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

Stem definitionDrug idCAS RN
leukotriene receptor antagonists 1836 158966-92-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • montelukast
  • montelukast sodium
  • singulair
Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or beta-adrenergic receptor). Montelukast inhibits physiologic actions of cysteinyl leukotriene LTD4 at the CysLT1 receptor without any agonist activity.
  • Molecular weight: 586.19
  • Formula: C35H36ClNO3S
  • CLOGP: 8.47
  • LIPINSKI: 2
  • HAC: 4
  • HDO: 2
  • TPSA: 70.42
  • ALOGS: -7.85
  • ROTB: 12

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.28 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 62 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.68 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 1998 FDA MERCK

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
Asthma 4079.40 9.84 2901 145764 88641 46448756
Wheezing 1258.32 9.84 1169 147496 52217 46485180
Eosinophilic granulomatosis with polyangiitis 1204.22 9.84 378 148287 1458 46535939
Obstructive airways disorder 504.66 9.84 385 148280 13027 46524370
Sputum discoloured 481.22 9.84 367 148298 12411 46524986
Dyspnoea 478.28 9.84 3035 145630 512513 46024884
Cough 471.11 9.84 1706 146959 228543 46308854
Productive cough 414.64 9.84 648 148017 50067 46487330
Forced expiratory volume decreased 411.85 9.84 236 148429 4868 46532529
Sinusitis 344.71 9.84 1051 147614 128717 46408680
Urticaria 323.60 9.84 966 147699 116926 46420471
Chest discomfort 316.48 9.84 809 147856 89460 46447937
Toxicity to various agents 299.80 9.84 150 148515 211616 46325781
Bronchitis 233.91 9.84 806 147859 105173 46432224
Blood count abnormal 205.81 9.84 269 148396 17609 46519788
Nasal congestion 204.80 9.84 465 148200 47648 46489749
Food allergy 183.02 9.84 162 148503 6771 46530626
Nightmare 174.61 9.84 239 148426 16359 46521038
Completed suicide 173.31 9.84 127 148538 145793 46391604
Chronic obstructive pulmonary disease 171.13 9.84 486 148179 57147 46480250
Upper respiratory tract infection 169.66 9.84 516 148149 63040 46474357
Rheumatoid arthritis 169.37 9.84 317 148348 239898 46297499
Sleep disorder due to a general medical condition 169.30 9.84 117 148548 3382 46534015
Anaphylactic reaction 167.68 9.84 458 148207 52654 46484743
Acute kidney injury 166.50 9.84 311 148354 235544 46301853
Neutropenia 165.75 9.84 128 148537 143076 46394321
Nasal polyps 161.92 9.84 96 148569 2114 46535283
Blood immunoglobulin E increased 159.35 9.84 88 148577 1685 46535712
Treatment failure 155.87 9.84 51 148614 93036 46444361
Temperature regulation disorder 147.81 9.84 106 148559 3254 46534143
Death 143.07 9.84 567 148098 334981 46202416
Product quality issue 132.64 9.84 327 148338 35321 46502076
Anaemia 129.92 9.84 401 148264 255378 46282019
Pemphigus 129.62 9.84 3 148662 45271 46492126
Asthmatic crisis 126.40 9.84 71 148594 1407 46535990
Middle insomnia 125.11 9.84 153 148512 9362 46528035
Seasonal allergy 123.96 9.84 181 148484 13153 46524244
Sleep terror 123.81 9.84 57 148608 727 46536670
Influenza 123.22 9.84 587 148078 88683 46448714
Thrombocytopenia 122.86 9.84 133 148532 126448 46410949
Drug interaction 122.16 9.84 293 148372 202801 46334596
Pancytopenia 122.09 9.84 59 148606 84999 46452398
Drug abuse 114.81 9.84 30 148635 63378 46474019
Synovitis 114.27 9.84 27 148638 61048 46476349
Coeliac disease 113.94 9.84 127 148538 7034 46530363
Bronchospasm 113.67 9.84 190 148475 15517 46521880
Malignant neoplasm progression 111.47 9.84 34 148631 64892 46472505
Febrile neutropenia 111.47 9.84 83 148582 94544 46442853
Respiratory tract congestion 109.69 9.84 167 148498 12597 46524800
Pneumonia 109.40 9.84 1743 146922 374577 46162820
Breath sounds abnormal 108.19 9.84 129 148536 7686 46529711
Eosinophil count increased 107.52 9.84 129 148536 7737 46529660
Infective pulmonary exacerbation of cystic fibrosis 106.76 9.84 151 148514 10656 46526741
Suicidal ideation 105.81 9.84 407 148258 55975 46481422
Rhinitis allergic 103.92 9.84 119 148546 6789 46530608
Drug intolerance 103.57 9.84 194 148471 146855 46390542
Hyponatraemia 103.37 9.84 102 148563 101230 46436167
Hypersensitivity 102.09 9.84 823 147842 149498 46387899
Peak expiratory flow rate decreased 99.76 9.84 46 148619 589 46536808
Dyspnoea exertional 95.99 9.84 365 148300 49924 46487473
Nasopharyngitis 94.40 9.84 824 147841 153174 46384223
Blood pressure systolic increased 93.58 9.84 251 148414 28536 46508861
Contraindicated product administered 91.76 9.84 72 148593 79875 46457522
Rhinorrhoea 91.01 9.84 346 148319 47319 46490078
Hand deformity 89.67 9.84 5 148660 34569 46502828
Aggression 86.05 9.84 210 148455 22534 46514863
Headache 85.45 9.84 2058 146607 476294 46061103
Pruritus 84.58 9.84 1159 147506 241193 46296204
Upper-airway cough syndrome 84.05 9.84 114 148551 7733 46529664
Respiratory rate increased 83.66 9.84 139 148526 11294 46526103
Secretion discharge 82.60 9.84 123 148542 9096 46528301
Multiple organ dysfunction syndrome 80.30 9.84 32 148633 51678 46485719
Status asthmaticus 77.44 9.84 44 148621 892 46536505
Anxiety 77.43 9.84 903 147762 181054 46356343
Leukopenia 76.61 9.84 63 148602 68280 46469117
Lung hyperinflation 75.91 9.84 47 148618 1122 46536275
Off label use 75.71 9.84 809 147856 379032 46158365
Systemic lupus erythematosus 75.68 9.84 58 148607 65122 46472275
Dysphonia 74.28 9.84 280 148385 38134 46499263
Total lung capacity increased 73.94 9.84 40 148625 734 46536663
Hypotension 73.40 9.84 437 148228 232152 46305245
Heart rate increased 73.38 9.84 448 148217 74343 46463054
Joint swelling 72.28 9.84 278 148387 165795 46371602
Intentional overdose 71.40 9.84 61 148604 64883 46472514
Disease progression 71.05 9.84 113 148552 91187 46446210
Sputum increased 69.56 9.84 52 148613 1704 46535693
Chronic spontaneous urticaria 69.13 9.84 34 148631 507 46536890
Immunodeficiency 68.80 9.84 138 148527 12968 46524429
Renal impairment 67.94 9.84 82 148583 74290 46463107
Sleep apnoea syndrome 67.60 9.84 189 148476 22012 46515385
Perfume sensitivity 66.67 9.84 34 148631 550 46536847
Bradycardia 66.15 9.84 68 148597 66230 46471167
Mucosal inflammation 65.84 9.84 21 148644 38955 46498442
Throat irritation 65.57 9.84 222 148443 28679 46508718
Oropharyngeal pain 65.17 9.84 432 148233 73736 46463661
Septic shock 64.11 9.84 54 148611 57839 46479558
Lower respiratory tract infection 63.86 9.84 345 148320 54744 46482653
Forced vital capacity decreased 62.82 9.84 38 148627 869 46536528
Reversible airways obstruction 62.40 9.84 32 148633 524 46536873
General physical health deterioration 61.18 9.84 178 148487 115591 46421806
Infusion related reaction 60.78 9.84 146 148519 101062 46436335
Bone marrow failure 59.85 9.84 11 148654 29658 46507739
Sinus disorder 59.56 9.84 150 148515 16413 46520984
Coma 59.18 9.84 59 148606 58290 46479107
Sensitivity to weather change 58.87 9.84 80 148585 5436 46531961
Gastrooesophageal reflux disease 58.79 9.84 422 148243 73922 46463475
Toxic epidermal necrolysis 58.47 9.84 3 148662 22275 46515122
Abnormal behaviour 58.06 9.84 173 148492 20885 46516512
Hyperkalaemia 57.76 9.84 46 148619 50663 46486734
Sepsis 57.68 9.84 230 148435 135784 46401613
Sneezing 57.38 9.84 126 148539 12615 46524782
