loratadine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
histamine-H1 receptor antagonists, tricyclic compounds 1605 79794-75-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • loratadine
  • claritin
  • loracert
  • loradex
  • loratidine
  • loratyne
A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
  • Molecular weight: 382.89
  • Formula: C22H23ClN2O2
  • CLOGP: 5.05
  • LIPINSKI: 1
  • HAC: 4
  • HDO: 0
  • TPSA: 42.43
  • ALOGS: -4.46
  • ROTB: 2
  • 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
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.44 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 40 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 12, 1993 FDA BAYER HEALTHCARE LLC

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
Extra dose administered 278.69 9.89 150 91399 6200 63391273
Contraindicated product administered 239.25 9.89 20 91529 217628 63179845
Synovitis 211.56 9.89 15 91534 186903 63210570
Glossodynia 192.33 9.89 18 91531 178858 63218615
Hand deformity 192.03 9.89 9 91540 159448 63238025
Systemic lupus erythematosus 184.96 9.89 38 91511 208880 63188593
Drug ineffective 175.93 9.89 844 90705 1043921 62353552
Accidental exposure to product by child 172.82 9.89 65 91484 1128 63396345
Drug intolerance 171.01 9.89 118 91431 308543 63088930
Wound 163.92 9.89 21 91528 163242 63234231
Treatment failure 155.29 9.89 47 91502 198996 63198477
Gastrooesophageal reflux disease 149.54 9.89 386 91163 95253 63302220
Arthropathy 147.91 9.89 77 91472 234715 63162758
Pneumonia aspiration 146.48 9.89 213 91336 34327 63363146
Pericarditis 144.78 9.89 12 91537 131567 63265906
Joint swelling 123.16 9.89 176 91373 327490 63069983
Failure of child resistant product closure 119.91 9.89 23 91526 9 63397464
Therapeutic product effect decreased 114.92 9.89 68 91481 193119 63204354
Urticaria 109.84 9.89 502 91047 165300 63232173
Dermatitis atopic 108.56 9.89 99 91450 9625 63387848
Maternal exposure during pregnancy 99.81 9.89 102 91447 219960 63177513
Asthma 97.29 9.89 403 91146 127158 63270315
Somnolence 96.91 9.89 511 91038 178174 63219299
General physical health deterioration 91.73 9.89 93 91456 201309 63196164
Helicobacter infection 88.27 9.89 14 91535 92771 63304702
Hepatic enzyme increased 88.14 9.89 97 91452 202231 63195242
Off label use 86.47 9.89 594 90955 673868 62723605
Alopecia 85.42 9.89 229 91320 337307 63060166
Muscle injury 80.93 9.89 3 91546 65342 63332131
Folliculitis 73.13 9.89 8 91541 70309 63327164
Rheumatoid arthritis 73.01 9.89 161 91388 253658 63143815
Swelling 71.03 9.89 185 91364 275193 63122280
Swelling face 69.00 9.89 225 91324 63250 63334223
Toxicity to various agents 68.54 9.89 160 91389 247090 63150383
Anxiety 67.83 9.89 541 91008 217000 63180473
Product dose omission issue 63.66 9.89 565 90984 233748 63163725
Lower respiratory tract infection 62.64 9.89 59 91490 132248 63265225
Drug abuse 62.46 9.89 14 91535 72504 63324969
Pruritus 62.27 9.89 795 90754 360658 63036815
Cholecystitis chronic 60.97 9.89 75 91474 10286 63387187
Dizziness 60.85 9.89 913 90636 429012 62968461
Coma 60.20 9.89 217 91332 64147 63333326
Sleep disorder due to general medical condition, insomnia type 59.58 9.89 4 91545 52213 63345260
Feeling abnormal 58.86 9.89 391 91158 148001 63249472
Infective pulmonary exacerbation of cystic fibrosis 58.75 9.89 68 91481 8749 63388724
Insomnia 57.41 9.89 517 91032 214735 63182738
Cough 56.97 9.89 659 90890 292084 63105389
Chest discomfort 55.84 9.89 309 91240 109660 63287813
Muscle spasms 55.76 9.89 401 91148 155749 63241724
Musculoskeletal stiffness 53.15 9.89 117 91432 184501 63212972
C-reactive protein increased 50.01 9.89 38 91511 94669 63302804
Butterfly rash 48.92 9.89 31 91518 1742 63395731
Headache 48.90 9.89 1226 90323 632015 62765458
Palpitations 47.68 9.89 302 91247 112468 63285005
Mobility decreased 46.50 9.89 64 91485 121095 63276378
Seasonal allergy 46.39 9.89 97 91452 20853 63376620
Discomfort 45.80 9.89 109 91440 167265 63230208
Dyspnoea 45.47 9.89 1261 90288 660052 62737421
Liver injury 44.15 9.89 16 91533 60504 63336969
Bronchitis 44.11 9.89 320 91229 124615 63272858
C-reactive protein abnormal 43.73 9.89 7 91542 46089 63351384
Impaired healing 43.70 9.89 50 91499 102492 63294981
Depression 43.54 9.89 454 91095 196038 63201435
Lip swelling 43.08 9.89 120 91429 30943 63366530
Sinusitis 43.06 9.89 508 91041 226145 63171328
Acute kidney injury 42.63 9.89 215 91334 263200 63134273
Emotional distress 42.47 9.89 123 91426 32426 63365047
Angioedema 40.91 9.89 157 91392 47808 63349665
Blister 38.40 9.89 81 91468 129733 63267740
Abdominal discomfort 37.85 9.89 289 91260 320596 63076877
Periorbital oedema 36.48 9.89 43 91506 5641 63391832
Product use issue 36.23 9.89 179 91370 220341 63177132
Gallbladder disorder 35.77 9.89 82 91467 18760 63378713
Knee arthroplasty 35.25 9.89 17 91532 54189 63343284
Therapeutic product effect incomplete 34.56 9.89 81 91468 124975 63272498
Nasal congestion 34.32 9.89 186 91363 65474 63331999
Ill-defined disorder 33.62 9.89 41 91508 81714 63315759
Anaphylactic reaction 33.05 9.89 185 91364 65915 63331558
Sinus disorder 32.24 9.89 93 91456 24460 63373013
Throat irritation 30.30 9.89 121 91428 37526 63359947
Intentional product use issue 29.90 9.89 90 91459 127802 63269671
Diarrhoea 29.22 9.89 1285 90264 714081 62683392
