chlorphenamine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
616 132-22-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • chlorphenamine
  • chloropheniramine
  • chlorophenylpyridamine
  • chloroprophenpyridamine
  • chlorpheniramine
  • chlorprophenpyridamine
  • chlorpheniramine maleate
  • chlorpheniramine tannate
  • chlorpheniramine polistirex
A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
  • Molecular weight: 274.79
  • Formula: C16H19ClN2
  • CLOGP: 3.15
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 16.13
  • ALOGS: -3.72
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
12 mg O
12 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.48 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 41 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.70 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 22 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 3 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Aug. 15, 1950 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
Contraindicated product administered 199.11 10.47 7 67141 217641 63204233
Drug ineffective 194.85 10.47 521 66627 1044244 62377630
Drug intolerance 163.66 10.47 61 67087 308600 63113274
Synovitis 161.15 10.47 9 67139 186909 63234965
Glossodynia 138.96 10.47 14 67134 178862 63243012
Systemic lupus erythematosus 133.34 10.47 29 67119 208889 63212985
Treatment failure 124.28 10.47 29 67119 199014 63222860
Pericarditis 121.10 10.47 4 67144 131575 63290299
Chest discomfort 112.47 10.47 312 66836 109657 63312217
Sinusitis 111.52 10.47 505 66643 226148 63195726
Dyspnoea 111.45 10.47 1127 66021 660186 62761688
Therapeutic product effect decreased 111.38 10.47 33 67115 193154 63228720
Maternal exposure during pregnancy 110.81 10.47 47 67101 220015 63201859
Arthropathy 100.55 10.47 62 67086 234730 63187144
Joint swelling 98.61 10.47 121 67027 327545 63094329
Wound 95.73 10.47 27 67121 163236 63258638
Hepatic enzyme increased 94.45 10.47 48 67100 202280 63219594
Neuropathy peripheral 88.47 10.47 293 66855 113374 63308500
Asthma 88.11 10.47 316 66832 127245 63294629
Cough 88.00 10.47 570 66578 292173 63129701
General physical health deterioration 86.48 10.47 53 67095 201349 63220525
Helicobacter infection 78.31 10.47 5 67143 92780 63329094
Rheumatoid factor positive 76.15 10.47 3 67145 84403 63337471
Rheumatoid arthritis 71.91 10.47 98 67050 253721 63168153
Anaphylactic reaction 69.98 10.47 190 66958 65910 63355964
Discomfort 69.16 10.47 46 67102 167328 63254546
Ejection fraction decreased 59.49 10.47 94 67054 22238 63399636
Sinusitis fungal 56.91 10.47 31 67117 1800 63420074
Flushing 56.13 10.47 191 66957 74896 63346978
Chest pain 52.20 10.47 399 66749 215560 63206314
Diarrhoea 51.35 10.47 1050 66098 714316 62707558
Sputum increased 50.93 10.47 32 67116 2427 63419447
Folliculitis 50.86 10.47 7 67141 70310 63351564
Completed suicide 49.02 10.47 49 67099 145624 63276250
Abdominal discomfort 48.67 10.47 175 66973 320710 63101164
Neutropenic sepsis 47.72 10.47 72 67076 16366 63405508
Product use issue 47.00 10.47 102 67046 220418 63201456
Musculoskeletal stiffness 46.71 10.47 77 67071 184541 63237333
Infective pulmonary exacerbation of cystic fibrosis 46.70 10.47 52 67096 8765 63413109
Salpingo-oophorectomy unilateral 45.35 10.47 21 67127 860 63421014
Deep vein thrombosis 45.13 10.47 192 66956 83608 63338266
Excessive eye blinking 43.51 10.47 23 67125 1257 63420617
Anxiety 42.95 10.47 384 66764 217157 63204717
Eosinophilic colitis 41.61 10.47 13 67135 174 63421700
Nausea 40.98 10.47 1187 65961 853284 62568590
Swelling 39.90 10.47 153 66995 275225 63146649
Back pain 39.43 10.47 440 66708 263705 63158169
Diverticulum 38.39 10.47 55 67093 11936 63409938
Off label use 38.19 10.47 494 66654 673968 62747906
C-reactive protein abnormal 37.40 10.47 3 67145 46093 63375781
Drug interaction 36.72 10.47 122 67026 229009 63192865
Sleep apnoea syndrome 35.19 10.47 88 67060 29045 63392829
Pneumonia 35.18 10.47 678 66470 456089 62965785
Pulmonary embolism 34.83 10.47 227 66921 116457 63305417
Headache 34.62 10.47 895 66253 632346 62789528
Swelling face 34.61 10.47 146 67002 63329 63358545
Bronchitis 34.27 10.47 238 66910 124697 63297177
Toxicity to various agents 34.14 10.47 140 67008 247110 63174764
Impaired healing 33.91 10.47 35 67113 102507 63319367
Upper respiratory tract infection 33.20 10.47 173 66975 81874 63340000
Palpitations 32.82 10.47 218 66930 112552 63309322
Infusion site erythema 32.27 10.47 50 67098 11629 63410245
Product quality issue 32.03 10.47 97 67051 35768 63386106
Bronchospasm 32.03 10.47 62 67086 17218 63404656
Nail infection 31.39 10.47 24 67124 2499 63419375
Oropharyngeal pain 30.80 10.47 188 66960 94299 63327575
Nasal congestion 30.50 10.47 144 67004 65516 63356358
Candida infection 30.50 10.47 82 67066 28269 63393605
Mobility decreased 30.20 10.47 51 67097 121108 63300766
Urinary tract infection 30.07 10.47 419 66729 264265 63157609
Gastrooesophageal reflux disease 29.74 10.47 188 66960 95451 63326423
Mucosal inflammation 29.63 10.47 113 67035 46815 63375059
Nasal polyps 29.24 10.47 34 67114 6005 63415869
Diastolic dysfunction 28.97 10.47 35 67113 6436 63415438
