fexofenadine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
1170 83799-24-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fexofenadine
  • terfenadine carboxylate
  • fexofenadine hydrochloride
  • fexofenadine HCl
a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; ; RN refers to HCl
  • Molecular weight: 501.67
  • Formula: C32H39NO4
  • CLOGP: 1.96
  • LIPINSKI: 1
  • HAC: 5
  • HDO: 3
  • TPSA: 81
  • ALOGS: -5.28
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.12 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.13 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 33 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 3.60 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.405 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 16.558 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.415 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.466 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 22.420 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 40.390 % High 1
herg hERG pIC50 4.734 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.084 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 2.917 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 27.870 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK,TGFBR1 20
kinase-selectivity-class AXL,EIF2AK3,EPHB4,GRK2,PDK4,TEK,TGFBR1 7
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 14.488 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.020 High 1
mh-clint Mouse hepatocyte intrinsic clearance 11.220 High 1
mppb Mouse plasma protein binding (% unbound) 27.960 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 4.055 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 30.100 % High 1
rat-kpuu-brain Rat brain Kpuu 0.015 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.445 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 71.480 % High 1
rppb Rat plasma protein binding (% unbound) 26.010 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 933.254 uM High 1

Approvals:

DateAgencyCompanyOrphan
July 25, 1996 FDA SANOFI AVENTIS US

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
Dermatitis atopic 271.44 11.05 165 48748 23307 90556227
Pruritus 218.76 11.05 715 48198 540810 90038724
Urticaria 201.01 11.05 489 48424 312245 90267289
Angioedema 171.71 11.05 193 48720 64683 90514851
Synovitis 163.04 11.05 3 48910 329749 90249785
Lip swelling 145.76 11.05 139 48774 38471 90541063
Contraindicated product administered 134.56 11.05 10 48903 320129 90259405
Hand deformity 131.29 11.05 7 48906 296355 90283179
No adverse event 130.61 11.05 172 48741 67810 90511724
Systemic lupus erythematosus 130.06 11.05 20 48893 361876 90217658
Glossodynia 127.23 11.05 13 48900 321766 90257768
General physical health deterioration 112.02 11.05 27 48886 355088 90224446
COVID-19 111.47 11.05 267 48646 168576 90410958
Helicobacter infection 108.45 11.05 3 48910 226847 90352687
Dry skin 104.73 11.05 178 48735 87895 90491639
Product dose omission issue 100.66 11.05 366 48547 291321 90288213
Eczema 98.83 11.05 132 48781 52738 90526796
Asthma 97.61 11.05 320 48593 241840 90337694
Swelling face 96.17 11.05 164 48749 81188 90498346
Wound 95.61 11.05 23 48890 302957 90276577
Seasonal allergy 94.93 11.05 87 48826 22896 90556638
Anaphylactic reaction 93.82 11.05 169 48744 87355 90492179
Folliculitis 93.14 11.05 4 48909 204349 90375185
Eye pruritus 90.16 11.05 94 48819 28933 90550601
Arthropathy 86.31 11.05 45 48868 366197 90213337
Muscle injury 82.05 11.05 3 48910 176651 90402883
Liver injury 78.87 11.05 3 48910 170564 90408970
Therapeutic product effect decreased 78.43 11.05 26 48887 277545 90301989
Hepatic enzyme increased 78.31 11.05 49 48864 360687 90218847
Infusion related reaction 75.84 11.05 68 48845 416712 90162822
Rash 75.57 11.05 707 48206 795393 89784141
Impaired healing 75.42 11.05 17 48896 234182 90345352
Maternal exposure during pregnancy 70.11 11.05 55 48858 360008 90219526
Feeling abnormal 70.05 11.05 224 48689 167011 90412523
Type 2 diabetes mellitus 69.06 11.05 13 48900 203231 90376303
Illness 67.94 11.05 142 48771 81827 90497707
Treatment failure 67.74 11.05 40 48873 303888 90275646
Skin exfoliation 63.86 11.05 124 48789 67789 90511745
Cough 63.09 11.05 377 48536 368585 90210949
Drug intolerance 62.94 11.05 90 48823 447501 90132033
Injection site pain 62.44 11.05 221 48692 173478 90406056
Pericarditis 60.99 11.05 35 48878 270116 90309418
Eye swelling 58.98 11.05 76 48837 29310 90550224
Joint swelling 58.04 11.05 115 48798 503185 90076349
Rheumatoid arthritis 57.06 11.05 67 48846 362547 90216987
Pharyngeal swelling 56.07 11.05 45 48868 9899 90569635
Headache 54.93 11.05 708 48205 862038 89717496
Anosmia 50.15 11.05 42 48871 9806 90569728
Mobility decreased 47.90 11.05 39 48874 250695 90328839
Bronchitis 46.96 11.05 185 48728 152742 90426792
Nasal pruritus 46.95 11.05 17 48896 733 90578801
Dizziness 46.44 11.05 504 48409 588780 89990754
Rash macular 45.32 11.05 68 48845 30212 90549322
Throat tightness 45.26 11.05 67 48846 29417 90550117
Impaired quality of life 45.11 11.05 59 48854 23085 90556449
Neurosis 44.46 11.05 14 48899 391 90579143
Toxicity to various agents 44.40 11.05 54 48859 287792 90291742
Inappropriate schedule of product administration 44.13 11.05 179 48734 149754 90429780
Nasal congestion 43.71 11.05 121 48792 83293 90496241
Therapeutic response shortened 42.55 11.05 57 48856 22822 90556712
Irritable bowel syndrome 42.52 11.05 30 48883 207418 90372116
