Bethanechol
/api/v1/drug/bethanecholMechanism of action
Sourced from openFDAMechanism-of-action class: Cholinergic Muscarinic Agonists.
Indications
Sourced from openFDA- Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
Contraindications
Sourced from openFDA- Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism. Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.contraindicated
Dosage & administration
Sourced from openFDADosage must be individualized, depending on the type and severity of the condition to be treated. Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur. The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour. If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE ).
Adverse reactions
Sourced from openFDAAdverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased. The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating; Respiratory: bronchial constriction, asthmatic attacks; Special Senses: lacrimation, miosis. Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a whole: malaise; Nervous System: seizures. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Overdosage
Sourced from openFDAEarly signs of overdosage are abdominal discomfort, salivation, flushing of the skin (“hot feeling”), sweating, nausea, and vomiting. Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed. The oral LD 50 of bethanechol chloride is 1510 mg/kg in the mouse.
Approval history
Sourced from openFDA- Jun 1, 2005ANDAANDA040633Upsher Smith Labs
- Jun 1, 2005ANDAANDA040634Upsher Smith Labs
- Jun 1, 2005ANDAANDA040635Upsher Smith Labs
- Jun 1, 2005ANDAANDA040636Upsher Smith Labs
- Oct 26, 2007ANDAANDA040728Chartwell Rx
- Nov 21, 2007ANDAANDA040855Amneal Pharm
- May 4, 2010ANDAANDA091256Heritage Pharma
Literature
Recent PubMed references pinned to Bethanechol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Physicochemical and Microbiological Stability of Compounded Bethanechol Chloride Oral Suspensions in PCCA Base, SuspendIt®.International journal of pharmaceutical compounding · 2024 · Pramar YV, Davis C, Ip K, et al.PMID 39094044
- Efficacy of bethanechol chloride in the treatment of radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2023 · Moral Nakamura D, da Graça Pinto H, Baena Elchin C, et al.PMID 37207874DOI 10.1016/j.radonc.2023.109715
- The beneficial effects of a muscarinic agonist on pancreatic β-cells.Scientific reports · 2019 · Ito Y, Kaji M, Sakamoto E, et al.PMID 31700039DOI 10.1038/s41598-019-52691-8
- Bethanechol as a Corrective for Urinary Retention Associated With Olanzapine Administration.The primary care companion for CNS disorders · 2019 · Greco FA, Simms NJ, Athappilly GK, et al.PMID 31682336DOI 10.4088/PCC.19l02429
- Bethanechol: Is it still being prescribed for bladder dysfunction in women?International journal of clinical practice · 2019 · Gaitonde S, Malik RD, Christie AL, et al.PMID 30112787DOI 10.1111/ijcp.13248
- Solitary Cholinergic Stimulation Induces Airway Hyperreactivity and Transcription of Distinct Pro-inflammatory Pathways.Lung · 2018 · Reznikov LR, Meyerholz DK, Kuan SP, et al.PMID 29380034DOI 10.1007/s00408-018-0091-0
- Identification of Drug Candidates to Suppress Cigarette Smoke-induced Inflammation via Connectivity Map Analyses.American journal of respiratory cell and molecular biology · 2018 · Vanderstocken G, Dvorkin-Gheva A, Shen P, et al.PMID 29256623DOI 10.1165/rcmb.2017-0202OC
- Salt, sweat, and unclear? Diaphoresis and hypernatremia in end-stage kidney disease: Questions.Pediatric nephrology (Berlin, Germany) · 2018 · Levy Erez D, Copelovitch L, Denburg M, et al.PMID 28451894DOI 10.1007/s00467-017-3667-7
Clinical trials
The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Bethanechol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic AdenocarcinomaRecruiting · Phase 2 · Interventional · 37 enrolled · Susan E. BatesNCT05241249updated 2025-06-05
- Bethanechol Prior to Pancreatic SurgeryCompleted · Early phase 1 · Interventional · 17 enrolled · Columbia UniversityNCT03572283updated 2025-06-05
- The Effect of Bethanechol on TracheobronchomalaciaUnknown · Observational · 20 enrolled · Arkansas Children's Hospital Research InstituteNCT05299008updated 2024-01-30
- Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIACompleted · Phase 4 · Interventional · 56 enrolled · Department of Medical Services Ministry of Public Health of ThailandNCT02910596updated 2020-10-23
- The Effects of Bethanechol on Glucose HomeostasisCompleted · Phase 1 · Interventional · 50 enrolled · Washington University School of MedicineNCT01434901updated 2018-05-08
- Bethanechol for Eosinophilic EsophagitisTerminated · Phase 2 · Interventional · 2 enrolled · University of IowaNCT02058537updated 2016-04-22
- Topical Bethanechol for Improvement of Esophageal DysmotilityCompleted · Phase 1 · Interventional · 5 enrolled · Augusta UniversityNCT01031043updated 2015-01-29
Frequently asked questions
- How does Bethanechol work?
- Mechanism-of-action class: Cholinergic Muscarinic Agonists.
- What is Bethanechol used for?
- According to FDA labeling, Bethanechol carries indications including: Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Bethanechol?
- Bethanechol is classified as Choline esters, Cholinergic Muscarinic Agonist, Cholinergic Muscarinic Agonists, Increased Bladder Contractility, Increased GI Smooth Muscle Tone, Stimulation Gastric Mucous Secretion, Stimulation Pancreatic Enzymatic Secretion, Stimulation Pancreatic Fluid/Electrolyte Secretion.
- What are the contraindications for Bethanechol?
- Bethanechol labeling lists contraindications including: Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism. Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.. Always consult the full prescribing information and a clinician.
bethanechol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.