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

Stem definition	Drug id	CAS RN
bronchodilators, phenethylamine derivatives	2598	23031-25-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: terbutaline bricaril terbutalin brican terbutaline sulfate terbutaline hemisulfate	A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic. Molecular weight: 225.29 Formula: C12H19NO3 CLOGP: 0.48 LIPINSKI: 0 HAC: 4 HDO: 4 TPSA: 72.72 ALOGS: -1.59 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

terbutaline
bricaril
terbutalin
brican
terbutaline sulfate
terbutaline hemisulfate

A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic.

Molecular weight: 225.29
Formula: C12H19NO3
CLOGP: 0.48
LIPINSKI: 0
HAC: 4
HDO: 4
TPSA: 72.72
ALOGS: -1.59
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2	mg	Inhal.aerosol
2	mg	Inhal.powder
20	mg	Inhal.solution
15	mg	O
15	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	213 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	56 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.11 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	14 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.75 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	15 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 25, 1974	FDA

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
Asthma	165.57	16.67	121	7054	89216	50508733
Dyspnoea	79.87	16.67	212	6963	547396	50050553
Wheezing	78.06	16.67	67	7108	61980	50535969
Lactic acidosis	50.22	16.67	40	7135	33315	50564634
Squamous cell carcinoma of the oral cavity	44.49	16.67	10	7165	295	50597654
Sputum discoloured	41.37	16.67	25	7150	13370	50584579
Allergy to metals	39.24	16.67	10	7165	507	50597442
Acute kidney injury	36.78	16.67	92	7083	227966	50369983
Iodine allergy	36.22	16.67	10	7165	691	50597258
Shock haemorrhagic	34.96	16.67	19	7156	8325	50589624
Hyperlactacidaemia	34.54	16.67	13	7162	2420	50595529
Sleep disorder due to a general medical condition	34.30	16.67	18	7157	7353	50590596
Forced expiratory volume decreased	33.36	16.67	15	7160	4379	50593570
Obstructive airways disorder	33.03	16.67	23	7152	15629	50582320
Nasal discharge discolouration	32.53	16.67	11	7164	1503	50596446
Tremor	32.06	16.67	58	7117	114845	50483104
Middle insomnia	31.89	16.67	19	7156	9902	50588047
Exposure during pregnancy	31.15	16.67	59	7116	120956	50476993
Full blood count abnormal	28.85	16.67	25	7150	23363	50574586
Hepatocellular injury	28.56	16.67	26	7149	25921	50572028
Bronchospasm	27.15	16.67	20	7155	14834	50583115
Rubber sensitivity	26.90	16.67	10	7165	1799	50596150
Lung diffusion disorder	26.34	16.67	5	7170	62	50597887
Folate deficiency	26.14	16.67	10	7165	1945	50596004
Cholestasis	25.15	16.67	24	7151	25377	50572572
Cough	24.95	16.67	83	7092	241181	50356768
Heart rate increased	24.14	16.67	41	7134	77209	50520740
Post viral fatigue syndrome	23.70	16.67	6	7169	296	50597653
Eosinophilic granulomatosis with polyangiitis	22.61	16.67	9	7166	1946	50596003
Productive cough	22.06	16.67	32	7143	52662	50545287
Haematoma	21.48	16.67	24	7151	30486	50567463
Pleural rub	21.19	16.67	4	7171	48	50597901
Eosinophilia	21.13	16.67	19	7156	18633	50579316
Exposure to allergen	21.04	16.67	5	7170	189	50597760
Phlebectomy	20.69	16.67	4	7171	55	50597894
Asthmatic crisis	20.60	16.67	8	7167	1620	50596329
Spirometry abnormal	20.58	16.67	5	7170	208	50597741
Premature separation of placenta	20.36	16.67	8	7167	1670	50596279
Forced expiratory volume abnormal	19.79	16.67	4	7171	70	50597879
Polyp	18.79	16.67	11	7164	5551	50592398
Foetal exposure during pregnancy	18.37	16.67	21	7154	27338	50570611
Smoke sensitivity	18.22	16.67	5	7170	338	50597611
Tachycardia	17.91	16.67	42	7133	99721	50498228
Hyperkinesia	17.89	16.67	7	7168	1445	50596504
Respiratory rate increased	17.87	16.67	14	7161	11371	50586578
Food allergy	17.27	16.67	12	7163	8125	50589824
Eosinophil count abnormal	16.78	16.67	5	7170	454	50597495
Seasonal allergy	16.72	16.67	15	7160	14661	50583288