Respiration abnormal 56.70 9.84 71 148594 4450 46532947
Crying 56.70 9.84 172 148493 20969 46516428
Abnormal dreams 56.09 9.84 110 148555 10169 46527228
Respiratory symptom 55.89 9.84 49 148616 2021 46535376
Cardiac failure 55.78 9.84 106 148559 79842 46457555
Rhinitis 53.72 9.84 93 148572 7813 46529584
Respiratory disorder 53.61 9.84 200 148465 27100 46510297
Metabolic acidosis 52.50 9.84 29 148636 38751 46498646
Haemoglobin decreased 51.60 9.84 223 148442 128726 46408671
Cystic fibrosis 51.25 9.84 61 148604 3627 46533770
Vital capacity decreased 50.47 9.84 28 148637 541 46536856
Respiratory tract infection 50.30 9.84 209 148456 29763 46507634
Rales 50.07 9.84 101 148564 9530 46527867
Product dose omission issue 49.67 9.84 783 147882 167737 46369660
Glossodynia 49.60 9.84 41 148624 44332 46493065
Cardiac arrest 49.22 9.84 137 148528 90262 46447135
Poor quality device used 49.18 9.84 46 148619 2066 46535331
C-reactive protein increased 48.98 9.84 69 148596 58521 46478876
Hypokalaemia 48.97 9.84 132 148533 87892 46449505
Sinus congestion 48.48 9.84 120 148545 12989 46524408
Aspirin-exacerbated respiratory disease 48.38 9.84 30 148635 718 46536679
Eye pruritus 47.30 9.84 112 148553 11786 46525611
Throat tightness 47.22 9.84 159 148506 20480 46516917
Dust allergy 46.88 9.84 26 148639 502 46536895
Throat clearing 46.85 9.84 24 148641 392 46537005
Insomnia 46.62 9.84 761 147904 164163 46373234
Pulmonary function test decreased 46.34 9.84 59 148606 3761 46533636
Chronic sinusitis 46.31 9.84 68 148597 4965 46532432
Malaise 45.75 9.84 1379 147286 329853 46207544
Eczema 45.66 9.84 156 148509 20244 46517153
Bursitis 45.52 9.84 153 148512 19689 46517708
Diarrhoea 45.21 9.84 1398 147267 558204 45979193
Arthropathy 44.90 9.84 130 148535 84570 46452827
Mood altered 44.90 9.84 116 148549 12891 46524506
Cardio-respiratory arrest 44.79 9.84 76 148589 59793 46477604
Smoke sensitivity 44.23 9.84 20 148645 244 46537153
Maternal exposure during pregnancy 43.09 9.84 174 148491 102375 46435022
Eosinophilia 43.05 9.84 147 148518 19070 46518327
Migraine 42.99 9.84 375 148290 69651 46467746
C-reactive protein abnormal 42.65 9.84 8 148657 21262 46516135
Renal failure 42.12 9.84 202 148463 113392 46424005
Angioedema 42.00 9.84 241 148424 39101 46498296
Pulmonary function test abnormal 41.85 9.84 34 148631 1261 46536136
Platelet count decreased 41.22 9.84 171 148494 99853 46437544
Metastases to bone 41.13 9.84 4 148661 17472 46519925
Weight increased 41.08 9.84 744 147921 163729 46373668
Depressed level of consciousness 40.79 9.84 55 148610 47514 46489883
Ascites 40.65 9.84 34 148631 36550 46500847
Dehydration 39.78 9.84 321 148344 159219 46378178
Cholestasis 39.58 9.84 18 148647 26875 46510522
Hepatocellular injury 38.64 9.84 23 148642 29499 46507898
Stomatitis 38.30 9.84 102 148563 68195 46469202
Alopecia 38.14 9.84 332 148333 162082 46375315
Mood swings 37.89 9.84 126 148539 16126 46521271
Cholecystitis chronic 37.66 9.84 95 148570 10404 46526993
White blood cell count decreased 37.42 9.84 207 148458 112024 46425373
Infusion site pruritus 37.33 9.84 48 148617 3090 46534307
Nasal oedema 37.19 9.84 27 148638 845 46536552
Product use issue 37.04 9.84 165 148500 94479 46442918
Atopy 36.93 9.84 16 148649 175 46537222
Scratch 36.77 9.84 60 148605 4802 46532595
Therapeutic product effect incomplete 36.42 9.84 395 148270 77758 46459639
Drug ineffective 36.00 9.84 1779 146886 676059 45861338
Gastrointestinal haemorrhage 35.94 9.84 126 148539 77247 46460150
Osteonecrosis of jaw 35.79 9.84 34 148631 34368 46503029
Hypoventilation 35.63 9.84 54 148611 4056 46533341
Blood pressure increased 35.60 9.84 584 148081 126082 46411315
Therapeutic product effect decreased 35.43 9.84 139 148526 82462 46454935
Bronchial secretion retention 35.30 9.84 27 148638 916 46536481
Rhonchi 34.75 9.84 39 148626 2176 46535221
Alanine aminotransferase increased 34.74 9.84 154 148511 88297 46449100
Neoplasm progression 34.63 9.84 21 148644 26662 46510735
Hereditary angioedema 33.77 9.84 62 148603 5454 46531943
Emphysema 33.60 9.84 83 148582 8971 46528426
Infusion site swelling 33.56 9.84 63 148602 5636 46531761
Lipohypertrophy 33.15 9.84 24 148641 748 46536649
Bronchial disorder 33.08 9.84 27 148638 1008 46536389
Aphonia 32.90 9.84 76 148589 7869 46529528
Encephalopathy 32.88 9.84 35 148630 33554 46503843
Palmar-plantar erythrodysaesthesia syndrome 32.84 9.84 12 148653 20439 46516958
Asthma-chronic obstructive pulmonary disease overlap syndrome 32.62 9.84 20 148645 469 46536928
Sinusitis fungal 32.57 9.84 25 148640 853 46536544
Disseminated intravascular coagulation 32.52 9.84 10 148655 18995 46518402
Biliary dyskinesia 32.33 9.84 42 148623 2731 46534666
Cytomegalovirus infection 32.05 9.84 9 148656 18135 46519262
Hepatotoxicity 32.01 9.84 20 148645 24989 46512408
Anger 31.38 9.84 96 148569 11756 46525641
Bronchitis chronic 30.94 9.84 51 148614 4116 46533281
Agranulocytosis 30.89 9.84 16 148649 22169 46515228
Pericarditis 30.82 9.84 19 148646 23908 46513489
Neutrophil count decreased 30.79 9.84 57 148608 43369 46494028
Metastases to liver 30.60 9.84 12 148653 19573 46517824
Infusion site erythema 30.45 9.84 72 148593 7570 46529827
Poor quality sleep 30.16 9.84 112 148553 15141 46522256
Rash erythematous 30.10 9.84 200 148465 34150 46503247
Increased viscosity of bronchial secretion 30.10 9.84 16 148649 283 46537114
Polycystic ovaries 30.05 9.84 29 148636 1355 46536042
Decreased appetite 29.79 9.84 436 148229 193400 46343997
Acute myeloid leukaemia 29.45 9.84 7 148658 15771 46521626
Bronchopulmonary aspergillosis allergic 29.35 9.84 22 148643 724 46536673
Bronchial obstruction 29.27 9.84 28 148637 1294 46536103
Prolonged expiration 29.05 9.84 17 148648 365 46537032
Humidity intolerance 28.97 9.84 17 148648 367 46537030
Inappropriate antidiuretic hormone secretion 28.94 9.84 5 148660 14097 46523300
Pulmonary pain 28.88 9.84 31 148634 1645 46535752
Peritonitis 28.75 9.84 15 148650 20699 46516698
Vomiting 28.73 9.84 1165 147500 451629 46085768
Neutropenic sepsis 28.54 9.84 3 148662 12321 46525076
Lactic acidosis 28.27 9.84 40 148625 33869 46503528
Feeling abnormal 28.21 9.84 557 148108 124503 46412894
Irritability 28.12 9.84 173 148492 28773 46508624
Circulatory collapse 28.09 9.84 17 148648 21607 46515790
Aspartate aminotransferase increased 27.98 9.84 142 148523 78558 46458839
Interstitial lung disease 27.72 9.84 84 148581 53865 46483532
Pharyngeal oedema 27.57 9.84 105 148560 14366 46523031
Rhabdomyolysis 27.14 9.84 58 148607 41851 46495546
Blood creatinine increased 27.08 9.84 138 148527 76265 46461132
Blood bilirubin increased 26.87 9.84 42 148623 34142 46503255
Musculoskeletal stiffness 26.85 9.84 192 148473 97801 46439596
Oxygen saturation decreased 26.63 9.84 337 148328 68827 46468570
Salpingo-oophorectomy unilateral 26.37 9.84 16 148649 368 46537029
Liver disorder 26.31 9.84 49 148616 37197 46500200
Allergy test positive 25.76 9.84 15 148650 319 46537078
Colitis 25.62 9.84 50 148615 37297 46500100
Depression 25.55 9.84 716 147949 169388 46368009
Hyper IgE syndrome 25.51 9.84 13 148652 210 46537187
Hypomagnesaemia 25.47 9.84 20 148645 22190 46515207
Skin ulcer 25.40 9.84 40 148625 32418 46504979
Impaired healing 25.37 9.84 49 148616 36694 46500703