Infection 29.12 9.89 202 91347 228971 63168502
Tinnitus 28.26 9.89 114 91435 35514 63361959
Pancytopenia 28.23 9.89 61 91488 96872 63300601
Photosensitivity reaction 28.18 9.89 65 91484 14929 63382544
Hip arthroplasty 27.98 9.89 17 91532 47629 63349844
Upper respiratory tract infection 27.72 9.89 208 91341 81839 63315634
Infusion related reaction 27.59 9.89 224 91325 245297 63152176
Head discomfort 27.27 9.89 60 91489 13355 63384118
Oropharyngeal pain 26.73 9.89 230 91319 94257 63303216
Allergy test positive 25.41 9.89 14 91535 606 63396867
Pulmonary fibrosis 25.11 9.89 13 91536 39796 63357677
Multiple allergies 25.03 9.89 59 91490 13743 63383730
Hypersomnia 24.30 9.89 69 91480 17986 63379487
Mast cell activation syndrome 24.21 9.89 15 91534 810 63396663
Throat tightness 24.20 9.89 85 91464 24802 63372671
Impaired quality of life 24.00 9.89 58 91491 13725 63383748
Multiple organ dysfunction syndrome 23.82 9.89 28 91521 56724 63340749
Deep vein thrombosis 23.71 9.89 204 91345 83596 63313877
Illness 23.66 9.89 136 91413 48923 63348550
Urinary tract infection 23.54 9.89 523 91026 264161 63133312
Acquired haemophilia 23.51 9.89 16 91533 1015 63396458
Medication error 22.81 9.89 25 91524 52259 63345214
Tinea pedis 22.78 9.89 18 91531 1438 63396035
Rhabdomyolysis 22.73 9.89 18 91531 43933 63353540
Chest pain 22.56 9.89 437 91112 215522 63181951
Abdominal distension 22.52 9.89 207 91342 86408 63311065
Gastrointestinal disorder 22.43 9.89 105 91444 131134 63266339
Suicidal ideation 22.08 9.89 160 91389 62261 63335212
Vision blurred 22.06 9.89 216 91333 91708 63305765
Dry skin 21.99 9.89 149 91400 56738 63340735
Biliary dyskinesia 21.55 9.89 23 91526 2706 63394767
Cystoid macular oedema 21.53 9.89 18 91531 1557 63395916
Cystitis noninfective 21.53 9.89 15 91534 988 63396485
Nervousness 21.37 9.89 95 91454 30884 63366589
Essential hypertension 21.27 9.89 31 91518 5002 63392471
Malignant neoplasm progression 21.26 9.89 55 91494 82066 63315407
Expired product administered 20.44 9.89 34 91515 6147 63391326
Incorrect dose administered 20.23 9.89 152 91397 59816 63337657
Eye swelling 20.15 9.89 78 91471 23840 63373633
Rhinitis allergic 20.05 9.89 49 91500 11678 63385795
Hepatotoxicity 19.37 9.89 15 91534 37026 63360447
Paraesthesia 19.34 9.89 326 91223 156640 63240833
Red blood cell sedimentation rate increased 19.22 9.89 21 91528 43961 63353512
White blood cell count decreased 19.04 9.89 294 91255 138810 63258663
Feeling hot 18.93 9.89 131 91418 50223 63347250
Psoriatic arthropathy 18.90 9.89 68 91481 91452 63306021
Thrombocytopenia 18.81 9.89 134 91415 151023 63246450
Hepatocellular injury 18.72 9.89 8 91541 27373 63370100
Chills 18.45 9.89 247 91302 113131 63284342
Migraine 18.44 9.89 229 91320 103117 63294356
Status asthmaticus 18.20 9.89 13 91536 891 63396582
Lupus hepatitis 18.17 9.89 5 91544 29 63397444
Cardiac failure 17.91 9.89 67 91482 89075 63308398
Neuropathy peripheral 17.83 9.89 246 91303 113421 63284052
Septic shock 17.73 9.89 44 91505 66585 63330888
Prescribed overdose 17.65 9.89 14 91535 34139 63363334
Condition aggravated 17.46 9.89 444 91105 401773 62995700
Nasal disorder 17.28 9.89 21 91528 2843 63394630
Joint range of motion decreased 17.13 9.89 13 91536 32415 63365058
Inflammation 17.08 9.89 61 91488 82212 63315261
Reflux gastritis 17.05 9.89 14 91535 1181 63396292
Back pain 17.02 9.89 500 91049 263645 63133828
Temperature intolerance 17.00 9.89 39 91510 8925 63388548
Pre-existing condition improved 16.90 9.89 37 91512 8207 63389266
Gallbladder injury 16.89 9.89 15 91534 1408 63396065
Drug resistance 16.83 9.89 6 91543 22927 63374546
Erythema 16.80 9.89 351 91198 175400 63222073
Eye pruritus 16.65 9.89 62 91487 18609 63378864
Allergic cystitis 16.63 9.89 3 91546 0 63397473
Nausea 16.55 9.89 1438 90111 853033 62544440
Loss of personal independence in daily activities 16.52 9.89 78 91471 97212 63300261
Cholelithiasis 16.35 9.89 114 91435 43811 63353662
Renal impairment 16.11 9.89 69 91480 88286 63309187
Emotional disorder 15.97 9.89 49 91500 13330 63384143
Premature baby 15.96 9.89 5 91544 20730 63376743
Abnormal dreams 15.96 9.89 42 91507 10474 63386999
Sopor 15.93 9.89 6 91543 22158 63375315
Hyperkalaemia 15.87 9.89 34 91515 54169 63343304
Swollen tongue 15.83 9.89 95 91454 34705 63362768
Crying 15.66 9.89 71 91478 23272 63374201
Posterior reversible encephalopathy syndrome 15.65 9.89 3 91546 17342 63380131
Hyponatraemia 15.53 9.89 96 91453 111804 63285669
Dry mouth 15.42 9.89 176 91373 77687 63319786
Skin oedema 15.16 9.89 12 91537 961 63396512
COVID-19 15.08 9.89 238 91311 112865 63284608
Depressed level of consciousness 15.00 9.89 43 91506 62035 63335438
Pulmonary embolism 14.98 9.89 244 91305 116440 63281033
Sinus headache 14.84 9.89 28 91521 5588 63391885
Upper-airway cough syndrome 14.75 9.89 43 91506 11375 63386098
Irritable bowel syndrome 14.63 9.89 65 91484 82347 63315126
Myelosuppression 14.57 9.89 8 91541 23695 63373778
Flushing 14.54 9.89 169 91380 74918 63322555
Arthralgia 14.44 9.89 673 90876 569037 62828436
Bone pain 14.41 9.89 131 91418 54510 63342963
Hot flush 14.18 9.89 124 91425 51035 63346438
Type 2 diabetes mellitus 14.18 9.89 46 91503 63822 63333651
Palmar erythema 14.14 9.89 15 91534 1752 63395721
Cluster headache 13.98 9.89 10 91539 687 63396786
Frustration tolerance decreased 13.92 9.89 31 91518 6957 63390516
