Atropine

Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists.

• & USAGE Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

• None.contraindicated

DOSAGE & ADMINISTRATION 2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each vial is intended for single dose only. Discard unused portion. For Intravenous administration. Titrate based on heart rate, PR interval, blood pressure and symptoms. 2.2 Adult Dosage 2.3 Pediatric Dosage Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 to 0.03 mg/kg. 2.4 Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 to 0.04 mg/kg [see WARNINGS AND PRECAUTIONS (5.1 )]. DOSAGE

5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. 5.5 Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.

The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.

USE IN SPECIFIC POPULATION 8.1 Pregnancy Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations). Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Animal reproduction studies have not been conducted with atropine. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3) ]. No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation.

Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal. In the event of toxic overdosage, a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required.

• Sep 15, 1960NDANDA012462Pfizer
• May 15, 1973NDANDA017106Mmt
• Jul 14, 1978NDANDA017744Legacy Pharma
• Jul 9, 2001NDANDA021146Hospira
• Jan 17, 2002NDANDA021175Us Army
• Sep 28, 2006NDANDA021983Mmt
• Dec 1, 2016NDANDA208151Alcon Labs Inc
• Jan 26, 2018NDANDA209260Fresenius Kabi Usa

1. 1Diarrhoea3,44913%
2. 2Nausea2,2818.7%
3. 3Fatigue2,0267.7%
4. 4Drug Ineffective1,9977.6%
5. 5Off Label Use1,4845.7%
6. 6Death1,4585.6%
7. 7Vomiting1,4225.4%
8. 8Pain1,3195.0%
9. 9Dyspnoea1,1974.6%
10. 10Weight Decreased1,0974.2%
11. 11Abdominal Pain1,0444.0%
12. 12Asthenia1,0404.0%
13. 13Headache1,0203.9%
14. 14Pyrexia9913.8%
15. 15Dehydration9453.6%

Recent PubMed references pinned to Atropine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Pediatric oral cavity physiologically based pharmacokinetic model to predict pharmacokinetics of mucoadhesive atropine gel to treat sialorrhea.
  Journal of pharmacokinetics and pharmacodynamics · 2026 · Parrot M, Murphy N, Rower JE, et al.
  PMID 42243578DOI 10.1007/s10928-026-10039-6
• Acceptability of Atropine Eyedrops Administered Sublingually for Sialorrhea Treatment Related to Neurological Conditions.
  Pharmacology research & perspectives · 2026 · Michelon H, Lefèvre-Dognin C, Paquereau J, et al.
  PMID 42170793DOI 10.1002/prp2.70250
• Exploring the role of low-dose atropine in myopia management in children with inherited retinal diseases.
  Optometry and vision science : official publication of the American Academy of Optometry · 2026 · Azmon R, Kreindler A, Ezra Kahtan B, et al.
  PMID 42087059DOI 10.1002/ovs2.70053
• LQT1 patients have augmented response of repolarization dispersion following atropine induced heart rate increase versus healthy controls.
  Physiological reports · 2026 · Dahlberg P, Axelsson KJ, Jensen SM, et al.
  PMID 42036388DOI 10.14814/phy2.70889
• Control of myopia progression by low-dose atropine (0.01%, 0.025% and 0.05%), defocus incorporated multiple segments/highly aspherical lenslets spectacles, and combined therapy in European children: A 3-year retrospective study.
  Optometry and vision science : official publication of the American Academy of Optometry · 2026 · Grégoire M, Dormegny L, Gaucher D, et al.
  PMID 42020349DOI 10.1002/ovs2.70007
• Effectiveness of Low-Dose Atropine Combined With Bright Light Therapy for Controlling Myopic Eye Growth in Schoolchildren: Study Protocol for a Randomized Controlled Trial.
  JMIR research protocols · 2026 · Tse DY, Ma MM, Hon Y, et al.
  PMID 41973601DOI 10.2196/90893
• Atropine Eye Drops in Childhood Myopia Control: A Review.
  International journal of medical sciences · 2026 · Zhu Q, Chen Y, Li X, et al.
  PMID 41938514DOI 10.7150/ijms.126651
• [The use of 'Caucasian' in medical studies: Ethical, legal and scientific perspectives using the example of the ophthalmological Low-dose AtropIne for Myopia Control in Children (AIM) study].
  Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen · 2026 · Kaymak H, Seitz B
  PMID 41934059DOI 10.1016/j.zefq.2026.02.003

The 10 most recently updated of 500 ClinicalTrials.gov registrations naming Atropine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer
  Not yet recruiting · Phase 2 · Interventional · 120 enrolled · Tianjin Medical University Cancer Institute and Hospital
  NCT07358689updated 2026-06-12
• Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression
  Completed · Phase 3 · Interventional · 95 enrolled · Khyber Medical College, Peshawar
  NCT07626892updated 2026-06-10
• Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome
  Recruiting · Interventional · 258 enrolled · Beijing Tiantan Hospital
  NCT07635394updated 2026-06-09
• Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
  Completed · Phase 3 · Interventional · 233 enrolled · University Hospital, Grenoble
  NCT04016246updated 2026-06-09
• Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor
  Completed · Interventional · 60 enrolled · Indonesia University
  NCT06764667updated 2026-06-08
• Minimal Flow Anesthesia and Infection Risk
  Completed · Interventional · 140 enrolled · Ankara City Hospital Bilkent
  NCT07092046updated 2026-06-05
• 0.01% and 0.025% Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change
  Enrolling by invitation · Interventional · 420 enrolled · China Medical University Hospital
  NCT07537166updated 2026-06-04
• A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
  Recruiting · Phase 3 · Interventional · 348 enrolled · Jaeb Center for Health Research
  NCT07095894updated 2026-06-04
• Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children
  Completed · Interventional · 210 enrolled · University of Faisalabad
  NCT07614113updated 2026-05-29
• Safety and Accuracy of Regadenoson-Atropine Stress Echocardiography in CAD
  Terminated · Interventional · 45 enrolled · Henry Ford Health System
  NCT00894179updated 2026-05-22

Frequently asked questions

How does Atropine work?

Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists.

What is Atropine used for?

According to FDA labeling, Atropine carries indications including: & USAGE Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Atropine?

Atropine is classified as Anticholinergics, Belladonna alkaloids, tertiary amines, Anticholinergic, Cholinergic Muscarinic Antagonist, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Decreased Parasympathetic Acetylcholine Activity, Decreased Respiratory Secretions, Positive Chronotropy, Pupillary Dilation, Salivation Inhibition.

What are the brand names for Atropine?

Atropine is marketed under brand names including Atropen, Donnatal, Duodote, Isopto Atropine, Lomotil, Motofen, Phenohytro.

What are the contraindications for Atropine?

Atropine labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.