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

Stem definitionDrug idCAS RN
mucolytic, bromhexine derivatives 147 18683-91-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ambroxol hydrochloride
  • ambroxol
  • ambroxils
  • lasolvan
  • ambroxol HCl
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
  • Molecular weight: 378.11
  • Formula: C13H18Br2N2O
  • CLOGP: 2.33
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 3
  • TPSA: 58.28
  • ALOGS: -4.31
  • ROTB: 3

Drug dosage:

DoseUnitRoute
0.12 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10.90 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.53 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 77 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 58
kinase-selectivity-class AXL,CDK4,CDK7,CDK9,EIF2AK3,MAP2K6,TEK 7
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Jan. 1, 1978 YEAR INTRODUCED

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
Macular degeneration 189.05 23.04 83 7727 37887 90582750
Female genital tract fistula 139.81 23.04 54 7756 17814 90602823
Radiculopathy 134.46 23.04 53 7757 18452 90602185
Vaginal flatulence 131.17 23.04 47 7763 12591 90608046
Proctitis 122.54 23.04 47 7763 15212 90605425
Chronic sinusitis 115.09 23.04 51 7759 23751 90596886
Vaginal discharge 111.46 23.04 47 7763 19417 90601220
Paraesthesia oral 110.11 23.04 54 7756 31605 90589032
Procedural pain 95.82 23.04 50 7760 33310 90587327
Oral candidiasis 92.95 23.04 50 7760 35405 90585232
Sinobronchitis 78.96 23.04 17 7793 684 90619953
Haematochezia 78.80 23.04 58 7752 70855 90549782
Hepatic function abnormal 70.58 23.04 46 7764 46242 90574395
Anaemia 68.86 23.04 115 7695 352687 90267950
Frequent bowel movements 68.79 23.04 49 7761 56886 90563751
Dyspepsia 68.79 23.04 85 7725 198075 90422562
Colitis ulcerative 66.29 23.04 49 7761 60217 90560420
Erythema 65.03 23.04 89 7721 229157 90391480
Rectal haemorrhage 60.58 23.04 53 7757 82691 90537946
Colitis 59.83 23.04 49 7761 69893 90550744
Allergic sinusitis 55.81 23.04 16 7794 2097 90618540
Constipation 55.46 23.04 92 7718 280303 90340334
Autoimmune thyroiditis 54.00 23.04 20 7790 5873 90614764
Product prescribing error 48.51 23.04 31 7779 30114 90590523
Dyslalia 46.06 23.04 11 7799 707 90619930
Pyrexia 43.37 23.04 140 7670 660345 89960292
Therapeutic product effect incomplete 42.92 23.04 67 7743 193829 90426808
Interstitial lung disease 42.49 23.04 42 7768 76363 90544274
Pneumonia bacterial 42.02 23.04 21 7789 12769 90607868
Stevens-Johnson syndrome 41.87 23.04 28 7782 29348 90591289
Neutrophil count decreased 41.04 23.04 40 7770 71492 90549145
Nasal polyps 33.21 23.04 17 7793 10863 90609774
Drug interaction 32.72 23.04 73 7737 276380 90344257
Amniotic fluid index increased 32.45 23.04 6 7804 109 90620528
Lymphocyte count decreased 30.89 23.04 25 7785 35025 90585612
Pneumonia 30.50 23.04 122 7688 637937 89982700
Hypokalaemia 29.96 23.04 46 7764 131070 90489567
Drug eruption 28.58 23.04 24 7786 35383 90585254
Platelet count decreased 28.45 23.04 46 7764 136923 90483714
Pneumonia aspiration 27.51 23.04 25 7785 40915 90579722
Cardiac failure 27.27 23.04 40 7770 109456 90511181
Pneumomediastinum 26.64 23.04 9 7801 2022 90618615
Food interaction 26.49 23.04 8 7802 1256 90619381
Incision site pain 25.80 23.04 8 7802 1370 90619267
Mydriasis 25.55 23.04 16 7794 14996 90605641
Fatigue 24.18 23.04 39 7771 1153984 89466653
Pneumonitis 24.03 23.04 24 7786 44146 90576491
Hypervigilance 23.69 23.04 6 7804 492 90620145
Erythema multiforme 23.26 23.04 14 7796 12232 90608405