Chronic spontaneous urticaria 41.26 11.05 20 48893 1800 90577734
Pulmonary fibrosis 40.79 11.05 5 48908 107498 90472036
Dry eye 40.78 11.05 94 48819 57837 90521697
Pre-existing condition improved 40.40 11.05 36 48877 9133 90570401
Completed suicide 40.23 11.05 14 48899 145044 90434490
Skin swelling 39.59 11.05 31 48882 6583 90572951
Bursitis 39.57 11.05 11 48902 131643 90447891
Cardiospasm 39.25 11.05 24 48889 3422 90576112
Chest discomfort 38.99 11.05 163 48750 138202 90441332
Palmoplantar keratoderma 38.86 11.05 24 48889 3483 90576051
Erythema 38.33 11.05 233 48680 229013 90350521
Pruritus genital 37.77 11.05 26 48887 4532 90575002
Sinusitis 37.70 11.05 315 48598 342773 90236761
Lower respiratory tract infection 37.63 11.05 48 48865 250611 90328923
Diplopia 35.39 11.05 59 48854 28655 90550879
Rash pruritic 35.20 11.05 111 48802 82103 90497431
Pain of skin 34.50 11.05 43 48870 16039 90563495
Gait inability 34.45 11.05 18 48895 146438 90433096
Injection site rash 34.36 11.05 53 48860 24120 90555414
Eye irritation 34.35 11.05 64 48849 33914 90545620
Ill-defined disorder 33.78 11.05 30 48883 184861 90394673
Pathergy reaction 33.72 11.05 8 48905 73 90579461
Fibromyalgia 33.63 11.05 37 48876 206232 90373302
Sleep terror 33.58 11.05 24 48889 4440 90575094
Injury 32.61 11.05 35 48878 197314 90382220
Rhinorrhoea 32.25 11.05 113 48800 88203 90491331
Musculoskeletal stiffness 32.24 11.05 70 48843 296462 90283072
Skin burning sensation 32.18 11.05 46 48867 19565 90559969
Exposure during pregnancy 31.47 11.05 50 48863 238360 90341174
Joint range of motion decreased 31.42 11.05 17 48896 135626 90443908
Inflammation 31.42 11.05 30 48883 178562 90400972
Hypotension 31.26 11.05 82 48831 325315 90254219
Product dose omission in error 30.62 11.05 46 48867 20457 90559077
Multiple allergies 30.12 11.05 39 48874 15107 90564427
Injection site bruising 29.53 11.05 78 48835 52229 90527305
Product administration interrupted 29.40 11.05 35 48878 12457 90567077
Atrial tachycardia 29.38 11.05 25 48888 5965 90573569
Immunisation 29.34 11.05 17 48896 2196 90577338
Tinnitus 29.31 11.05 69 48844 43033 90536501
Peripheral venous disease 29.29 11.05 5 48908 83916 90495618
Lung disorder 29.00 11.05 23 48890 149860 90429674
Mast cell activation syndrome 28.74 11.05 15 48898 1579 90577955
Exposure via skin contact 28.56 11.05 32 48881 10673 90568861
Tension headache 28.26 11.05 27 48886 7482 90572052
Hallucination 28.18 11.05 89 48824 65870 90513664
Injection site swelling 27.67 11.05 83 48830 59756 90519778
Gastrointestinal disorder 27.56 11.05 61 48852 256626 90322908
Product use issue 27.42 11.05 89 48824 329830 90249704
Oropharyngeal pain 27.38 11.05 129 48784 115058 90464476
Ocular hyperaemia 27.35 11.05 58 48855 33740 90545794
Grip strength decreased 27.33 11.05 8 48905 92568 90486966
Swelling 27.15 11.05 125 48788 418933 90160601
C-reactive protein increased 26.94 11.05 35 48878 181354 90398180
Osteoarthritis 26.84 11.05 40 48873 195690 90383844
Palpitations 26.79 11.05 145 48768 136583 90442951
Wound infection 26.66 11.05 12 48901 106390 90473144
Drug eruption 26.64 11.05 59 48854 35348 90544186
Red blood cell sedimentation rate increased 26.56 11.05 6 48907 82589 90496945
Thrombocytopenia 26.40 11.05 45 48868 208680 90370854
Carotid artery occlusion 26.17 11.05 24 48889 6318 90573216
Sciatica 26.09 11.05 11 48902 101371 90478163
Night sweats 25.88 11.05 19 48894 128747 90450787
Hypercholesterolaemia 25.88 11.05 11 48902 100881 90478653
Confusional state 25.74 11.05 114 48799 386091 90193443
Lower limb fracture 25.74 11.05 7 48906 85006 90494528
Carcinoid syndrome 25.73 11.05 8 48905 214 90579320
Nasal disorder 25.46 11.05 18 48895 3274 90576260
Facial pain 24.76 11.05 33 48880 13149 90566385
Alopecia 24.75 11.05 161 48752 494910 90084624
Skin fissures 24.64 11.05 42 48871 20767 90558767
Prescribed overdose 24.48 11.05 11 48902 97614 90481920
Swollen tongue 24.40 11.05 67 48846 45889 90533645
Diarrhoea 24.08 11.05 670 48243 938520 89641014
Hypohidrosis 23.88 11.05 6 48907 71 90579463
Lip discolouration 23.49 11.05 10 48903 665 90578869
Insomnia 23.39 11.05 279 48634 333195 90246339
Oropharyngeal spasm 23.31 11.05 8 48905 294 90579240
Dysphonia 23.27 11.05 81 48832 63003 90516531
Persistent depressive disorder 23.16 11.05 12 48901 1245 90578289
Stomatitis 22.89 11.05 74 48839 274624 90304910
Nausea 22.86 11.05 771 48142 1109545 89469989
Sneezing 22.73 11.05 50 48863 29819 90549715
Rash erythematous 22.65 11.05 82 48831 65022 90514512
Injection site pruritus 22.41 11.05 72 48841 53762 90525772
Infusion site pain 22.27 11.05 39 48874 19699 90559835
Myalgia 22.06 11.05 166 48747 174959 90404575
Therapeutic response unexpected 21.85 11.05 41 48872 21839 90557695
Hip arthroplasty 21.75 11.05 7 48906 76201 90503333
Infusion site swelling 21.49 11.05 29 48884 11691 90567843
Periorbital swelling 21.46 11.05 19 48894 4779 90574755
Disturbance in attention 21.45 11.05 65 48848 47044 90532490
Blood cholesterol increased 21.06 11.05 51 48862 207961 90371573
Subarachnoid haemorrhage 21.02 11.05 36 48877 17868 90561666
Psoriatic arthropathy 20.82 11.05 59 48854 228276 90351258
Musculoskeletal pain 20.68 11.05 38 48875 171213 90408321
Adjustment disorder with depressed mood 20.67 11.05 3 48910 56750 90522784
Drug interaction 20.67 11.05 78 48835 276375 90303159
Genital rash 20.51 11.05 9 48904 644 90578890
Blister 20.35 11.05 70 48843 254928 90324606
Urinary tract infection 20.25 11.05 253 48660 305379 90274155