Drug tolerance decreased 13.84 9.89 4 91545 17469 63380004
Basophil count decreased 13.78 9.89 6 91543 154 63397319
Drug interaction 13.73 9.89 240 91309 228891 63168582
Reversible cerebral vasoconstriction syndrome 13.68 9.89 18 91531 2640 63394833
Post-traumatic stress disorder 13.65 9.89 26 91523 5225 63392248
Sinus congestion 13.59 9.89 57 91492 18066 63379407
Bronchospasm 13.47 9.89 55 91494 17225 63380248
Anger 13.39 9.89 44 91505 12412 63385061
Agranulocytosis 13.37 9.89 10 91539 25124 63372349
Eczema 13.34 9.89 86 91463 32205 63365268
Stomatitis 13.19 9.89 132 91417 138593 63258880
Red blood cell sedimentation rate abnormal 13.17 9.89 6 91543 19776 63377697
Neurological examination abnormal 13.14 9.89 7 91542 283 63397190
Acute hepatic failure 13.11 9.89 5 91544 18322 63379151
Xanthogranuloma 13.03 9.89 3 91546 7 63397466
Oesophageal adenocarcinoma recurrent 13.01 9.89 4 91545 36 63397437
Cataract subcapsular 12.97 9.89 9 91540 589 63396884
Neurological examination normal 12.92 9.89 4 91545 37 63397436
Sleep apnoea syndrome 12.91 9.89 79 91470 29054 63368419
Blood pressure fluctuation 12.79 9.89 30 91519 46287 63351186
Live birth 12.63 9.89 11 91538 25619 63371854
Neuralgia 12.58 9.89 72 91477 25854 63371619
Cerebral disorder 12.50 9.89 23 91526 4503 63392970
Ear swelling 12.47 9.89 13 91536 1488 63395985
Ear discomfort 12.43 9.89 32 91517 7874 63389599
Snoring 12.43 9.89 22 91527 4180 63393293
Constipation 12.42 9.89 418 91131 224525 63172948
Acute sinusitis 12.35 9.89 21 91528 3866 63393607
Infusion site erythema 12.33 9.89 41 91508 11638 63385835
Panic disorder 12.28 9.89 17 91532 2616 63394857
Bacterial test positive 12.25 9.89 25 91524 5282 63392191
Rash 12.11 9.89 952 90597 559919 62837554
Laryngeal oedema 12.11 9.89 26 91523 5692 63391781
Prescribed underdose 12.08 9.89 15 91534 29674 63367799
Exposure during pregnancy 12.04 9.89 155 91394 155392 63242081
Mitral valve prolapse 12.00 9.89 16 91533 2377 63395096
Autoimmune hepatitis 11.92 9.89 33 91516 8477 63388996
Initial insomnia 11.91 9.89 27 91522 6130 63391343
Ligament sprain 11.83 9.89 43 91506 12757 63384716
Fatigue 11.68 9.89 1456 90093 886572 62510901
Therapy non-responder 11.66 9.89 63 91486 75838 63321635
Victim of chemical submission 11.52 9.89 8 91541 524 63396949
Somnambulism 11.50 9.89 25 91524 5518 63391955
Fracture 11.48 9.89 7 91542 19577 63377896
Presbyoesophagus 11.45 9.89 3 91546 14 63397459
Biliary sepsis 11.42 9.89 10 91539 921 63396552
Chronic spontaneous urticaria 11.42 9.89 11 91538 1146 63396327
Rash macular 11.41 9.89 65 91484 23299 63374174
Circulatory collapse 11.32 9.89 9 91540 21929 63375544
Dysgeusia 11.32 9.89 110 91439 46600 63350873
Priapism 11.25 9.89 5 91544 135 63397338
Oropharyngeal discomfort 11.23 9.89 24 91525 5236 63392237
Burning sensation 11.23 9.89 124 91425 54283 63343190
Tenosynovitis 11.22 9.89 3 91546 13792 63383681
Stress 11.20 9.89 147 91402 67020 63330453
Full blood count decreased 11.17 9.89 70 91479 25954 63371519
Osteonecrosis of jaw 11.16 9.89 21 91528 35102 63362371
Overdose 11.15 9.89 109 91440 114969 63282504
Burns first degree 10.96 9.89 3 91546 17 63397456
Infusion site swelling 10.94 9.89 35 91514 9735 63387738
Drug level increased 10.91 9.89 10 91539 22726 63374747
Leukopenia 10.88 9.89 66 91483 77224 63320249
Psoriasis 10.85 9.89 181 91368 86776 63310697
Broad ligament tear 10.82 9.89 3 91546 18 63397455
Creatinine renal clearance decreased 10.78 9.89 5 91544 16303 63381170
Death 10.76 9.89 436 91113 373945 63023528
Hepatic failure 10.74 9.89 22 91527 35634 63361839
Atopy 10.74 9.89 6 91543 267 63397206
Multiple lentigines syndrome 10.67 9.89 5 91544 153 63397320
Premature delivery 10.63 9.89 17 91532 30264 63367209
Bezoar 10.56 9.89 12 91537 1514 63395959
Myxoedema coma 10.51 9.89 7 91542 428 63397045
Anxiety disorder 10.46 9.89 20 91529 4030 63393443
Oropharyngeal spasm 10.44 9.89 6 91543 282 63397191
Polyneuropathy 10.40 9.89 4 91545 14585 63382888
Cytomegalovirus infection 10.32 9.89 9 91540 20943 63376530
Heart rate increased 10.27 9.89 192 91357 94046 63303427
Patellofemoral pain syndrome 10.20 9.89 8 91541 632 63396841
Delirium 10.14 9.89 38 91511 50503 63346970
Coronary ostial stenosis 10.06 9.89 4 91545 81 63397392
Cerumen impaction 10.05 9.89 10 91539 1084 63396389
Defaecation urgency 10.03 9.89 20 91529 4155 63393318
Torsade de pointes 10.02 9.89 42 91507 13309 63384164
Product quality issue 9.98 9.89 87 91462 35778 63361695
Blood pressure orthostatic 9.93 9.89 4 91545 84 63397389

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
Accidental exposure to product by child 287.26 10.76 96 42712 1380 34912743
Extra dose administered 209.44 10.76 101 42707 3908 34910215
Drug abuse 81.73 10.76 12 42796 99084 34815039
Failure of child resistant product closure 77.92 10.76 16 42792 21 34914102
Urticaria 71.01 10.76 202 42606 62175 34851948
General physical health deterioration 69.70 10.76 35 42773 128234 34785889
Pruritus 60.87 10.76 338 42470 141643 34772480
Rash 54.63 10.76 462 42346 222290 34691833
Off label use 53.99 10.76 298 42510 419226 34494897
Dermatitis atopic 52.20 10.76 47 42761 5300 34908823
Infective pulmonary exacerbation of cystic fibrosis 49.77 10.76 51 42757 6750 34907373
Drug interaction 45.77 10.76 134 42674 225812 34688311
Fatigue 44.57 10.76 668 42140 369985 34544138
Sinusitis 42.24 10.76 129 42679 41273 34872850