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
Fractional exhaled nitric oxide increased 254.56 20.18 61 9178 1548 42610548
Myoglobin blood increased 208.86 20.18 62 9177 3620 42608476
Sensation of foreign body 205.65 20.18 61 9178 3552 42608544
Plantar fasciitis 201.97 20.18 58 9181 3012 42609084
Brain natriuretic peptide increased 179.30 20.18 64 9175 6706 42605390
Pneumothorax 137.35 20.18 77 9162 23466 42588630
Exostosis 136.98 20.18 50 9189 5581 42606515
Pneumonia 125.47 20.18 279 8960 421870 42190226
Dysphonia 113.81 20.18 73 9166 28377 42583719
Secretion discharge 112.04 20.18 47 9192 7588 42604508
Obstructive airways disorder 105.19 20.18 66 9173 24693 42587403
Chest discomfort 104.44 20.18 96 9143 63520 42548576
Interstitial lung disease 103.56 20.18 105 9134 78357 42533739
Pneumonia aspiration 82.99 20.18 76 9163 50002 42562094
Incision site pain 82.18 20.18 26 9213 1877 42610219
Lymphocyte count decreased 81.77 20.18 59 9180 27750 42584346
Nasopharyngitis 80.47 20.18 95 9144 83901 42528195
Eosinophilia 79.38 20.18 62 9177 32837 42579259
Hepatic function abnormal 75.37 20.18 73 9166 51494 42560602
Increased upper airway secretion 70.82 20.18 25 9214 2531 42609565
Wheezing 64.47 20.18 69 9170 54712 42557384
Dyspnoea exertional 62.27 20.18 65 9174 50083 42562013
Cardiac disorder 60.00 20.18 63 9176 48869 42563227
Coronary artery disease 58.57 20.18 65 9174 53655 42558441
Foreign body in throat 52.70 20.18 14 9225 542 42611554
Pneumonia bacterial 52.39 20.18 36 9203 15656 42596440
Cough 50.55 20.18 116 9123 177987 42434109
Neutrophil count increased 47.05 20.18 37 9202 19767 42592329
Atrial fibrillation 44.17 20.18 95 9144 139498 42472598
Drug eruption 44.12 20.18 38 9201 23037 42589059
Platelet count decreased 41.22 20.18 92 9147 138489 42473607
Pityriasis rubra pilaris 40.36 20.18 10 9229 292 42611804
Red blood cells urine positive 39.27 20.18 15 9224 1895 42610201
Sleep deficit 36.88 20.18 12 9227 947 42611149
Toxicity to various agents 35.71 20.18 4 9235 229132 42382964
Cerebral infarction 32.72 20.18 37 9202 31132 42580964
Bronchospasm 32.61 20.18 25 9214 12860 42599236
Respiratory failure 32.55 20.18 80 9159 128052 42484044
Muscle spasms 32.44 20.18 63 9176 85981 42526115
Post herpetic neuralgia 30.05 20.18 11 9228 1235 42610861
Upper respiratory tract inflammation 28.91 20.18 12 9227 1884 42610212
Protein urine present 28.54 20.18 17 9222 5784 42606312
Decreased appetite 28.25 20.18 99 9140 193038 42419058
Drug ineffective 27.56 20.18 60 9179 630137 41981959
Pain 26.49 20.18 10 9229 244838 42367258
Blood urea increased 26.36 20.18 34 9205 32759 42579337
White blood cell count increased 26.19 20.18 40 9199 45047 42567049
Sleep apnoea syndrome 25.01 20.18 27 9212 21581 42590515
Application site pain 23.41 20.18 11 9228 2318 42609778
Product dose omission issue 23.28 20.18 3 9236 154362 42457734
Pyrexia 22.44 20.18 154 9085 393888 42218208
Application site erythema 22.39 20.18 11 9228 2555 42609541
Drug-induced liver injury 20.89 20.18 33 9206 38240 42573856
Lymphangiosis carcinomatosa 20.80 20.18 8 9231 1029 42611067