Croup infectious 20.08 11.05 9 48904 678 90578856
Hereditary angioedema 20.02 11.05 25 48888 9340 90570194
Insurance issue 19.92 11.05 27 48886 10931 90568603
Upper-airway cough syndrome 19.87 11.05 32 48881 15103 90564431
Sleep apnoea syndrome 19.63 11.05 49 48864 31698 90547836
Surgery 19.57 11.05 61 48852 44826 90534708
Prescribed underdose 19.53 11.05 8 48905 75011 90504523
Epilepsy 19.48 11.05 10 48903 82196 90497338
Obesity 19.41 11.05 17 48896 105490 90474044
Swelling of eyelid 19.38 11.05 19 48894 5435 90574099
Eye discharge 19.20 11.05 23 48890 8235 90571299
Nerve compression 19.15 11.05 26 48887 10540 90568994
Sinus disorder 19.07 11.05 51 48862 34396 90545138
Endometriosis 18.98 11.05 20 48893 6228 90573306
Acute kidney injury 18.76 11.05 99 48814 320288 90259246
Autoimmune disorder 18.69 11.05 9 48904 76735 90502799
Oesophageal irritation 18.65 11.05 7 48906 334 90579200
Allergic cough 18.60 11.05 10 48903 1118 90578416
Abdominal discomfort 18.31 11.05 167 48746 477161 90102373
Skin wound 18.21 11.05 12 48901 1946 90577588
Eosinophilic oesophagitis 18.14 11.05 9 48904 852 90578682
Lacrimation increased 18.05 11.05 43 48870 27019 90552515
Somnolence 17.89 11.05 182 48731 208902 90370632
Rash papular 17.72 11.05 36 48877 20319 90559215
Mucosal discolouration 17.43 11.05 8 48905 637 90578897
Paranasal sinus discomfort 17.32 11.05 19 48894 6191 90573343
Conversion disorder 17.22 11.05 12 48901 2134 90577400
Nasal dryness 17.19 11.05 18 48895 5565 90573969
Urticaria aquagenic 17.11 11.05 4 48909 34 90579500
Knee arthroplasty 17.07 11.05 12 48901 83170 90496364
Upper respiratory tract infection 16.94 11.05 123 48790 128195 90451339
Infusion site erythema 16.73 11.05 28 48885 13642 90565892
Microcephaly 16.69 11.05 10 48903 1374 90578160
Urticaria cholinergic 16.62 11.05 4 48909 39 90579495
Sinus congestion 16.61 11.05 42 48871 27382 90552152
Eye pain 16.54 11.05 57 48856 44111 90535423
Eye haematoma 16.52 11.05 5 48908 122 90579412
Essential tremor 16.51 11.05 10 48903 1402 90578132
Blindness 16.42 11.05 41 48872 26527 90553007
Influenza 16.42 11.05 130 48783 139134 90440400
Vasculitis 16.16 11.05 37 48876 22656 90556878
Ear swelling 16.14 11.05 11 48902 1886 90577648
Adverse event 16.08 11.05 24 48889 117394 90462140
Blepharospasm 15.98 11.05 5 48908 55440 90524094
Vision blurred 15.89 11.05 108 48805 110185 90469349
Injection site urticaria 15.85 11.05 32 48881 17979 90561555
Neurodermatitis 15.56 11.05 13 48900 3025 90576509
Hepatotoxicity 15.42 11.05 3 48910 45839 90533695
Quadriparesis 15.37 11.05 12 48901 2537 90576997
Disease recurrence 15.35 11.05 50 48863 37603 90541931
Flatulence 15.16 11.05 53 48860 41314 90538220
Tendinous contracture 15.03 11.05 5 48908 167 90579367
Throat irritation 15.01 11.05 59 48854 48636 90530898
Rhinitis allergic 14.99 11.05 30 48883 16755 90562779
Malaise 14.95 11.05 418 48495 585568 89993966
Chills 14.90 11.05 122 48791 131859 90447675
Tremor 14.90 11.05 137 48776 153036 90426498
Bone erosion 14.90 11.05 5 48908 53016 90526518
Vulvovaginal injury 14.88 11.05 7 48906 589 90578945
Mechanical urticaria 14.79 11.05 7 48906 597 90578937
Product use in unapproved indication 14.67 11.05 259 48654 335977 90243557
Oropharyngeal oedema 14.65 11.05 6 48907 362 90579172
Scratch 14.54 11.05 22 48891 9844 90569690
Foot deformity 14.52 11.05 7 48906 59644 90519890
Injection site erythema 14.51 11.05 97 48816 98405 90481129
Sleep disorder due to a general medical condition 14.43 11.05 55 48858 44683 90534851
Skin weeping 14.38 11.05 12 48901 2788 90576746
Infusion site pruritus 14.37 11.05 18 48895 6747 90572787
Agitated depression 14.34 11.05 6 48907 382 90579152
Discomfort 14.31 11.05 88 48825 274247 90305287
Dermatitis contact 14.23 11.05 26 48887 13569 90565965
Coma 14.23 11.05 11 48902 72621 90506913
Acarodermatitis 14.14 11.05 9 48904 1377 90578157
Hypersomnia 14.13 11.05 34 48879 21497 90558037
Psychomotor skills impaired 14.11 11.05 12 48901 2860 90576674
Migraine 14.09 11.05 161 48752 190231 90389303
Oropharyngeal discomfort 13.97 11.05 19 48894 7716 90571818
Infective pulmonary exacerbation of cystic fibrosis 13.86 11.05 22 48891 10257 90569277
Incorrect dose administered 13.67 11.05 81 48832 78849 90500685
Anxiety 13.65 11.05 239 48674 309533 90270001
Cerebral disorder 13.47 11.05 16 48897 5678 90573856
Leukopenia 13.40 11.05 21 48892 100689 90478845
Frequent bowel movements 13.38 11.05 7 48906 56928 90522606
Hyperhidrosis 13.30 11.05 122 48791 136183 90443351
Infusion site bruising 13.29 11.05 14 48899 4358 90575176
Back pain 13.02 11.05 242 48671 316933 90262601
Allergic bronchitis 13.00 11.05 3 48910 24 90579510
Skin irritation 12.98 11.05 25 48888 13578 90565956
Constipation 12.95 11.05 218 48695 280177 90299357
Coeliac disease 12.90 11.05 4 48909 44606 90534928
Foreign body in reproductive tract 12.90 11.05 8 48905 1169 90578365
Nightmare 12.88 11.05 33 48880 21692 90557842
Leukoplakia oral 12.68 11.05 5 48908 273 90579261
Multiple organ dysfunction syndrome 12.58 11.05 11 48902 68325 90511209
Cognitive disorder 12.52 11.05 72 48841 69335 90510199
Respiratory tract infection 12.49 11.05 64 48849 59014 90520520
Perinatal depression 12.47 11.05 7 48906 852 90578682
Sensitive skin 12.43 11.05 12 48901 3369 90576165
Seborrhoeic dermatitis 12.37 11.05 9 48904 1711 90577823
Burning feet syndrome 12.37 11.05 4 48909 122 90579412
Exposure to allergen 12.34 11.05 6 48907 544 90578990
Somnambulism 12.33 11.05 16 48897 6212 90573322
