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

Stem definition	Drug id	CAS RN
mucolytic, bromhexine derivatives	147	18683-91-5

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.12	g	O

ADMET properties:

Property	Value	Reference
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

Approvals:

Date	Agency	Company	Orphan
Jan. 1, 1978	YEAR INTRODUCED

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Macular degeneration	109.34	23.15	46	4215	24330	63460431
Hepatic function abnormal	65.44	23.15	37	4224	37105	63447656
Product prescribing error	48.50	23.15	27	4234	26262	63458499
Stevens-Johnson syndrome	47.05	23.15	26	4235	24924	63459837
Vaginal flatulence	44.32	23.15	14	4247	3279	63481482
Interstitial lung disease	41.73	23.15	34	4227	61874	63422887
Pneumonia	39.10	23.15	91	4170	456676	63028085
Paraesthesia oral	38.89	23.15	21	4240	19235	63465526
Chronic sinusitis	37.60	23.15	18	4243	12825	63471936
Proctitis	37.44	23.15	14	4247	5427	63479334
Female genital tract fistula	36.33	23.15	15	4246	7544	63477217
Pyrexia	36.25	23.15	90	4171	470388	63014373
Radiculopathy	34.45	23.15	15	4246	8596	63476165
Neutrophil count decreased	31.88	23.15	28	4233	56378	63428383
Drug-induced liver injury	31.19	23.15	24	4237	40198	63444563
Vaginal discharge	30.34	23.15	14	4247	9184	63475577
Incision site pain	29.16	23.15	8	4253	1150	63483611
Procedural pain	28.85	23.15	18	4243	21551	63463210
Cardiac failure	26.06	23.15	31	4230	89111	63395650
Oral candidiasis	25.49	23.15	17	4244	22781	63461980
Pneumonia aspiration	23.32	23.15	19	4242	34521	63450240

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Fractional exhaled nitric oxide increased	189.96	20.80	44	6987	1038	34948862
Plantar fasciitis	151.41	20.80	42	6989	2074	34947826
Sensation of foreign body	148.73	20.80	44	6987	2739	34947161
Myoglobin blood increased	145.14	20.80	44	6987	2979	34946921
Brain natriuretic peptide increased	129.16	20.80	47	6984	5612	34944288
Secretion discharge	109.06	20.80	42	6989	5863	34944037
Pneumonia	105.38	20.80	227	6804	362400	34587500
Interstitial lung disease	92.94	20.80	88	6943	65194	34884706
Dysphonia	87.61	20.80	56	6975	23327	34926573
Incision site pain	85	20.80	26	7005	1812	34948088
Pneumothorax	84.90	20.80	51	6980	19041	34930859
Lymphocyte count decreased	84.31	20.80	54	6977	22568	34927332
Obstructive airways disorder	83.79	20.80	47	6984	15447	34934453
Exostosis	81.57	20.80	32	6999	4691	34945209
Chest discomfort	76.61	20.80	73	6958	54457	34895443
Hepatic function abnormal	57.79	20.80	57	6974	44306	34905594
Nasopharyngitis	56.59	20.80	70	6961	69898	34880002
Pneumonia aspiration	54.88	20.80	54	6977	41849	34908051
Eosinophilia	54.72	20.80	44	6987	26178	34923722
Neutrophil count increased	54.33	20.80	37	6994	17109	34932791
Wheezing	51.71	20.80	52	6979	41350	34908550
Cardiac disorder	41.20	20.80	47	6984	43079	34906821
Red blood cells urine positive	41.17	20.80	15	7016	1794	34948106
Dyspnoea exertional	41.06	20.80	47	6984	43232	34906668
Cough	37.64	20.80	89	6942	150051	34799849
Coronary artery disease	36.91	20.80	47	6984	48258	34901642
Cerebral infarction	31.57	20.80	33	6998	27422	34922478
Protein urine present	31.38	20.80	17	7014	5211	34944689
White blood cell count increased	29.80	20.80	39	6992	41112	34908788
Decreased appetite	29.79	20.80	87	6944	166305	34783595
Respiratory failure	28.98	20.80	66	6965	108506	34841394
Platelet count decreased	28.93	20.80	70	6961	119647	34830253
Blood urea increased	27.16	20.80	32	6999	30332	34919568
Toxicity to various agents	27.15	20.80	4	7027	200358	34749542
Pneumonia bacterial	24.92	20.80	20	7011	11852	34938048
Sleep apnoea syndrome	24.39	20.80	25	7006	20296	34929604
Atrial fibrillation	23.83	20.80	66	6965	122327	34827573
Drug eruption	23.02	20.80	24	7007	19874	34930026
Muscle spasms	21.57	20.80	47	6984	74954	34874946