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
Pneumonia 176.19 18.51 396 16069 876318 109696516
Interstitial lung disease 156.21 18.51 144 16321 139190 110433644
Hepatic function abnormal 155.46 18.51 119 16346 89176 110483658
Fractional exhaled nitric oxide increased 125.87 18.51 28 16437 748 110572086
Lymphocyte count decreased 121.51 18.51 86 16379 57157 110515677
Pneumonia aspiration 119.36 18.51 98 16367 81135 110491699
Incision site pain 112.30 18.51 34 16431 3101 110569733
Female genital tract fistula 112.27 18.51 53 16412 16466 110556368
Pneumothorax 111.50 18.51 68 16397 35217 110537617
Vaginal flatulence 104.74 18.51 46 16419 12098 110560736
Macular degeneration 104.31 18.51 55 16410 21604 110551230
Radiculopathy 101.43 18.51 52 16413 19284 110553550
Platelet count decreased 95.79 18.51 143 16322 230300 110342534
Pneumonia bacterial 94.40 18.51 55 16410 26206 110546628
Proctitis 90.18 18.51 46 16419 16881 110555953
Vaginal discharge 87.73 18.51 46 16419 17862 110554972
Chronic sinusitis 86.13 18.51 51 16414 25033 110547801
Brain natriuretic peptide increased 85.62 18.51 39 16426 11170 110561664
Paraesthesia oral 84.24 18.51 56 16409 33615 110539219
Procedural pain 83.82 18.51 57 16408 35508 110537326
Myoglobin blood increased 82.70 18.51 29 16436 4203 110568631
Sinobronchitis 76.03 18.51 17 16448 465 110572369
Plantar fasciitis 73.79 18.51 28 16437 5073 110567761
Drug eruption 73.12 18.51 62 16403 53597 110519237
Pyrexia 68.17 18.51 289 16176 897976 109674858
Anaemia 68.00 18.51 207 16258 546879 110025955
Oral candidiasis 67.82 18.51 55 16410 44705 110528129
Neutrophil count decreased 66.62 18.51 86 16379 120855 110451979
Haematochezia 66.55 18.51 84 16381 115440 110457394
Neutrophil count increased 64.28 18.51 48 16417 34604 110538230
Increased upper airway secretion 62.51 18.51 25 16440 5207 110567627
Sensation of foreign body 61.70 18.51 28 16437 7947 110564887
Constipation 57.81 18.51 149 16316 357637 110215197
Stevens-Johnson syndrome 57.45 18.51 51 16414 46850 110525984
Erythema 56.27 18.51 130 16335 291317 110281517
Respiratory failure 54.19 18.51 107 16358 215225 110357609
Allergic sinusitis 49.87 18.51 16 16449 1765 110571069
Cerebral infarction 49.34 18.51 49 16416 51789 110521045
Red blood cells urine positive 49.16 18.51 21 16444 5164 110567670
Foreign body in throat 48.92 18.51 14 16451 1049 110571785
Arthralgia 48.50 18.51 28 16437 779604 109793230
Blood urea increased 45.15 18.51 48 16417 54909 110517925
Pityriasis rubra pilaris 44.95 18.51 10 16455 267 110572567
Fatigue 43.02 18.51 72 16393 1215886 109356948
Upper respiratory tract inflammation 42.42 18.51 18 16447 4353 110568481
Dysphonia 41.80 18.51 54 16411 75875 110496959
Autoimmune thyroiditis 41.74 18.51 20 16445 6414 110566420
Hypokalaemia 41.54 18.51 87 16378 182361 110390473
Drug hypersensitivity 40.56 18.51 9 16456 454081 110118753
Cardiac failure 39.88 18.51 87 16378 187539 110385295
Colitis ulcerative 37.95 18.51 52 16413 77311 110495523
Alopecia 37.45 18.51 5 16460 364748 110208086
Drug-induced liver injury 36.85 18.51 65 16400 120002 110452832
Frequent bowel movements 36.56 18.51 49 16416 71341 110501493
Chest discomfort 36.25 18.51 80 16385 173768 110399066
Colitis 36.18 18.51 59 16406 102264 110470570
Protein urine present 35.93 18.51 22 16443 11462 110561372
Decreased appetite 34.32 18.51 151 16314 475695 110097139
Peripheral swelling 34.14 18.51 9 16456 404025 110168809
Sleep deficit 33.95 18.51 12 16453 1780 110571054
White blood cell count increased 33.10 18.51 55 16410 96787 110476047
Dyslalia 32.86 18.51 11 16454 1386 110571448
Anxiety 32.56 18.51 6 16459 345072 110227762
Pneumonitis 32.46 18.51 48 16417 76483 110496351
White blood cell count decreased 31.46 18.51 90 16375 229300 110343534
Hypoproteinaemia 31.21 18.51 16 16449 5929 110566905
Hyperuricaemia 31.20 18.51 22 16443 14509 110558325
Musculoskeletal stiffness 30.81 18.51 3 16462 279819 110293015
Product dose omission issue 29.50 18.51 6 16459 321776 110251058
Malignant neoplasm progression 29.49 18.51 74 16391 174493 110398341
Swelling 29.31 18.51 8 16457 351033 110221801
Dyspepsia 29.22 18.51 78 16387 190887 110381947
Hypoalbuminaemia 28.70 18.51 28 16437 28946 110543888
Cough 28.49 18.51 140 16325 461501 110111333
Idiopathic pulmonary fibrosis 27.82 18.51 14 16451 4990 110567844
Systemic lupus erythematosus 27.30 18.51 3 16462 254335 110318499
Obstructive airways disorder 27.26 18.51 34 16431 46115 110526719
Rheumatoid arthritis 26.62 18.51 6 16459 299607 110273227
Lower respiratory tract infection 25.76 18.51 3 16462 243103 110329731
Altered state of consciousness 25.68 18.51 37 16428 57589 110515245
Pain in extremity 25.58 18.51 21 16444 487097 110085737
Sputum retention 25.36 18.51 9 16456 1350 110571484
Cardiac failure acute 25.23 18.51 24 16441 24054 110548780
Abdominal discomfort 24.65 18.51 14 16451 393844 110178990
Bronchospasm 24.11 18.51 26 16439 30213 110542621
Amniotic fluid index increased 23.90 18.51 5 16460 99 110572735
Post herpetic neuralgia 23.69 18.51 11 16454 3290 110569544
Therapeutic product effect decreased 23.58 18.51 4 16461 244312 110328522
Therapeutic product effect incomplete 23.45 18.51 80 16385 223725 110349109
Blood creatinine increased 23.38 18.51 70 16395 182819 110390015
Alanine aminotransferase increased 23.17 18.51 70 16395 183703 110389131
Rectal haemorrhage 22.58 18.51 53 16412 119780 110453054
Haemoptysis 22.37 18.51 39 16426 71315 110501519
Nasal polyps 21.65 18.51 17 16448 13183 110559651
Product prescribing error 21.49 18.51 32 16433 51299 110521535
Food interaction 21.34 18.51 9 16456 2143 110570691
Sideroblastic anaemia 21.05 18.51 6 16459 443 110572391
Secretion discharge 20.87 18.51 20 16445 20224 110552610
Benign prostatic hyperplasia 20.69 18.51 19 16446 18215 110554619
Organising pneumonia 20.51 18.51 17 16448 14226 110558608
Radiation pneumonitis 20.37 18.51 11 16454 4525 110568309
Aspartate aminotransferase increased 20.24 18.51 61 16404 159875 110412959
Wound 20.22 18.51 5 16460 234432 110338402
Bronchitis 19.97 18.51 60 16405 156972 110415862
Marasmus 19.92 18.51 8 16457 1683 110571151
Drug interaction 19.89 18.51 135 16330 500048 110072786
Exostosis 19.74 18.51 29 16436 45927 110526907
Impaired healing 19.47 18.51 3 16462 196714 110376120
Blood albumin decreased 19.00 18.51 22 16443 27630 110545204
Cardiac failure chronic 18.89 18.51 16 16449 13795 110559039
Cystatin C increased 18.85 18.51 4 16461 85 110572749
Hypervigilance 18.80 18.51 6 16459 651 110572183

