loratadine ๐Ÿถ 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 ยตM/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 294.31 9.83 149 79928 4927 50520120
Accidental exposure to product by child 175.63 9.83 65 80012 975 50524072
Drug ineffective 171.72 9.83 693 79384 818640 49706407
Contraindicated product administered 171.71 9.83 18 80059 148940 50376107
Gastrooesophageal reflux disease 152.90 9.83 359 79718 76069 50448978
Synovitis 145.26 9.83 14 80063 123851 50401196
Pneumonia aspiration 137.35 9.83 205 79872 30799 50494248
Glossodynia 135.69 9.83 13 80064 115556 50409491
Drug intolerance 133.06 9.83 92 79985 219012 50306035
Hand deformity 123.87 9.83 9 80068 100190 50424857
Systemic lupus erythematosus 123.00 9.83 35 80042 140587 50384460
Failure of child resistant product closure 117.78 9.83 23 80054 9 50525038
Treatment failure 113.65 9.83 38 80039 137599 50387448
Wound 107.20 9.83 19 80058 105775 50419272
Urticaria 101.38 9.83 440 79637 129121 50395926
Arthropathy 93.58 9.83 68 80009 157838 50367209
Joint swelling 92.12 9.83 154 79923 245132 50279915
Maternal exposure during pregnancy 89.35 9.83 73 80004 159705 50365342
Asthma 88.81 9.83 327 79750 89010 50436037
Pericarditis 86.91 9.83 11 80066 78678 50446369
Somnolence 82.59 9.83 472 79605 154513 50370534
Off label use 73.07 9.83 446 79631 473980 50051067
Therapeutic product effect decreased 72.58 9.83 65 80012 135985 50389062
Toxicity to various agents 66.20 9.83 149 79928 212350 50312697
Rheumatoid arthritis 63.11 9.83 142 79935 202408 50322639
Dizziness 60.95 9.83 825 79252 345544 50179503
General physical health deterioration 59.60 9.83 83 79994 142351 50382696
Coma 58.02 9.83 210 79867 56669 50468378
Alopecia 57.58 9.83 197 79880 244850 50280197
Cholecystitis chronic 56.39 9.83 73 80004 9596 50515451
Swelling face 56.05 9.83 197 79880 52398 50472649
Drug abuse 55.93 9.83 13 80064 59833 50465214
Anxiety 55.04 9.83 474 79603 177132 50347915
Butterfly rash 53.87 9.83 30 80047 1206 50523841
Hepatic enzyme increased 51.75 9.83 86 79991 137294 50387753
Infective pulmonary exacerbation of cystic fibrosis 51.35 9.83 63 80014 7846 50517201
Muscle spasms 49.89 9.83 355 79722 125198 50399849
Feeling abnormal 48.23 9.83 352 79725 125140 50399907
Insomnia 47.20 9.83 453 79624 174412 50350635
Chest discomfort 46.49 9.83 278 79799 92444 50432603
Acute kidney injury 45.40 9.83 196 79881 227862 50297185
Swelling 44.82 9.83 165 79912 200707 50324340
Helicobacter infection 44.12 9.83 12 80065 49690 50475357
Lower respiratory tract infection 43.39 9.83 52 80025 95149 50429898
Headache 41.39 9.83 1071 79006 505464 50019583
Pruritus 41.35 9.83 654 79423 282914 50242133
Palpitations 40.95 9.83 273 79804 94233 50430814
Cough 40.86 9.83 571 79506 240693 50284354
Angioedema 39.17 9.83 140 79937 37536 50487511
Dyspnoea 39.14 9.83 1138 78939 546470 49978577
C-reactive protein increased 38.86 9.83 29 80048 66445 50458602
Folliculitis 37.70 9.83 8 80069 39217 50485830
Sinusitis 37.57 9.83 424 79653 170134 50354913
Emotional distress 37.38 9.83 115 79962 28548 50496499
Discomfort 36.21 9.83 73 80004 108307 50416740
Sleep disorder due to general medical condition, insomnia type 35.69 9.83 4 80073 31443 50493604
Depression 34.98 9.83 408 79669 165015 50360032
Gallbladder disorder 34.92 9.83 80 79997 16662 50508385
Bronchitis 34.36 9.83 282 79795 103877 50421170
Seasonal allergy 33.85 9.83 73 80004 14603 50510444
Periorbital oedema 32.66 9.83 40 80037 4972 50520075
Dermatitis atopic 32.55 9.83 34 80043 3552 50521495
Tinnitus 32.26 9.83 108 79969 28024 50497023
Pancytopenia 31.26 9.83 53 80024 83977 50441070
Musculoskeletal stiffness 30.33 9.83 103 79974 128378 50396669
Lip swelling 29.29 9.83 96 79981 24640 50500407
Product dose omission issue 29.07 9.83 430 79647 183408 50341639
Rhinitis allergic 28.21 9.83 45 80032 7155 50517892
Impaired healing 27.86 9.83 42 80035 69744 50455303
Mobility decreased 27.43 9.83 53 80024 79895 50445152
Sinus disorder 26.86 9.83 77 80000 18381 50506666
Allergy test positive 26.77 9.83 13 80064 392 50524655