Asthma 40.84 10.76 130 42678 42526 34871597
Completed suicide 38.53 10.76 38 42770 98130 34815993
Drug ineffective 38.12 10.76 367 42441 456384 34457739
Toxicity to various agents 37.60 10.76 123 42685 200239 34713884
Acute kidney injury 33.21 10.76 228 42580 304760 34609363
Throat irritation 31.84 10.76 51 42757 10534 34903589
Swelling face 30.44 10.76 79 42729 23026 34891097
Cough 28.96 10.76 296 42512 149844 34764279
Sinus disorder 28.30 10.76 39 42769 7046 34907077
Laryngospasm 26.99 10.76 19 42789 1502 34912621
Infusion related reaction 25.88 10.76 131 42677 52926 34861197
Treatment failure 24.95 10.76 13 42795 46684 34867439
Lacrimation increased 24.33 10.76 40 42768 8442 34905681
Chronic spontaneous urticaria 23.26 10.76 8 42800 126 34913997
Pharyngeal dystonia 23.25 10.76 7 42801 70 34914053
Eye pruritus 22.41 10.76 36 42772 7453 34906670
Glossodynia 22.27 10.76 25 42783 3668 34910455
Conduction disorder 21.50 10.76 19 42789 2091 34912032
Bronchitis 20.74 10.76 104 42704 41859 34872264
Gastrointestinal mucosal necrosis 20.45 10.76 8 42800 184 34913939
Agitation 20.27 10.76 130 42678 57269 34856854
Oral pruritus 19.65 10.76 9 42799 309 34913814
Drug resistance 19.47 10.76 4 42804 25923 34888200
Renal impairment 19.13 10.76 56 42752 94457 34819666
Expired product administered 19.10 10.76 22 42786 3319 34910804
Spasmodic dysphonia 19.05 10.76 8 42800 222 34913901
Visual evoked potentials abnormal 18.64 10.76 6 42802 76 34914047
Seasonal allergy 18.50 10.76 31 42777 6644 34907479
Hyperkalaemia 18.08 10.76 36 42772 69353 34844770
Interstitial lung disease 17.77 10.76 33 42775 65249 34848874
Muscle spasms 16.97 10.76 153 42655 74848 34839275
Chills 16.67 10.76 162 42646 80881 34833242
CADASIL 16.50 10.76 6 42802 112 34914011
Rhabdomyolysis 16.39 10.76 37 42771 68126 34845997
Pneumonia 16.31 10.76 569 42239 362058 34552065
PO2 increased 16.29 10.76 10 42798 627 34913496
Blood pH decreased 16.17 10.76 17 42791 2317 34911806
Chest pain 16.12 10.76 231 42577 126531 34787592
C-reactive protein increased 15.95 10.76 26 42782 54072 34860051
Rheumatoid arthritis 15.94 10.76 14 42794 38224 34875899
Rhinorrhoea 15.92 10.76 68 42740 25600 34888523
Sneezing 15.41 10.76 25 42783 5217 34908906
Dizziness 15.39 10.76 363 42445 218158 34695965
Lip swelling 15.37 10.76 49 42759 16031 34898092
Metamorphopsia 15.33 10.76 9 42799 520 34913603
Magnetic resonance imaging spinal abnormal 15.22 10.76 6 42802 141 34913982
Forced expiratory volume decreased 14.90 10.76 19 42789 3184 34910939
Cardiogenic shock 14.84 10.76 7 42801 26611 34887512
Tunnel vision 14.61 10.76 9 42799 568 34913555
Ejaculation delayed 14.41 10.76 7 42801 275 34913848
Dry skin 14.39 10.76 76 42732 31211 34882912
Wheezing 14.14 10.76 93 42715 41309 34872814
Saccadic eye movement 14.08 10.76 6 42802 173 34913950
Gastrooesophageal reflux disease 14.07 10.76 87 42721 37837 34876286
Heart rate increased 14.00 10.76 101 42707 46242 34867881
Feeling abnormal 13.80 10.76 128 42680 63107 34851016
Vision blurred 13.78 10.76 100 42708 45863 34868260
Upper respiratory tract infection 13.65 10.76 78 42730 32981 34881142
Leukopenia 13.64 10.76 36 42772 62820 34851303
Ear infection 13.49 10.76 35 42773 10196 34903927
Renal failure 13.47 10.76 99 42709 130458 34783665
Cerebral microangiopathy 13.38 10.76 6 42802 196 34913927
Anxiety 13.37 10.76 183 42625 99245 34814878
Burning sensation 13.21 10.76 51 42757 18343 34895780
Intentional self-injury 13.20 10.76 42 42766 13729 34900394
Intercepted medication error 13.06 10.76 8 42800 500 34913623
Contraindicated product administered 13.01 10.76 5 42803 21476 34892647
Eosinophilia 13 10.76 8 42800 26214 34887909
Cytomegalovirus infection 12.92 10.76 8 42800 26127 34887996
Double stranded DNA antibody positive 12.92 10.76 6 42802 213 34913910
Angioedema 12.79 10.76 84 42724 37290 34876833
Acute respiratory distress syndrome 12.77 10.76 8 42800 25961 34888162
Suicidal ideation 12.76 10.76 89 42719 40299 34873824
Muscle tightness 12.64 10.76 22 42786 4862 34909261
Headache 12.54 10.76 328 42480 200307 34713816
Central nervous system inflammation 12.54 10.76 6 42802 228 34913895
Oropharyngeal pain 12.30 10.76 80 42728 35405 34878718
Insomnia 12.28 10.76 187 42621 103720 34810403
Product dose omission issue 12.12 10.76 210 42598 119501 34794622
Pneumonitis 12.12 10.76 77 42731 33801 34880322
Nasal congestion 12.00 10.76 58 42750 22999 34891124
Intertrigo 11.98 10.76 6 42802 252 34913871
Spinal osteoarthritis 11.95 10.76 28 42780 7655 34906468
Lactic acidosis 11.94 10.76 15 42793 34757 34879366
Testicular cyst 11.81 10.76 4 42804 60 34914063
Skin warm 11.63 10.76 14 42794 2213 34911910
Drug intolerance 11.54 10.76 36 42772 59534 34854589
Thrombocytopenia 11.53 10.76 129 42679 156118 34758005
Product quality issue 11.24 10.76 46 42762 16989 34897134
Sleep apnoea syndrome 11.22 10.76 52 42756 20269 34893854
Intervertebral disc protrusion 11.08 10.76 32 42776 9924 34904199
Rhinitis allergic 11.01 10.76 16 42792 3034 34911089
Crying 10.96 10.76 23 42785 5839 34908284
Depression 10.81 10.76 173 42635 96925 34817198
Physical examination abnormal 10.76 10.76 6 42802 314 34913809

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
Extra dose administered 514.72 9.73 242 105165 8173 79630808
Accidental exposure to product by child 447.05 9.73 162 105245 2764 79636217