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R02AD05 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Anesthetics, local
ATC R03CC63 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS FOR SYSTEMIC USE
Selective beta-2-adrenoreceptor agonists
ATC R05CB06 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
Mucolytics
MeSH PA D005100 Expectorants
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:51177 antitussive

Related Drugs by ATC class:

R02AD Anesthetics, local 4 drugs
benzocainecocainedycloninelidocaine
R03CC Selective beta-2-adrenoreceptor agonists 14 drugs
bambuterolcarbuterolclenbuterolfenoterolformoterolhexoprenalineisoetarinepirbuterolprocaterolreproterolsalbutamolterbutaline show all 14 →
R05CB Mucolytics 13 drugs
acetylcysteinebromhexinecarbocisteinedomiodoldornase alfaeprazinoneerdosteineletosteinemannitolmesnaneltenexinesobrerol show all 13 →

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

DiseaseRelationSNOMED_IDDOID
Sore throat symptom indication 267102003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.75 Basic
pKa2 0.27 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
Glucosylceramidase Enzyme IC50 5.39 CHEMBL IUPHAR
Sodium-dependent serotonin transporter Transporter Ki 5.74 DRUG MATRIX
Cytochrome P450 2D6 Enzyme IC50 6.25 DRUG MATRIX
Sodium channel protein type 10 subunit alpha Ion channel WOMBAT-PK

External reference:

IDSource
D01479 KEGG_DRUG
23828-92-4 SECONDARY_CAS_RN
438399 RXNORM
C0002421 UMLSCUI
CHEBI:135590 CHEBI
CHEMBL153479 ChEMBL_ID
DB06742 DRUGBANK_ID
D000551 MESH_DESCRIPTOR_UI
2132 PUBCHEM_CID
10692 IUPHAR_LIGAND_ID
3692 INN_ID
200168S0CL UNII
004176 NDDF
004295 NDDF
698024002 SNOMEDCT_US
703352000 SNOMEDCT_US
703353005 SNOMEDCT_US
200168S0CL INXIGHT DRUGS

Pharmaceutical products:

None