terbutaline 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 |
|---|---|
|
Synonyms:
|
A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic.
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 | 147.11 | 16.82 | 116 | 6813 | 91426 | 46587707 |
| Lactic acidosis | 72.30 | 16.82 | 51 | 6878 | 33858 | 46645275 |
| Wheezing | 52.02 | 16.82 | 51 | 6878 | 53335 | 46625798 |
| Dyspnoea | 44.50 | 16.82 | 172 | 6757 | 515376 | 46163757 |
| Squamous cell carcinoma of the oral cavity | 43.80 | 16.82 | 10 | 6919 | 302 | 46678831 |
| Bronchospasm | 36.68 | 16.82 | 25 | 6904 | 15682 | 46663451 |
| Shock haemorrhagic | 36.28 | 16.82 | 20 | 6909 | 8604 | 46670529 |
| Exposure during pregnancy | 35.28 | 16.82 | 60 | 6869 | 108152 | 46570981 |
| Acute kidney injury | 32.14 | 16.82 | 92 | 6837 | 235763 | 46443370 |
| Hyperlactacidaemia | 27.95 | 16.82 | 11 | 6918 | 2204 | 46676929 |
| Post viral fatigue syndrome | 27.64 | 16.82 | 6 | 6923 | 143 | 46678990 |
| Allergy to metals | 25.76 | 16.82 | 7 | 6922 | 435 | 46678698 |
| Cholestasis | 24.89 | 16.82 | 25 | 6904 | 26868 | 46652265 |
| Hepatocellular injury | 24.71 | 16.82 | 26 | 6903 | 29496 | 46649637 |
| Middle insomnia | 24.27 | 16.82 | 16 | 6913 | 9499 | 46669634 |
| Iodine allergy | 24.17 | 16.82 | 7 | 6922 | 549 | 46678584 |
| Tremor | 24.02 | 16.82 | 53 | 6876 | 115586 | 46563547 |
| Folate deficiency | 23.34 | 16.82 | 9 | 6920 | 1709 | 46677424 |
| Premature separation of placenta | 23.28 | 16.82 | 9 | 6920 | 1719 | 46677414 |
| Phlebectomy | 20.51 | 16.82 | 4 | 6925 | 55 | 46679078 |
| Haematoma | 19.74 | 16.82 | 24 | 6905 | 31848 | 46647285 |
| Eosinophilic granulomatosis with polyangiitis | 19.31 | 16.82 | 8 | 6921 | 1828 | 46677305 |
| Forced expiratory volume decreased | 19.20 | 16.82 | 11 | 6918 | 5093 | 46674040 |
| Cough | 19.05 | 16.82 | 76 | 6853 | 230173 | 46448960 |
| Maternal drugs affecting foetus | 18.40 | 16.82 | 11 | 6918 | 5507 | 46673626 |
| Fallopian tube disorder | 18.30 | 16.82 | 5 | 6924 | 317 | 46678816 |
| Eosinophilia | 18.03 | 16.82 | 18 | 6911 | 19199 | 46659934 |
| Nasal discharge discolouration | 17.60 | 16.82 | 7 | 6922 | 1441 | 46677692 |
| Forced expiratory volume abnormal | 17.55 | 16.82 | 4 | 6925 | 120 | 46679013 |
| Asthmatic crisis | 17.46 | 16.82 | 7 | 6922 | 1471 | 46677662 |
| Premature labour | 17.40 | 16.82 | 14 | 6915 | 11285 | 46667848 |
| Obstructive airways disorder | 17.30 | 16.82 | 15 | 6914 | 13397 | 46665736 |
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 | 116.14 | 18.20 | 69 | 4166 | 36105 | 29912138 |
| Wheezing | 48.66 | 18.20 | 38 | 4197 | 30900 | 29917343 |
| Dyspnoea | 45.79 | 18.20 | 126 | 4109 | 333169 | 29615074 |
| Exposure during pregnancy | 44.28 | 18.20 | 23 | 4212 | 9238 | 29939005 |
| Hyperkaliuria | 44.26 | 18.20 | 9 | 4226 | 163 | 29948080 |
| Wolff-Parkinson-White syndrome | 42.73 | 18.20 | 9 | 4226 | 195 | 29948048 |
| Agranulocytosis | 39 | 18.20 | 29 | 4206 | 21913 | 29926330 |
| Premature baby | 36.43 | 18.20 | 25 | 4210 | 16666 | 29931577 |