Knee arthroplasty 26.10 9.83 12 80065 35834 50489213
Infection 25.77 9.83 164 79913 172790 50352257
Multiple organ dysfunction syndrome 25.70 9.83 25 80052 50312 50474735
Nasal congestion 25.44 9.83 153 79924 50967 50474080
Diarrhoea 25.07 9.83 1154 78923 587322 49937725
Throat irritation 24.61 9.83 104 79973 30135 50494912
Chest pain 24.26 9.83 404 79673 176478 50348569
Upper respiratory tract infection 24.24 9.83 183 79894 65715 50459332
C-reactive protein abnormal 24.15 9.83 7 80070 27802 50497245
Acquired haemophilia 24.08 9.83 16 80061 887 50524160
Photosensitivity reaction 24.01 9.83 59 80018 12852 50512195
Malignant neoplasm progression 23.51 9.83 45 80032 68079 50456968
Tinea pedis 23.49 9.83 18 80059 1251 50523796
Head discomfort 23.37 9.83 53 80024 10966 50514081
Abdominal discomfort 22.94 9.83 245 79832 231396 50293651
Rhabdomyolysis 22.84 9.83 17 80060 39010 50486037
Therapeutic product effect incomplete 22.53 9.83 72 80005 91443 50433604
Injury 22.19 9.83 143 79934 48782 50476265
Anaphylactic reaction 22.12 9.83 154 79923 53901 50471146
Essential hypertension 22.02 9.83 31 80046 4413 50520634
Multiple allergies 21.74 9.83 44 80033 8419 50516628
Ill-defined disorder 21.71 9.83 33 80044 54621 50470426
Hepatocellular injury 21.68 9.83 7 80070 25940 50499107
Hypersomnia 21.43 9.83 63 80014 15251 50509796
Biliary dyskinesia 21.07 9.83 23 80054 2527 50522520
Expired product administered 20.22 9.83 33 80044 5349 50519698
Drug resistance 20.14 9.83 3 80074 18986 50506061
Gastrointestinal disorder 20.13 9.83 79 79998 94377 50430670
Feeling hot 19.93 9.83 118 79959 39084 50485963
Blister 19.80 9.83 69 80008 85349 50439698
Deep vein thrombosis 19.30 9.83 189 79888 73115 50451932
Wheezing 18.87 9.83 165 79912 61882 50463165
Nervousness 18.68 9.83 90 79987 27561 50497486
Cystitis noninfective 18.34 9.83 13 80064 801 50524246
Migraine 18.33 9.83 191 79886 75089 50449958
Paraesthesia 18.11 9.83 279 79798 119964 50405083
Status asthmaticus 18.07 9.83 13 80064 820 50524227
Dry mouth 17.92 9.83 151 79926 56027 50469020
Cholelithiasis 17.85 9.83 112 79965 37861 50487186
Oropharyngeal pain 17.83 9.83 195 79882 77606 50447441
Abdominal distension 17.77 9.83 185 79892 72718 50452329
Lupus hepatitis 17.71 9.83 5 80072 29 50525018
Renal impairment 17.61 9.83 61 80016 75600 50449447
Completed suicide 17.20 9.83 130 79947 131759 50393288
Throat tightness 17.20 9.83 72 80005 20775 50504272
Premature baby 17.09 9.83 4 80073 18333 50506714
Sinus headache 17.01 9.83 28 80049 4570 50520477
Gallbladder injury 16.92 9.83 15 80062 1279 50523768
Vision blurred 16.61 9.83 194 79883 78453 50446594
Thrombocytopenia 16.58 9.83 126 79951 127547 50397500
Product use issue 16.49 9.83 154 79923 149321 50375726
Hyperkalaemia 16.39 9.83 32 80045 48057 50476990
Allergic cystitis 16.35 9.83 3 80074 0 50525047
Septic shock 16.26 9.83 42 80035 57133 50467914
Victim of chemical submission 16.07 9.83 8 80069 255 50524792
Condition aggravated 16.05 9.83 353 79724 296705 50228342
Drug interaction 16.00 9.83 221 79856 199400 50325647
Basophil count decreased 15.91 9.83 6 80071 95 50524952
Hip arthroplasty 15.66 9.83 15 80062 30414 50494633
Reversible cerebral vasoconstriction syndrome 15.60 9.83 18 80059 2101 50522946
Arthralgia 15.57 9.83 553 79524 438149 50086898
Neuropathy peripheral 15.54 9.83 227 79850 96530 50428517
Sopor 15.52 9.83 6 80071 19873 50505174
Cardiac failure 15.32 9.83 65 80012 75975 50449072
Osteonecrosis of jaw 14.57 9.83 18 80059 32508 50492539
Hepatotoxicity 14.51 9.83 13 80064 27213 50497834
Posterior reversible encephalopathy syndrome 14.43 9.83 3 80074 14925 50510122
Dyspepsia 14.43 9.83 180 79897 73917 50451130
Hyponatraemia 14.39 9.83 91 79986 96048 50428999
Incorrect dose administered 14.33 9.83 128 79949 48286 50476761
Suicidal ideation 14.19 9.83 142 79935 55243 50469804
Neurological examination abnormal 14.03 9.83 7 80070 224 50524823
Nausea 13.96 9.83 1296 78781 704102 49820945
Urinary tract infection 13.89 9.83 458 79619 223562 50301485
Pre-existing condition improved 13.80 9.83 33 80044 7064 50517983