Vertigo 12.32 11.05 72 48841 69739 90509795
Poor quality device used 12.13 11.05 10 48903 2283 90577251
Tongue discolouration 12.10 11.05 12 48901 3481 90576053
Epistaxis 12.05 11.05 83 48830 85042 90494492
Axillary pain 12.03 11.05 10 48903 2311 90577223
Heart rate increased 12.02 11.05 103 48810 112799 90466735
Myelosuppression 12.00 11.05 7 48906 53584 90525950
Conjunctivitis allergic 12.00 11.05 8 48905 1324 90578210
Mouth swelling 11.92 11.05 15 48898 5647 90573887
Oropharyngeal swelling 11.89 11.05 7 48906 931 90578603
Hepatic cirrhosis 11.87 11.05 10 48903 63243 90516291
Sinus headache 11.84 11.05 16 48897 6460 90573074
Fat embolism 11.61 11.05 5 48908 342 90579192
Muscle twitching 11.59 11.05 34 48879 24168 90555366
Product taste abnormal 11.52 11.05 10 48903 2450 90577084
Perfume sensitivity 11.51 11.05 7 48906 988 90578546
Infusion site rash 11.44 11.05 10 48903 2473 90577061
Pregnancy 11.41 11.05 10 48903 62037 90517497
Eyelids pruritus 11.31 11.05 9 48904 1955 90577579
Respiratory failure 11.23 11.05 30 48883 118388 90461146
Antibody test negative 11.22 11.05 3 48910 46 90579488
Taste disorder 11.22 11.05 10 48903 61536 90517998
Urticarial vasculitis 11.20 11.05 7 48906 1038 90578496
Alopecia universalis 11.10 11.05 4 48909 170 90579364
Laryngeal oedema 11.08 11.05 16 48897 6865 90572669
Gastrointestinal motility disorder 11.06 11.05 15 48898 6076 90573458

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
Pruritus 129.43 12.87 277 19603 188494 42412961
Dermatitis atopic 120.51 12.87 74 19806 12330 42589125
Lip swelling 89.72 12.87 73 19807 18980 42582475
Urticaria 73.14 12.87 127 19753 73909 42527546
Rash 69.51 12.87 284 19596 276670 42324785
Dry skin 55.86 12.87 89 19791 48249 42553206
Toxicity to various agents 51.89 12.87 21 19859 229115 42372340
No adverse event 48.07 12.87 74 19806 38947 42562508
Skin fissures 45.38 12.87 37 19843 9639 42591816
Skin exfoliation 43.26 12.87 73 19807 41480 42559975
General physical health deterioration 39.19 12.87 11 19869 151235 42450220
Therapeutic response decreased 35.87 12.87 63 19817 36949 42564506
Dry eye 35.67 12.87 40 19840 15466 42585989
Sinusitis 35.30 12.87 72 19808 47220 42554235
Injection site pain 35.14 12.87 81 19799 57717 42543738
Angioedema 34.50 12.87 67 19813 42410 42559045
Anaphylactic reaction 33.00 12.87 66 19814 42677 42558778
Pemphigoid 32.42 12.87 33 19847 11434 42590021
Alopecia areata 31.32 12.87 10 19870 340 42601115
Eczema 30.45 12.87 56 19824 34030 42567425
Rhinitis allergic 30.05 12.87 20 19860 3822 42597633
Asthma 29.12 12.87 79 19801 62235 42539220
Eye pruritus 28.96 12.87 31 19849 11381 42590074
Patient uncooperative 28.47 12.87 11 19869 660 42600795
Butterfly rash 26.86 12.87 7 19873 113 42601342
Drug eruption 25.97 12.87 42 19838 23033 42578422
Skin texture abnormal 25.49 12.87 6 19874 62 42601393
Myalgia 25.16 12.87 100 19780 95980 42505475
Rash macular 25.09 12.87 35 19845 16856 42584599
Vision blurred 25.01 12.87 68 19812 53631 42547824
Headache 24.45 12.87 193 19687 239176 42362279
Hypotension 23.90 12.87 53 19827 257578 42343877
Thrombocytopenia 23.18 12.87 33 19847 190246 42411209
Therapeutic response shortened 23.05 12.87 30 19850 13524 42587931
Swelling face 23.03 12.87 44 19836 27510 42573945
Hypersensitivity 22.84 12.87 80 19800 72290 42529165
Sleep disorder due to a general medical condition 22.76 12.87 34 19846 17419 42584036
Hepatic function abnormal 22.73 12.87 64 19816 51503 42549952
Pharyngeal swelling 22.55 12.87 16 19864 3391 42598064
Genital ulceration 22.22 12.87 10 19870 881 42600574
Pharyngeal ulceration 21.84 12.87 8 19872 414 42601041
Lacrimation increased 21.53 12.87 27 19853 11731 42589724
Taste disorder 21.23 12.87 25 19855 10182 42591273
Rhinorrhoea 20.93 12.87 46 19834 31748 42569707
Renal failure 20.58 12.87 22 19858 143704 42457751
Overdose 20.23 12.87 12 19868 105252 42496203
Nasopharyngitis 20.07 12.87 85 19795 83911 42517544
Acne 19.86 12.87 28 19852 13616 42587839
Mast cell activation syndrome 19.71 12.87 7 19873 331 42601124
Tooth injury 19.00 12.87 10 19870 1241 42600214
Death 18.68 12.87 136 19744 471049 42130406
Genital swelling 17.44 12.87 6 19874 258 42601197
Drug interaction 17.36 12.87 65 19815 266934 42334521
Acute kidney injury 17.08 12.87 101 19779 367236 42234219
Interstitial lung disease 16.91 12.87 77 19803 78385 42523070
Swelling of eyelid 16.45 12.87 11 19869 2117 42599338
Discomfort 16.05 12.87 36 19844 25183 42576272
Product use complaint 15.98 12.87 11 19869 2220 42599235
Alopecia universalis 15.95 12.87 5 19875 160 42601295
Skin haemorrhage 15.88 12.87 19 19861 7866 42593589
Eye discharge 15.21 12.87 12 19868 2983 42598472
Intellectual disability 14.99 12.87 10 19870 1917 42599538
Inappropriate schedule of product administration 14.99 12.87 86 19794 95816 42505639
Impaired quality of life 14.87 12.87 25 19855 14152 42587303
Dermatitis allergic 14.77 12.87 19 19861 8464 42592991
Acute generalised exanthematous pustulosis 14.58 12.87 19 19861 8576 42592879
Alopecia 14.56 12.87 38 19842 29238 42572217
Upper respiratory tract infection 14.51 12.87 48 19832 42125 42559330
Stevens-Johnson syndrome 14.49 12.87 32 19848 22146 42579309
Oropharyngeal pain 14.29 12.87 48 19832 42462 42558993
Sleep disorder 14.17 12.87 52 19828 48043 42553412
Mixed anxiety and depressive disorder 14.05 12.87 5 19875 238 42601217
Respiratory tract infection viral 13.86 12.87 12 19868 3394 42598061
Treatment failure 13.73 12.87 6 19874 62618 42538837