Embolism venous 28.69 10.47 25 67123 3129 63418745
Therapeutic product effect incomplete 28.18 10.47 56 67092 125000 63296874
Dilatation intrahepatic duct acquired 28.17 10.47 14 67134 672 63421202
Emotional distress 28.11 10.47 87 67061 32462 63389412
Blister 27.67 10.47 60 67088 129754 63292120
Chronic sinusitis 27.46 10.47 49 67099 12794 63409080
Red blood cell sedimentation rate increased 26.27 10.47 7 67141 43975 63377899
Chronic obstructive pulmonary disease 25.92 10.47 133 67015 62553 63359321
Liver injury 25.84 10.47 16 67132 60504 63361370
Respiratory symptom 25.48 10.47 24 67124 3323 63418551
Psoriatic arthropathy 25.22 10.47 36 67112 91484 63330390
Dizziness 25.01 10.47 613 66535 429312 62992562
Condition aggravated 24.81 10.47 289 66859 401928 63019946
Throat tightness 24.80 10.47 70 67078 24817 63397057
Necrotic lymphadenopathy 24.63 10.47 7 67141 66 63421808
Vulvovaginal candidiasis 24.62 10.47 23 67125 3152 63418722
C-reactive protein increased 24.41 10.47 39 67109 94668 63327206
Arthralgia 23.47 10.47 443 66705 569267 62852607
Muscle spasms 23.21 10.47 260 66888 155890 63265984
Erythema 23.19 10.47 286 66862 175465 63246409
Infusion site swelling 23.14 10.47 39 67109 9731 63412143
Irritable bowel syndrome 23.12 10.47 32 67116 82380 63339494
Infusion site pruritus 22.82 10.47 30 67118 6005 63415869
Abdominal pain 22.34 10.47 435 66713 293021 63128853
Lip swelling 22.31 10.47 78 67070 30985 63390889
Band sensation 22.31 10.47 13 67135 860 63421014
Wheezing 22.16 10.47 175 66973 95420 63326454
Constipation 21.97 10.47 347 66801 224596 63197278
Hiatus hernia 21.78 10.47 61 67087 21533 63400341
Lacrimation increased 21.52 10.47 59 67089 20572 63401302
Foetal exposure during pregnancy 21.27 10.47 4 67144 31958 63389916
Vascular compression 21.20 10.47 8 67140 194 63421680
Hip arthroplasty 21.18 10.47 12 67136 47634 63374240
Hiccups 20.94 10.47 18 67130 2213 63419661
Gallbladder polyp 20.85 10.47 12 67136 775 63421099
Ill-defined disorder 20.75 10.47 34 67114 81721 63340153
Acute sinusitis 20.72 10.47 23 67125 3864 63418010
Tonsillar hypertrophy 20.66 10.47 13 67135 988 63420886
Sinus disorder 20.62 10.47 65 67083 24488 63397386
Rhinitis allergic 20.43 10.47 41 67107 11686 63410188
Alopecia 20.23 10.47 244 66904 337292 63084582
Migraine 20.14 10.47 182 66966 103164 63318710
Gastroenteritis viral 20.14 10.47 63 67085 23637 63398237
Ear infection 20.13 10.47 87 67061 38126 63383748
Acute respiratory failure 20.12 10.47 81 67067 34404 63387470
Catheter site bruise 20.10 10.47 10 67138 481 63421393
Poor quality device used 20.03 10.47 17 67131 2054 63419820
Retinal detachment 20.03 10.47 28 67120 5941 63415933
Swollen tongue 19.71 10.47 81 67067 34719 63387155
Hypoxia 19.50 10.47 119 67029 59673 63362201
Pain in jaw 19.19 10.47 94 67054 43402 63378472
Hepatocellular injury 19.16 10.47 3 67145 27378 63394496
Biliary sepsis 18.99 10.47 12 67136 919 63420955
Chemical burns of eye 18.96 10.47 6 67142 84 63421790
Hysterectomy 18.74 10.47 35 67113 9464 63412410
Product dose omission issue 18.73 10.47 350 66798 233963 63187911
Panic attack 18.64 10.47 59 67089 22272 63399602
Rhinorrhoea 18.61 10.47 126 67022 65451 63356423
Exposure during pregnancy 18.50 10.47 93 67055 155454 63266420
Diffuse large B-cell lymphoma refractory 18.23 10.47 13 67135 1217 63420657
Infusion site nodule 18.14 10.47 14 67134 1478 63420396
Disease recurrence 18.11 10.47 68 67080 27962 63393912
Coma 18.04 10.47 25 67123 64339 63357535
Emphysema 17.59 10.47 37 67111 10901 63410973
Tricuspid valve incompetence 17.48 10.47 44 67104 14577 63407297
Urticaria 17.42 10.47 259 66889 165543 63256331
Pain 17.39 10.47 625 66523 740003 62681871
Depression 17.29 10.47 298 66850 196194 63225680
Seasonal allergy 17.17 10.47 55 67093 20895 63400979
Iron deficiency anaemia 16.89 10.47 53 67095 19916 63401958
Loss of personal independence in daily activities 16.83 10.47 50 67098 97240 63324634
Tachycardia 16.77 10.47 195 66953 117961 63303913
Type 2 diabetes mellitus 16.74 10.47 26 67122 63842 63358032
Cholecystitis chronic 16.61 10.47 35 67113 10326 63411548
Gastrointestinal disorder 16.46 10.47 77 67071 131162 63290712
Infusion site extravasation 16.46 10.47 35 67113 10391 63411483
Diverticulitis 16.40 10.47 84 67064 39473 63382401
Female genital tract fistula 16.37 10.47 29 67119 7530 63414344
Hyperkalaemia 16.28 10.47 20 67128 54183 63367691
Therapy non-responder 16.24 10.47 35 67113 75866 63346008
Premature delivery 15.98 10.47 6 67142 30275 63391599
Delirium 15.87 10.47 18 67130 50523 63371351
Acute kidney injury 15.55 10.47 191 66957 263224 63158650
Nasal discomfort 15.48 10.47 22 67126 4738 63417136
Nail dystrophy 15.40 10.47 11 67137 1032 63420842
Presyncope 15.21 10.47 64 67084 27721 63394153
Malignant neoplasm progression 15.09 10.47 41 67107 82080 63339794
Feeling hot 15.04 10.47 98 67050 50256 63371618
Agranulocytosis 15.01 10.47 4 67144 25130 63396744
Intentional product use issue 14.91 10.47 77 67071 127815 63294059
Axillary pain 14.68 10.47 14 67134 1969 63419905
Myalgia 14.66 10.47 227 66921 146302 63275572
Laryngospasm 14.58 10.47 17 67131 3011 63418863
Anosmia 14.44 10.47 26 67122 6834 63415040