Failure of child resistant product closure 194.13 9.73 39 105368 36 79638945
Urticaria 180.60 9.73 597 104810 184604 79454377
Drug ineffective 151.33 9.73 827 104580 1080086 78558895
Off label use 144.05 9.73 664 104743 906551 78732430
Drug abuse 140.81 9.73 23 105384 162668 79476313
Synovitis 138.12 9.73 18 105389 150716 79488265
Contraindicated product administered 136.95 9.73 22 105385 157516 79481465
Gastrooesophageal reflux disease 133.52 9.73 370 105037 103876 79535105
General physical health deterioration 131.16 9.73 103 105304 275135 79363846
Treatment failure 114.64 9.73 41 105366 170445 79468536
Pruritus 113.19 9.73 900 104507 393748 79245233
Drug intolerance 110.05 9.73 112 105295 264007 79374974
Hand deformity 103.91 9.73 9 105398 103910 79535071
Dermatitis atopic 103.20 9.73 94 105313 9962 79629019
Infective pulmonary exacerbation of cystic fibrosis 101.47 9.73 104 105303 12747 79626234
Toxicity to various agents 94.91 9.73 266 105141 421274 79217707
Asthma 91.88 9.73 388 105019 134707 79504274
Swelling face 90.41 9.73 252 105155 70960 79568021
Joint swelling 80.14 9.73 163 105244 288483 79350498
Therapeutic product effect decreased 79.69 9.73 60 105347 163803 79475178
Pericarditis 79.25 9.73 20 105387 104216 79534765
Somnolence 77.38 9.73 561 104846 238420 79400561
Acute kidney injury 76.41 9.73 390 105017 519014 79119967
Systemic lupus erythematosus 73.52 9.73 34 105373 121115 79517866
Wound 68.37 9.73 34 105373 116145 79522836
Dizziness 64.13 9.73 1014 104393 525427 79113554
Arthropathy 64.12 9.73 84 105323 177027 79461954
Pneumonia aspiration 63.51 9.73 214 105193 66753 79572228
C-reactive protein increased 63.05 9.73 47 105360 128980 79510001
Helicobacter infection 62.23 9.73 9 105398 69695 79569286
Glossodynia 61.17 9.73 30 105377 103307 79535674
Rheumatoid arthritis 60.19 9.73 115 105292 208355 79430626
Lip swelling 56.14 9.73 149 105258 40762 79598219
Headache 55.41 9.73 1190 104217 652582 78986399
Drug interaction 54.29 9.73 324 105083 414859 79224122
Throat irritation 53.05 9.73 146 105261 40800 79598181
Butterfly rash 52.67 9.73 31 105376 1665 79637316
Cholecystitis chronic 52.25 9.73 65 105342 9841 79629140
Cough 52.23 9.73 726 104681 366063 79272918
Product dose omission issue 52.06 9.73 528 104879 247009 79391972
Muscle spasms 51.89 9.73 402 105005 174328 79464653
Angioedema 50.59 9.73 217 105190 75818 79563163
C-reactive protein abnormal 48.86 9.73 4 105403 48363 79590618
Emotional distress 47.37 9.73 138 105269 39831 79599150
Feeling abnormal 47.12 9.73 366 105041 158833 79480148
Fatigue 47.06 9.73 1582 103825 928145 78710836
Insomnia 46.87 9.73 513 104894 244657 79394324
Anxiety 46.60 9.73 518 104889 247994 79390987
Dyspnoea 46.38 9.73 1470 103937 855555 78783426
Chest discomfort 45.75 9.73 326 105081 137718 79501263
Rash 45.56 9.73 1042 104365 577316 79061665
Sinusitis 42.53 9.73 420 104987 195081 79443900
Bronchitis 41.84 9.73 306 105101 130338 79508643
Palpitations 41.38 9.73 298 105109 126312 79512669
Folliculitis 41.37 9.73 11 105396 55369 79583612
Sleep disorder due to general medical condition, insomnia type 40.37 9.73 5 105402 43551 79595430
Chest pain 39.84 9.73 558 104849 281746 79357235
Nasal congestion 39.57 9.73 203 105204 76349 79562632
Intentional product use issue 38.78 9.73 90 105317 152022 79486959
Expired product administered 38.37 9.73 47 105360 7004 79631977
Rhabdomyolysis 38.25 9.73 48 105359 103083 79535898
Renal impairment 37.36 9.73 97 105310 157686 79481295
Maternal exposure during pregnancy 36.26 9.73 79 105328 136459 79502522
Vision blurred 35.61 9.73 251 105156 105647 79533334
Completed suicide 34.67 9.73 187 105220 245580 79393401
Oropharyngeal pain 34.36 9.73 255 105152 109098 79529883
Drug resistance 34.28 9.73 7 105400 42206 79596775
Pancytopenia 33.35 9.73 110 105297 165635 79473346
Hyperkalaemia 33.09 9.73 63 105344 114335 79524646
Hepatic enzyme increased 32.88 9.73 127 105280 182483 79456498
Thrombocytopenia 32.05 9.73 212 105195 265047 79373934
Seasonal allergy 31.41 9.73 68 105339 16338 79622643
Therapeutic product effect incomplete 31.35 9.73 90 105317 141555 79497426
Multiple organ dysfunction syndrome 29.96 9.73 72 105335 120174 79518807
Mobility decreased 29.78 9.73 74 105333 122101 79516880
Chills 29.55 9.73 333 105074 159901 79479080
Eye pruritus 29.32 9.73 76 105331 20494 79618487
Gallbladder disorder 29.17 9.73 73 105334 19267 79619714
Sinus disorder 28.99 9.73 80 105327 22384 79616597
Upper respiratory tract infection 28.87 9.73 213 105194 90955 79548026
Sopor 27.81 9.73 5 105402 33005 79605976
Head discomfort 27.64 9.73 60 105347 14442 79624539
Photosensitivity reaction 27.03 9.73 75 105332 21052 79617929
Anaphylactic reaction 26.71 9.73 196 105211 83547 79555434
Musculoskeletal stiffness 26.46 9.73 130 105277 174878 79464103
Hepatocellular injury 26.42 9.73 15 105392 47578 79591403
Burning sensation 25.92 9.73 149 105258 58483 79580498
Infection 25.88 9.73 200 105207 241512 79397469
Tinnitus 25.35 9.73 121 105286 44212 79594769
Urinary tract infection 25.22 9.73 506 104901 274006 79364975
Rhinitis allergic 24.81 9.73 52 105355 12217 79626764
Status asthmaticus 24.73 9.73 16 105391 1018 79637963
Chronic spontaneous urticaria 24.60 9.73 17 105390 1207 79637774
Depression 24.59 9.73 413 104994 216377 79422604
Allergy test positive 24.45 9.73 14 105393 714 79638267
Cytomegalovirus infection 24.31 9.73 13 105394 42631 79596350
