Glycopyrrolateside effects

glycopyrrolate 1 MG Oral Tablet

Adverse reactions

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

Precipitation of Acute Glaucoma

Partial or Complete Mechanical Intestinal Obstruction

Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility

Cognitive and Visual Adverse Reactions

Heat Prostration at High Environmental Temperatures

Other Conditions Exacerbated by Anticholinergic Adverse Reactions

Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients The following adverse reactions associated with the use of glycopyrrolate, or other anticholinergic drugs, were identified in clinical studies or postmarketing reports. Because some of 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. Cardiac Disorders: chest, pain, hypertension, tachycardia Endocrine Disorders: decreased sweating Eye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension Gastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting Immune System Disorders: anaphylaxis Nervous System Disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness Respiratory Disorders: respiratory depression, throat irritation Renal and Urinary Disorders: urinary hesitancy, urinary retention Reproductive System and Breast Disorders: impotence, suppression of lactation Vascular Disorders: flushing Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 17, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Warnings

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of glycopyrrolate. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomyor colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful. Glycopyrrolate may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug. Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis. Pregnancy The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed. Nursing Mothers It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. Pediatric Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

Contraindications

Glycopyrrolate are contraindicated in:

Patients at risk for anticholinergic toxicity due to an underlying medical condition, including: o Glaucoma o Obstructive uropathies, including prostatic hypertrophy o Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) o Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) o Bleeding gastrointestinal ulcer o Active inflammatory or infectious colitis which can lead to toxic megacolon o History of or current toxic megacolon o Myasthenia gravis

Patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in glycopyrrolate.

Patients at risk for anticholinergic toxicity due to various underlying medical conditions.

Hypersensitivity to glycopyrrolate or the inactive ingredients.

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