Swollen tongue 13.80 9.83 85 79992 28545 50496502
Upper-airway cough syndrome 13.76 9.83 37 80040 8513 50516534
Initial insomnia 13.62 9.83 27 80050 5088 50519959
Bronchospasm 13.60 9.83 53 80024 14801 50510246
Mast cell activation syndrome 13.56 9.83 8 80069 359 50524688
Temperature intolerance 13.54 9.83 34 80043 7505 50517542
Abnormal dreams 13.53 9.83 39 80038 9338 50515709
Eye pruritus 13.39 9.83 47 80030 12487 50512560
Hepatic failure 13.30 9.83 19 80058 32264 50492783
Medication error 13.21 9.83 23 80054 36081 50488966
Hot flush 13.19 9.83 117 79960 44052 50480995
Snoring 13.05 9.83 21 80056 3363 50521684
Agranulocytosis 12.97 9.83 9 80068 21412 50503635
Back pain 12.92 9.83 447 79630 219583 50305464
Burning sensation 12.86 9.83 119 79958 45327 50479720
Leukopenia 12.83 9.83 59 80018 67469 50457578
Panic disorder 12.83 9.83 17 80060 2286 50522761
Xanthogranuloma 12.75 9.83 3 80074 7 50525040
Death 12.74 9.83 405 79672 324974 50200073
Cataract subcapsular 12.68 9.83 9 80068 556 50524491
Circulatory collapse 12.65 9.83 8 80069 19992 50505055
Oesophageal adenocarcinoma recurrent 12.65 9.83 4 80073 36 50525011
Eye swelling 12.49 9.83 64 80013 20080 50504967
Lactic acidosis 12.43 9.83 21 80056 33334 50491713
Red blood cell sedimentation rate increased 12.43 9.83 17 80060 29399 50495648
Pulmonary embolism 12.39 9.83 228 79849 101476 50423571
Sleep apnoea syndrome 12.23 9.83 72 80005 23796 50501251
Overdose 12.21 9.83 100 79977 99627 50425420
Mitral valve prolapse 12.17 9.83 16 80061 2134 50522913
Depressed level of consciousness 12.01 9.83 42 80035 51911 50473136
Somnambulism 11.94 9.83 25 80052 4899 50520148
Intentional product use issue 11.93 9.83 72 80005 76846 50448201
Acute hepatic failure 11.80 9.83 5 80072 15672 50509375
Infusion related reaction 11.76 9.83 193 79884 169364 50355683
Rash 11.74 9.83 823 79254 436648 50088399
Loss of personal independence in daily activities 11.71 9.83 64 80013 69986 50455061
Fracture 11.70 9.83 6 80071 16827 50508220
Cyclic vomiting syndrome 11.69 9.83 4 80073 47 50525000
Cytomegalovirus infection 11.62 9.83 7 80070 17955 50507092
Skin burning sensation 11.59 9.83 39 80038 10146 50514901
Autoimmune hepatitis 11.56 9.83 32 80045 7487 50517560
Pulmonary fibrosis 11.50 9.83 13 80064 24424 50500623
Ear congestion 11.49 9.83 15 80062 1988 50523059
Metastases to liver 11.45 9.83 9 80068 20095 50504952
Erythema 11.42 9.83 308 79769 146106 50378941
Biliary sepsis 11.41 9.83 10 80067 840 50524207
Chronic sinusitis 11.34 9.83 28 80049 6117 50518930
Presbyoesophagus 11.17 9.83 3 80074 14 50525033
Psoriasis 11.12 9.83 162 79915 68838 50456209
Red blood cell sedimentation rate abnormal 11.10 9.83 6 80071 16337 50508710
Dysgeusia 11.06 9.83 102 79975 38814 50486233
Palmar erythema 11.05 9.83 13 80064 1550 50523497
Acute sinusitis 10.98 9.83 20 80057 3540 50521507
Chronic spontaneous urticaria 10.96 9.83 8 80069 516 50524531
Hypoaesthesia 10.88 9.83 271 79806 126986 50398061
Bezoar 10.86 9.83 12 80065 1336 50523711
Cluster headache 10.82 9.83 8 80069 527 50524520
Premature delivery 10.70 9.83 13 80064 23650 50501397
Burns first degree 10.69 9.83 3 80074 17 50525030
Myelosuppression 10.69 9.83 4 80073 13513 50511534
Ear discomfort 10.67 9.83 29 80048 6715 50518332
Torsade de pointes 10.65 9.83 42 80035 11793 50513254
Sinus congestion 10.56 9.83 47 80030 13924 50511123
Full blood count decreased 10.56 9.83 66 80011 22280 50502767
Broad ligament tear 10.54 9.83 3 80074 18 50525029
Patellofemoral pain syndrome 10.49 9.83 8 80069 552 50524495
Myxoedema coma 10.47 9.83 7 80070 392 50524655
Pneumonia 10.34 9.83 713 79364 377688 50147359
Fatigue 10.33 9.83 1274 78803 706327 49818720
Multiple lentigines syndrome 10.23 9.83 5 80072 153 50524894
Restless legs syndrome 10.20 9.83 51 80026 15846 50509201
Chills 10.17 9.83 212 79865 96475 50428572
Incorrect dosage administered 10.09 9.83 13 80064 1701 50523346
Cerumen impaction 10.04 9.83 10 80067 988 50524059
Flushing 9.89 9.83 155 79922 66860 50458187