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
Asthma	139.56	18.68	78	4432	33771	29536246
Wheezing	79.09	18.68	54	4456	33186	29536831
Dyspnoea	53.29	18.68	138	4372	326594	29243423
Forced expiratory volume decreased	49.73	18.68	18	4492	2795	29567222
Chest discomfort	49.61	18.68	47	4463	45936	29524081
Hyperkaliuria	48.10	18.68	9	4501	95	29569922
Cholestasis	46.24	18.68	34	4476	23428	29546589
Wolff-Parkinson-White syndrome	42.00	18.68	9	4501	196	29569821
Exposure during pregnancy	41.51	18.68	22	4488	8532	29561485
Agranulocytosis	39.00	18.68	29	4481	20311	29549706
Obstructive airways disorder	36.32	18.68	22	4488	10994	29559023
Bronchospasm	33.78	18.68	20	4490	9589	29560428
Blood immunoglobulin E increased	32.70	18.68	12	4498	1935	29568082
Gastrointestinal mucosal necrosis	32.30	18.68	7	4503	161	29569856
Nasal disorder	32.22	18.68	11	4499	1438	29568579
Placental transfusion syndrome	28.38	18.68	4	4506	4	29570013
Meralgia paraesthetica	27.10	18.68	6	4504	153	29569864
Penile erythema	26.63	18.68	6	4504	166	29569851
Unmasking of previously unidentified disease	26.39	18.68	8	4502	715	29569302
Bronchospasm paradoxical	26.37	18.68	5	4505	57	29569960
Rhinitis	25.21	18.68	13	4497	4765	29565252
Nasal inflammation	24.76	18.68	6	4504	229	29569788
Foetal distress syndrome	23.85	18.68	8	4502	991	29569026
Premature baby	23.21	18.68	20	4490	17260	29552757
Middle insomnia	23.04	18.68	13	4497	5695	29564322
Heart rate increased	22.99	18.68	29	4481	38909	29531108
Respiratory distress	22.36	18.68	26	4484	32080	29537937
Prothrombin time ratio decreased	22.24	18.68	6	4504	353	29569664
Cyanosis	21.44	18.68	16	4494	11251	29558766
Stillbirth	21.11	18.68	5	4505	173	29569844
Cough	20.95	18.68	54	4456	126673	29443344
Ductus arteriosus premature closure	19.86	18.68	5	4505	224	29569793
Interstitial lung disease	19.48	18.68	33	4477	57685	29512332