Product administration interrupted 13.51 12.87 14 19866 4952 42596503
Decreased appetite 13.24 12.87 143 19737 192994 42408461
COVID-19 13.22 12.87 96 19784 115852 42485603
Rash pruritic 13.17 12.87 40 19840 33563 42567892
Allergy to plants 13.12 12.87 3 19877 27 42601428

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pruritus 299.22 10.46 793 54116 580767 109953623
Dermatitis atopic 271.25 10.46 165 54744 25376 110509014
Urticaria 249.59 10.46 513 54396 318344 110216046
Lip swelling 227.71 10.46 194 54715 50473 110483917
Angioedema 159.99 10.46 220 54689 98280 110436110
Rash 140.37 10.46 788 54121 820176 109714214
Swelling face 131.93 10.46 194 54715 92127 110442263
General physical health deterioration 128.94 10.46 27 54882 425268 110109122
Synovitis 121.81 10.46 3 54906 274089 110260301
Dry skin 117.56 10.46 200 54709 107453 110426937
No adverse event 99.53 10.46 151 54758 73688 110460702
Anaphylactic reaction 97.71 10.46 191 54718 114109 110420281
Pemphigus 89.50 10.46 4 54905 214566 110319824
Skin exfoliation 89.36 10.46 158 54751 87493 110446897
Eczema 85.18 10.46 139 54770 72154 110462236
Toxicity to various agents 83.02 10.46 70 54839 480485 110053905
COVID-19 82.94 10.46 289 54620 244771 110289619
Hand deformity 82.40 10.46 7 54902 218499 110315891
Injection site pain 81.50 10.46 233 54676 177689 110356701
Contraindicated product administered 78.92 10.46 14 54895 248253 110286137
Eye pruritus 78.54 10.46 89 54820 32686 110501704
Pharyngeal swelling 77.57 10.46 57 54852 11975 110522415
Systemic lupus erythematosus 77.34 10.46 16 54893 254322 110280068
Asthma 73.58 10.46 282 54627 250009 110284381
Eye swelling 71.26 10.46 85 54824 32963 110501427
Glossodynia 69.53 10.46 13 54896 221991 110312399
Treatment failure 68.43 10.46 26 54883 277208 110257182
Helicobacter infection 68.10 10.46 6 54903 181871 110352519
Seasonal allergy 67.85 10.46 65 54844 19657 110514733
Product dose omission issue 67.23 10.46 327 54582 321455 110212935
Drug intolerance 63.36 10.46 65 54844 406447 110127943
Headache 62.57 10.46 691 54218 881686 109652704
Hepatic enzyme increased 61.45 10.46 42 54867 320850 110213540
Rash macular 60.67 10.46 85 54824 38601 110495789
Feeling abnormal 60.15 10.46 212 54697 180499 110353891
Drug eruption 57.64 10.46 99 54810 53560 110480830
Arthropathy 57.27 10.46 36 54873 287486 110246904
Hypotension 55.64 10.46 110 54799 523739 110010651
Dry eye 54.84 10.46 99 54810 55694 110478696
Impaired healing 54.63 10.46 15 54894 196702 110337688
Wound 53.02 10.46 25 54884 234412 110299978
C-reactive protein abnormal 52.23 10.46 3 54906 129692 110404698
Muscle injury 51.76 10.46 5 54904 140802 110393588
Therapeutic product effect decreased 50.88 10.46 29 54880 244287 110290103
Erythema 49.70 10.46 280 54629 291167 110243223
Liver injury 48.85 10.46 8 54901 150405 110383985
Rash pruritic 48.40 10.46 132 54777 97937 110436453
Illness 48.17 10.46 118 54791 82053 110452337
Folliculitis 48.05 10.46 12 54897 167641 110366749
Throat tightness 47.27 10.46 70 54839 33419 110500971
Drug abuse 46.58 10.46 15 54894 177396 110356994
Dizziness 45.45 10.46 538 54371 697655 109836735
Skin swelling 44.83 10.46 35 54874 8045 110526345
Myalgia 44.28 10.46 223 54686 222158 110312232
Skin fissures 43.30 10.46 57 54852 24401 110509989
Nasal congestion 42.38 10.46 126 54783 98156 110436234
Vision blurred 41.75 10.46 150 54759 128872 110405518
Chronic spontaneous urticaria 41.12 10.46 20 54889 1973 110532417
Chest discomfort 40.17 10.46 182 54727 173666 110360724
Neurosis 39.97 10.46 14 54895 596 110533794
Thrombocytopenia 39.90 10.46 70 54839 348815 110185575
Impaired quality of life 39.89 10.46 61 54848 29956 110504434
Bursitis 39.84 10.46 8 54901 129910 110404480
Rheumatoid arthritis 38.13 10.46 56 54853 299557 110234833
Type 2 diabetes mellitus 36.95 10.46 21 54888 177211 110357179
Mobility decreased 36.92 10.46 38 54871 237384 110297006
Completed suicide 36.35 10.46 40 54869 242341 110292049
Drug interaction 36.31 10.46 127 54782 500056 110034334
Maternal exposure during pregnancy 36.13 10.46 44 54865 254839 110279551
Pemphigoid 35.00 10.46 46 54863 19661 110514729
Infusion related reaction 34.73 10.46 87 54822 381075 110153315
Injection site rash 34.57 10.46 50 54859 23369 110511021
Cough 34.20 10.46 365 54544 461276 110073114
Nasal pruritus 34.08 10.46 14 54895 926 110533464
Exposure via skin contact 33.73 10.46 37 54872 13110 110521280
Injection site bruising 33.72 10.46 77 54832 51186 110483204
Therapeutic response shortened 33.65 10.46 56 54853 29527 110504863
Acute kidney injury 33.54 10.46 182 54727 635248 109899142
Swelling of eyelid 33.03 10.46 27 54882 6626 110527764
Rhinorrhoea 32.90 10.46 119 54790 102547 110431843
Product administration interrupted 32.90 10.46 34 54875 11258 110523132
Hepatic function abnormal 32.53 10.46 108 54801 89187 110445203
Inappropriate schedule of product administration 32.31 10.46 192 54717 203445 110330945
Pericarditis 31.93 10.46 37 54872 219077 110315313
Anosmia 31.82 10.46 35 54874 12437 110521953
Gait inability 31.67 10.46 14 54895 136362 110398028
Swollen tongue 31.54 10.46 83 54826 60279 110474111
Peripheral venous disease 30.88 10.46 3 54906 84114 110450276
Periorbital swelling 30.88 10.46 24 54885 5481 110528909
Joint swelling 30.44 10.46 115 54794 442730 110091660
Overdose 30.43 10.46 43 54866 233751 110300639
Eye discharge 30.39 10.46 29 54880 8725 110525665
Lung disorder 30.11 10.46 27 54882 180020 110354370