Inflammation 14.44 10.47 42 67106 82231 63339643
Drug reaction with eosinophilia and systemic symptoms 14.37 10.47 9 67139 33827 63388047
Sopor 14.28 10.47 3 67145 22161 63399713
Disease progression 14.18 10.47 195 66953 122563 63299311
Neutropenia 14.18 10.47 262 66886 174743 63247131
Infusion site mass 14.18 10.47 14 67134 2054 63419820
Acute interstitial pneumonitis 14.18 10.47 9 67139 695 63421179
Prosopagnosia 13.95 10.47 4 67144 39 63421835
Hereditary angioedema 13.85 10.47 27 67121 7535 63414339
Administration site extravasation 13.84 10.47 10 67138 955 63420919
Cellulitis 13.82 10.47 140 67008 81818 63340056
Victim of chemical submission 13.80 10.47 8 67140 524 63421350
Ventricular extrasystoles 13.79 10.47 35 67113 11652 63410222
Haemodialysis complication 13.79 10.47 6 67142 212 63421662
Blood cholesterol increased 13.75 10.47 52 67096 93980 63327894
Myelosuppression 13.73 10.47 4 67144 23699 63398175
Confusional state 13.35 10.47 173 66975 236207 63185667
Haemoptysis 13.34 10.47 63 67085 28663 63393211
Blood creatinine increased 13.22 10.47 48 67100 87796 63334078
Oral pain 12.98 10.47 62 67086 28332 63393542
Transient ischaemic attack 12.86 10.47 76 67072 37677 63384197
Pulmonary fibrosis 12.69 10.47 14 67134 39795 63382079
Biliary dyskinesia 12.61 10.47 15 67133 2714 63419160
Retching 12.51 10.47 39 67109 14606 63407268
Catheter site haemorrhage 12.34 10.47 16 67132 3159 63418715
Genital ulceration 12.27 10.47 8 67140 647 63421227
Tubulointerstitial nephritis 12.21 10.47 3 67145 19900 63401974
Anhedonia 12.06 10.47 32 67116 10942 63410932
Pancreatitis chronic 12.05 10.47 14 67134 2470 63419404
Dyspnoea at rest 12.03 10.47 18 67130 4061 63417813
Dermatitis contact 12 10.47 32 67116 10976 63410898
Autoimmune haemolytic anaemia 11.75 10.47 19 67129 4582 63417292
Vomiting 11.74 10.47 713 66435 558904 62862970
Poor peripheral circulation 11.71 10.47 17 67131 3732 63418142
Cyanosis 11.71 10.47 42 67106 16893 63404981
Low turnover osteopathy 11.68 10.47 18 67130 4167 63417707
Insomnia 11.61 10.47 304 66844 214948 63206926
Gallbladder disorder 11.59 10.47 45 67103 18797 63403077
Hypervolaemia 11.55 10.47 60 67088 28353 63393521
Sinus headache 11.46 10.47 21 67127 5595 63416279
Infusion site bruising 11.43 10.47 17 67131 3815 63418059
Insurance issue 11.39 10.47 22 67126 6099 63415775
Drug resistance 11.36 10.47 5 67143 22928 63398946
Rhinitis 11.35 10.47 32 67116 11334 63410540
Terminal ileitis 11.32 10.47 8 67140 738 63421136
Ageusia 11.21 10.47 36 67112 13692 63408182
Product used for unknown indication 11.21 10.47 7 67141 525 63421349
Prescribed underdose 11.16 10.47 9 67139 29680 63392194
Tongue pruritus 11.14 10.47 7 67141 531 63421343
Blood magnesium decreased 11.14 10.47 35 67113 13163 63408711
Multiple allergies 11.10 10.47 36 67112 13766 63408108
Cholestasis 10.97 10.47 9 67139 29425 63392449
Infusion site pain 10.96 10.47 41 67107 16828 63405046
Sedation 10.95 10.47 15 67133 38794 63383080
Coronary artery disease 10.91 10.47 65 67083 32312 63389562
Stomatitis 10.89 10.47 94 67054 138631 63283243
Grip strength decreased 10.82 10.47 5 67143 22282 63399592
Incorrect route of product administration 10.73 10.47 8 67140 27444 63394430
HER2 positive breast cancer 10.68 10.47 6 67142 370 63421504
Lethargy 10.59 10.47 98 67050 55909 63365965

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
Sinusitis 71.39 11.19 136 33350 41266 34882179
Lower respiratory tract infection 67.45 11.19 114 33372 31523 34891922
Delusion of grandeur 66.72 11.19 29 33457 1131 34922314
Rhinalgia 59.50 11.19 26 33460 1027 34922418
Drug ineffective 56.46 11.19 236 33250 456515 34466930
Upper respiratory tract infection 47.88 11.19 101 33385 32958 34890487
Asthma 41.87 11.19 112 33374 42544 34880901
Painful respiration 40.58 11.19 21 33465 1215 34922230
Infusion related reaction 40.22 11.19 127 33359 52930 34870515
Affective disorder 39.40 11.19 33 33453 4327 34919118
Lymphocyte count abnormal 38.31 11.19 20 33466 1178 34922267
Chest injury 38.26 11.19 22 33464 1569 34921876
Infective pulmonary exacerbation of cystic fibrosis 37.32 11.19 39 33447 6762 34916683
Urticaria 34.87 11.19 135 33351 62242 34861203
Walking aid user 31.94 11.19 21 33465 1903 34921542
Flushing 30.68 11.19 84 33402 32336 34891109
Bronchitis 30.48 11.19 99 33387 41864 34881581
Nasal discomfort 30.07 11.19 19 33467 1609 34921836
General physical health deterioration 29.84 11.19 48 33438 128221 34795224
Cough 28.42 11.19 243 33243 149897 34773548
Dyspnoea 28.29 11.19 512 32974 376270 34547175
Constipation 26.07 11.19 222 33264 136760 34786685
Neutropenic sepsis 25.94 11.19 47 33439 13720 34909725
Dry skin 25.66 11.19 77 33409 31210 34892235
SARS-CoV-2 test positive 25.60 11.19 30 33456 5903 34917542
Failure to anastomose 25.20 11.19 9 33477 206 34923239
Dyspepsia 25.19 11.19 85 33401 36647 34886798
Pneumonia 23.86 11.19 483 33003 362144 34561301
Hypoacusis 23.82 11.19 50 33436 16251 34907194
Feeling cold 23.54 11.19 39 33447 10600 34912845
Toxic epidermal necrolysis 23.45 11.19 59 33427 21587 34901858
Pruritus 22.40 11.19 221 33265 141760 34781685
Cellulitis 22.16 11.19 105 33381 52846 34870599
