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What are the side effects of cevimeline?

4 min read

Sjögren's syndrome affects an estimated 0.5% to 1.0% of the population, often causing significant dry mouth (xerostomia) [1.7.2]. A key question for those prescribed treatment is, what are the side effects of cevimeline?

Quick Summary

Cevimeline is a medication for dry mouth in Sjögren's syndrome. Common side effects include sweating, nausea, and runny nose. Serious effects can involve heart rhythm changes, breathing issues, and vision problems.

Key Points

  • Primary Use: Cevimeline (Evoxac) is prescribed to treat dry mouth (xerostomia) in adults with Sjögren's syndrome by increasing saliva production [1.8.1, 1.8.2].

  • Common Side Effects: The most frequent side effects are excessive sweating, nausea, headache, and a runny nose [1.2.3].

  • Serious Risks: Serious side effects can include heart rhythm changes, breathing difficulties, severe allergic reactions, and vision problems, especially at night [1.2.2, 1.4.3].

  • Contraindications: The drug should not be used by people with uncontrolled asthma, narrow-angle glaucoma, or acute iritis [1.4.2].

  • Important Precautions: Patients should stay well-hydrated to avoid dehydration from sweating and use caution when driving at night due to potential vision changes [1.5.1, 1.5.2].

  • Medical History is Key: Before taking cevimeline, inform your doctor about any history of heart disease, lung conditions (like asthma), or kidney/gallbladder stones [1.4.2].

  • Alternative Medication: Pilocarpine is a similar drug used for the same purpose; the choice between them depends on patient-specific factors and physician judgment [1.6.1].

In This Article

Understanding Cevimeline and Its Purpose

Cevimeline, sold under the brand name Evoxac, is a prescription medication primarily used to treat the symptoms of dry mouth, a condition known as xerostomia, in patients with Sjögren's syndrome [1.8.1, 1.8.2]. Sjögren's syndrome is a chronic autoimmune disorder where the body's immune system attacks its own moisture-producing glands, leading to dryness in the mouth and eyes [1.3.7, 1.8.2]. Cevimeline belongs to a class of drugs called cholinergic agonists. It works by binding to and stimulating specific proteins called muscarinic receptors (M1 and M3) located on salivary glands. This action increases the production and secretion of saliva, helping to alleviate the discomfort and complications associated with a dry mouth, such as difficulty speaking and swallowing [1.3.1, 1.3.5, 1.8.2]. The typical dosage is a 30 mg capsule taken three times a day [1.8.1].

Common Side Effects of Cevimeline

Like all medications, cevimeline can cause side effects. Many users experience mild to moderate side effects, which are often related to the drug's mechanism of increasing bodily secretions. According to clinical data, the most frequently reported side effects include:

  • Excessive Sweating: This is one of the most common side effects, reported in up to 19% of patients in some studies [1.2.3].
  • Nausea: Approximately 14% of users may experience nausea [1.2.3].
  • Headache: This side effect occurs in about 14% of individuals taking the medication [1.2.3].
  • Runny Nose (Rhinitis): About 11-12% of patients report a runny or stuffy nose [1.2.3, 1.2.2].
  • Diarrhea: Experienced by around 10% of users [1.2.3].
  • Other common effects: Less frequent but still common side effects can include flushing, frequent urination, stomach discomfort, coughing, and visual changes like blurred vision [1.2.3, 1.2.4].

These effects are generally dose-related and may decrease as the body adjusts to the medication. It's often recommended to take cevimeline with food to help reduce gastrointestinal side effects [1.3.2].

Serious Side Effects and When to Seek Medical Attention

While less common, cevimeline can cause serious side effects that require immediate medical attention. It is crucial to be aware of these potential risks. Stop taking cevimeline and contact a healthcare provider right away if you experience any of the following:

  • Cardiovascular Effects: The drug can alter cardiac conduction and heart rate. Symptoms like a fast, slow, or irregular heartbeat, chest pain, dizziness, or fainting can indicate a serious heart rhythm change [1.2.2, 1.4.3]. Patients with a history of significant cardiovascular disease, such as angina or myocardial infarction, should use this medication with caution and under close medical supervision [1.4.3].
  • Pulmonary Issues: Cevimeline can increase airway resistance and bronchial secretions, which may lead to breathing difficulties [1.4.3]. People with controlled asthma, chronic bronchitis, or COPD should be closely monitored. Uncontrolled asthma is a contraindication for its use [1.4.2, 1.4.3]. Symptoms to watch for include a new or worsening cough, shortness of breath, and chest tightness [1.2.2].
  • Vision Problems: The medication can cause blurred vision and difficulty with night vision or seeing in low light [1.2.1, 1.4.1]. Caution is advised when driving at night or performing other tasks that require clear sight [1.5.1]. It is contraindicated in patients with conditions where pupil constriction (miosis) is undesirable, such as acute iritis and narrow-angle glaucoma [1.4.2].
  • Dehydration: Due to excessive sweating, there's a risk of dehydration. Symptoms include feeling very thirsty or hot, being unable to urinate, and hot, dry skin [1.4.2, 1.5.1]. It is important to drink plenty of fluids to prevent this complication [1.5.1].
  • Allergic Reactions: Signs of a severe allergic reaction include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat [1.4.2].
  • Kidney or Gallbladder Problems: Patients with a history of kidney stones (nephrolithiasis) or gallstones (cholelithiasis) should use cevimeline with caution. The drug can cause muscle contractions that could lead to complications like renal colic or biliary obstruction [1.4.3]. Symptoms like severe stomach or back pain, bloody or cloudy urine, or yellowing of the skin or eyes warrant immediate medical consultation [1.2.1].

Comparison with Pilocarpine

Pilocarpine is another cholinergic agonist used to treat dry mouth. Both medications work similarly and have comparable common side effects like sweating, flushing, and urinary frequency [1.6.1].

Feature Cevimeline (Evoxac) Pilocarpine (Salagen)
Mechanism More selective for M1 and M3 muscarinic receptors [1.3.5]. Less selective muscarinic agonist [1.6.5].
Dosage Typically 30 mg, three times daily [1.8.1]. Typically 5 to 7.5 mg, three to four times daily [1.6.5].
Duration Longer duration of action (3 to 4 hours) [1.6.5]. Shorter duration of action (2 to 3 hours) [1.6.5].
Side Effects Both have similar side effect profiles [1.6.3]. Some studies suggest pilocarpine may cause a higher incidence of severe sweating [1.6.4]. Common side effects include sweating, nausea, and flushing [1.6.1].
Indications Approved for dry mouth in Sjögren's syndrome [1.8.6]. Approved for Sjögren's and dry mouth from radiation therapy [1.8.6].

Some studies have found no significant difference in the efficacy or side effects between the two drugs [1.6.3, 1.6.6]. The choice between them often depends on the physician's experience and the patient's individual medical history and tolerance [1.6.1].

Conclusion

Cevimeline is an effective medication for managing the debilitating symptom of dry mouth in patients with Sjögren's syndrome by stimulating saliva production [1.3.7]. However, it is accompanied by a range of potential side effects. The most common, such as sweating and nausea, are generally manageable. Patients must remain vigilant for more serious adverse effects, particularly those affecting the heart, lungs, and eyes, and seek immediate medical help if they occur. Before starting treatment, it's essential to discuss your full medical history with your healthcare provider, including any history of heart, lung, kidney, or eye conditions, to ensure the benefits of cevimeline outweigh the risks [1.4.2].


For more detailed information, consult the official documentation provided by the U.S. National Library of Medicine. [https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=773a19e8-4c3e-4414-99a6-aea98c9790ee] [1.4.3]

Frequently Asked Questions

The most commonly reported side effect of cevimeline is excessive sweating, which was noted in up to 19% of patients in clinical studies [1.2.3].

Yes, cevimeline can potentially alter your heart rate and rhythm. You should contact your doctor immediately if you experience a fast, slow, or irregular heartbeat, chest pain, or dizziness [1.2.2, 1.4.3].

Cevimeline may cause blurred vision or decreased visual acuity, especially at night. It is recommended to use caution when driving at night or performing other activities that require clear vision until you know how the medication affects you [1.5.1, 1.5.2].

You should not take cevimeline if you have uncontrolled asthma, narrow-angle glaucoma, or an eye condition called acute iritis, as the medication can worsen these conditions [1.4.2, 1.4.3].

To manage side effects, take cevimeline as prescribed, possibly with food to reduce nausea [1.3.2]. Drink plenty of fluids to prevent dehydration from sweating [1.5.1]. If side effects are bothersome or severe, contact your healthcare provider [1.2.2].

Both are medications for dry mouth. Cevimeline has a longer duration of action and is more selective in its mechanism [1.6.5]. While studies show they have similar efficacy and side effect profiles, the choice depends on the individual patient and physician preference [1.6.1, 1.6.3].

An overdose of cevimeline can cause symptoms like headache, vision problems, excessive sweating, breathing trouble, and irregular heartbeats. Seek emergency medical attention or call a poison control center immediately [1.4.2].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.