Lower respiratory tract infection 29.42 10.46 47 54862 243059 110291331
Lacrimation increased 29.25 10.46 54 54855 30896 110503494
Sleep disorder due to a general medical condition 28.61 10.46 73 54836 52039 110482351
Stevens-Johnson syndrome 28.18 10.46 68 54841 46833 110487557
Fibromyalgia 28.14 10.46 26 54883 170883 110363507
Ocular hyperaemia 28.07 10.46 61 54848 39225 110495165
Mast cell activation syndrome 27.57 10.46 14 54895 1514 110532876
Sinusitis 27.55 10.46 246 54663 296442 110237948
Diarrhoea 27.21 10.46 749 54160 1138756 109395634
Skin burning sensation 27.11 10.46 43 54866 21782 110512608
Rash erythematous 26.35 10.46 95 54814 81737 110452653
Eye irritation 26.29 10.46 54 54855 33398 110500992
Rhinitis allergic 26.07 10.46 38 54871 17884 110516506
Injection site urticaria 25.77 10.46 37 54872 17178 110517212
Obesity 25.75 10.46 12 54897 113339 110421051
Alopecia universalis 25.70 10.46 9 54900 383 110534007
Ill-defined disorder 25.66 10.46 24 54885 156829 110377561
Bronchitis 25.51 10.46 149 54760 156883 110377507
Injection site swelling 25.48 10.46 78 54831 61712 110472678
Irritable bowel syndrome 24.72 10.46 27 54882 164188 110370202
Exposure during pregnancy 24.69 10.46 28 54881 167396 110366994
Insomnia 24.35 10.46 280 54629 360310 110174080
Injection site pruritus 24.30 10.46 68 54841 51190 110483200
Pain of skin 24.25 10.46 39 54870 19990 110514400
Carcinoid syndrome 24.10 10.46 8 54901 289 110534101
Wound infection 23.86 10.46 9 54900 96456 110437934
Gastrointestinal disorder 23.80 10.46 53 54856 241899 110292491
Oropharyngeal pain 23.72 10.46 131 54778 135145 110399245
Red blood cell sedimentation rate increased 23.63 10.46 5 54904 78297 110456093
Product dose omission in error 23.46 10.46 42 54867 23470 110510920
Palpitations 23.28 10.46 147 54762 159065 110375325
Hypercholesterolaemia 23.28 10.46 8 54901 90829 110443561
Joint range of motion decreased 23.23 10.46 16 54893 121816 110412574
Dermatitis allergic 23.22 10.46 40 54869 21684 110512706
Sleep terror 23.14 10.46 22 54887 6588 110527802
Alopecia areata 22.88 10.46 14 54895 2173 110532217
Nasal disorder 22.76 10.46 18 54891 4216 110530174
Dysphonia 22.65 10.46 86 54823 75843 110458547
Lip discolouration 22.56 10.46 10 54899 798 110533592
Grip strength decreased 22.46 10.46 6 54903 80168 110454222
Oropharyngeal swelling 22.30 10.46 12 54897 1462 110532928
Persistent depressive disorder 22.28 10.46 12 54897 1465 110532925
Sneezing 22.10 10.46 49 54860 31935 110502455
Multiple organ dysfunction syndrome 21.69 10.46 26 54883 151684 110382706
Facial pain 21.56 10.46 32 54877 15307 110519083
Hepatotoxicity 21.43 10.46 3 54906 63397 110470993
Patient uncooperative 20.91 10.46 10 54899 950 110533440
Insurance issue 20.78 10.46 26 54883 10586 110523804
Injection site erythema 20.56 10.46 97 54812 94079 110440311
Therapeutic response unexpected 20.55 10.46 40 54869 23803 110510587
Osteoarthritis 20.54 10.46 37 54872 182586 110351804
Coma 20.52 10.46 17 54892 117852 110416538
Lower limb fracture 20.44 10.46 6 54903 75342 110459048
Skin weeping 20.34 10.46 16 54893 3719 110530671
Cardiospasm 20.25 10.46 18 54891 4949 110529441
Inflammation 20.11 10.46 41 54868 193197 110341193
Pulmonary fibrosis 19.99 10.46 13 54896 102029 110432361
Upper respiratory tract infection 19.67 10.46 122 54787 131206 110403184
Confusional state 19.66 10.46 144 54765 468536 110065854
Pruritus genital 19.66 10.46 20 54889 6502 110527888
Renal failure 19.64 10.46 53 54856 226521 110307869
Tension headache 19.53 10.46 24 54885 9594 110524796
Conversion disorder 19.41 10.46 13 54896 2357 110532033
Pathergy reaction 19.41 10.46 5 54904 72 110534318
Sciatica 19.18 10.46 11 54898 92388 110442002
Depressed mood 19.07 10.46 70 54839 60739 110473651
Palmoplantar keratoderma 18.99 10.46 18 54891 5369 110529021
Death 18.99 10.46 239 54670 698630 109835760
Rash papular 18.71 10.46 42 54867 27597 110506793
Skin irritation 18.70 10.46 31 54878 16288 110518102
Eye pain 18.61 10.46 61 54848 50038 110484352
Endometriosis 18.25 10.46 16 54893 4318 110530072
Musculoskeletal pain 18.07 10.46 40 54869 182983 110351407
Pre-existing condition improved 17.85 10.46 19 54890 6507 110527883
Genital rash 17.80 10.46 10 54899 1325 110533065
Cholestasis 17.75 10.46 5 54904 64513 110469877
Blepharospasm 17.62 10.46 3 54906 54848 110479542
Genital swelling 17.57 10.46 7 54902 428 110533962
Urticaria aquagenic 17.34 10.46 4 54905 35 110534355
Injection site mass 17.34 10.46 38 54871 24575 110509815
Flatulence 17.18 10.46 61 54848 52088 110482302
Croup infectious 17.16 10.46 9 54900 1041 110533349
Psoriatic arthropathy 17.07 10.46 46 54863 196715 110337675
Tinnitus 16.77 10.46 67 54842 60473 110473917
Scratch 16.72 10.46 26 54883 12953 110521437
Lactic acidosis 16.64 10.46 13 54896 92798 110441592
Oropharyngeal spasm 16.62 10.46 7 54902 493 110533897
Genital ulceration 16.57 10.46 11 54898 1964 110532426
Musculoskeletal stiffness 16.53 10.46 77 54832 279745 110254645
Hereditary angioedema 16.50 10.46 19 54890 7095 110527295
Interstitial lung disease 16.42 10.46 122 54787 139212 110395178
Adverse event 16.25 10.46 18 54891 108791 110425599
Oesophageal irritation 16.23 10.46 6 54903 299 110534091
Night sweats 16.11 10.46 26 54883 133957 110400433
C-reactive protein increased 16.01 10.46 55 54854 217864 110316526
Product use complaint 15.94 10.46 14 54895 3789 110530601
Hypohidrosis 15.84 10.46 6 54903 320 110534070
Injury 15.71 10.46 41 54868 177224 110357166