Nasal discharge discolouration 25.33 9.84 27 148638 1421 46535976
Educational problem 25.31 9.84 14 148651 269 46537128
Bronchiectasis 25.17 9.84 76 148589 9240 46528157
Rash maculo-papular 25.16 9.84 31 148634 27843 46509554
Hypocalcaemia 25.02 9.84 29 148636 26756 46510641
Paranasal sinus discomfort 24.86 9.84 36 148629 2596 46534801
Frustration tolerance decreased 24.83 9.84 53 148612 5204 46532193
Type 2 diabetes mellitus 24.76 9.84 127 148538 19748 46517649
Viral infection 24.68 9.84 173 148492 30062 46507335
Lymphocyte count decreased 24.67 9.84 27 148638 25562 46511835
Illness 24.37 9.84 90 148575 12134 46525263
Mastocytosis 24.37 9.84 16 148649 424 46536973
Skin plaque 24.37 9.84 56 148609 5779 46531618
Increased upper airway secretion 24.35 9.84 40 148625 3219 46534178
Lung opacity 24.19 9.84 24 148641 1160 46536237
Neurosensory hypoacusis 24.16 9.84 14 148651 295 46537102
Sensitisation 24.02 9.84 19 148646 678 46536719
Gamma-glutamyltransferase increased 24.01 9.84 40 148625 31700 46505697
Pneumonia aspiration 23.75 9.84 40 148625 31565 46505832
Anuria 23.57 9.84 4 148661 11427 46525970
Restrictive pulmonary disease 23.49 9.84 24 148641 1202 46536195
Red blood cell sedimentation rate increased 23.37 9.84 23 148642 22866 46514531
Eosinophilic oesophagitis 23.26 9.84 12 148653 199 46537198
Swelling face 23.26 9.84 265 148400 52794 46484603
Confusional state 23.07 9.84 364 148301 159528 46377869
Nocturnal fear 23.05 9.84 6 148659 9 46537388
Pleural effusion 22.98 9.84 162 148503 82790 46454607
Lower respiratory tract congestion 22.98 9.84 29 148636 1832 46535565
Haemoptysis 22.66 9.84 152 148513 26037 46511360
Anosmia 22.49 9.84 43 148622 3901 46533496
Mast cell activation syndrome 22.39 9.84 12 148653 216 46537181
Nasal turbinate hypertrophy 22.31 9.84 15 148650 414 46536983
Inflammation 22.27 9.84 80 148585 48701 46488696
Fluid retention 21.95 9.84 254 148411 50792 46486605
Contusion 21.90 9.84 396 148269 87091 46450306
Blood creatine phosphokinase increased 21.85 9.84 34 148631 27690 46509707
Idiopathic intracranial hypertension 21.80 9.84 33 148632 2476 46534921
Occupational asthma 21.76 9.84 10 148655 127 46537270
Nasal inflammation 21.60 9.84 15 148650 437 46536960
Product substitution issue 21.55 9.84 100 148565 14931 46522466
Anaphylactic shock 21.51 9.84 124 148541 20150 46517247
Urticaria chronic 21.45 9.84 15 148650 442 46536955
Bronchial neoplasm 21.40 9.84 12 148653 237 46537160
Increased bronchial secretion 21.29 9.84 26 148639 1588 46535809
Acute respiratory distress syndrome 21.28 9.84 23 148642 21899 46515498
Progressive multifocal leukoencephalopathy 21.25 9.84 5 148660 11341 46526056
Pulmonary mass 20.79 9.84 112 148553 17745 46519652
Breast cancer metastatic 20.37 9.84 9 148656 13669 46523728
Nasal obstruction 20.20 9.84 17 148648 663 46536734
Gluten sensitivity 20.18 9.84 15 148650 487 46536910
Transaminases increased 20.07 9.84 36 148629 27725 46509672
Atrial fibrillation 19.99 9.84 222 148443 103368 46434029
Total lung capacity decreased 19.97 9.84 21 148644 1088 46536309
Hypoalbuminaemia 19.90 9.84 4 148661 10123 46527274
Pneumocystis jirovecii pneumonia 19.79 9.84 12 148653 15236 46522161
Eye paraesthesia 19.73 9.84 8 148657 73 46537324
Hepatic function abnormal 19.60 9.84 51 148614 34370 46503027
Airway peak pressure increased 19.47 9.84 12 148653 284 46537113
Hepatic failure 19.42 9.84 49 148616 33367 46504030
Lip swelling 19.40 9.84 143 148522 25252 46512145
Mycotic allergy 19.28 9.84 15 148650 522 46536875
Swollen tongue 19.23 9.84 159 148506 29073 46508324
Cortisol decreased 19.21 9.84 20 148645 1024 46536373
Upper airway obstruction 19.21 9.84 15 148650 525 46536872
Body tinea 19.19 9.84 19 148646 916 46536481
Dyspnoea at rest 19.09 9.84 38 148627 3550 46533847
Cerebral infarction 19.05 9.84 28 148637 23338 46514059
Altered state of consciousness 19.01 9.84 28 148637 23320 46514077
Adrenal suppression 18.92 9.84 19 148646 932 46536465
Lung diffusion test decreased 18.84 9.84 16 148649 632 46536765
Neuroleptic malignant syndrome 18.77 9.84 6 148659 11116 46526281
Overdose 18.72 9.84 221 148444 101758 46435639
Respiratory gas exchange disorder 18.59 9.84 13 148652 383 46537014
Pulmonary arterial hypertension 18.41 9.84 34 148631 25894 46511503
Delirium 18.39 9.84 59 148606 37169 46500228
Tuberculosis 18.30 9.84 5 148660 10260 46527137
Drug level increased 18.29 9.84 19 148646 18422 46518975
Pharyngitis streptococcal 18.29 9.84 64 148601 8404 46528993
Administration site erythema 18.13 9.84 15 148650 571 46536826
Ear discomfort 18.12 9.84 55 148610 6706 46530691
Torsade de pointes 18.09 9.84 8 148657 12146 46525251
Abdominal discomfort 18.01 9.84 356 148309 150809 46386588
Bone erosion 18.00 9.84 4 148661 9439 46527958
Stevens-Johnson syndrome 17.95 9.84 29 148636 23268 46514129
Fatigue 17.93 9.84 2206 146459 606491 45930906
Mite allergy 17.88 9.84 13 148652 408 46536989
Palpitations 17.83 9.84 413 148252 94846 46442551
Bronchial haemorrhage 17.79 9.84 12 148653 333 46537064
Drug reaction with eosinophilia and systemic symptoms 17.43 9.84 43 148622 29505 46507892
Infusion site pain 17.37 9.84 71 148594 10036 46527361
Decubitus ulcer 17.32 9.84 5 148660 9893 46527504
Bronchial hyperreactivity 17.26 9.84 22 148643 1404 46535993
Bacteraemia 17.25 9.84 12 148653 14167 46523230
Hypoglycaemia 17.16 9.84 102 148563 54247 46483150
Multiple allergies 17.05 9.84 57 148608 7314 46530083
Haemophagocytic lymphohistiocytosis 17.02 9.84 3 148662 8339 46529058
Inhibitory drug interaction 16.99 9.84 26 148639 1969 46535428
Body temperature decreased 16.92 9.84 86 148579 13323 46524074
Infusion site urticaria 16.91 9.84 16 148649 729 46536668
Ischaemic stroke 16.84 9.84 17 148648 16705 46520692
Blood alkaline phosphatase increased 16.76 9.84 67 148598 39542 46497855
Diabetic ketoacidosis 16.70 9.84 20 148645 18190 46519207
Live birth 16.69 9.84 6 148659 10324 46527073
Paraesthesia oral 16.64 9.84 78 148587 11695 46525702
Acute sinusitis 16.61 9.84 38 148627 3909 46533488
Eosinophil count abnormal 16.58 9.84 13 148652 458 46536939
Premature delivery 16.52 9.84 28 148637 22041 46515356
Wound 16.51 9.84 75 148590 42727 46494670
Blood test abnormal 16.45 9.84 67 148598 9453 46527944
Respiratory arrest 16.42 9.84 54 148611 33762 46503635
Influenza like illness 16.36 9.84 266 148399 57304 46480093
Paranasal cyst 16.28 9.84 8 148657 119 46537278
Acute myocardial infarction 16.19 9.84 50 148615 31874 46505523
Thinking abnormal 16.12 9.84 68 148597 9746 46527651
Product container issue 16.11 9.84 24 148641 1775 46535622
Urinary retention 16.11 9.84 37 148628 26024 46511373
Anticholinergic syndrome 16.04 9.84 24 148641 1782 46535615
Heart sounds 15.99 9.84 10 148655 243 46537154
Liver function test abnormal 15.89 9.84 85 148580 46402 46490995
Neurogenic shock 15.89 9.84 10 148655 246 46537151
International normalised ratio increased 15.87 9.84 86 148579 46797 46490600
Myocardial infarction 15.80 9.84 217 148448 97311 46440086
Drug hypersensitivity 15.69 9.84 626 148039 243199 46294198
Intentional product misuse 15.65 9.84 87 148578 47041 46490356
Sputum retention 15.57 9.84 12 148653 412 46536985
Expiratory reserve volume decreased 15.49 9.84 6 148659 48 46537349
