72 31.69 15 14703 383 1731680
Dyspnoea at rest 34.42 31.69 14 14704 306 1731757
Gastrointestinal disorder 34.42 31.69 38 14680 4710 1727353
Pulmonary hypoplasia 34.38 31.69 11 14707 116 1731947
Urinary tract infection 34.38 31.69 56 14662 10097 1721966
Pemphigoid 34.29 31.69 21 14697 1126 1730937
Product substitution issue 34.25 31.69 32 14686 3254 1728809
Transient ischaemic attack 34.14 31.69 38 14680 4753 1727310
Colon cancer 33.76 31.69 25 14693 1839 1730224
Concomitant disease progression 33.58 31.69 16 14702 516 1731547
Orthostatic intolerance 33.56 31.69 11 14707 126 1731937
Gastroenteritis 33.43 31.69 26 14692 2058 1730005
Melaena 33.20 31.69 39 14679 5171 1726892
Hip fracture 33.13 31.69 24 14694 1706 1730357
Foetal exposure during pregnancy 33.11 31.69 43 14675 6316 1725747
Dyspepsia 32.91 31.69 38 14680 4947 1727116
Electrocardiogram ST segment elevation 32.84 31.69 19 14699 917 1731146
Red blood cell sedimentation rate increased 32.65 31.69 20 14698 1073 1730990
Hepatic failure 32.44 31.69 41 14677 5862 1726201
Dependence on oxygen therapy 32.30 31.69 7 14711 11 1732052
Left ventricular failure 32.24 31.69 17 14701 683 1731380
Pulmonary congestion 32.22 31.69 24 14694 1781 1730282
Actinic keratosis 32.19 31.69 16 14702 567 1731496
Gastrointestinal haemorrhage 32.19 31.69 66 14652 14201 1717862
General physical condition abnormal 31.96 31.69 17 14701 695 1731368
Heart rate abnormal 31.93 31.69 13 14705 285 1731778
Atrioventricular block complete 31.86 31.69 22 14696 1449 1730614
Serum ferritin increased 31.74 31.69 18 14700 836 1731227
Neck pain 31.71 31.69 31 14687 3335 1728728

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
HMG CoA reductase inhibitors, 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:35674 antihypertensive agent
CHEBI has role CHEBI:61016 angiotensin receptor antagonist

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
80MG BYVALSON ALLERGAN N206302 June 3, 2016 DISCN TABLET ORAL 7838552 Oct. 4, 2027 METHOD OF TREATING HYPERTENSION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL July 7, 2020 NEW CHEMICAL ENTITY
26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL July 7, 2020 NEW CHEMICAL ENTITY
51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL July 7, 2020 NEW CHEMICAL ENTITY
103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Jan. 7, 2021 PEDIATRIC EXCLUSIVITY
26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Jan. 7, 2021 PEDIATRIC EXCLUSIVITY
51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Jan. 7, 2021 PEDIATRIC EXCLUSIVITY
103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY

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
D000068756 MESH_DESCRIPTOR_UI
C0719949 UMLSCUI
D00400 KEGG_DRUG
108581009 SNOMEDCT_US
4020986 VANDF
006279 NDDF
d04113 MMSL
5663 MMSL
69749 RXNORM
386876001 SNOMEDCT_US
53010 MMSL
80M03YXJ7I UNII
7016 INN_ID
CHEMBL1069 ChEMBL_ID
DB00177 DRUGBANK_ID
CHEBI:9927 CHEBI
60846 PUBCHEM_CID
3937 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 80 mg ORAL NDA 18 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0358 TABLET 80 mg ORAL NDA 18 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0359 TABLET 160 mg ORAL NDA 18 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0360 TABLET 320 mg ORAL NDA 18 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0423 TABLET 40 mg ORAL NDA 18 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 320 mg ORAL NDA 18 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 320 mg ORAL NDA 18 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 320 mg ORAL NDA 18 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 320 mg ORAL NDA 18 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0561 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0562 TABLET, FILM COATED 160 mg ORAL NDA 18 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0563 TABLET, FILM COATED 320 mg ORAL NDA 18 sections
ENTRESTO HUMAN PRESCRIPTION DRUG LABEL 2 0078-0659 TABLET, FILM COATED 26 mg ORAL NDA 19 sections
ENTRESTO HUMAN PRESCRIPTION DRUG LABEL 2 0078-0696 TABLET, FILM COATED 103 mg ORAL NDA 19 sections
ENTRESTO HUMAN PRESCRIPTION DRUG LABEL 2 0078-0777 TABLET, FILM COATED 51 mg ORAL NDA 19 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1721 TABLET, FILM COATED 160 mg ORAL ANDA 18 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1722 TABLET, FILM COATED 160 mg ORAL ANDA 18 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1723 TABLET, FILM COATED 320 mg ORAL ANDA 18 sections
AMLODIPINE AND VALSARTAN HUMAN PRESCRIPTION DRUG LABEL 2 0378-1724 TABLET, FILM COATED 320 mg ORAL ANDA 18 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5807 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5813 TABLET, FILM COATED 80 mg ORAL ANDA 18 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5814 TABLET, FILM COATED 160 mg ORAL ANDA 18 sections
Valsartan HUMAN PRESCRIPTION DRUG LABEL 1 0378-5815 TABLET, FILM COATED 320 mg ORAL ANDA 18 sections
Valsartan and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-6321 TABLET, FILM COATED 80 mg ORAL ANDA 18 sections