Frequent bowel movements 15.54 10.46 8 54901 71382 110463008
Infective pulmonary exacerbation of cystic fibrosis 15.53 10.46 27 54882 14744 110519646
Product use issue 15.48 10.46 91 54818 311604 110222786
Acne 15.43 10.46 44 54865 33476 110500914
Intentional product use issue 15.37 10.46 67 54842 247839 110286551
Dermatitis contact 15.32 10.46 26 54883 13927 110520463
Oropharyngeal discomfort 15.17 10.46 22 54887 10305 110524085
Pharyngeal ulceration 15.10 10.46 9 54900 1332 110533058
Hallucination 15.04 10.46 94 54815 101338 110433052
Poor quality device used 15.02 10.46 12 54897 2851 110531539
Colitis ulcerative 14.96 10.46 10 54899 77353 110457037
Urticaria cholinergic 14.96 10.46 4 54905 67 110534323
Mucosal discolouration 14.93 10.46 8 54901 966 110533424
Drug ineffective 14.89 10.46 611 54298 1519929 109014461
Urticarial vasculitis 14.84 10.46 8 54901 978 110533412
Essential tremor 14.76 10.46 10 54899 1848 110532542
Paranasal sinus discomfort 14.68 10.46 17 54892 6388 110528002
Nasal dryness 14.53 10.46 16 54893 5690 110528700
White blood cell count decreased 14.53 10.46 176 54733 229214 110305176
International normalised ratio increased 14.52 10.46 13 54896 86759 110447631
Allergic cough 14.48 10.46 8 54901 1027 110533363
Metabolic acidosis 14.36 10.46 17 54892 99727 110434663
Leukopenia 14.30 10.46 33 54876 148758 110385632
Eyelid skin dryness 14.28 10.46 7 54902 702 110533688
Sensitive skin 14.24 10.46 13 54896 3699 110530691
Acarodermatitis 14.18 10.46 10 54899 1971 110532419
Hip arthroplasty 14.15 10.46 5 54904 55808 110478582
Upper-airway cough syndrome 14.15 10.46 27 54882 15830 110518560
Sinus disorder 14.14 10.46 42 54867 32686 110501704
Skin oedema 14.09 10.46 10 54899 1989 110532401
Nerve compression 13.91 10.46 22 54887 11115 110523275
Immunisation 13.91 10.46 12 54897 3171 110531219
Flushing 13.67 10.46 94 54815 104642 110429748
Multiple allergies 13.66 10.46 23 54886 12240 110522150
Tremor 13.62 10.46 157 54752 202075 110332315
Accidental exposure to product 13.58 10.46 55 54854 49953 110484437
Cardiac arrest 13.56 10.46 51 54858 196702 110337688
Cellulitis 13.54 10.46 108 54801 125908 110408482
Ear swelling 13.50 10.46 10 54899 2126 110532264
Periorbital pain 13.49 10.46 5 54904 251 110534139
Constipation 13.46 10.46 251 54658 357535 110176855
Hepatitis 13.34 10.46 15 54894 90039 110444351
Oral mucosal blistering 13.29 10.46 18 54891 7916 110526474
Skin disorder 13.12 10.46 49 54860 42864 110491526
Mouth ulceration 13.12 10.46 53 54856 48085 110486305
Enterocolitis 13.06 10.46 29 54880 18920 110515470
Tooth injury 13.05 10.46 10 54899 2236 110532154
Somnambulism 13.03 10.46 16 54893 6389 110528001
Bipolar disorder 12.96 10.46 19 54890 8988 110525402
Tendinous contracture 12.73 10.46 5 54904 294 110534096
Eye haematoma 12.72 10.46 5 54904 295 110534095
Neurodermatitis 12.70 10.46 11 54898 2921 110531469
Eyelids pruritus 12.69 10.46 9 54900 1788 110532602
Atrial tachycardia 12.69 10.46 19 54890 9159 110525231
Myelosuppression 12.62 10.46 17 54892 94323 110440067
Dermatophytosis of nail 12.54 10.46 5 54904 306 110534084
Mechanical urticaria 12.48 10.46 6 54903 577 110533813
Upper respiratory tract inflammation 12.44 10.46 13 54896 4358 110530032
Agitated depression 12.44 10.46 6 54903 581 110533809
Therapeutic product effect incomplete 12.39 10.46 63 54846 223742 110310648
Throat irritation 12.31 10.46 56 54853 53496 110480894
Abdominal pain 12.27 10.46 180 54729 512809 110021581
Nausea 12.18 10.46 739 54170 1234951 109299439
Influenza 12.16 10.46 133 54776 168968 110365422
Sinus headache 12.16 10.46 15 54894 6017 110528373
Platelet count decreased 12.16 10.46 171 54738 230272 110304118
Sinus congestion 12.14 10.46 38 54871 30421 110503969
Miliaria 12.12 10.46 9 54900 1920 110532470
Diplopia 12.12 10.46 47 54862 41847 110492543
Carotid artery occlusion 12.09 10.46 19 54890 9546 110524844
Haematoma 12.08 10.46 7 54902 58469 110475921
Food allergy 12.06 10.46 29 54880 19919 110514471
Blood cholesterol increased 12.03 10.46 49 54860 184736 110349654
Intellectual disability 11.92 10.46 9 54900 1970 110532420
Axillary pain 11.81 10.46 10 54899 2576 110531814
Onychomadesis 11.74 10.46 4 54905 45659 110488731
Rebound atopic dermatitis 11.67 10.46 9 54900 2032 110532358
Back pain 11.54 10.46 253 54656 370743 110163647
Acute generalised exanthematous pustulosis 11.53 10.46 30 54879 21634 110512756
Sialoadenitis 11.52 10.46 10 54899 2663 110531727
Intentional overdose 11.47 10.46 31 54878 132470 110401920
Gastrointestinal motility disorder 11.42 10.46 16 54893 7260 110527130
Tongue discolouration 11.37 10.46 12 54897 4069 110530321
Neutropenia 11.36 10.46 125 54784 374495 110159895
Initial insomnia 10.93 10.46 19 54890 10370 110524020
Pulmonary resection 10.88 10.46 4 54905 196 110534194
Hyperuricaemia 10.88 10.46 23 54886 14508 110519882
Autoimmune disorder 10.73 10.46 10 54899 65473 110468917
Pregnancy 10.71 10.46 6 54903 51061 110483329
Incorrect dose administered 10.69 10.46 88 54821 103553 110430837
Respiratory arrest 10.66 10.46 8 54901 58291 110476099
Oropharyngeal oedema 10.61 10.46 5 54904 460 110533930
Sleep apnoea syndrome 10.60 10.46 44 54865 40403 110493987
Knee arthroplasty 10.54 10.46 10 54899 64938 110469452
Therapeutic response decreased 10.53 10.46 83 54826 96416 110437974
Leukoplakia oral 10.52 10.46 5 54904 469 110533921
Middle insomnia 10.51 10.46 28 54881 20474 110513916