Spirometry abnormal 15.47 9.84 9 148656 191 46537206
Lip discolouration 15.44 9.84 13 148652 507 46536890
Allergy to animal 15.44 9.84 14 148651 604 46536793
Gallbladder disorder 15.40 9.84 102 148563 17396 46520001
Respiratory tract irritation 15.27 9.84 12 148653 424 46536973
Infusion site extravasation 15.27 9.84 44 148621 5212 46532185
Akathisia 15.26 9.84 3 148662 7711 46529686
Myalgia 15.23 9.84 506 148159 122582 46414815
Unresponsive to stimuli 15.20 9.84 52 148613 32122 46505275
Embolism venous 15.12 9.84 28 148637 2479 46534918
Choking sensation 15.09 9.84 33 148632 3294 46534103
Dermatitis atopic 14.83 9.84 21 148644 1483 46535914
Respiratory tract inflammation 14.82 9.84 12 148653 443 46536954
Eosinophilic pneumonia 14.71 9.84 24 148641 1920 46535477
Myelodysplastic syndrome 14.68 9.84 17 148648 15694 46521703
Lactose intolerance 14.65 9.84 27 148638 2382 46535015
Blood pressure fluctuation 14.53 9.84 49 148616 30399 46506998
Accidental overdose 14.52 9.84 26 148639 20040 46517357
Serotonin syndrome 14.48 9.84 35 148630 24185 46513212
Somnambulism 14.47 9.84 42 148623 4995 46532402
Miller Fisher syndrome 14.44 9.84 7 148658 101 46537296
Pulmonary thrombosis 14.34 9.84 54 148611 7348 46530049
Metastases to central nervous system 14.33 9.84 9 148656 11212 46526185
Sinus headache 14.29 9.84 40 148625 4660 46532737
Sleep study abnormal 14.26 9.84 3 148662 0 46537397
Glomus tumour 14.26 9.84 3 148662 0 46537397
Stress 14.21 9.84 237 148428 51314 46486083
Pneumococcal infection 14.14 9.84 11 148654 383 46537014
Paranoia 14.10 9.84 69 148596 10528 46526869
Squamous cell carcinoma of the oral cavity 14.09 9.84 10 148655 302 46537095
Laryngeal oedema 14.00 9.84 43 148622 5276 46532121
Cerebral haemorrhage 13.99 9.84 45 148620 28326 46509071
Lymphopenia 13.81 9.84 17 148648 15276 46522121
Lung disorder 13.80 9.84 204 148461 43100 46494297
Schizophrenia 13.80 9.84 5 148660 8563 46528834
Melaena 13.73 9.84 44 148621 27728 46509669
Hypercapnia 13.70 9.84 39 148626 4587 46532810
Acute hepatic failure 13.68 9.84 16 148649 14705 46522692
Bronchial wall thickening 13.67 9.84 15 148650 816 46536581
Epilepsy 13.65 9.84 35 148630 23703 46513694
FEV1/FVC ratio decreased 13.50 9.84 4 148661 12 46537385
Cytopenia 13.45 9.84 4 148661 7764 46529633
Drug eruption 13.41 9.84 30 148635 21299 46516098
Left ventricular dysfunction 13.41 9.84 8 148657 10247 46527150
Jaundice 13.37 9.84 47 148618 28798 46508599
Device expulsion 13.36 9.84 44 148621 27498 46509899
Condition aggravated 13.32 9.84 641 148024 244411 46292986
Erythema 13.32 9.84 569 148096 142251 46395146
Oesophageal dilatation 13.31 9.84 10 148655 330 46537067
Tic 13.30 9.84 18 148647 1218 46536179
Functional residual capacity decreased 13.28 9.84 6 148659 73 46537324
Malnutrition 13.25 9.84 15 148650 13988 46523409
Intentional product use issue 13.22 9.84 106 148559 52674 46484723
Mandibular mass 13.22 9.84 8 148657 183 46537214
Ejection fraction decreased 13.20 9.84 23 148642 17914 46519483
Hepatic encephalopathy 13.17 9.84 8 148657 10149 46527248
Infusion site bruising 13.16 9.84 20 148645 1506 46535891
Chest pain 13.14 9.84 687 147978 175637 46361760
Microscopic polyangiitis 13.11 9.84 7 148658 125 46537272
PCO2 increased 13.10 9.84 18 148647 1236 46536161
Infusion site nodule 13.09 9.84 16 148649 978 46536419
Vocal cord disorder 13.05 9.84 18 148647 1240 46536157
Antibody test negative 13.04 9.84 4 148661 14 46537383
Ear infection 12.97 9.84 121 148544 22892 46514505
Hypercalcaemia 12.91 9.84 30 148635 21016 46516381
Serum sickness 12.89 9.84 26 148639 2452 46534945
Mucosal discolouration 12.87 9.84 11 148654 438 46536959
Nausea 12.83 9.84 1958 146707 685496 45851901
Eczema impetiginous 12.83 9.84 4 148661 15 46537382
Infusion site haemorrhage 12.76 9.84 24 148641 2150 46535247
Blood lactate dehydrogenase increased 12.75 9.84 29 148636 20471 46516926
Plasma cell myeloma 12.74 9.84 86 148579 44392 46493005
Infection susceptibility increased 12.72 9.84 24 148641 2155 46535242
Muscle rigidity 12.70 9.84 8 148657 9953 46527444
Nephropathy toxic 12.62 9.84 4 148661 7450 46529947
Female reproductive neoplasm 12.59 9.84 5 148660 43 46537354
Middle ear effusion 12.58 9.84 22 148643 1863 46535534
Oxygen consumption decreased 12.45 9.84 8 148657 204 46537193
Blood immunoglobulin E decreased 12.41 9.84 6 148659 86 46537311
Proteinuria 12.39 9.84 21 148644 16532 46520865
Foetal exposure during pregnancy 12.39 9.84 53 148612 30694 46506703
Cushingoid 12.38 9.84 46 148619 6220 46531177
Diverticulum oesophageal 12.36 9.84 7 148658 141 46537256
Miosis 12.33 9.84 3 148662 6654 46530743
Abnormal weight gain 12.22 9.84 19 148646 1459 46535938
Platelet adhesiveness decreased 12.19 9.84 3 148662 3 46537394
Laryngitis fungal 12.19 9.84 7 148658 145 46537252
Intestinal perforation 12.16 9.84 10 148655 10841 46526556
Osteomyelitis 12.11 9.84 34 148631 22349 46515048
Ejection fraction 12.10 9.84 12 148653 580 46536817
Bronchial irritation 12.08 9.84 4 148661 19 46537378
Fracture pain 12.06 9.84 10 148655 382 46537015
Pulmonary renal syndrome 12.06 9.84 10 148655 382 46537015
Mobility decreased 12.03 9.84 129 148536 60465 46476932
Seizure 12.02 9.84 299 148366 122755 46414642
Urinary tract infection 12.00 9.84 576 148089 219690 46317707
Product prescribing error 11.96 9.84 29 148636 20018 46517379
Product taste abnormal 11.94 9.84 22 148643 1941 46535456
Osteonecrosis 11.90 9.84 42 148623 25702 46511695
Cephalo-pelvic disproportion 11.83 9.84 8 148657 223 46537174
Aplastic anaemia 11.82 9.84 4 148661 7149 46530248
Exposure to allergen 11.81 9.84 7 148658 154 46537243
Hip arthroplasty 11.78 9.84 25 148640 18087 46519310
Sinus bradycardia 11.75 9.84 16 148649 13766 46523631
Helicobacter infection 11.74 9.84 12 148653 11724 46525673
Systemic mastocytosis 11.73 9.84 7 148658 156 46537241
Administration site pruritus 11.70 9.84 9 148656 308 46537089
Amnesia 11.70 9.84 192 148473 41439 46495958
Sinus polyp 11.68 9.84 9 148656 309 46537088
Mouth ulceration 11.60 9.84 45 148620 26787 46510610
Phlebectomy 11.60 9.84 5 148660 54 46537343
Hypothermia 11.58 9.84 13 148652 12170 46525227
Therapy non-responder 11.57 9.84 80 148585 41072 46496325
Orthostatic hypotension 11.55 9.84 40 148625 24618 46512779
Hyperplastic cholecystopathy 11.50 9.84 6 148659 102 46537295
Periorbital pain 11.45 9.84 4 148661 23 46537374
Animal scratch 11.44 9.84 13 148652 735 46536662
Hypertensive crisis 11.41 9.84 16 148649 13599 46523798
Acute generalised exanthematous pustulosis 11.39 9.84 8 148657 9397 46528000
Ulcer 11.32 9.84 24 148641 17368 46520029
Hypereosinophilic syndrome 11.29 9.84 8 148657 241 46537156
Impaired quality of life 11.28 9.84 29 148636 3213 46534184
Drug resistance 11.27 9.84 24 148641 17344 46520053
Cognitive disorder 11.23 9.84 70 148595 36813 46500584
Pulmonary eosinophilia 11.23 9.84 8 148657 243 46537154
Nephrectomy 11.22 9.84 11 148654 524 46536873
Oliguria 11.22 9.84 7 148658 8752 46528645
Creatinine renal clearance decreased 11.21 9.84 4 148661 6916 46530481
Neuropsychiatric syndrome 11.20 9.84 5 148660 59 46537338
Breast neoplasm 11.20 9.84 17 148648 1278 46536119
Rhinitis perennial 11.17 9.84 4 148661 25 46537372
Ligament pain 11.16 9.84 7 148658 171 46537226