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
Asthma	229.59	15.79	162	10707	95063	64392800
Wheezing	129.94	15.79	108	10761	80471	64407392
Dyspnoea	110.93	15.79	317	10552	718357	63769506
Forced expiratory volume decreased	75.43	15.79	32	10837	6835	64481028
Cholestasis	67.85	15.79	58	10811	44814	64443049
Bronchospasm	57.06	15.79	39	10830	21643	64466220
Obstructive airways disorder	57.01	15.79	40	10829	23145	64464718
Lactic acidosis	55.91	15.79	60	10809	61350	64426513
Middle insomnia	51	15.79	30	10839	12847	64475016
Chest discomfort	46.84	15.79	76	10793	116030	64371833
Shock haemorrhagic	46.08	15.79	31	10838	16760	64471103
Heart rate increased	45.94	15.79	69	10800	98606	64389257
Cough	44.97	15.79	132	10737	302016	64185847
Sputum discoloured	44.35	15.79	31	10838	17825	64470038
Hyperkaliuria	42.52	15.79	9	10860	166	64487697
Wolff-Parkinson-White syndrome	38.84	15.79	9	10860	255	64487608
Squamous cell carcinoma of the oral cavity	38.45	15.79	10	10859	461	64487402
Bronchospasm paradoxical	38.14	15.79	8	10861	141	64487722
Productive cough	35.22	15.79	52	10817	73151	64414712
Hyperlactacidaemia	32.44	15.79	16	10853	4828	64483035
Hepatocellular injury	32.33	15.79	39	10830	45196	64442667
Full blood count abnormal	30.52	15.79	31	10838	29726	64458137
Gastrointestinal mucosal necrosis	30.35	15.79	7	10862	194	64487669
Eosinophilic granulomatosis with polyangiitis	30.23	15.79	13	10856	2869	64484994
Acute kidney injury	29.93	15.79	152	10717	449088	64038775
Small intestinal haemorrhage	29.72	15.79	14	10855	3819	64484044
Blood immunoglobulin E increased	29.68	15.79	14	10855	3830	64484033
Tremor	29.30	15.79	72	10797	148158	64339705
Agranulocytosis	29.04	15.79	34	10835	38195	64449668
Haematoma	28.46	15.79	37	10832	46213	64441650
Nasal disorder	26.97	15.79	12	10857	2872	64484991
Penile erythema	26.89	15.79	6	10863	143	64487720
Respiratory distress	26.37	15.79	38	10831	52293	64435570
Nasal discharge discolouration	25.51	15.79	10	10859	1744	64486119
Sleep disorder due to a general medical condition	24.52	15.79	16	10853	8218	64479645
Bronchitis	23.84	15.79	55	10814	108688	64379175
Death	23.61	15.79	28	10841	482677	64005186
Lung disorder	23.46	15.79	39	10830	60661	64427202
Meralgia paraesthetica	23.10	15.79	6	10863	275	64487588
Post viral fatigue syndrome	22.63	15.79	6	10863	298	64487565
Lung diffusion disorder	22.53	15.79	5	10864	116	64487747
Folate deficiency	21.14	15.79	10	10859	2753	64485110
Pleural rub	20.91	15.79	4	10865	43	64487820
Rhinitis	20.66	15.79	16	10853	10749	64477114
Respiratory rate increased	20.46	15.79	20	10849	18311	64469552
Sinus tachycardia	20.19	15.79	26	10843	32162	64455701
Exposure to allergen	20.11	15.79	5	10864	192	64487671
Smoke sensitivity	19.79	15.79	6	10863	485	64487378
Drug intolerance	19.44	15.79	4	10865	187988	64299875
Unmasking of previously unidentified disease	19.17	15.79	8	10861	1639	64486224
Asthmatic crisis	18.68	15.79	8	10861	1748	64486115
Nasal inflammation	18.56	15.79	6	10863	598	64487265
Eosinophilia	18.23	15.79	27	10842	38049	64449814
Systolic hypertension	18.04	15.79	6	10863	654	64487209
Forced expiratory volume abnormal	17.86	15.79	4	10865	97	64487766
Polyp	17.54	15.79	12	10857	6661	64481202
Prothrombin time ratio decreased	17.11	15.79	6	10863	767	64487096
Dermatitis bullous	17.03	15.79	15	10854	12039	64475824
Blood pressure increased	16.42	15.79	65	10804	172487	64315376
Accelerated idioventricular rhythm	16.20	15.79	4	10865	149	64487714

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R03AC03	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Selective beta-2-adrenoreceptor agonists
ATC	R03CC03	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS FOR SYSTEMIC USE Selective beta-2-adrenoreceptor agonists
ATC	R03CC53	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS FOR SYSTEMIC USE Selective beta-2-adrenoreceptor agonists
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058666	Adrenergic beta-2 Receptor Agonists
MeSH PA	D000318	Adrenergic beta-Agonists
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D001993	Bronchodilator Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D012102	Reproductive Control Agents
MeSH PA	D019141	Respiratory System Agents
MeSH PA	D013566	Sympathomimetics
MeSH PA	D015149	Tocolytic Agents
CHEBI has role	CHEBI:35522	beta-adrenergic agonists
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:38462	acetylcholinesterase inhibitors
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
CHEBI has role	CHEBI:66993	tocolytic drugs