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 289.93 10.69 96 38287 1258 29534886
Extra dose administered 222.95 10.69 99 38284 2978 29533166
Failure of child resistant product closure 76.99 10.69 16 38367 21 29536123
Drug abuse 68.11 10.69 11 38372 79872 29456272
Urticaria 59.63 10.69 181 38202 54479 29481665
General physical health deterioration 53.12 10.69 34 38349 102823 29433321
Infective pulmonary exacerbation of cystic fibrosis 51.00 10.69 51 38332 6185 29529959
Drug interaction 50.14 10.69 114 38269 197271 29338873
Rash 44.02 10.69 407 37976 189412 29346732
Fatigue 39.93 10.69 604 37779 316217 29219927
Off label use 39.58 10.69 229 38154 300571 29235573
Pruritus 39.34 10.69 273 38110 116576 29419568
Completed suicide 36.43 10.69 38 38345 90208 29445936
Toxicity to various agents 35.94 10.69 111 38272 173550 29362594
Asthma 35.88 10.69 111 38272 33738 29502406
Sinusitis 35.81 10.69 112 38271 34238 29501906
Drug ineffective 31.79 10.69 310 38073 362860 29173284
Acute kidney injury 30.21 10.69 211 38172 265056 29271088
Cough 28.95 10.69 271 38112 126456 29409688
Sinus disorder 28.68 10.69 37 38346 5918 29530226
Throat irritation 28.20 10.69 45 38338 8740 29527404
Chronic spontaneous urticaria 27.27 10.69 8 38375 68 29536076
Swelling face 26.65 10.69 72 38311 20278 29515866
Treatment failure 23.91 10.69 9 38374 36930 29499214
Gastrointestinal mucosal necrosis 21.04 10.69 8 38375 160 29535984
Bronchitis 19.43 10.69 97 38286 36771 29499373
Expired product administered 19.41 10.69 21 38362 2790 29533354
Infusion related reaction 19.39 10.69 110 38273 43776 29492368
CADASIL 18.99 10.69 6 38377 67 29536077
Magnetic resonance imaging spinal abnormal 18.67 10.69 6 38377 71 29536073
Dizziness 18.43 10.69 347 38036 189337 29346807
Visual evoked potentials abnormal 18.30 10.69 6 38377 76 29536068
Drug resistance 18.27 10.69 3 38380 21537 29514607
Eye pruritus 17.93 10.69 25 38358 4307 29531837
Oral pruritus 17.67 10.69 8 38375 252 29535892
Renal impairment 17.50 10.69 51 38332 81282 29454862
Glossodynia 16.97 10.69 21 38362 3222 29532922
Central nervous system inflammation 16.74 10.69 6 38377 101 29536043
Blood pH decreased 16.63 10.69 17 38366 2116 29534028
Wheezing 16.50 10.69 86 38297 33154 29502990
PO2 increased 16.40 10.69 10 38373 584 29535560
Tunnel vision 16.29 10.69 9 38374 436 29535708
Muscle spasms 16.28 10.69 142 38241 64940 29471204
Seasonal allergy 16.19 10.69 26 38357 5076 29531068
Hyperkalaemia 15.91 10.69 35 38348 61357 29474787
Interstitial lung disease 15.72 10.69 32 38351 57686 29478458
Pneumonitis 15.64 10.69 75 38308 27969 29508175
Saccadic eye movement 15.33 10.69 6 38377 130 29536014
Metamorphopsia 15.28 10.69 9 38374 493 29535651
Ejaculation delayed 15.18 10.69 7 38376 230 29535914
Lacrimation increased 14.99 10.69 30 38353 6950 29529194
Rheumatoid arthritis 14.78 10.69 12 38371 32140 29504004
Feeling abnormal 14.78 10.69 121 38262 54324 29481820
Tension headache 14.72 10.69 13 38370 1348 29534796
Rhabdomyolysis 14.69 10.69 36 38347 60772 29475372
Chills 14.55 10.69 149 38234 71151 29464993
Contraindicated product administered 14.51 10.69 3 38380 18263 29517881
Anxiety 14.49 10.69 172 38211 85193 29450951
Upper respiratory tract infection 14.44 10.69 72 38311 27277 29508867
Lip swelling 14.37 10.69 42 38341 12368 29523776
Chest pain 14.21 10.69 214 38169 111759 29424385
Vision blurred 14.16 10.69 95 38288 40081 29496063
Suicidal ideation 14.03 10.69 85 38298 34631 29501513
Leukopenia 13.87 10.69 32 38351 55171 29480973
Cerebral microangiopathy 13.81 10.69 6 38377 171 29535973
Heart rate increased 13.68 10.69 92 38291 38846 29497298
Muscle tightness 13.62 10.69 22 38361 4316 29531828
Double stranded DNA antibody positive 13.43 10.69 6 38377 183 29535961
Gastrooesophageal reflux disease 13.29 10.69 78 38305 31418 29504726
Intercepted medication error 13.17 10.69 8 38375 464 29535680
Conduction disorder 13.15 10.69 14 38369 1826 29534318
Burning sensation 13.10 10.69 48 38335 15890 29520254
Sleep apnoea syndrome 12.82 10.69 51 38332 17548 29518596