Oropharyngeal blistering 22.09 11.19 8 33478 191 34923254
Treatment failure 21.32 11.19 9 33477 46688 34876757
Acute kidney injury 21.00 11.19 189 33297 304799 34618646
Lip swelling 20.85 11.19 47 33439 16033 34907412
Lactic acidosis 20.84 11.19 4 33482 34768 34888677
Personality change 20.55 11.19 25 33461 5114 34918331
Hypersomnia 20.44 11.19 40 33446 12367 34911078
Renal failure 20.33 11.19 61 33425 130496 34792949
Nasal congestion 20.10 11.19 58 33428 22999 34900446
Rash 20.06 11.19 312 33174 222440 34701005
Alopecia 20.03 11.19 60 33426 24295 34899150
Drug interaction 18.78 11.19 133 33353 225813 34697632
Therapeutic product effect incomplete 18.34 11.19 13 33473 50528 34872917
Febrile neutropenia 17.39 11.19 204 33282 136645 34786800
Fatigue 17.36 11.19 471 33015 370182 34553263
Drug hypersensitivity 17.19 11.19 134 33352 80395 34843050
Malignant neoplasm progression 16.89 11.19 37 33449 88009 34835436
Seasonal allergy 16.87 11.19 26 33460 6649 34916796
Hypersensitivity 16.78 11.19 108 33378 60927 34862518
Hypoxic-ischaemic encephalopathy 16.45 11.19 21 33465 4511 34918934
Infusion site pruritus 16.19 11.19 10 33476 813 34922632
Cystic fibrosis 15.92 11.19 13 33473 1645 34921800
Wheezing 15.82 11.19 80 33406 41322 34882123
Tonsillitis 15.35 11.19 15 33471 2401 34921044
Oral candidiasis 15.26 11.19 35 33451 12075 34911370
Sputum discoloured 15.13 11.19 27 33459 7785 34915660
HIV associated nephropathy 14.94 11.19 7 33479 326 34923119
Neutropenic infection 14.92 11.19 12 33474 1486 34921959
Limb mass 14.74 11.19 9 33477 717 34922728
Lip dry 14.56 11.19 11 33475 1243 34922202
Schizophrenia 14.35 11.19 28 33458 8638 34914807
Gastroenteritis viral 14.29 11.19 25 33461 7099 34916346
Hyperkalaemia 14.28 11.19 28 33458 69361 34854084
Infusion site erythema 14.23 11.19 14 33472 2259 34921186
Infusion site pain 14.22 11.19 18 33468 3833 34919612
Chest discomfort 14.08 11.19 95 33391 54435 34869010
Stress 14.05 11.19 62 33424 30285 34893160
Abnormal behaviour 13.91 11.19 54 33432 24915 34898530
Aortic aneurysm 13.87 11.19 24 33462 6755 34916690
C-reactive protein increased 13.77 11.19 19 33467 54079 34869366
Sputum increased 13.74 11.19 14 33472 2356 34921089
Productive cough 13.71 11.19 72 33414 37741 34885704
Rhabdomyolysis 13.61 11.19 28 33458 68135 34855310
Dry mouth 13.49 11.19 61 33425 30104 34893341
Hot flush 13.45 11.19 43 33443 18023 34905422
Death 13.19 11.19 286 33200 397763 34525682
Chills 13.18 11.19 127 33359 80916 34842529
Paraesthesia oral 13.01 11.19 18 33468 4179 34919266
Accidental exposure to product by child 12.98 11.19 11 33475 1465 34921980
Off label use 12.61 11.19 306 33180 419218 34504227
Rhinitis allergic 12.46 11.19 15 33471 3035 34920410
Ear infection 12.27 11.19 29 33457 10202 34913243
Swelling face 12.09 11.19 49 33437 23056 34900389
Interstitial lung disease 12.05 11.19 28 33458 65254 34858191
Anaphylactic reaction 12.05 11.19 62 33424 32239 34891206
Incorrect dose administered 11.95 11.19 73 33413 40442 34883003
Ingrowing nail 11.90 11.19 9 33477 1019 34922426
Sinus disorder 11.86 11.19 23 33463 7062 34916383
Cystic fibrosis related diabetes 11.85 11.19 5 33481 181 34923264
Reading disorder 11.68 11.19 7 33479 539 34922906
Otitis media 11.53 11.19 14 33472 2858 34920587
Cerebral infarction 11.44 11.19 6 33480 27449 34895996
Bradycardia foetal 11.42 11.19 6 33480 358 34923087
Neuropathy peripheral 11.41 11.19 126 33360 83137 34840308
Bronchospasm 11.36 11.19 29 33457 10702 34912743

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
Drug ineffective 185.65 9.87 534 81122 1080379 78582353
Contraindicated product administered 135.71 9.87 6 81650 157532 79505200
Dyspnoea 121.10 9.87 1374 80282 855651 78807081
Synovitis 119.90 9.87 9 81647 150725 79512007
Chest discomfort 108.05 9.87 349 81307 137695 79525037
Neuropathy peripheral 102.35 9.87 348 81308 140957 79521775
Drug intolerance 95.69 9.87 78 81578 264041 79398691
Treatment failure 95.46 9.87 28 81628 170458 79492274
Cough 91.02 9.87 665 80991 366124 79296608
General physical health deterioration 89.33 9.87 90 81566 275148 79387584
Pemphigus 85.07 9.87 4 81652 99578 79563154
Pericarditis 83.53 9.87 6 81650 104230 79558502
Infective pulmonary exacerbation of cystic fibrosis 79.39 9.87 81 81575 12770 79649962
Flushing 79.10 9.87 234 81422 88034 79574698
Asthma 74.65 9.87 305 81351 134790 79527942
Joint swelling 70.34 9.87 117 81539 288529 79374203
Neutropenic sepsis 68.02 9.87 109 81547 26955 79635777
Systemic lupus erythematosus 67.62 9.87 20 81636 121129 79541603
Therapeutic product effect decreased 66.34 9.87 43 81613 163820 79498912
Anaphylactic reaction 63.04 9.87 209 81447 83534 79579198
Delusion of grandeur 62.02 9.87 30 81626 1402 79661330
Sputum increased 61.17 9.87 45 81611 4568 79658164
Helicobacter infection 58.90 9.87 3 81653 69701 79593031
Drug interaction 57.21 9.87 225 81431 414958 79247774
Maternal exposure during pregnancy 55.03 9.87 36 81620 136502 79526230
Glossodynia 54.23 9.87 19 81637 103318 79559414
Rheumatoid arthritis 53.12 9.87 82 81574 208388 79454344
Arthropathy 50.78 9.87 64 81592 177047 79485685
Sinusitis 50.44 9.87 358 81298 195143 79467589
Sinusitis fungal 50.35 9.87 31 81625 2343 79660389