Device dislocation 11.16 9.84 34 148631 21768 46515629
Folliculitis 11.10 9.84 3 148662 6200 46531197
Administration site swelling 11.10 9.84 16 148649 1149 46536248
Ankle fracture 11.09 9.84 86 148579 15425 46521972
Neoplasm malignant 11.08 9.84 38 148627 23461 46513936
Sinonasal obstruction 11.00 9.84 6 148659 112 46537285
School refusal 10.98 9.84 3 148662 6 46537391
Peak expiratory flow rate increased 10.98 9.84 3 148662 6 46537391
Clostridium difficile colitis 10.94 9.84 27 148638 18526 46518871
Encephalitis 10.93 9.84 5 148660 7443 46529954
Glucose tolerance impaired 10.86 9.84 37 148628 4794 46532603
Infusion site mass 10.85 9.84 14 148651 904 46536493
Coagulopathy 10.85 9.84 27 148638 18472 46518925
Pneumonitis 10.84 9.84 50 148615 28370 46509027
Mouth swelling 10.83 9.84 31 148634 3658 46533739
Renal tubular necrosis 10.77 9.84 11 148654 10748 46526649
Pneumonia respiratory syncytial viral 10.76 9.84 12 148653 665 46536732
Ear pruritus 10.74 9.84 22 148643 2098 46535299
Knee arthroplasty 10.67 9.84 39 148626 23626 46513771
Self-injurious ideation 10.65 9.84 23 148642 2277 46535120
Nervousness 10.64 9.84 138 148527 28337 46509060
Metastases to lung 10.63 9.84 11 148654 10685 46526712
Injection site hypoaesthesia 10.63 9.84 9 148656 354 46537043
Posterior reversible encephalopathy syndrome 10.62 9.84 20 148645 15121 46522276
Prothrombin time prolonged 10.56 9.84 9 148656 9587 46527810
Gastric ulcer 10.55 9.84 35 148630 21828 46515569
Screaming 10.54 9.84 28 148637 3163 46534234
Factor V Leiden mutation 10.46 9.84 6 148659 124 46537273
Alice in wonderland syndrome 10.43 9.84 4 148661 31 46537366
Peripheral sensory neuropathy 10.39 9.84 4 148661 6599 46530798
Adenotonsillectomy 10.38 9.84 5 148660 71 46537326
Attention deficit hyperactivity disorder 10.37 9.84 22 148643 2150 46535247
Sunburn 10.37 9.84 24 148641 2488 46534909
Cardiogenic shock 10.34 9.84 23 148642 16361 46521036
Fall 10.30 9.84 905 147760 328192 46209205
Ligament sprain 10.30 9.84 63 148602 10456 46526941
Exposure to fungus 10.29 9.84 6 148659 128 46537269
Device delivery system issue 10.26 9.84 7 148658 198 46537199
Hyperhidrosis 10.25 9.84 364 148301 88944 46448453
Poisoning 10.25 9.84 18 148647 13976 46523421
Faecaloma 10.20 9.84 6 148659 7746 46529651
Pertussis 10.20 9.84 11 148654 587 46536810
Premature baby 10.19 9.84 27 148638 18085 46519312
Snoring 10.18 9.84 29 148636 3413 46533984
Sedation 10.17 9.84 38 148627 22872 46514525
Otorrhoea 10.12 9.84 17 148648 1393 46536004
Cold agglutinins positive 10.11 9.84 4 148661 34 46537363
Breast adenoma 10.11 9.84 4 148661 34 46537363
Allergic respiratory disease 10.11 9.84 4 148661 34 46537363
Hyperbilirubinaemia 10.08 9.84 11 148654 10427 46526970
Asthma exercise induced 10.04 9.84 6 148659 134 46537263
Conjunctivitis allergic 10.01 9.84 12 148653 719 46536678
Axonal neuropathy 9.89 9.84 14 148651 988 46536409
Cold urticaria 9.89 9.84 3 148662 10 46537387
Hypernatraemia 9.87 9.84 4 148661 6397 46531000

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
Asthma 2692.63 10.71 1352 58551 34822 29857753
Eosinophilic granulomatosis with polyangiitis 882.66 10.71 248 59655 1067 29891508
Wheezing 800.15 10.71 588 59315 30350 29862225
Obstructive airways disorder 409.02 10.71 244 59659 8815 29883760
Forced expiratory volume decreased 375.35 10.71 165 59738 3085 29889490
Suicidal ideation 375.09 10.71 410 59493 35704 29856871
Sleep terror 365.07 10.71 110 59793 633 29891942
Abnormal behaviour 332.79 10.71 328 59575 25295 29867280
Aggression 299.37 10.71 369 59534 36538 29856037
Cough 285.78 10.71 715 59188 124927 29767648
Blood count abnormal 244.94 10.71 196 59707 11456 29881119
Nightmare 242.98 10.71 198 59705 11878 29880697
Dyspnoea 227.58 10.71 1284 58619 332011 29560564
Anger 223.04 10.71 182 59721 10938 29881637
Productive cough 210.54 10.71 279 59624 29674 29862901
Toxicity to various agents 207.22 10.71 50 59853 177133 29715442
Nasal congestion 198.22 10.71 214 59689 18352 29874223
Sputum discoloured 197.95 10.71 138 59765 6530 29886045
Middle insomnia 182.02 10.71 124 59779 5649 29886926
Sinusitis 173.20 10.71 269 59634 33076 29859499
Chest discomfort 152.95 10.71 303 59600 45177 29847398
Nasal polyps 149.54 10.71 67 59836 1312 29891263
Acute kidney injury 137.33 10.71 210 59693 273632 29618943
Blood immunoglobulin E increased 135.05 10.71 67 59836 1663 29890912
Sleep disorder due to a general medical condition 131.56 10.71 63 59840 1444 29891131
Anaemia 129.71 10.71 135 59768 207857 29684718
Mood altered 128.77 10.71 117 59786 8133 29884442
Crying 125.69 10.71 98 59805 5511 29887064
Anxiety 123.60 10.71 428 59475 89443 29803132
Depression 121.18 10.71 427 59476 90010 29802565
Death 112.30 10.71 355 59548 356928 29535647
Urticaria 108.64 10.71 296 59607 54310 29838265
Infective pulmonary exacerbation of cystic fibrosis 107.99 10.71 108 59795 8464 29884111
Therapeutic product effect incomplete 101.40 10.71 215 59688 33619 29858956
Pulmonary function test decreased 100.51 10.71 77 59826 4218 29888357
Rhinorrhoea 98.87 10.71 161 59742 20593 29871982
Nasopharyngitis 97.74 10.71 299 59604 58550 29834025
Drug abuse 92.26 10.71 25 59878 82047 29810528
Eosinophilia 87.28 10.71 158 59745 22002 29870573
Eosinophilic pneumonia chronic 86.90 10.71 21 59882 41 29892534
Febrile neutropenia 86.78 10.71 53 59850 106640 29785935
Irritability 86.56 10.71 161 59742 22889 29869686
Thrombocytopenia 84.14 10.71 90 59813 136954 29755621
Bronchospasm 83.13 10.71 103 59800 10235 29882340
Chronic obstructive pulmonary disease 81.91 10.71 240 59663 45886 29846689
Asthmatic crisis 81.50 10.71 32 59871 443 29892132
Tic 79.58 10.71 50 59853 1982 29890593
Mood swings 78.05 10.71 86 59817 7540 29885035
Screaming 76.54 10.71 42 59861 1289 29891286
Drug interaction 75.39 10.71 181 59722 199387 29693188
Psychomotor hyperactivity 72.75 10.71 86 59817 8138 29884437
Influenza 72.50 10.71 221 59682 43177 29849398
Ear infection 70.06 10.71 80 59823 7294 29885281
Bronchial obstruction 69.84 10.71 41 59862 1435 29891140
Eosinophil count increased 69.19 10.71 80 59823 7393 29885182
Sleep disorder 68.12 10.71 151 59752 24328 29868247
Educational problem 67.35 10.71 25 59878 294 29892281
Bronchitis 66.06 10.71 200 59703 38925 29853650
Rhinitis 65.99 10.71 62 59841 4497 29888078
Renal failure 63.38 10.71 100 59803 128866 29763709
Pancytopenia 62.77 10.71 47 59856 85005 29807570
Dyspnoea exertional 62.55 10.71 184 59719 35246 29857329
Hypersensitivity 62.14 10.71 243 59660 53785 29838790
Nasal disorder 62.00 10.71 35 59868 1136 29891439
Neutropenia 61.92 10.71 101 59802 128439 29764136
Heart rate increased 60.80 10.71 193 59710 38528 29854047
Blood creatinine increased 60.65 10.71 56 59847 91319 29801256
Hypotension 60.19 10.71 203 59700 200362 29692213
Sensitivity to weather change 60.03 10.71 37 59866 1417 29891158
Headache 59.98 10.71 592 59311 181714 29710861
Vital capacity decreased 58.15 10.71 24 59879 381 29892194
Social avoidant behaviour 57.68 10.71 47 59856 2816 29889759
Upper respiratory tract infection 57.68 10.71 152 59751 27324 29865251
Gastrooesophageal reflux disease 56.45 10.71 167 59736 32088 29860487
Leukopenia 56.17 10.71 21 59882 56138 29836437