Forced expiratory volume decreased 12.80 10.69 17 38366 2796 29533348
Hyponatraemia 12.74 10.69 45 38338 67588 29468556
Acute respiratory distress syndrome 12.64 10.69 7 38376 22928 29513216
Chronic obstructive pulmonary disease 12.20 10.69 93 38290 40862 29495282
Testicular cyst 12.18 10.69 4 38379 51 29536093
Spinal osteoarthritis 12.10 10.69 26 38357 6330 29529814
Oropharyngeal pain 12.02 10.69 72 38311 29213 29506931
Blood cholesterol increased 12.01 10.69 46 38337 15549 29520595
Upper-airway cough syndrome 11.94 10.69 17 38366 2986 29533158
Metabolic acidosis 11.94 10.69 19 38364 37643 29498501
Lactic acidosis 11.90 10.69 13 38370 30234 29505910
Eosinophilia 11.88 10.69 7 38376 22154 29513990
Renal failure 11.72 10.69 98 38285 118501 29417643
Depression 11.69 10.69 165 38218 84982 29451162
C-reactive protein increased 11.66 10.69 25 38358 44238 29491906
Migraine 11.57 10.69 39 38344 12391 29523753
Cytomegalovirus infection 11.53 10.69 8 38375 23207 29512937
Intentional self-injury 11.51 10.69 39 38344 12422 29523722
Crying 11.49 10.69 23 38360 5328 29530816
Physical examination abnormal 11.29 10.69 6 38377 269 29535875
Insomnia 11.01 10.69 169 38214 88592 29447552
Convulsions local 10.99 10.69 3 38380 19 29536125
Pneumonia 10.97 10.69 514 37869 319658 29216486
Angioedema 10.96 10.69 75 38308 31840 29504304
Mucosal inflammation 10.93 10.69 15 38368 31580 29504564
Rhinorrhoea 10.90 10.69 56 38327 21463 29514681
Nasal congestion 10.90 10.69 51 38332 18828 29517316
Sneezing 10.74 10.69 20 38363 4394 29531750

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 538.54 9.72 240 93048 6510 64398934
Accidental exposure to product by child 458.67 9.72 162 93126 2323 64403121
Failure of child resistant product closure 190.62 9.72 39 93249 36 64405408
Urticaria 160.22 9.72 523 92765 146794 64258650
Gastrooesophageal reflux disease 139.13 9.72 345 92943 82798 64322646
Drug ineffective 132.81 9.72 696 92592 839551 63565893
Drug abuse 124.20 9.72 21 93267 132353 64273091
Off label use 115.12 9.72 498 92790 632308 63773136
Infective pulmonary exacerbation of cystic fibrosis 97.49 9.72 102 93186 11694 64393750
Contraindicated product administered 97.06 9.72 19 93269 107810 64297634
General physical health deterioration 96.49 9.72 92 93196 204333 64201111
Toxicity to various agents 96.43 9.72 242 93046 363271 64042173
Synovitis 88.06 9.72 18 93270 99072 64306372
Drug intolerance 84.81 9.72 88 93200 187904 64217540
Asthma 82.67 9.72 314 92974 94911 64310533
Acute kidney injury 79.43 9.72 357 92931 448883 63956561
Pruritus 78.84 9.72 743 92545 311657 64093787
Swelling face 76.26 9.72 223 93065 58943 64346501
Treatment failure 75.86 9.72 37 93251 116779 64288665
Somnolence 68.68 9.72 517 92771 203128 64202316
Dizziness 68.56 9.72 935 92353 429228 63976216
Drug interaction 61.41 9.72 292 92996 361791 64043653
Joint swelling 61.32 9.72 138 93150 215244 64190200
Hand deformity 61.02 9.72 9 93279 62762 64342682
Pneumonia aspiration 59.53 9.72 205 93083 59066 64346378
Butterfly rash 57.66 9.72 30 93258 1152 64404292
Rheumatoid arthritis 52.93 9.72 98 93190 164196 64241248
C-reactive protein increased 49.25 9.72 39 93249 94870 64310574
Therapeutic product effect decreased 48.69 9.72 57 93231 115294 64290150
Cholecystitis chronic 47.81 9.72 63 93225 9224 64396220
Completed suicide 47.41 9.72 166 93122 224248 64181196
Muscle spasms 46.93 9.72 357 92931 140666 64264778
Throat irritation 45.75 9.72 127 93161 32584 64372860
Angioedema 44.20 9.72 192 93096 61629 64343815
Headache 43.89 9.72 1038 92250 528429 63877015
Feeling abnormal 43.78 9.72 337 92951 133265 64272179
Emotional distress 42.81 9.72 132 93156 35906 64369538
Lip swelling 42.78 9.72 122 93166 31785 64373659
Anxiety 41.94 9.72 463 92825 202186 64203258
Pericarditis 41.81 9.72 19 93269 62497 64342947
Cough 41.40 9.72 640 92648 301508 64103936
Glossodynia 41.22 9.72 21 93267 64675 64340769
Chest discomfort 40.36 9.72 297 92991 115809 64289635
Sinusitis 40.24 9.72 354 92934 145574 64259870
Palpitations 40.24 9.72 274 93014 104214 64301230