| Chest discomfort | 34.29 | 18.20 | 37 | 4198 | 45443 | 29902800 |
| Bronchospasm | 33.83 | 18.20 | 20 | 4215 | 10318 | 29937925 |
| Gastrointestinal mucosal necrosis | 32.92 | 18.20 | 7 | 4228 | 159 | 29948084 |
| Placental transfusion syndrome | 28.69 | 18.20 | 4 | 4231 | 4 | 29948239 |
| Unmasking of previously unidentified disease | 28.49 | 18.20 | 8 | 4227 | 590 | 29947653 |
| Forced expiratory volume decreased | 27.63 | 18.20 | 12 | 4223 | 3238 | 29945005 |
| Cholestasis | 27.54 | 18.20 | 25 | 4210 | 24925 | 29923318 |
| Pulmonary valve stenosis | 27.35 | 18.20 | 7 | 4228 | 362 | 29947881 |
| Penile erythema | 27.22 | 18.20 | 6 | 4229 | 162 | 29948081 |
| Respiratory distress | 26.92 | 18.20 | 28 | 4207 | 32944 | 29915299 |
| Meralgia paraesthetica | 26.64 | 18.20 | 6 | 4229 | 179 | 29948064 |
| Nasal inflammation | 25.11 | 18.20 | 6 | 4229 | 233 | 29948010 |
| Foetal distress syndrome | 24.51 | 18.20 | 8 | 4227 | 983 | 29947260 |
| Middle insomnia | 23.82 | 18.20 | 13 | 4222 | 5760 | 29942483 |
| Ductus arteriosus premature closure | 23.79 | 18.20 | 5 | 4230 | 107 | 29948136 |
| Obstructive airways disorder | 23.21 | 18.20 | 15 | 4220 | 9044 | 29939199 |
| Lactic acidosis | 22.82 | 18.20 | 25 | 4210 | 31188 | 29917055 |
| Prothrombin time ratio decreased | 22.62 | 18.20 | 6 | 4229 | 357 | 29947886 |
| Heart rate increased | 21.61 | 18.20 | 27 | 4208 | 38694 | 29909549 |
| Stillbirth | 21.16 | 18.20 | 5 | 4230 | 185 | 29948058 |
| Accelerated idioventricular rhythm | 20.44 | 18.20 | 4 | 4231 | 59 | 29948184 |
| Interstitial lung disease | 20.30 | 18.20 | 33 | 4202 | 60164 | 29888079 |
| Clonic convulsion | 20.26 | 18.20 | 6 | 4229 | 535 | 29947708 |
| Atrial septal defect | 19.43 | 18.20 | 12 | 4223 | 6689 | 29941554 |
| Gastrointestinal oedema | 18.55 | 18.20 | 7 | 4228 | 1316 | 29946927 |
| Patent ductus arteriosus | 18.46 | 18.20 | 9 | 4226 | 3160 | 29945083 |
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 receptor agonist |
| CHEBI has role | CHEBI:35523 | bronchodilator agents |
| CHEBI has role | CHEBI:35524 | sympathomimetic |
| CHEBI has role | CHEBI:35526 | hypoglycemic drug |
| CHEBI has role | CHEBI:38462 | acetylcholinesterase inhibitors |
| CHEBI has role | CHEBI:49167 | anti-asthmatic agents |
| CHEBI has role | CHEBI:66993 | anti-contraction drug |
Drug Use (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 |
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 | AGONIST | Ki | 5.60 | WOMBAT-PK | CHEMBL | |||
| Beta-2 adrenergic receptor | GPCR | 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 |
| CHEMBL1160544 | ChEMBL_ID |
| CHEMBL1315867 | ChEMBL_ID |
| D013726 | MESH_DESCRIPTOR_UI |
| 5403 | PUBCHEM_CID |
| 2616 | INN_ID |
| DB00871 | DRUGBANK_ID |
| N8ONU3L3PG | UNII |
| 560 | IUPHAR_LIGAND_ID |
| 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 | 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 | 71205-939 | 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 |