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pneumonia	175.48	18.02	312	10215	659934	79073927
Interstitial lung disease	143.92	18.02	119	10408	112481	79621380
Hepatic function abnormal	127.68	18.02	93	10434	73014	79660847
Incision site pain	119.80	18.02	34	10493	2796	79731065
Lymphocyte count decreased	105.63	18.02	70	10457	47219	79686642
Pneumonia aspiration	77.70	18.02	67	10460	66900	79666961
Neutrophil count increased	74.20	18.02	47	10480	29349	79704512
Platelet count decreased	64.59	18.02	102	10425	194562	79539299
Stevens-Johnson syndrome	64.22	18.02	48	10479	39118	79694743
Pyrexia	54.08	18.02	204	10323	678505	79055356
Red blood cells urine positive	52.49	18.02	21	10506	4942	79728919
Decreased appetite	51.82	18.02	129	10398	342289	79391572
Blood urea increased	50.95	18.02	46	10481	48744	79685117
Neutrophil count decreased	47.09	18.02	60	10467	93899	79639962
White blood cell count increased	46.12	18.02	53	10474	74580	79659281
Cerebral infarction	45.61	18.02	42	10485	45634	79688227
Drug eruption	45.04	18.02	41	10486	43894	79689967
Pneumothorax	44.84	18.02	34	10493	28289	79705572
Pneumonia bacterial	44.07	18.02	29	10498	19302	79714559
Respiratory failure	43.20	18.02	82	10445	180829	79553032
Protein urine present	41.00	18.02	22	10505	10090	79723771
Drug-induced liver injury	39.25	18.02	46	10481	66071	79667790
Malignant neoplasm progression	36.69	18.02	65	10462	135925	79597936
Upper respiratory tract inflammation	35.61	18.02	15	10512	4020	79729841
Vaginal flatulence	34.72	18.02	13	10514	2562	79731299
Cardiac failure	31.90	18.02	66	10461	154776	79579085
Idiopathic pulmonary fibrosis	31.68	18.02	14	10513	4214	79729647
Procedural pain	30.69	18.02	25	10502	23059	79710802
Anaemia	30.66	18.02	128	10399	444887	79288974
Female genital tract fistula	27.07	18.02	14	10513	5961	79727900
Haemoglobin decreased	26.77	18.02	77	10450	222042	79511819
Chronic sinusitis	26.00	18.02	18	10509	13008	79720853
Macular degeneration	25.88	18.02	17	10510	11279	79722582
Paraesthesia oral	24.78	18.02	21	10506	20450	79713411
Marasmus	24.75	18.02	8	10519	1020	79732841
Cystatin C increased	24.57	18.02	4	10523	20	79733841
Drug hypersensitivity	24.19	18.02	5	10522	298911	79434950
Organising pneumonia	23.94	18.02	16	10511	10923	79722938
Proctitis	23.33	18.02	13	10514	6419	79727442
Constipation	23.17	18.02	86	10441	282964	79450897
Arthralgia	22.98	18.02	25	10502	571778	79162083
Fatigue	22.22	18.02	57	10470	929670	78804191
Cardiac failure acute	22.06	18.02	19	10508	18910	79714951
Radiculopathy	21.98	18.02	14	10513	8810	79725051
Altered state of consciousness	21.96	18.02	28	10499	43794	79690067
Hepatitis fulminant	21.86	18.02	13	10514	7249	79726612
Vaginal discharge	21.53	18.02	13	10514	7450	79726411
Mechanical ileus	21.51	18.02	7	10520	912	79732949
Product prescribing error	21.47	18.02	28	10499	44785	79689076
Cardiac failure chronic	21.32	18.02	15	10512	11120	79722741
Haematochezia	21.23	18.02	40	10487	87605	79646256
Haemoptysis	20.86	18.02	31	10496	55968	79677893
Product dose omission issue	20.32	18.02	4	10523	247533	79486328
Radiation pneumonitis	20.10	18.02	10	10517	3923	79729938
Erythema	20.10	18.02	70	10457	223220	79510641
Kidney transplant rejection	20.08	18.02	14	10513	10232	79723629
Blood albumin decreased	19.86	18.02	20	10507	24223	79709638
White blood cell count decreased	19.59	18.02	62	10465	188226	79545635
Laryngopharyngitis	19.56	18.02	4	10523	80	79733781
Blood glucose increased	19.13	18.02	45	10482	114930	79618931
Blood creatinine increased	18.91	18.02	54	10473	155003	79578858
Liver disorder	18.73	18.02	34	10493	72383	79661478
Adrenocorticotropic hormone deficiency	18.70	18.02	7	10520	1378	79732483
Complications of transplanted kidney	18.14	18.02	11	10516	6355	79727506

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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

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

Disease	Relation	SNOMED_ID	DOID
Sore throat symptom	indication	267102003

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source	MoA source
Glucosylceramidase	Enzyme	P04062	GLCM_HUMAN	IC50	5.39	CHEMBL	IUPHAR
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN	Ki	5.74	DRUG MATRIX
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN	IC50	6.25	DRUG MATRIX
Sodium channel protein type 10 subunit alpha	Ion channel	Q9Y5Y9	SCNAA_HUMAN			WOMBAT-PK

External reference:

ID	Source
D01479	KEGG_DRUG
23828-92-4	SECONDARY_CAS_RN
438399	RXNORM
C0002421	UMLSCUI
CHEBI:31198	CHEBI
CHEMBL153479	ChEMBL_ID
DB06742	DRUGBANK_ID
D000551	MESH_DESCRIPTOR_UI
2132	PUBCHEM_CID
10692	IUPHAR_LIGAND_ID
3692	INN_ID
200168S0CL	UNII
698024002	SNOMEDCT_US
703352000	SNOMEDCT_US
703353005	SNOMEDCT_US
004176	NDDF
004295	NDDF

Pharmaceutical products:

None