Wound 40.21 9.72 31 93257 76446 64328998
Systemic lupus erythematosus 40.13 9.72 32 93256 77580 64327864
Dyspnoea 40.01 9.72 1339 91949 717335 63688109
Expired product administered 39.49 9.72 46 93242 5941 64399503
Rash 39.21 9.72 903 92385 457646 63947798
Insomnia 39.12 9.72 448 92840 197388 64208056
Renal impairment 38.82 9.72 86 93202 134931 64270513
Chest pain 38.75 9.72 516 92772 235464 64169980
Fatigue 38.43 9.72 1382 91906 747348 63658096
Pancytopenia 38.23 9.72 95 93193 143214 64262230
Arthropathy 37.34 9.72 74 93214 120893 64284551
Rhabdomyolysis 36.94 9.72 47 93241 91679 64313765
Rhinitis allergic 34.38 9.72 50 93238 8028 64397416
Helicobacter infection 34.01 9.72 7 93281 38355 64367089
Maternal exposure during pregnancy 32.85 9.72 55 93233 95829 64309615
Hyperkalaemia 32.84 9.72 60 93228 101069 64304375
Bronchitis 32.71 9.72 269 93019 108474 64296970
Drug resistance 31.97 9.72 6 93282 35096 64370348
Tinnitus 31.64 9.72 115 93173 34018 64371426
Nasal congestion 31.61 9.72 170 93118 59488 64345956
Vision blurred 30.80 9.72 230 93058 90086 64315358
Injury 29.97 9.72 160 93128 55832 64349612
Thrombocytopenia 29.96 9.72 195 93093 223606 64181838
Hepatocellular injury 29.85 9.72 14 93274 45221 64360223
Wheezing 29.08 9.72 208 93080 80371 64325073
Gallbladder disorder 28.81 9.72 71 93217 16959 64388485
C-reactive protein abnormal 28.61 9.72 4 93284 29043 64376401
Eye pruritus 28.36 9.72 59 93229 12600 64392844
Dermatitis atopic 27.62 9.72 31 93257 3845 64401599
Head discomfort 27.50 9.72 56 93232 11778 64393666
Sopor 27.16 9.72 5 93283 29656 64375788
Allergy test positive 26.97 9.72 13 93275 423 64405021
Upper respiratory tract infection 26.91 9.72 189 93099 72596 64332848
Leukopenia 26.31 9.72 68 93220 101174 64304270
Product dose omission issue 25.68 9.72 410 92878 194337 64211107
Multiple organ dysfunction syndrome 25.68 9.72 69 93219 101344 64304100
Cytomegalovirus infection 25.35 9.72 11 93277 37188 64368256
Burning sensation 25.28 9.72 140 93148 49524 64355920
Chronic spontaneous urticaria 25.21 9.72 13 93275 490 64404954
Lactic acidosis 25.21 9.72 31 93257 61379 64344065
Sinus disorder 24.99 9.72 67 93221 16841 64388603
Status asthmaticus 24.38 9.72 16 93272 952 64404492
Oropharyngeal pain 24.18 9.72 215 93073 88652 64316792
Renal failure 23.96 9.72 159 93129 181529 64223915
Coma 23.85 9.72 212 93076 87403 64318041
Migraine 23.32 9.72 163 93125 62514 64342930
Depression 23.09 9.72 383 92905 182908 64222536
Photosensitivity reaction 22.93 9.72 68 93220 18105 64387339
Sleep disorder due to general medical condition, insomnia type 22.86 9.72 5 93283 26265 64379179
Malignant neoplasm progression 22.81 9.72 85 93203 112786 64292658
Infection 21.84 9.72 167 93121 184713 64220731
Deep vein thrombosis 21.59 9.72 240 93048 104942 64300502
Septic shock 21.57 9.72 79 93209 105358 64300086
Interstitial lung disease 21.49 9.72 71 93217 97661 64307783
Acute respiratory distress syndrome 21.48 9.72 15 93273 38920 64366524
Circulatory collapse 21.41 9.72 11 93277 33721 64371723
Chills 21.21 9.72 297 92991 136967 64268477
Therapeutic product effect incomplete 20.86 9.72 78 93210 103404 64302040
Periorbital oedema 20.80 9.72 38 93250 7376 64398068
Hepatic failure 20.66 9.72 30 93258 55364 64350080
Lower respiratory tract infection 20.62 9.72 69 93219 94545 64310899
Cardiac failure 20.53 9.72 110 93178 132263 64273181
Drug level increased 20.47 9.72 12 93276 34184 64371260
Overdose 20.36 9.72 141 93147 159425 64246019
Swollen tongue 20.16 9.72 102 93186 34852 64370592
Bone marrow failure 19.90 9.72 24 93264 47928 64357516
Myelosuppression 19.82 9.72 5 93283 23825 64381619
Gallbladder injury 19.68 9.72 15 93273 1133 64404311
Oral pruritus 19.37 9.72 18 93270 1787 64403657
Hypotension 19.05 9.72 413 92875 380561 64024883
Acquired haemophilia 19.03 9.72 17 93271 1603 64403841
Gastrointestinal mucosal necrosis 18.81 9.72 8 93280 193 64405251
Back pain 18.42 9.72 483 92805 249688 64155756
Nervousness 18.30 9.72 88 93200 29468 64375976
Agranulocytosis 18.25 9.72 17 93271 38212 64367232