Blood pressure increased 55.95 10.71 288 59615 71640 29820935
Malignant neoplasm progression 55.89 10.71 38 59865 72249 29820326
Confusional state 53.50 10.71 119 59784 134715 29757860
Solar lentigo 51.72 10.71 21 59882 319 29892256
Loss of personal independence in daily activities 51.32 10.71 125 59778 21410 29871165
Blood pressure systolic increased 51.13 10.71 101 59802 15009 29877566
Seasonal allergy 51.07 10.71 55 59848 4698 29887877
Dysplastic naevus 50.56 10.71 21 59882 339 29892236
Photodermatosis 49.94 10.71 22 59881 413 29892162
Sneezing 49.92 10.71 52 59851 4275 29888300
Multiple organ dysfunction syndrome 49.58 10.71 33 59870 63454 29829121
Respiratory tract congestion 49.40 10.71 58 59845 5448 29887127
Bronchopulmonary aspergillosis allergic 49.13 10.71 20 59883 306 29892269
Anaphylactic reaction 49.08 10.71 145 59758 27837 29864738
Dyspnoea at rest 48.79 10.71 41 59862 2565 29890010
Bronchial hyperreactivity 48.23 10.71 30 59873 1168 29891407
Completed suicide 48.05 10.71 78 59825 99414 29793161
Emotional disorder 47.94 10.71 55 59848 5039 29887536
Product quality issue 46.91 10.71 111 59792 18663 29873912
Haemoglobin decreased 46.66 10.71 99 59804 113999 29778576
Sepsis 46.07 10.71 145 59758 146250 29746325
Allergy to animal 46.06 10.71 16 59887 153 29892422
Breath sounds abnormal 45.97 10.71 53 59850 4882 29887693
Vocal cord dysfunction 45.51 10.71 16 59887 159 29892416
Upper-airway cough syndrome 45.38 10.71 40 59863 2670 29889905
Depressed mood 43.98 10.71 102 59801 16927 29875648
Hyponatraemia 43.62 10.71 42 59861 67160 29825415
Forced vital capacity decreased 43.40 10.71 24 59879 748 29891827
Insomnia 43.16 10.71 327 59576 93009 29799566
Lower respiratory tract infection 40.87 10.71 132 59771 26582 29865993
Restrictive pulmonary disease 40.79 10.71 26 59877 1057 29891518
Body temperature decreased 40.78 10.71 71 59832 9584 29882991
Personality change 40.51 10.71 48 59855 4552 29888023
Excessive eye blinking 39.89 10.71 16 59887 235 29892340
Rhabdomyolysis 38.69 10.71 42 59861 63538 29829037
Suffocation feeling 38.67 10.71 20 59883 543 29892032
Panic attack 38.19 10.71 65 59838 8616 29883959
Dehydration 37.71 10.71 124 59779 123415 29769160
Stress 37.54 10.71 107 59796 20128 29872447
Anosmia 37.19 10.71 32 59871 2068 29890507
Aspirin-exacerbated respiratory disease 37.16 10.71 17 59886 350 29892225
Off label use 36.94 10.71 320 59583 248970 29643605
Platelet count decreased 36.35 10.71 101 59802 106028 29786547
Respiratory rate increased 35.64 10.71 64 59839 8851 29883724
Septic shock 35.50 10.71 45 59858 63562 29829013
Nasal oedema 34.90 10.71 16 59887 331 29892244
Negative thoughts 34.83 10.71 20 59883 671 29891904
Food allergy 34.70 10.71 22 59881 886 29891689
Multiple allergies 34.63 10.71 31 59872 2112 29890463
Hypoventilation 34.28 10.71 36 59867 2987 29889588
Nasal inflammation 33.76 10.71 14 59889 225 29892350
Renal impairment 33.61 10.71 74 59829 84110 29808465
Sinus congestion 33.16 10.71 44 59859 4678 29887897
Diarrhoea 33.16 10.71 470 59433 333633 29558942
Respiratory disorder 32.93 10.71 93 59810 17401 29875174
Status asthmaticus 32.74 10.71 15 59888 310 29892265
Attention deficit hyperactivity disorder 32.72 10.71 28 59875 1796 29890779
Morbid thoughts 32.57 10.71 14 59889 247 29892328
Chronic sinusitis 32.27 10.71 26 59877 1533 29891042
Malaise 32.05 10.71 490 59413 166472 29726103
Rhinitis allergic 32.00 10.71 34 59869 2860 29889715
Gastrointestinal haemorrhage 31.97 10.71 75 59828 83371 29809204
Bone marrow failure 31.74 10.71 10 59893 29775 29862800
Reversible airways obstruction 31.67 10.71 14 59889 265 29892310
Product substitution issue 31.47 10.71 65 59838 9970 29882605
Cardiac arrest 31.32 10.71 89 59814 92761 29799814
Lung hyperinflation 31.01 10.71 20 59883 830 29891745
Respiratory tract infection 30.74 10.71 84 59819 15422 29877153
Cardio-respiratory arrest 30.49 10.71 42 59861 57264 29835311
Eosinophil count 30.46 10.71 11 59892 119 29892456
Smoke sensitivity 30.44 10.71 12 59891 168 29892407
Myocardial infarction 30.07 10.71 139 59764 125486 29767089
Tearfulness 29.65 10.71 25 59878 1571 29891004
Total lung capacity abnormal 29.45 10.71 12 59891 184 29892391
Throat tightness 29.22 10.71 52 59851 7140 29885435
Eye swelling 29.22 10.71 59 59844 8905 29883670
Homicidal ideation 29.13 10.71 30 59873 2433 29890142
Rheumatoid arthritis 28.82 10.71 24 59879 41173 29851402
Suicidal behaviour 28.80 10.71 23 59880 1339 29891236
Peak expiratory flow rate decreased 28.78 10.71 11 59892 141 29892434
Sputum increased 28.32 10.71 26 59877 1831 29890744
Blebitis 28.24 10.71 6 59897 4 29892571
Bronchial wall thickening 28.04 10.71 15 59888 437 29892138
Delirium 28.02 10.71 24 59879 40607 29851968
Attention-seeking behaviour 27.82 10.71 8 59895 38 29892537
Blood cholesterol 27.70 10.71 10 59893 108 29892467
Endocarditis fibroplastica 27.67 10.71 6 59897 5 29892570
Foetal exposure during pregnancy 27.67 10.71 20 59883 36851 29855724
Nasal discharge discolouration 27.25 10.71 12 59891 225 29892350
Snoring 26.84 10.71 31 59872 2860 29889715
Eosinophilic bronchitis 26.70 10.71 8 59895 45 29892530
Disease progression 26.61 10.71 77 59826 79797 29812778
Oropharyngeal pain 26.38 10.71 120 59783 28376 29864199
Hyperkalaemia 26.36 10.71 58 59845 65952 29826623
Dust allergy 26.32 10.71 14 59889 403 29892172
Hepatic failure 26.16 10.71 18 59885 34025 29858550
Pruritus 25.86 10.71 355 59548 117849 29774726
Intentional overdose 25.68 10.71 27 59876 41454 29851121
Self-injurious ideation 25.46 10.71 23 59880 1586 29890989
Coma 25.41 10.71 26 59877 40423 29852152
Chronic spontaneous urticaria 25.29 10.71 9 59894 93 29892482
Eye pruritus 25.16 10.71 35 59868 3892 29888683
Pigment dispersion syndrome 24.73 10.71 6 59897 12 29892563
Hypereosinophilic syndrome 24.33 10.71 11 59892 220 29892355
Haematemesis 24.25 10.71 11 59892 26192 29866383
Throat irritation 24.08 10.71 53 59850 8495 29884080
Cardiac failure 23.90 10.71 86 59817 83332 29809243
Cystic fibrosis 23.88 10.71 26 59877 2248 29890327
Enuresis 23.54 10.71 23 59880 1751 29890824
Affective disorder 23.44 10.71 30 59873 3078 29889497
Lower respiratory tract congestion 23.35 10.71 18 59885 995 29891580
Acute myocardial infarction 23.27 10.71 44 59859 52895 29839680
Sinus polyp 23.08 10.71 10 59893 180 29892395
Meningitis eosinophilic 23.02 10.71 6 59897 18 29892557
Fear 22.82 10.71 60 59843 10765 29881810
Pneumonia 22.68 10.71 849 59054 333457 29559118
Nasal discomfort 22.56 10.71 19 59884 1192 29891383
Agranulocytosis 22.28 10.71 8 59895 21934 29870641
Dysphonia 22.18 10.71 86 59817 18946 29873629
Pulmonary function test abnormal 22.18 10.71 20 59883 1376 29891199
Pleural effusion 22.13 10.71 75 59828 73991 29818584
Bronchial secretion retention 21.96 10.71 15 59888 686 29891889
Blood lactic acid 21.87 10.71 12 59891 368 29892207
International normalised ratio increased 21.59 10.71 39 59864 47700 29844875
Ascites 21.55 10.71 24 59879 35897 29856678
Sinus disorder 21.53 10.71 42 59861 6183 29886392
Alopecia areata 21.46 10.71 9 59894 149 29892426
Mast cell activation syndrome 21.26 10.71 8 59895 98 29892477
Temperature intolerance 21.17 10.71 28 59875 2967 29889608
General physical health deterioration 20.82 10.71 116 59787 99828 29792747