Swollen tongue 24.21 9.73 116 105291 42454 79596527
Cardiac failure 24.00 9.73 114 105293 154728 79484253
Dry skin 23.94 9.73 163 105244 67832 79571149
Lower respiratory tract infection 23.82 9.73 89 105318 129131 79509850
Deep vein thrombosis 23.53 9.73 254 105153 120665 79518316
Red blood cell sedimentation rate increased 23.40 9.73 16 105391 45926 79593055
Myelosuppression 23.39 9.73 12 105395 40284 79598697
Lacrimation increased 23.25 9.73 74 105333 22403 79616578
Coma 23.23 9.73 219 105188 100430 79538551
Incorrect dose administered 23.11 9.73 177 105230 76453 79562528
Migraine 23.08 9.73 196 105211 87297 79551684
Crying 23.05 9.73 75 105332 22968 79616013
Leukopenia 22.97 9.73 78 105329 116435 79522546
Pulmonary fibrosis 22.95 9.73 15 105392 44097 79594884
Throat tightness 22.85 9.73 85 105322 27822 79611159
Interstitial lung disease 22.46 9.73 75 105332 112525 79526456
Illness 22.43 9.73 121 105286 46390 79592591
Impaired healing 22.22 9.73 52 105355 87603 79551378
Knee arthroplasty 22.11 9.73 15 105392 43233 79595748
Lactic acidosis 21.91 9.73 37 105370 70322 79568659
Renal failure 21.64 9.73 166 105241 200802 79438179
Agranulocytosis 21.23 9.73 17 105390 45013 79593968
Periorbital oedema 21.10 9.73 39 105368 8363 79630618
Psoriatic arthropathy 20.81 9.73 45 105362 77954 79561027
Laryngospasm 20.72 9.73 26 105381 3971 79635010
Septic shock 20.47 9.73 88 105319 122713 79516268
Nervousness 20.43 9.73 93 105314 33322 79605659
Acute respiratory distress syndrome 20.32 9.73 17 105390 44050 79594931
Gallbladder injury 20.06 9.73 15 105392 1206 79637775
Hepatotoxicity 20.00 9.73 23 105384 51329 79587652
Malignant neoplasm progression 19.99 9.73 102 105305 135888 79503093
Drug level increased 19.94 9.73 14 105393 39637 79599344
Back pain 19.69 9.73 534 104873 303646 79335335
Circulatory collapse 19.34 9.73 13 105394 37655 79601326
Flushing 18.87 9.73 189 105218 88079 79550902
Cystitis noninfective 18.82 9.73 15 105392 1325 79637656
Skin exfoliation 18.75 9.73 131 105276 54969 79584012
Eye swelling 18.74 9.73 77 105330 26391 79612590
Discomfort 18.59 9.73 94 105313 125523 79513458
Swelling 18.49 9.73 190 105217 216521 79422460
Gastrointestinal mucosal necrosis 18.47 9.73 8 105399 222 79638759
Erythema 18.35 9.73 405 105002 222885 79416096
Cardiogenic shock 18.33 9.73 17 105390 41897 79597084
Wheezing 18.24 9.73 235 105172 116429 79522552
Bezoar 18.11 9.73 20 105387 2668 79636313
Acquired haemophilia 17.94 9.73 17 105390 1894 79637087
Oral pruritus 17.87 9.73 19 105388 2429 79636552
Hypersomnia 17.82 9.73 69 105338 23017 79615964
Bone marrow failure 17.71 9.73 25 105382 51082 79587899
Alopecia 17.69 9.73 208 105199 231147 79407834
Ear infection 17.57 9.73 91 105316 34341 79604640
Product quality issue 17.53 9.73 90 105317 33850 79605131
Biliary dyskinesia 17.26 9.73 19 105388 2526 79636455
Medication error 17.18 9.73 41 105366 68601 79570380
Thrombotic microangiopathy 17.11 9.73 3 105404 20166 79618815
Eczema 16.92 9.73 102 105305 40716 79598265
Allergic cystitis 16.89 9.73 3 105404 0 79638981
Blood pressure fluctuation 16.89 9.73 40 105367 67105 79571876
Condition aggravated 16.63 9.73 520 104887 500604 79138377
Hypotension 16.60 9.73 449 104958 439868 79199113
Hepatic failure 16.59 9.73 35 105372 61177 79577804
Liver injury 16.52 9.73 31 105376 56583 79582398
Cerebral haemorrhage 16.46 9.73 32 105375 57641 79581340
Hyponatraemia 16.40 9.73 153 105254 177695 79461286
Emotional disorder 16.40 9.73 49 105358 14338 79624643
Bone pain 16.39 9.73 128 105279 55614 79583367
Pneumonia 16.31 9.73 1046 104361 659200 78979781
Transplant rejection 16.25 9.73 3 105404 19434 79619547
Hip arthroplasty 16.24 9.73 14 105393 35742 79603239
Therapy non-responder 16.09 9.73 65 105342 92240 79546741
Red blood cell sedimentation rate abnormal 15.97 9.73 4 105403 20959 79618022
Sinus headache 15.92 9.73 26 105381 5054 79633927
Feeling hot 15.85 9.73 134 105273 59600 79579381
Incorrect dosage administered 15.79 9.73 19 105388 2780 79636201
Cystoid macular oedema 15.59 9.73 16 105391 1964 79637017
Heart rate increased 15.56 9.73 235 105172 120489 79518492
Impaired quality of life 15.47 9.73 48 105359 14338 79624643
Status epilepticus 15.23 9.73 7 105400 25034 79613947
Overdose 15.10 9.73 163 105244 184043 79454938
Nausea 15.04 9.73 1464 103943 955732 78683249
Posterior reversible encephalopathy syndrome 15.00 9.73 8 105399 26273 79612708
Sinus congestion 14.98 9.73 59 105348 19837 79619144
Injury 14.71 9.73 162 105245 77334 79561647
Liver disorder 14.60 9.73 48 105359 72369 79566612
Heart rate decreased 14.60 9.73 46 105361 70270 79568711
Syncope 14.59 9.73 325 105082 179124 79459857
Conduction disorder 14.45 9.73 20 105387 3359 79635622
Hepatic cytolysis 14.44 9.73 9 105398 27142 79611839
Ear swelling 14.35 9.73 14 105393 1617 79637364
Polyneuropathy 14.30 9.73 7 105400 24144 79614837
Osteonecrosis of jaw 14.15 9.73 22 105385 43204 79595777
Hyperlipidaemia 14.04 9.73 70 105337 26023 79612958
Palmar erythema 14.02 9.73 15 105392 1932 79637049
Loss of personal independence in daily activities 13.93 9.73 79 105328 102501 79536480
Depressed level of consciousness 13.92 9.73 73 105334 96579 79542402
Paraesthesia 13.91 9.73 318 105089 176005 79462976
Transient ischaemic attack 13.87 9.73 118 105289 52577 79586404
Carotid artery disease 13.82 9.73 16 105391 2248 79636733