Throat tightness 18.16 9.72 74 93214 23086 64382358
Incorrect dose administered 18.10 9.72 150 93138 60615 64344829
Incorrect dosage administered 17.95 9.72 19 93269 2207 64403237
Product quality issue 17.93 9.72 88 93200 29711 64375733
Sinus headache 17.85 9.72 26 93262 4181 64401263
Folliculitis 17.38 9.72 11 93277 30066 64375378
Feeling hot 17.13 9.72 119 93169 45544 64359900
Hypersomnia 17.08 9.72 65 93223 19652 64385792
Hyponatraemia 17.04 9.72 135 93153 148204 64257240
Biliary dyskinesia 16.95 9.72 19 93269 2353 64403091
Intentional product use issue 16.65 9.72 76 93212 95288 64310156
Allergic cystitis 16.62 9.72 3 93285 0 64405444
Hepatic enzyme increased 16.48 9.72 115 93173 129828 64275616
Mobility decreased 16.47 9.72 66 93222 85774 64319670
Osteonecrosis of jaw 16.45 9.72 20 93268 39805 64365639
Red blood cell sedimentation rate increased 15.99 9.72 13 93275 31222 64374222
Cerebral haemorrhage 15.98 9.72 31 93257 51059 64354385
Seasonal allergy 15.88 9.72 45 93243 11681 64393763
Cystitis noninfective 15.84 9.72 13 93275 1093 64404351
Transplant rejection 15.79 9.72 3 93285 17398 64388046
Victim of chemical submission 15.75 9.72 8 93280 292 64405152
Altered state of consciousness 15.69 9.72 19 93269 37883 64367561
Hepatotoxicity 15.55 9.72 21 93267 39941 64365503
Melaena 15.47 9.72 34 93254 53514 64351930
Paraesthesia 15.45 9.72 277 93011 134245 64271199
Knee arthroplasty 15.43 9.72 10 93278 26989 64378455
Initial insomnia 15.35 9.72 29 93259 5775 64399669
Transient ischaemic attack 15.33 9.72 113 93175 44069 64361375
Nausea 15.18 9.72 1326 91962 784474 63620970
Discomfort 15.01 9.72 63 93225 80815 64324629
Impaired healing 14.67 9.72 42 93246 60431 64345013
Administration site inflammation 14.55 9.72 3 93285 3 64405441
Chronic obstructive pulmonary disease 14.52 9.72 162 93126 70886 64334558
Urinary tract infection 14.49 9.72 438 92850 231158 64174286
Condition aggravated 14.48 9.72 419 92869 372007 64033437
Upper-airway cough syndrome 14.24 9.72 36 93252 8734 64396710
Anaphylactic reaction 14.23 9.72 157 93131 68507 64336937
Crying 14.05 9.72 62 93226 20028 64385416
Hyperlipidaemia 13.93 9.72 68 93220 22908 64382536
Status epilepticus 13.84 9.72 7 93281 21656 64383788
Reversible cerebral vasoconstriction syndrome 13.81 9.72 17 93271 2325 64403119
Posterior reversible encephalopathy syndrome 13.81 9.72 8 93280 22938 64382506
Burns first degree 13.53 9.72 4 93284 31 64405413
Polyneuropathy 13.37 9.72 6 93282 19888 64385556
Blood pressure fluctuation 13.35 9.72 35 93253 51836 64353608
Carotid artery disease 13.24 9.72 16 93272 2147 64403297
Panic disorder 13.12 9.72 18 93270 2739 64402705
Oesophageal adenocarcinoma recurrent 13.00 9.72 4 93284 36 64405408
Autoimmune hepatitis 12.98 9.72 38 93250 10046 64395398
Dry mouth 12.92 9.72 139 93149 60279 64345165
Dyspepsia 12.90 9.72 175 93113 80137 64325307
Bronchial hyperreactivity 12.87 9.72 17 93271 2495 64402949
Musculoskeletal stiffness 12.85 9.72 115 93173 123091 64282353
Eye swelling 12.84 9.72 65 93223 22216 64383228
Hypoaesthesia 12.79 9.72 277 93011 138831 64266613
Patellofemoral pain syndrome 12.67 9.72 8 93280 445 64404999
Pneumonia 12.67 9.72 956 92332 558620 63846824
Cardiogenic shock 12.65 9.72 17 93271 32410 64373034
Erythema 12.57 9.72 357 92931 186713 64218731
Breast pain 12.54 9.72 30 93258 7031 64398413
Red blood cell sedimentation rate abnormal 12.49 9.72 4 93284 16302 64389142
Multiple lentigines syndrome 12.48 9.72 6 93282 194 64405250
Flushing 12.48 9.72 171 93117 78477 64326967
Neutropenia 12.47 9.72 258 93030 239366 64166078
Full blood count decreased 12.40 9.72 65 93223 22517 64382927
Pulmonary fibrosis 12.35 9.72 15 93273 29863 64375581
Tinea pedis 12.22 9.72 15 93273 2046 64403398
Respiratory failure 12.19 9.72 162 93126 161021 64244423
Basophil count decreased 12.15 9.72 6 93282 206 64405238
Heart rate decreased 12.11 9.72 40 93248 55027 64350417
Eczema 12.07 9.72 79 93209 29641 64375803
Syncope 12.07 9.72 306 92982 157329 64248115
Neuroleptic malignant syndrome 12.07 9.72 11 93277 24985 64380459