Hepatic enzyme increased 50.29 9.87 68 81588 182542 79480190
Chest pain 49.69 9.87 474 81182 281830 79380902
Rheumatoid factor positive 49.24 9.87 3 81653 59836 79602896
Upper respiratory tract infection 48.12 9.87 203 81453 90965 79571767
Salpingo-oophorectomy unilateral 47.11 9.87 21 81635 813 79661919
Pneumonia 46.64 9.87 941 80715 659305 79003427
Pulmonary embolism 45.84 9.87 317 81339 171337 79491395
Constipation 45.80 9.87 467 81189 282583 79380149
Rhinalgia 45.41 9.87 29 81627 2338 79660394
Acute kidney injury 43.65 9.87 332 81324 519072 79143660
Swelling face 42.71 9.87 165 81491 71047 79591685
Deep vein thrombosis 42.08 9.87 239 81417 120680 79542052
Lip swelling 41.05 9.87 113 81543 40798 79621934
Nasal discomfort 38.39 9.87 37 81619 5446 79657286
Ejection fraction decreased 38.23 9.87 99 81557 34478 79628254
C-reactive protein abnormal 38.13 9.87 3 81653 48364 79614368
Excessive eye blinking 38.10 9.87 23 81633 1678 79661054
Therapeutic product effect incomplete 37.74 9.87 54 81602 141591 79521141
Off label use 37.20 9.87 680 80976 906535 78756197
Nausea 35.84 9.87 1255 80401 955941 78706791
C-reactive protein increased 35.56 9.87 48 81608 128979 79533753
Nasal congestion 35.50 9.87 164 81492 76388 79586344
Lacrimation increased 35.46 9.87 74 81582 22403 79640329
Wound 35.41 9.87 40 81616 116139 79546593
Palpitations 35.09 9.87 236 81420 126374 79536358
Musculoskeletal stiffness 34.74 9.87 80 81576 174928 79487804
Completed suicide 34.57 9.87 132 81524 245635 79417097
Anxiety 33.72 9.87 396 81260 248116 79414616
Mucosal inflammation 33.64 9.87 160 81496 75420 79587312
Sleep disorder due to general medical condition, insomnia type 33.51 9.87 3 81653 43553 79619179
Back pain 33.36 9.87 466 81190 303714 79359018
Hyperkalaemia 33.13 9.87 41 81615 114357 79548375
Cellulitis 33.10 9.87 208 81448 108852 79553880
Urticaria 33.07 9.87 312 81344 184889 79477843
Lymphocyte count abnormal 32.83 9.87 20 81636 1483 79661249
Bronchospasm 32.60 9.87 76 81580 24783 79637949
Diarrhoea 32.58 9.87 1153 80503 879336 78783396
Wheezing 32.05 9.87 217 81439 116447 79546285
Sleep apnoea syndrome 31.99 9.87 96 81560 36382 79626350
Product quality issue 31.37 9.87 91 81565 33849 79628883
Gastrooesophageal reflux disease 31.13 9.87 198 81458 104048 79558684
Discomfort 30.49 9.87 51 81605 125566 79537166
Eosinophilic colitis 29.71 9.87 13 81643 481 79662251
Lower respiratory tract infection 29.54 9.87 230 81426 128990 79533742
Renal failure 29.53 9.87 106 81550 200862 79461870
Erythema 29.49 9.87 354 81302 222936 79439796
Oropharyngeal pain 29.20 9.87 202 81454 109151 79553581
Impaired healing 29.16 9.87 28 81628 87627 79575105
Mobility decreased 28.37 9.87 51 81605 122124 79540608
Infusion site erythema 27.85 9.87 41 81615 9419 79653313
Vulvovaginal candidiasis 27.78 9.87 22 81634 2492 79660240
Chest injury 27.61 9.87 23 81633 2798 79659934
Drug resistance 27.45 9.87 5 81651 42208 79620524
Necrotic lymphadenopathy 26.89 9.87 8 81648 93 79662639
Hiatus hernia 26.03 9.87 67 81589 23245 79639487
Urinary tract infection 25.96 9.87 410 81246 274102 79388630
Plethoric face 24.76 9.87 6 81650 29 79662703
Dilatation intrahepatic duct acquired 24.74 9.87 13 81643 725 79662007
Folliculitis 24.57 9.87 13 81643 55367 79607365
Tachycardia 24.42 9.87 284 81372 177484 79485248
Nail infection 24.40 9.87 20 81636 2379 79660353
Gastroenteritis viral 24.33 9.87 68 81588 24763 79637969
Hypoxia 24.28 9.87 185 81471 103058 79559674
Band sensation 23.94 9.87 13 81643 775 79661957
Diastolic dysfunction 23.76 9.87 41 81615 10770 79651962
Infusion site pruritus 23.72 9.87 25 81631 4093 79658639
Sopor 23.54 9.87 3 81653 33007 79629725
Emotional distress 23.46 9.87 92 81564 39877 79622855
Nasal polyps 23.39 9.87 33 81623 7294 79655438
Bronchitis 23.26 9.87 220 81436 130424 79532308
Lactic acidosis 22.80 9.87 23 81633 70336 79592396
Fatigue 22.71 9.87 1166 80490 928561 78734171
Neutropenia 22.58 9.87 417 81239 287293 79375439
Malignant neoplasm progression 22.54 9.87 68 81588 135922 79526810
Rhinitis allergic 22.48 9.87 43 81613 12226 79650506
Headache 22.38 9.87 849 80807 652923 79009809
Female genital tract fistula 22.25 9.87 29 81627 5946 79656786
Febrile neutropenia 22.21 9.87 346 81310 230653 79432079
Myelosuppression 21.85 9.87 7 81649 40289 79622443
Coma 21.63 9.87 44 81612 100605 79562127
Affective disorder 21.58 9.87 34 81622 8285 79654447
Acute sinusitis 21.57 9.87 25 81631 4545 79658187
Red blood cell sedimentation rate increased 21.57 9.87 10 81646 45932 79616800
Dry skin 21.45 9.87 131 81525 67864 79594868
Oral candidiasis 21.45 9.87 73 81583 29555 79633177
Embolism venous 21.38 9.87 24 81632 4215 79658517
Blood creatinine increased 21.33 9.87 84 81572 154973 79507759
Throat tightness 21.30 9.87 70 81586 27837 79634895
Condition aggravated 21.28 9.87 373 81283 500751 79161981
Interstitial lung disease 21.13 9.87 53 81603 112547 79550185
Catheter site bruise 21.07 9.87 10 81646 448 79662284
Respiratory symptom 20.62 9.87 25 81631 4766 79657966
Chronic obstructive pulmonary disease 20.61 9.87 154 81502 85265 79577467
Product use issue 20.61 9.87 128 81528 209694 79453038