Hyperkaliuria 20.72 10.71 9 59894 163 29892412
Perfume sensitivity 20.56 10.71 8 59895 108 29892467
Physical assault 20.50 10.71 18 59885 1195 29891380
Cortisol decreased 20.48 10.71 16 59887 902 29891673
Bronchiectasis 20.34 10.71 37 59866 5167 29887408
Secretion discharge 20.34 10.71 31 59872 3744 29888831
Self esteem decreased 20.29 10.71 13 59890 533 29892042
Neuroleptic malignant syndrome 20.21 10.71 4 59899 16291 29876284
Mental disorder 20.15 10.71 66 59837 13383 29879192
Stomatitis 20.15 10.71 27 59876 37252 29855323
Migraine 20.04 10.71 64 59839 12810 29879765
Allergic respiratory disease 19.84 10.71 6 59897 35 29892540
Neutrophil count decreased 19.81 10.71 34 59869 42420 29850155
Peritonitis 19.74 10.71 9 59894 21366 29871209
Cerebral haemorrhage 19.70 10.71 22 59881 32865 29859710
Lactic acidosis 19.68 10.71 20 59883 31193 29861382
Sleep apnoea syndrome 19.51 10.71 76 59827 16781 29875794
Drug resistance 19.35 10.71 8 59895 20125 29872450
Behaviour disorder 19.34 10.71 24 59879 2388 29890187
Polyp 19.29 10.71 28 59875 3238 29889337
Mononeuropathy multiplex 19.21 10.71 8 59895 130 29892445
Victim of child abuse 19.05 10.71 10 59893 280 29892295
Pyrexia 18.30 10.71 449 59454 294040 29598535
Gastroenteritis viral 18.10 10.71 38 59865 5895 29886680
Growth retardation 18.05 10.71 19 59884 1581 29890994
Neurodevelopmental disorder 17.88 10.71 8 59895 156 29892419
Cerebrovascular accident 17.87 10.71 96 59807 83381 29809194
Intentional product misuse 17.85 10.71 26 59877 34641 29857934
Hypokalaemia 17.74 10.71 47 59856 50145 29842430
Blood urea increased 17.71 10.71 22 59881 31359 29861216
Hepatocellular injury 17.61 10.71 15 59888 25456 29867119
Blood test abnormal 17.58 10.71 36 59867 5489 29887086
Deep vein thrombosis 17.57 10.71 62 59841 60439 29832136
Cytomegalovirus infection 17.55 10.71 13 59890 23661 29868914
Disturbance in social behaviour 17.55 10.71 18 59885 1453 29891122
Bronchiolitis 17.48 10.71 23 59880 2425 29890150
Feeling abnormal 17.48 10.71 182 59721 56574 29836001
Eye disorder 17.47 10.71 44 59859 7690 29884885
Sputum purulent 17.35 10.71 11 59892 443 29892132
Acute respiratory distress syndrome 17.26 10.71 13 59890 23459 29869116
White blood cell count decreased 17.17 10.71 98 59805 83849 29808726
Rhinitis perennial 17.02 10.71 7 59896 110 29892465
Rhonchi 16.83 10.71 19 59884 1710 29890865
Onychophagia 16.56 10.71 5 59898 29 29892546
Hostility 16.53 10.71 14 59889 885 29891690
Blood bilirubin increased 16.50 10.71 30 59873 36606 29855969
Hypogammaglobulinaemia 16.45 10.71 34 59869 5218 29887357
Dermatitis atopic 16.42 10.71 15 59888 1049 29891526
Hypoglycaemia 16.35 10.71 50 59853 50931 29841644
Panic reaction 16.23 10.71 17 59886 1406 29891169
Pneumocystis jirovecii pneumonia 16.13 10.71 7 59896 17113 29875462
Abnormal dreams 16.12 10.71 44 59859 8071 29884504
Eczema 16.06 10.71 61 59842 13308 29879267
Prolonged expiration 16.03 10.71 8 59895 201 29892374
Altered state of consciousness 16.02 10.71 10 59893 19909 29872666
Neoplasm progression 16.01 10.71 8 59895 18015 29874560
Acute myeloid leukaemia 15.98 10.71 8 59895 17998 29874577
Hypohidrosis 15.92 10.71 8 59895 204 29892371
C-reactive protein increased 15.91 10.71 40 59863 43433 29849142
Syncope 15.86 10.71 102 59801 84801 29807774
Human ehrlichiosis 15.85 10.71 8 59895 206 29892369
Palmar-plantar erythrodysaesthesia syndrome 15.83 10.71 5 59898 14865 29877710
Tubulointerstitial nephritis 15.80 10.71 8 59895 17883 29874692
Metabolic acidosis 15.71 10.71 32 59871 37429 29855146
Asthma-chronic obstructive pulmonary disease overlap syndrome 15.66 10.71 12 59891 657 29891918
Separation anxiety disorder 15.65 10.71 3 59900 0 29892575
Seizure anoxic 15.65 10.71 3 59900 0 29892575
Exophthalmos congenital 15.65 10.71 3 59900 0 29892575
Pigmentary glaucoma 15.65 10.71 3 59900 0 29892575
Cephalo-pelvic disproportion 15.65 10.71 3 59900 0 29892575
Stiff person syndrome 15.62 10.71 7 59896 137 29892438
Urinary tract infection 15.60 10.71 85 59818 73574 29819001
Mucosal inflammation 15.57 10.71 23 59880 30471 29862104
Scleroderma 15.40 10.71 16 59887 1311 29891264
Respiratory tract irritation 15.35 10.71 7 59896 143 29892432
Oropharyngeal discomfort 15.24 10.71 17 59886 1510 29891065
Melaena 15.11 10.71 26 59877 32411 29860164
Encephalopathy 14.84 10.71 26 59877 32179 29860396
Contraindicated product administered 14.78 10.71 8 59895 17223 29875352
Weight increased 14.77 10.71 221 59682 74692 29817883
Bone density decreased 14.75 10.71 18 59885 1760 29890815
Liver function test decreased 14.66 10.71 5 59898 45 29892530
Hyperbilirubinaemia 14.34 10.71 8 59895 16934 29875641
Bronchial disorder 14.33 10.71 13 59890 901 29891674
Bronchitis viral 14.33 10.71 8 59895 254 29892321
Respiratory symptom 14.14 10.71 12 59891 761 29891814
Nausea 14.06 10.71 470 59433 296487 29596088
Weight decreased 13.99 10.71 398 59505 150523 29742052
Nasal mucosal disorder 13.95 10.71 6 59897 106 29892469
Electrocardiogram QT prolonged 13.88 10.71 32 59871 35803 29856772
Upper respiratory tract congestion 13.85 10.71 12 59891 783 29891792
Swelling face 13.84 10.71 81 59822 21123 29871452
Dacryostenosis congenital 13.74 10.71 4 59899 20 29892555
Nocturnal dyspnoea 13.64 10.71 10 59893 512 29892063
Unresponsive to stimuli 13.42 10.71 20 59883 26399 29866176
Agitation 13.31 10.71 166 59737 53907 29838668
Respiration abnormal 13.26 10.71 21 59882 2621 29889954
Asthma exercise induced 13.18 10.71 6 59897 122 29892453
Bradycardia 13.13 10.71 77 59826 65449 29827126
Sputum abnormal 13.11 10.71 9 59894 415 29892160
Disseminated intravascular coagulation 13.09 10.71 15 59888 22156 29870419
Carbon dioxide increased 13.06 10.71 13 59890 1012 29891563
Device related infection 13.06 10.71 9 59894 17006 29875569
Hepatic encephalopathy 13.06 10.71 6 59897 14186 29878389
Head banging 13.05 10.71 6 59897 125 29892450
Central obesity 13.05 10.71 10 59893 548 29892027
Sopor 13.01 10.71 3 59900 10988 29881587
Eosinophilic oesophagitis 12.93 10.71 7 59896 209 29892366
Cardiogenic shock 12.84 10.71 9 59894 16852 29875723
Erythema 12.84 10.71 222 59681 77229 29815346
Child abuse 12.78 10.71 7 59896 214 29892361
Fight in school 12.72 10.71 3 59900 5 29892570
Vasculitis 12.69 10.71 40 59863 7950 29884625
Circulatory collapse 12.68 10.71 13 59890 20201 29872374
Episcleritis 12.59 10.71 6 59897 136 29892439
Pregnancy 12.58 10.71 7 59896 221 29892354
Constipation 12.53 10.71 155 59748 112751 29779824
ACTH stimulation test abnormal 12.37 10.71 3 59900 6 29892569
Allergy to plants 12.37 10.71 3 59900 6 29892569
Painful respiration 12.24 10.71 14 59889 1278 29891297
Product dose omission issue 12.22 10.71 254 59649 91377 29801198
Cardiac failure congestive 12.16 10.71 109 59794 84298 29808277
Subdural haematoma 12.13 10.71 12 59891 18960 29873615
Product taste abnormal 12.12 10.71 13 59890 1105 29891470
Drug intolerance 12.11 10.71 48 59855 45243 29847332
Choking 12.09 10.71 29 59874 4917 29887658
Breath holding 12.05 10.71 3 59900 7 29892568
Obsessive-compulsive disorder 12.03 10.71 26 59877 4115 29888460
Ischaemic stroke 11.98 10.71 9 59894 16266 29876309
Autism spectrum disorder 11.95 10.71 14 59889 1311 29891264
Nervousness 11.94 10.71 51 59852 11737 29880838