Heart rate increased 11.98 9.72 205 93083 98470 64306974
Neurological examination abnormal 11.72 9.72 8 93280 508 64404936
Ear congestion 11.71 9.72 15 93273 2135 64403309
Cardio-respiratory arrest 11.55 9.72 89 93199 98304 64307140
Coronary artery disease 11.54 9.72 136 93152 60297 64345147
Pulmonary embolism 11.47 9.72 285 93003 146071 64259373
Cystic fibrosis 11.46 9.72 19 93269 3415 64402029
Face oedema 11.42 9.72 68 93220 24693 64380751
Essential hypertension 11.39 9.72 24 93264 5170 64400274
Mitral valve prolapse 11.38 9.72 14 93274 1913 64403531
Cholelithiasis 11.31 9.72 108 93180 45398 64360046
Pneumocystis jirovecii pneumonia 11.29 9.72 14 93274 27620 64377824
Death 11.26 9.72 577 92711 482128 63923316
Blood creatinine increased 11.19 9.72 134 93154 135648 64269796
Intervertebral disc degeneration 11.15 9.72 43 93245 13077 64392367
Intercepted medication error 11.08 9.72 9 93279 746 64404698
Laryngeal pain 11.07 9.72 25 93263 5643 64399801
Neurotoxicity 11.07 9.72 14 93274 27390 64378054
Sinus congestion 11.07 9.72 48 93240 15391 64390053
Palmar erythema 11.05 9.72 13 93275 1697 64403747
Cholestasis 11.00 9.72 31 93257 44841 64360603
Skin burning sensation 10.97 9.72 37 93251 10546 64394898
Bronchospasm 10.95 9.72 61 93227 21621 64383823
Visual impairment 10.92 9.72 159 93129 73918 64331526
Aspergillus infection 10.91 9.72 5 93283 16374 64389070
Bone pain 10.90 9.72 111 93177 47461 64357983
Rash pruritic 10.88 9.72 129 93159 57275 64348169
Anuria 10.87 9.72 7 93281 18957 64386487
Depressed level of consciousness 10.86 9.72 71 93217 81365 64324079
Ventricular hypertrophy 10.84 9.72 27 93261 6489 64398955
Haemophagocytic lymphohistiocytosis 10.80 9.72 6 93282 17603 64387841
Exposure to toxic agent 10.76 9.72 26 93262 6133 64399311
Nasal oedema 10.71 9.72 10 93278 998 64404446
Nephropathy toxic 10.69 9.72 6 93282 17508 64387936
Suicidal ideation 10.69 9.72 145 93143 66397 64339047
Therapy non-responder 10.64 9.72 54 93234 65845 64339599
Ear infection 10.62 9.72 64 93224 23340 64382104
Allergy to animal 10.61 9.72 10 93278 1011 64404433
Rotator cuff syndrome 10.56 9.72 40 93248 12067 64393377
Non-cardiac chest pain 10.50 9.72 32 93256 8648 64396796
Lymphopenia 10.48 9.72 13 93275 25644 64379800
Emotional disorder 10.46 9.72 41 93247 12566 64392878
Carpal tunnel syndrome 10.43 9.72 48 93240 15780 64389664
Metabolic acidosis 10.43 9.72 60 93228 70898 64334546
Chronic sinusitis 10.40 9.72 26 93262 6266 64399178
Bradycardia 10.39 9.72 115 93173 118104 64287340
Pneumonitis 10.36 9.72 115 93173 50250 64355194
Paraesthesia oral 10.33 9.72 42 93246 13089 64392355
Accident at home 10.25 9.72 5 93283 167 64405277
Tunnel vision 10.25 9.72 10 93278 1055 64404389
Mood altered 10.20 9.72 48 93240 15931 64389513
Aphthous ulcer 10.18 9.72 3 93285 12903 64392541
Hypertensive crisis 10.11 9.72 7 93281 18241 64387203
Uterine cyst 10.07 9.72 6 93282 301 64405143
Lethargy 10.00 9.72 154 93134 72440 64333004
Abdominal pain upper 9.88 9.72 327 92961 174703 64230741
Cataract subcapsular 9.80 9.72 9 93279 880 64404564
Disseminated intravascular coagulation 9.79 9.72 20 93268 32328 64373116
Serotonin syndrome 9.73 9.72 27 93261 39255 64366189

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.77 WOMBAT-PK
Sodium-dependent neutral amino acid transporter B(0)AT2 Transporter IC50 5.40 CHEMBL
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 15 sections
allergy relief HUMAN OTC DRUG LABEL 1 0067-6122 TABLET 10 mg ORAL NDA 15 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 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
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
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
Wal-itin Allergy Relief HUMAN OTC DRUG LABEL 1 0363-2085 SOLUTION 5 mg ORAL ANDA 15 sections
Childrens Wal-itin HUMAN OTC DRUG LABEL 1 0363-2092 SOLUTION 5 mg ORAL ANDA 16 sections
Childrens Walitin HUMAN OTC DRUG LABEL 1 0363-2108 SOLUTION 5 mg ORAL ANDA 16 sections
Childrens Loratadine Sugar Free HUMAN OTC DRUG LABEL 1 0363-2131 SOLUTION 5 mg ORAL ANDA 16 sections