Suicidal ideation 13.77 9.73 158 105249 76182 79562799
Administration site inflammation 13.60 9.73 3 105404 6 79638975
Initial insomnia 13.56 9.73 29 105378 6909 79632072
Burns first degree 13.56 9.73 4 105403 34 79638947
Upper-airway cough syndrome 13.49 9.73 40 105367 11653 79627328
Haemophagocytic lymphohistiocytosis 13.44 9.73 6 105401 21831 79617150
Infusion site swelling 13.37 9.73 31 105376 7795 79631186
Oesophageal adenocarcinoma recurrent 13.36 9.73 4 105403 36 79638945
Neurological examination normal 13.36 9.73 4 105403 36 79638945
Pneumocystis jirovecii pneumonia 13.27 9.73 14 105393 32494 79606487
Bacterial test positive 13.27 9.73 30 105377 7419 79631562
Melaena 13.24 9.73 39 105368 60851 79578130
Panic disorder 13.23 9.73 18 105389 2974 79636007
Gastrointestinal disorder 13.12 9.73 101 105306 122104 79516877
Full blood count decreased 13.08 9.73 70 105337 26749 79612232
Multiple lentigines syndrome 13.00 9.73 6 105401 194 79638787
Coronary artery disease 12.95 9.73 138 105269 65336 79573645
Tinea pedis 12.85 9.73 16 105391 2424 79636557
Face oedema 12.76 9.73 72 105335 28064 79610917
Blister 12.71 9.73 99 105308 119377 79519604
Essential hypertension 12.64 9.73 26 105381 6027 79632954
Visual impairment 12.52 9.73 181 105226 91950 79547031
Laryngeal pain 12.46 9.73 26 105381 6088 79632893
Ill-defined disorder 12.38 9.73 45 105362 65830 79573151
Autoimmune hepatitis 12.38 9.73 39 105368 11744 79627237
Blood pressure diastolic decreased 12.35 9.73 13 105394 30203 79608778
Pharyngeal dystonia 12.32 9.73 4 105403 48 79638933
Neuroleptic malignant syndrome 12.26 9.73 11 105396 27548 79611433
Breast pain 12.26 9.73 31 105376 8234 79630747
Bronchospasm 12.21 9.73 65 105342 24794 79614187
Pulmonary embolism 12.15 9.73 305 105102 171349 79467632
Delirium 12.14 9.73 64 105343 84563 79554418
Patellofemoral pain syndrome 12.13 9.73 8 105399 526 79638455
Chronic obstructive pulmonary disease 12.09 9.73 169 105238 85250 79553731
Allergy to animal 12.01 9.73 12 105395 1427 79637554
Dry mouth 12.00 9.73 173 105234 87846 79551135
Temperature intolerance 11.97 9.73 34 105373 9671 79629310
Nephropathy toxic 11.97 9.73 6 105401 20413 79618568
Rash pruritic 11.93 9.73 146 105261 71483 79567498
Altered state of consciousness 11.92 9.73 25 105382 43797 79595184
Victim of chemical submission 11.86 9.73 8 105399 546 79638435
Skin oedema 11.81 9.73 13 105394 1728 79637253
Rhinorrhoea 11.79 9.73 153 105254 75921 79563060
Haematotoxicity 11.75 9.73 3 105404 15516 79623465
Bronchial hyperreactivity 11.54 9.73 17 105390 3023 79635958
Reflux gastritis 11.51 9.73 11 105396 1238 79637743
Ear discomfort 11.51 9.73 31 105376 8552 79630429
Death 11.48 9.73 622 104785 565892 79073089
Reversible cerebral vasoconstriction syndrome 11.47 9.73 17 105390 3040 79635941
Pneumonitis 11.45 9.73 127 105280 60733 79578248
Mitral valve prolapse 11.39 9.73 14 105393 2093 79636888
Non-cardiac chest pain 11.39 9.73 33 105374 9491 79629490
Multiple allergies 11.34 9.73 35 105372 10425 79628556
Ventricular hypertrophy 11.33 9.73 27 105380 6911 79632070
Neurological examination abnormal 11.32 9.73 8 105399 589 79638392
Anxiety disorder 11.23 9.73 20 105387 4167 79634814
Rash macular 11.22 9.73 71 105336 28828 79610153
Blood pressure systolic increased 11.16 9.73 48 105359 66938 79572043
Skin necrosis 11.09 9.73 5 105402 18082 79620899
Hypoaesthesia 11.06 9.73 313 105094 179039 79459942
Influenza like illness 11.02 9.73 144 105263 71563 79567418
Cystic fibrosis 11.01 9.73 19 105388 3861 79635120
Intentional product misuse 11.01 9.73 77 105330 95088 79543893
Pain in extremity 10.97 9.73 588 104819 363950 79275031
Hypertensive crisis 10.89 9.73 7 105400 20763 79618218
Sinus operation 10.88 9.73 15 105392 2510 79636471
Basophil count decreased 10.87 9.73 6 105401 285 79638696
Rotator cuff syndrome 10.77 9.73 42 105365 14053 79624928
Lethargy 10.77 9.73 159 105248 81133 79557848
Obsessive-compulsive disorder 10.70 9.73 24 105383 5903 79633078
Aspergillus infection 10.69 9.73 6 105401 19155 79619826
Lymphopenia 10.54 9.73 15 105392 30542 79608439
Metabolic acidosis 10.44 9.73 65 105342 82464 79556517
Dry eye 10.41 9.73 84 105323 36847 79602134
Accident at home 10.41 9.73 5 105402 177 79638804
Mood altered 10.41 9.73 49 105358 17798 79621183
Serotonin syndrome 10.41 9.73 28 105379 44999 79593982
Protein total decreased 10.40 9.73 31 105376 9061 79629920
Haemodynamic instability 10.35 9.73 5 105402 17377 79621604
Uterine cyst 10.34 9.73 6 105401 314 79638667
Bradycardia 10.30 9.73 122 105285 135435 79503546
Exposure to toxic agent 10.26 9.73 31 105376 9127 79629854
Priapism 10.19 9.73 20 105387 4485 79634496
Intercepted medication error 10.16 9.73 9 105398 920 79638061
Respiratory failure 10.15 9.73 173 105234 180738 79458243
Sedation complication 10.14 9.73 4 105403 15665 79623316
Disseminated intravascular coagulation 10.13 9.73 20 105387 35822 79603159
Irritable bowel syndrome 10.13 9.73 45 105362 62196 79576785
Surgery 10.05 9.73 76 105331 32690 79606291
Tenosynovitis 10.01 9.73 4 105403 15550 79623431
Cellulitis 9.99 9.73 201 105206 108859 79530122
Rhinovirus infection 9.94 9.73 28 105379 7925 79631056
Cataract subcapsular 9.89 9.73 9 105398 952 79638029
Cerebrovascular accident 9.85 9.73 272 105135 155020 79483961
Aphthous ulcer 9.84 9.73 5 105402 16884 79622097