Blood pressure fluctuation 20.58 9.87 23 81633 67122 79595610
Hypersomnia 20.47 9.87 61 81595 23025 79639707
Gastrointestinal disorder 20.33 9.87 61 81595 122144 79540588
Loss of personal independence in daily activities 20.26 9.87 47 81609 102533 79560199
Failure to anastomose 20.24 9.87 8 81648 228 79662504
Painful respiration 19.95 9.87 21 81635 3432 79659300
Hysterectomy 19.65 9.87 28 81628 6244 79656488
Psoriatic arthropathy 19.55 9.87 31 81625 77968 79584764
Chronic sinusitis 19.52 9.87 42 81614 12984 79649748
Feeling cold 19.25 9.87 69 81587 28660 79634072
Delirium 19.05 9.87 36 81620 84591 79578141
Dizziness 18.55 9.87 686 80970 525755 79136977
Candida infection 18.55 9.87 83 81573 38131 79624601
Migraine 18.50 9.87 153 81503 87340 79575392
Rhinorrhoea 18.27 9.87 137 81519 75937 79586795
Cystic fibrosis 17.94 9.87 21 81635 3859 79658873
Diverticulum 17.87 9.87 44 81612 14852 79647880
Pruritus 17.40 9.87 528 81128 394120 79268612
Chemical burns of eye 17.31 9.87 6 81650 117 79662615
Renal impairment 17.23 9.87 93 81563 157690 79505042
Poor quality device used 17.10 9.87 16 81640 2269 79660463
Panic attack 16.95 9.87 59 81597 24157 79638575
Tubulointerstitial nephritis 16.93 9.87 9 81647 38226 79624506
Arthralgia 16.90 9.87 451 81205 571352 79091380
SARS-CoV-2 test positive 16.67 9.87 37 81619 11679 79651053
Lethargy 16.57 9.87 141 81515 81151 79581581
Pyrexia 16.48 9.87 851 80805 677858 78984874
Bradycardia 16.46 9.87 77 81579 135480 79527252
Hip arthroplasty 16.45 9.87 8 81648 35748 79626984
Sinus headache 16.39 9.87 23 81633 5057 79657675
Irritable bowel syndrome 16.30 9.87 24 81632 62217 79600515
Haemorrhoids 16.26 9.87 66 81590 29062 79633670
Blister 16.25 9.87 65 81591 119411 79543321
Gallbladder polyp 16.24 9.87 11 81645 979 79661753
Hot flush 16.23 9.87 104 81552 54773 79607959
Paraesthesia oral 16.21 9.87 52 81604 20419 79642313
Vascular compression 16.15 9.87 9 81647 565 79662167
Product dose omission issue 16.15 9.87 349 81307 247188 79415544
Therapy non-responder 16.14 9.87 45 81611 92260 79570472
Rhabdomyolysis 16.08 9.87 53 81603 103078 79559654
Nail dystrophy 16.01 9.87 11 81645 1002 79661730
Pulmonary fibrosis 15.99 9.87 13 81643 44099 79618633
Sinus disorder 15.95 9.87 55 81601 22409 79640323
Toxicity to various agents 15.95 9.87 320 81336 421220 79241512
Abdominal discomfort 15.89 9.87 172 81484 250555 79412177
Tonsillar hypertrophy 15.84 9.87 13 81643 1549 79661183
Myalgia 15.59 9.87 272 81384 185369 79477363
Inflammation 15.45 9.87 47 81609 93706 79569026
Swollen tongue 15.37 9.87 85 81571 42485 79620247
Product prescribing error 15.27 9.87 14 81642 44799 79617933
Pain in jaw 15.25 9.87 90 81566 46061 79616671
Incorrect dose administered 15.14 9.87 132 81524 76498 79586234
Infusion site swelling 15.05 9.87 28 81628 7798 79654934
Cholecystitis chronic 14.91 9.87 32 81624 9874 79652858
Bicuspid aortic valve 14.90 9.87 4 81652 31 79662701
Presyncope 14.84 9.87 82 81574 40972 79621760
Cyanosis 14.81 9.87 58 81598 25124 79637608
Vomiting 14.80 9.87 828 80828 665000 78997732
Intentional product misuse to child 14.69 9.87 5 81651 92 79662640
Dyspnoea exertional 14.69 9.87 145 81511 86928 79575804
Dyspepsia 14.63 9.87 173 81483 108514 79554218
Product use in unapproved indication 14.59 9.87 175 81481 250184 79412548
Feeling hot 14.58 9.87 108 81548 59626 79603106
Eosinophilia 14.49 9.87 15 81641 45330 79617402
HIV associated nephropathy 14.42 9.87 7 81649 330 79662402
Hypoacusis 14.27 9.87 65 81591 30085 79632647
Laryngospasm 14.26 9.87 19 81637 3978 79658754
Oxygen saturation decreased 14.24 9.87 198 81458 128849 79533883
Seasonal allergy 14.22 9.87 43 81613 16363 79646369
Pancreatitis chronic 14.18 9.87 19 81637 4000 79658732
Acute respiratory failure 14.17 9.87 107 81549 59434 79603298
Retinal detachment 14.07 9.87 30 81626 9217 79653515
Poor peripheral circulation 13.91 9.87 18 81638 3665 79659067
Prosopagnosia 13.90 9.87 4 81652 41 79662691
Seizure 13.88 9.87 271 81385 188563 79474169
Biliary dyskinesia 13.86 9.87 15 81641 2530 79660202
Toxic skin eruption 13.74 9.87 3 81653 22290 79640442
Victim of chemical submission 13.74 9.87 8 81648 546 79662186
Liver injury 13.72 9.87 23 81633 56591 79606141
Infusion site mass 13.58 9.87 12 81644 1581 79661151
Pelvic infection 13.55 9.87 7 81649 377 79662355
Rash macular 13.46 9.87 62 81594 28837 79633895
Altered state of consciousness 13.44 9.87 15 81641 43807 79618925
Biliary sepsis 13.42 9.87 12 81644 1605 79661127
Disease recurrence 13.30 9.87 84 81572 44025 79618707
Agranulocytosis 13.18 9.87 16 81640 45014 79617718
Ill-defined disorder 13.16 9.87 30 81626 65845 79596887
Rhinitis 13.01 9.87 39 81617 14768 79647964
Blood pressure systolic increased 12.98 9.87 31 81625 66955 79595777
Neuralgia 12.96 9.87 68 81588 33316 79629416
Suffocation feeling 12.79 9.87 12 81644 1708 79661024
Neutropenic infection 12.69 9.87 14 81642 2413 79660319
Abdominal pain 12.60 9.87 503 81153 389066 79273666
Emphysema 12.54 9.87 41 81615 16259 79646473
Pancytopenia 12.48 9.87 109 81547 165636 79497096
Ear canal erythema 12.47 9.87 3 81653 14 79662718
Tympanic membrane hyperaemia 12.47 9.87 3 81653 14 79662718
Insomnia 12.45 9.87 334 81322 244836 79417896