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

Disease	Relation	SNOMED_ID	DOID
Bronchitis	indication	32398004	DOID:6132
Tear film insufficiency	indication	46152009
Pulmonary emphysema	indication	87433001
Asthma	indication	195967001	DOID:2841
Skin irritation	indication	367466007
Asthma management	indication	406162001
Itching of skin	indication	418363000
Acute exacerbation of asthma	indication	708038006
Chronic Obstructive Pulmonary Disease with Bronchospasms	indication
Minor Skin Wound Pain	indication
Bronchospasm Prevention	indication
Premature labor	off-label use	6383007
Bronchiectasis	off-label use	12295008	DOID:9563
Keratoconjunctivitis sicca	off-label use	302896008	DOID:12895
Pulmonary edema	contraindication	19242006	DOID:11396
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypokalemia	contraindication	43339004
Conduction disorder of the heart	contraindication	44808001
Ketoacidosis	contraindication	56051008
Diabetes mellitus	contraindication	73211009	DOID:9351
Compression of umbilical cord	contraindication	79222000
Hyperglycemia	contraindication	80394007	DOID:4195
Decreased respiratory function	contraindication	80954004
Epilepsy	contraindication	84757009	DOID:1826
Open wound	contraindication	125643001
Seizure disorder	contraindication	128613002
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Myocardial ischemia	contraindication	414795007	DOID:3393
Placental abruption	contraindication	415105001
Denuded skin	contraindication	418242004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.48	acidic
pKa2	11.49	acidic
pKa3	12.74	acidic
pKa4	8.66	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Ki	5.60		WOMBAT-PK	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_BOVIN		Kd	5.40		CHEMBL

External reference:

ID	Source
4019941	VUID
N0000148026	NUI
D00688	KEGG_DRUG
23031-32-5	SECONDARY_CAS_RN
4018396	VANDF
4019941	VANDF
C0039542	UMLSCUI
CHEBI:9449	CHEBI
CHEMBL1760	ChEMBL_ID
DB00871	DRUGBANK_ID
CHEMBL1315867	ChEMBL_ID
CHEMBL1160544	ChEMBL_ID
D013726	MESH_DESCRIPTOR_UI
5403	PUBCHEM_CID
2616	INN_ID
560	IUPHAR_LIGAND_ID
N8ONU3L3PG	UNII
10368	RXNORM
41721	MMSL
5548	MMSL
d00752	MMSL
001812	NDDF
004731	NDDF
24583009	SNOMEDCT_US
372745006	SNOMEDCT_US
45311002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
TERBUTALINE SULFATE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-2611	TABLET	2.50 mg	ORAL	ANDA	23 sections
TERBUTALINE SULFATE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-2622	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9375	INJECTION	1 mg	SUBCUTANEOUS	ANDA	22 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9746	INJECTION	1 mg	SUBCUTANEOUS	ANDA	22 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9746	INJECTION	1 mg	SUBCUTANEOUS	ANDA	22 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9962	INJECTION, SOLUTION	1 mg	SUBCUTANEOUS	ANDA	11 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1311	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1318	TABLET	2.50 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-579	TABLET	2.50 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	10135-580	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	10271-101	INJECTION	1 mg	SUBCUTANEOUS	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	17478-933	INJECTION	1 mg	SUBCUTANEOUS	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	21695-121	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	21695-122	TABLET	2.50 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	24979-132	TABLET	2.50 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	24979-133	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	52584-665	INJECTION, SOLUTION	1 mg	SUBCUTANEOUS	ANDA	11 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0312	TABLET	2.50 mg	ORAL	ANDA	22 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	62559-721	TABLET	2.50 mg	ORAL	NDA authorized generic	22 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	62559-722	TABLET	5 mg	ORAL	NDA authorized generic	22 sections
Terbutaline Sulfate	Human Prescription Drug Label	1	63323-665	INJECTION, SOLUTION	1 mg	SUBCUTANEOUS	ANDA	13 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	67296-1053	TABLET	2.50 mg	ORAL	ANDA	13 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	71205-938	TABLET	2.50 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	71205-938	TABLET	2.50 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	71205-939	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	71205-939	TABLET	5 mg	ORAL	ANDA	23 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	71872-7080	INJECTION	1 mg	SUBCUTANEOUS	ANDA	22 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	71872-7130	INJECTION, SOLUTION	1 mg	SUBCUTANEOUS	ANDA	24 sections
Terbutaline Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	72843-101	INJECTION	1 mg	SUBCUTANEOUS	ANDA	23 sections