Prescribed overdose 11.93 10.71 41 59862 8520 29884055
Type III immune complex mediated reaction 11.92 10.71 7 59896 245 29892330
Breech presentation 11.80 10.71 6 59897 157 29892418
Frustration tolerance decreased 11.80 10.71 17 59886 1953 29890622
Neuropsychiatric symptoms 11.79 10.71 9 59894 490 29892085
Sputum retention 11.73 10.71 9 59894 494 29892081
Hyperglycaemia 11.66 10.71 34 59869 35166 29857409
Penile erythema 11.63 10.71 6 59897 162 29892413
Generalised anxiety disorder 11.54 10.71 10 59893 652 29891923
Sialadenosis 11.51 10.71 3 59900 9 29892566
Discomfort 11.50 10.71 58 59845 14298 29878277
Oedema peripheral 11.48 10.71 146 59757 105686 29786889
Pulmonary renal syndrome 11.43 10.71 6 59897 168 29892407
Deformity thorax 11.36 10.71 4 59899 40 29892535
Reaction to excipient 11.29 10.71 8 59895 388 29892187
Coronary artery disease 11.29 10.71 56 59847 49656 29842919
Hallucination, auditory 11.21 10.71 44 59859 9745 29882830
Depressed level of consciousness 11.21 10.71 39 59864 38183 29854392
Crepitations 11.19 10.71 21 59882 3003 29889572
Hemiparesis 11.14 10.71 8 59895 14794 29877781
Treatment failure 11.13 10.71 34 59869 34645 29857930
Subarachnoid haemorrhage 11.12 10.71 3 59900 9883 29882692
Meralgia paraesthetica 11.09 10.71 6 59897 179 29892396
Shock haemorrhagic 11.08 10.71 3 59900 9862 29882713
Violence-related symptom 11.06 10.71 9 59894 538 29892037
Asthenia 10.99 10.71 348 59555 220942 29671633
Ligament sprain 10.96 10.71 20 59883 2800 29889775
Angina pectoris 10.92 10.71 27 59876 29491 29863084
Administration site irritation 10.85 10.71 3 59900 12 29892563
Muscle spasms 10.80 10.71 186 59717 64652 29827923
Rales 10.75 10.71 33 59870 6467 29886108
Depression suicidal 10.72 10.71 13 59890 1263 29891312

Pharmacologic Action:

SourceCodeDescription
ATC R03DC03 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Leukotriene receptor antagonists
ATC R03DC53 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Leukotriene receptor antagonists
FDA MoA N0000000083 Leukotriene Receptor Antagonists
FDA EPC N0000175777 Leukotriene Receptor Antagonist
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D065694 Cytochrome P-450 CYP1A2 Inducers
MeSH PA D006727 Hormone Antagonists
MeSH PA D020024 Leukotriene Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:49159 ltra
CHEBI has role CHEBI:49167 anti-asthmatic agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Non-allergic asthma indication 266361008 DOID:9360
Allergic asthma indication 389145006 DOID:9415
Asthma management indication 406162001
Exercise-Induced Bronchospasm Prevention indication
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Mood swings contraindication 18963009
Feeling agitated contraindication 24199005
Depressive disorder contraindication 35489007
Anxiety contraindication 48694002
Vasculitis of the skin contraindication 53312001
Dream disorder contraindication 85418005
Eosinophil count raised contraindication 386789004
Tremors contraindication
Nervousness contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.28 acidic
pKa2 4.98 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Cysteinyl leukotriene receptor 1 GPCR ANTAGONIST Ki 9.30 CHEMBL CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.83 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.57 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.40 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 5.58 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 5.71 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 5.85 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 5.49 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 6.12 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.68 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 6.61 DRUG MATRIX
Delta-type opioid receptor GPCR Ki 5.77 DRUG MATRIX
Epidermal growth factor receptor Kinase IC50 5.50 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.33 DRUG MATRIX
Thromboxane-A synthase Enzyme IC50 5.82 DRUG MATRIX
Mitogen-activated protein kinase 14 Kinase IC50 6.07 DRUG MATRIX
Substance-K receptor GPCR Ki 5.89 DRUG MATRIX
Arachidonate 5-lipoxygenase Enzyme Ki 4.33 WOMBAT-PK
Cytochrome P450 2C8 Enzyme Ki 5.96 WOMBAT-PK
Cysteinyl leukotriene receptor 2 GPCR Ki 5.30 PDSP
Uracil nucleotide/cysteinyl leukotriene receptor GPCR Ki 5.18 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 5.62 DRUG MATRIX
Cysteinyl leukotriene receptor 1 GPCR Ki 9.30 CHEMBL
Uracil nucleotide/cysteinyl leukotriene receptor Unclassified ANTAGONIST IC50 7.21 IUPHAR

External reference:

IDSource
4024117 VUID
N0000022122 NUI
D00529 KEGG_DRUG
151767-02-1 SECONDARY_CAS_RN
4021110 VANDF
4024117 VANDF
C0298130 UMLSCUI
CHEBI:50730 CHEBI
MTK PDB_CHEM_ID
CHEMBL787 ChEMBL_ID
CHEMBL1200681 ChEMBL_ID
DB00471 DRUGBANK_ID
C093875 MESH_SUPPLEMENTAL_RECORD_UI
3340 IUPHAR_LIGAND_ID
7388 INN_ID
MHM278SD3E UNII
5281040 PUBCHEM_CID
115713 RXNORM
11578 MMSL
189710 MMSL
5134 MMSL
d04289 MMSL
007256 NDDF
007257 NDDF
108620002 SNOMEDCT_US
320883008 SNOMEDCT_US
373728005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 0006-1711 TABLET, CHEWABLE 4 mg ORAL NDA 30 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 0006-3841 GRANULE 4 mg ORAL NDA 30 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 0006-9117 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 0006-9275 TABLET, CHEWABLE 5 mg ORAL NDA 30 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0054-0259 TABLET 10 mg ORAL ANDA 28 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0054-0288 TABLET, CHEWABLE 4 mg ORAL ANDA 28 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0054-0289 TABLET, CHEWABLE 5 mg ORAL ANDA 28 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7424 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7425 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7426 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7487 GRANULE 4 mg ORAL ANDA 31 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9649 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9650 TABLET, CHEWABLE 5 mg ORAL ANDA 25 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9651 TABLET, CHEWABLE 4 mg ORAL ANDA 25 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5554 TABLET, CHEWABLE 4 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5555 TABLET, CHEWABLE 5 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5560 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0904-6808 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 26 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 26 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 26 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 16729-119 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-221 TABLET, FILM COATED 10 mg ORAL NDA 28 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-565 TABLET, CHEWABLE 5 mg ORAL NDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-015 GRANULE 4 mg ORAL ANDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-016 TABLET, CHEWABLE 4 mg ORAL ANDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-017 TABLET, CHEWABLE 5 mg ORAL ANDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-018 TABLET, COATED 10 mg ORAL ANDA 28 sections