Infusion site pain 9.84 9.73 41 105366 14135 79624846
Anuria 9.77 9.73 8 105399 20955 79618026
Chapped lips 9.74 9.73 14 105393 2436 79636545

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R06AX13 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Other antihistamines for systemic use
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:48873 acetylcholine receptor antagonist
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:176497 geroprotectors
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000982 Antipruritics
MeSH PA D003879 Dermatologic Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D039563 Histamine H1 Antagonists, Non-Sedating
MeSH PA D018377 Neurotransmitter Agents

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Chronic idiopathic urticaria indication 302162004
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Bone pain after neupogen off-label use 12584003
Urticaria off-label use 126485001
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Hepatic failure contraindication 59927004
Diabetes mellitus contraindication 73211009 DOID:9351
Kidney disease contraindication 90708001 DOID:557
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
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 4.43 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 6.97 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter Ki 4.94 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 6.81 DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor EC50 5.52 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 7.80 DRUG MATRIX
Potassium channel subfamily K member 9 Ion channel IC50 4.20 CHEMBL
Bile acid receptor Nuclear hormone receptor IC50 5.51 CHEMBL
Sodium-dependent neutral amino acid transporter B(0)AT2 Transporter IC50 5.40 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.77 WOMBAT-PK
Transient receptor potential cation channel subfamily V member 2 Ion channel BLOCKER IC50 5.52 IUPHAR
Histamine H1 receptor GPCR Kd 7.14 CHEMBL
Histamine H1 receptor GPCR Ki 6.46 CHEMBL

External reference:

IDSource
4020716 VUID
N0000148306 NUI
D00364 KEGG_DRUG
4020716 VANDF
C0065180 UMLSCUI
CHEBI:6538 CHEBI
CHEMBL998 ChEMBL_ID
DB00455 DRUGBANK_ID
D017336 MESH_DESCRIPTOR_UI
3957 PUBCHEM_CID
7216 IUPHAR_LIGAND_ID
5864 INN_ID
7AJO3BO7QN UNII
203576 RXNORM
191 MMSL
45829 MMSL
4994 MMSL
d03050 MMSL
003909 NDDF
015760 NDDF
108652002 SNOMEDCT_US
386884002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
allergy relief HUMAN OTC DRUG LABEL 1 0067-6066 TABLET 10 mg ORAL NDA 30 sections
allergy relief HUMAN OTC DRUG LABEL 1 0067-6122 TABLET 10 mg ORAL NDA 30 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-0612 TABLET 10 mg ORAL ANDA 15 sections
Good Sense childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-0671 SOLUTION 5 mg ORAL ANDA 14 sections
good sense childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-1019 TABLET, CHEWABLE 5 mg ORAL ANDA 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-1191 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-1612 TABLET 10 mg ORAL ANDA 15 sections
good sense childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-1719 SOLUTION 5 mg ORAL ANDA 14 sections
Allergy and Congestion Relief HUMAN OTC DRUG LABEL 2 0113-2007 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 14 sections
basic care childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-7500 TABLET, CHEWABLE 5 mg ORAL ANDA 15 sections
basic care childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-7500 TABLET, CHEWABLE 5 mg ORAL ANDA 15 sections
Basic Care allergy relief HUMAN OTC DRUG LABEL 1 0113-7612 TABLET 10 mg ORAL ANDA 15 sections
Basic Care Childrens Allergy Relief HUMAN OTC DRUG LABEL 1 0113-7671 SOLUTION 5 mg ORAL ANDA 14 sections
perrigo allergy d HUMAN OTC DRUG LABEL 2 0113-7777 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-9755 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 15 sections
Childrens Loratadine HUMAN OTC DRUG LABEL 1 0121-0849 SOLUTION 5 mg ORAL ANDA 16 sections
Childrens Loratadine HUMAN OTC DRUG LABEL 1 0121-0849 SOLUTION 5 mg ORAL ANDA 16 sections
Loratadine HUMAN OTC DRUG LABEL 1 0363-0522 TABLET 10 mg ORAL ANDA 15 sections
Loratadine HUMAN OTC DRUG LABEL 1 0363-0527 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 15 sections
Wal itin HUMAN OTC DRUG LABEL 1 0363-0699 TABLET 10 mg ORAL ANDA 15 sections
Loratadine and Pseudoephedrine HUMAN OTC DRUG LABEL 2 0363-0725 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 16 sections
Loratadine HUMAN OTC DRUG LABEL 1 0363-0752 TABLET, CHEWABLE 5 mg ORAL ANDA 16 sections
Wal-itin HUMAN OTC DRUG LABEL 1 0363-0754 TABLET, CHEWABLE 5 mg ORAL ANDA 16 sections
Loratadine HUMAN OTC DRUG LABEL 1 0363-0771 SOLUTION 5 mg ORAL ANDA 16 sections
Indoor Outdoor Allergy Relief HUMAN OTC DRUG LABEL 1 0363-0858 TABLET 10 mg ORAL ANDA 14 sections
Indoor Outdoor Allergy Relief HUMAN OTC DRUG LABEL 1 0363-0858 TABLET 10 mg ORAL ANDA 14 sections
12 hour allergy and congestion HUMAN OTC DRUG LABEL 2 0363-1133 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 14 sections
allergy relief HUMAN OTC DRUG LABEL 1 0363-1612 TABLET 10 mg ORAL ANDA 15 sections
allergy relief HUMAN OTC DRUG LABEL 1 0363-1612 TABLET 10 mg ORAL ANDA 15 sections
WAL-ITIN HUMAN OTC DRUG LABEL 1 0363-1686 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 16 sections