Muscle spasms 12.25 9.87 249 81407 174481 79488251
Accidental exposure to product by child 12.16 9.87 15 81641 2911 79659821
Infusion site pain 12.14 9.87 37 81619 14139 79648593
Hyperpyrexia 11.97 9.87 22 81634 6070 79656662
Otitis media 11.93 9.87 22 81634 6084 79656648
Iron deficiency anaemia 11.90 9.87 55 81601 25617 79637115
Failure of child resistant product closure 11.89 9.87 4 81652 71 79662661
Bronchopulmonary aspergillosis 11.86 9.87 4 81652 22290 79640442
Mood swings 11.86 9.87 46 81610 19834 79642898
Oral pain 11.82 9.87 64 81592 31734 79630998
Depression 11.78 9.87 298 81358 216492 79446240
Haemodialysis complication 11.74 9.87 6 81650 316 79662416
Paraesthesia 11.62 9.87 249 81407 176074 79486658
Reading disorder 11.57 9.87 9 81647 993 79661739
Sinus tachycardia 11.57 9.87 71 81585 36837 79625895
Device dislocation 11.57 9.87 55 81601 25915 79636817
Confusional state 11.54 9.87 243 81413 317754 79344978
COVID-19 11.49 9.87 226 81430 157448 79505284
Hypervolaemia 11.47 9.87 79 81577 42611 79620121
HER2 positive breast cancer 11.46 9.87 6 81650 332 79662400
Drug ineffective for unapproved indication 11.35 9.87 22 81634 51216 79611516
Administration site extravasation 11.22 9.87 10 81646 1333 79661399
Intentional self-injury 11.20 9.87 10 81646 32409 79630323
Oropharyngeal blistering 11.20 9.87 8 81648 776 79661956
Diverticulitis 11.18 9.87 83 81573 45853 79616879
Vision blurred 11.09 9.87 161 81495 105737 79556995
Cholestasis 11.01 9.87 23 81633 52086 79610646
Tongue pruritus 10.97 9.87 7 81649 563 79662169
Retching 10.90 9.87 41 81615 17426 79645306
Creatinine renal clearance decreased 10.85 9.87 3 81653 18999 79643733
Genital ulceration 10.83 9.87 9 81647 1091 79661641
Blood pressure diastolic decreased 10.83 9.87 9 81647 30207 79632525
Productive cough 10.76 9.87 138 81518 88193 79574539
Catheter site haemorrhage 10.72 9.87 19 81637 5098 79657634
Cardiac failure 10.72 9.87 104 81552 154738 79507994
Product complaint 10.65 9.87 34 81622 13315 79649417
Cystic fibrosis related diabetes 10.60 9.87 5 81651 221 79662511
Axillary pain 10.56 9.87 12 81644 2137 79660595
Multiple organ dysfunction syndrome 10.47 9.87 76 81580 120170 79542562
Exposure during pregnancy 10.28 9.87 61 81595 101071 79561661
Periorbital oedema 10.27 9.87 25 81631 8377 79654355
Hyperlipidaemia 10.02 9.87 53 81603 26040 79636692
Inappropriate schedule of product administration 10.00 9.87 88 81568 133540 79529192
Shock haemorrhagic 10.00 9.87 4 81652 20056 79642676
Stress 9.97 9.87 125 81531 79487 79583245
Grip strength decreased 9.90 9.87 5 81651 21864 79640868

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R06AB04 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Substituted alkylamines
ATC R06AB54 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Substituted alkylamines
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
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 D018377 Neurotransmitter Agents
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:37956 antihistamines
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:50949 SSRI
CHEBI has role CHEBI:59683 antipruritic drugs

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

DiseaseRelationSNOMED_IDDOID
Dermatographic urticaria indication 7632005 DOID:743
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
Urticaria indication 126485001
Influenza-like symptoms indication 315642008
Seasonal allergic rhinitis indication 367498001
Itching of skin indication 418363000
Allergic conjunctivitis indication 473460002 DOID:11204
Brain damage contraindication 2470005
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Goiter contraindication 3716002 DOID:12176
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Disorder of autonomic nervous system contraindication 15241006
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypovolemic shock contraindication 39419009
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Gastrointestinal perforation contraindication 51875005
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Diabetes mellitus contraindication 73211009 DOID:9351
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Epilepsy contraindication 84757009 DOID:1826
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Myasthenia gravis contraindication 91637004 DOID:437
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Coronary artery bypass graft contraindication 232717009
Myocardial dysfunction contraindication 233928007
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Hypocomplementemic urticarial vasculitis contraindication 239945009
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Drowsy contraindication 271782001
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Fever greater than 100.4 Fahrenheit contraindication 426000000
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Acute erosive gastritis contraindication 444926003
Smokes tobacco daily contraindication 449868002
Acute exacerbation of asthma contraindication 708038006
Acute Thromboembolic Stroke contraindication




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 9.47 Basic