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R06AX26 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Other antihistamines for systemic use
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018494 Histamine Agents
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D039563 Histamine H1 Antagonists, Non-Sedating
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
FDA EPC N0000175587 Histamine-1 Receptor Antagonist

Related Drugs by ATC class:

R06AX Other antihistamines for systemic use 26 drugs
acrivastineantazolineastemizoleazatadineazelastinebamipinebilastinecyproheptadinedeptropinedesloratadineebastineepinastine show all 26 →

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

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Sneezing indication 76067001
Chronic idiopathic urticaria indication 302162004
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Alopecia areata off-label use 68225006 DOID:986
Urticaria off-label use 126485001
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Diabetes mellitus contraindication 73211009 DOID:9351
Kidney disease contraindication 90708001 DOID:557
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Hypertensive urgency contraindication 443482000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.66 acidic
pKa2 8.85 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
Histamine H1 receptor GPCR ANTAGONIST Ki 8 WOMBAT-PK CHEMBL
D(2) dopamine receptor GPCR Ki 5.05 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.67 CHEMBL
Multidrug resistance protein 1 Transporter Km 5.70 WOMBAT-PK
D(3) dopamine receptor GPCR Ki 5.63 CHEMBL
Solute carrier organic anion transporter family member 1A2 Transporter Km 5.70 WOMBAT-PK

External reference:

IDSource
4024052 VUID
N0000022057 NUI
D00671 KEGG_DRUG
153439-40-8 SECONDARY_CAS_RN
4021012 VANDF
4024052 VANDF
C0296800 UMLSCUI
CHEBI:5050 CHEBI
CHEMBL914 ChEMBL_ID
CHEMBL1200618 ChEMBL_ID
DB00950 DRUGBANK_ID
C093230 MESH_SUPPLEMENTAL_RECORD_UI
4819 IUPHAR_LIGAND_ID
7469 INN_ID
E6582LOH6V UNII
3348 PUBCHEM_CID
236474 RXNORM
4726 MMSL
71159 MMSL
d04040 MMSL
006063 NDDF
006064 NDDF
108650005 SNOMEDCT_US
108653007 SNOMEDCT_US
372522002 SNOMEDCT_US
E6582LOH6V INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
good sense aller ease HUMAN OTC DRUG LABEL 1 0113-0847 TABLET, FILM COATED 180 mg ORAL ANDA 15 sections
good sense aller ease HUMAN OTC DRUG LABEL 1 0113-0847 TABLET, FILM COATED 180 mg ORAL ANDA 15 sections
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride HUMAN OTC DRUG LABEL 2 0363-0044 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 14 sections
Fexofenadine HCl and Pseudoephedrine HCl HUMAN OTC DRUG LABEL 2 0363-0049 TABLET, EXTENDED RELEASE 180 mg ORAL ANDA 14 sections
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Human OTC Drug Label 2 0363-0094 TABLET, FILM COATED, EXTENDED RELEASE 60 mg ORAL ANDA 11 sections
Fexofenadine hydrochloride Human OTC Drug Label 1 0363-0095 TABLET, FILM COATED 60 mg ORAL ANDA 13 sections
Fexofenadine hydrochloride Human OTC Drug Label 1 0363-0097 TABLET, FILM COATED 180 mg ORAL ANDA 13 sections
Fexofenadine hydrochloride HUMAN OTC DRUG LABEL 1 0363-0783 TABLET 60 mg ORAL ANDA 14 sections
Wal-Fex HUMAN OTC DRUG LABEL 1 0363-0784 TABLET 180 mg ORAL ANDA 16 sections
Fexofenadine HCl and Pseudoephedrine HCI HUMAN OTC DRUG LABEL 2 0363-1606 TABLET, EXTENDED RELEASE 60 mg ORAL ANDA 16 sections
Allergy Relief HUMAN OTC DRUG LABEL 1 0363-1847 TABLET, FILM COATED 180 mg ORAL ANDA 15 sections
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride HUMAN OTC DRUG LABEL 2 0363-2110 TABLET, FILM COATED, EXTENDED RELEASE 60 mg ORAL ANDA 16 sections
Childrens Fexofenadine HydrochlorideAllergy HUMAN OTC DRUG LABEL 1 0363-2141 SUSPENSION 30 mg ORAL ANDA 16 sections
Children Allergy HUMAN OTC DRUG LABEL 1 0363-2600 SUSPENSION 30 mg ORAL ANDA 15 sections
HIVES RELIEF HUMAN OTC DRUG LABEL 1 0363-4071 TABLET, FILM COATED 180 mg ORAL ANDA 14 sections
Fexofenadine HCL HUMAN OTC DRUG LABEL 1 0363-6231 TABLET 180 mg ORAL ANDA 14 sections
allergy relief HUMAN OTC DRUG LABEL 1 0363-7011 TABLET, FILM COATED 180 mg ORAL ANDA 15 sections
Dye Free Wal Fexchildrens allergy HUMAN OTC DRUG LABEL 1 0363-9230 SUSPENSION 30 mg ORAL ANDA 15 sections
Fexofenadine HCL HUMAN OTC DRUG LABEL 1 0363-9760 TABLET 180 mg ORAL ANDA 14 sections
Fexofenadine HCL HUMAN OTC DRUG LABEL 1 0363-9765 TABLET 60 mg ORAL ANDA 14 sections
Fexofenadine Hydrochloride HUMAN OTC DRUG LABEL 1 0363-9898 TABLET, FILM COATED 180 mg ORAL ANDA 14 sections
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Human OTC Drug Label 2 0536-1431 TABLET, FILM COATED, EXTENDED RELEASE 60 mg ORAL ANDA 12 sections
RUGBY ALLERGY RELIEF D HUMAN OTC DRUG LABEL 2 0536-1491 TABLET, FILM COATED, EXTENDED RELEASE 60 mg ORAL ANDA 15 sections
FEXOFENADINE HYDROCHLORIDE HUMAN OTC DRUG LABEL 1 0615-8648 TABLET, FILM COATED 180 mg ORAL ANDA 16 sections
Fexofenadine hydrochloride HUMAN OTC DRUG LABEL 1 0904-6711 TABLET 180 mg ORAL ANDA 15 sections
Fexofenadine Hydrochloride HUMAN OTC DRUG LABEL 1 0904-7050 TABLET 180 mg ORAL ANDA 15 sections
fexofenadine hcl HUMAN OTC DRUG LABEL 1 0904-7192 TABLET, FILM COATED 60 mg ORAL ANDA 15 sections
fexofenadine hcl HUMAN OTC DRUG LABEL 1 0904-7486 TABLET, FILM COATED 180 mg ORAL ANDA 15 sections
Fexofenadine hydrochloride Human OTC Drug Label 1 10202-229 TABLET, FILM COATED 180 mg ORAL ANDA 13 sections
Fexofenadine Hydrochloride HUMAN OTC DRUG LABEL 1 10544-231 TABLET, FILM COATED 60 mg ORAL ANDA 15 sections