pKa2 4.14 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
8MG;54.3MG TUXARIN ER MAINPOINTE N206323 June 22, 2015 RX TABLET, EXTENDED RELEASE ORAL 9066942 Jan. 3, 2032 TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS

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 8.15 WOMBAT-PK CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 7.82 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 5.17 PDSP
Histamine H4 receptor GPCR Ki 6.67 WOMBAT-PK
Cytochrome P450 2D6 Enzyme Ki 4.97 WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5 CHEMBL
Lethal(3)malignant brain tumor-like protein 1 Unclassified IC50 4.39 CHEMBL
Lethal(3)malignant brain tumor-like protein 3 Unclassified IC50 4.38 CHEMBL
MBT domain-containing protein 1 Unclassified IC50 4.47 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Kd 5.84 SCIENTIFIC LITERATURE
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.96 CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 5.98 SCIENTIFIC LITERATURE
Histamine H1 receptor GPCR IC50 8.06 CHEMBL
Histamine H1 receptor GPCR Ki 8.70 CHEMBL
Chloroquine resistance transporter Transporter IC50 4.27 CHEMBL

External reference:

IDSource
4017865 VUID
N0000146218 NUI
D00665 KEGG_DRUG
113-92-8 SECONDARY_CAS_RN
1405-56-7 SECONDARY_CAS_RN
142429 RXNORM
4017864 VANDF
4017865 VANDF
4018446 VANDF
4019408 VANDF
C0008281 UMLSCUI
CHEBI:52010 CHEBI
CHEMBL505 ChEMBL_ID
CHEMBL1659 ChEMBL_ID
DB01114 DRUGBANK_ID
6976 IUPHAR_LIGAND_ID
2725 PUBCHEM_CID
32347 MMSL
32562 MMSL
3966 MMSL
4425 MMSL
4426 MMSL
4427 MMSL
4751 MMSL
93262 MMSL
d00191 MMSL
003391 NDDF
003392 NDDF
004430 NDDF
004431 NDDF
372914003 SNOMEDCT_US
438256006 SNOMEDCT_US
85737002 SNOMEDCT_US
9944001 SNOMEDCT_US
D002744 MESH_DESCRIPTOR_UI
CHEMBL1201659 ChEMBL_ID
104 INN_ID
3U6IO1965U UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Childrens Robitussin Nighttime Cough Long-Acting DM HUMAN OTC DRUG LABEL 2 0031-8692 SOLUTION 2 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Nighttime Cough Long-Acting DM HUMAN OTC DRUG LABEL 2 0031-8692 SOLUTION 2 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Nighttime Cough Long-Acting DM HUMAN OTC DRUG LABEL 2 0031-8692 SOLUTION 2 mg ORAL OTC monograph final 17 sections
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING HUMAN OTC DRUG LABEL 2 0031-8693 LIQUID 1 mg ORAL OTC monograph final 17 sections
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING HUMAN OTC DRUG LABEL 2 0031-8693 LIQUID 2 mg ORAL OTC monograph final 17 sections
TriaminicMulti-Symptom Fever and Cold HUMAN OTC DRUG LABEL 4 0067-8116 SUSPENSION 1 mg ORAL OTC monograph final 15 sections
Theraflu Flu Relief Max StrengthNighttime HUMAN OTC DRUG LABEL 3 0067-8205 SYRUP 4 mg ORAL OTC monograph final 17 sections
good sense cold HUMAN OTC DRUG LABEL 4 0113-0903 SUSPENSION 1 mg ORAL OTC monograph final 15 sections
Allergy HUMAN OTC DRUG LABEL 3 0113-2476 TABLET 2 mg ORAL OTC monograph final 15 sections
basic care childrens cold plus flu HUMAN OTC DRUG LABEL 4 0113-7223 SUSPENSION 1 mg ORAL OTC monograph final 15 sections
FLONASEHeadache and Allergy Relief HUMAN OTC DRUG LABEL 3 0135-0578 TABLET 2 mg ORAL OTC monograph final 17 sections
TussiCaps HUMAN PRESCRIPTION DRUG LABEL 2 0187-0054 CAPSULE, EXTENDED RELEASE 4 mg ORAL ANDA 24 sections
TussiCaps HUMAN PRESCRIPTION DRUG LABEL 2 0187-0108 CAPSULE, EXTENDED RELEASE 8 mg ORAL ANDA 24 sections
Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest HUMAN OTC DRUG LABEL 3 0280-0020 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 17 sections
Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest HUMAN OTC DRUG LABEL 3 0280-0020 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 17 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0022 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0022 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0022 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0023 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0023 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0023 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections
ANTIFLU HUMAN OTC DRUG LABEL 3 0280-0044 TABLET, COATED 2 mg ORAL Export only 2 sections
Antiflupowder HUMAN OTC DRUG LABEL 3 0280-0045 POWDER, FOR SOLUTION 4 mg ORAL Export only 1 sections
Antiflu Kids HUMAN OTC DRUG LABEL 3 0280-0046 POWDER, FOR SOLUTION 1 mg ORAL Export only 2 sections
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0055 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 15 sections
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0055 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 15 sections
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0055 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 15 sections
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz HUMAN OTC DRUG LABEL 3 0280-0060 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 15 sections
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz HUMAN OTC DRUG LABEL 3 0280-0060 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 15 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0088 TABLET, EFFERVESCENT 2 mg ORAL OTC monograph final 16 sections