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What Is the Most Common Side Effect of Domperidone?

5 min read

According to the UK's National Health Service, more than 1 in 100 people who take domperidone will experience a dry mouth, establishing this as the most common side effect of domperidone. This typically mild and temporary condition is a frequent occurrence for individuals using this prokinetic medication.

Quick Summary

Dry mouth is the most common side effect of domperidone, a prokinetic medication used to treat nausea and gastrointestinal issues. Other potential effects include headaches, fatigue, and abdominal cramps. Serious, but rarer, risks involve cardiovascular complications and hormonal changes, requiring adherence to prescribed instructions and medical supervision.

Key Points

  • Dry Mouth is Most Common: The most frequent side effect of domperidone, occurring in over 1 in 100 users, is a dry mouth (xerostomia), which is usually mild and temporary.

  • Serious Cardiac Risks: Domperidone is associated with rare but serious cardiovascular side effects, including QT prolongation, arrhythmia, cardiac arrest, and sudden death, especially at higher quantities or in patients over 60.

  • Quantity-Dependent Risk: The risk of serious side effects is higher with higher daily quantities and in conjunction with certain other medications.

  • Hormonal Effects are Possible: As a dopamine antagonist, domperidone can increase prolactin levels, leading to side effects like galactorrhea, breast tenderness, and menstrual irregularities.

  • Not FDA Approved in the US: Due to safety concerns, particularly cardiac risks, domperidone is not approved for any human use by the FDA in the United States.

  • Management is Crucial: Management of domperidone should involve using the lowest effective quantity for the shortest duration, monitoring for heart-related symptoms, and avoiding specific drug interactions.

In This Article

Before taking any medication, including domperidone, it is important to consult with a healthcare professional. The information provided here is for general knowledge and should not be taken as medical advice.

Domperidone is a dopamine receptor antagonist widely used as a prokinetic agent and antiemetic to treat symptoms such as nausea, vomiting, and feelings of fullness from gastroparesis. It works by blocking dopamine receptors in the gut and the chemoreceptor trigger zone in the brainstem, thereby promoting gastrointestinal motility and reducing nausea. Its peripheral action, with minimal crossing of the blood-brain barrier at standard usage, generally leads to fewer central nervous system (CNS) side effects compared to other dopamine antagonists like metoclopramide. However, like all medications, domperidone carries a risk of side effects, ranging from the very common and mild to more rare and serious adverse events.

The Most Common Adverse Reaction: Dry Mouth

Clinical data consistently indicates that the most common adverse effect of domperidone is a dry mouth, also known as xerostomia. This side effect is reported in more than 1 in 100 people and is typically mild, resolving on its own over time. For most patients, this is an annoyance rather than a serious health concern. Simple measures can help manage this discomfort, such as chewing sugar-free gum or sucking on sugar-free sweets to stimulate saliva production. Staying well-hydrated throughout the day can also help to alleviate the symptoms of dry mouth.

Other Common and Less Common Side Effects

Beyond dry mouth, domperidone users may experience a variety of other side effects. These can be grouped into different categories, though their frequency is generally lower than that of xerostomia.

Commonly reported side effects include:

  • Headache
  • Abdominal cramping
  • Drowsiness or fatigue
  • Anxiety
  • Diarrhea
  • Skin rash or itching

These symptoms are often manageable and may subside as the body adjusts to the medication. However, if any of these side effects become persistent or bothersome, it is important to discuss them with a healthcare provider.

Serious Side Effects and Cardiovascular Risk

While less common, domperidone is associated with more serious risks, particularly affecting the cardiovascular system. The US Food and Drug Administration (FDA) has issued warnings regarding the potential for serious cardiac adverse events.

Serious risks include:

  • Cardiac arrhythmia: Irregular heartbeats, which can be life-threatening.
  • QT prolongation: A change in the heart's electrical activity that can be detected on an electrocardiogram (ECG) and can lead to a dangerous heart rhythm called Torsade de Pointes.
  • Cardiac arrest and sudden death: These are rare but have been reported, especially with higher quantities or in vulnerable individuals.

The risk of cardiac side effects is higher in people over 60 years old, those using higher daily quantities, or individuals with pre-existing heart conditions. Several regulatory bodies worldwide, including the European Medicines Agency (EMA), have introduced restrictions on the amount and duration of use to mitigate these risks. For instance, domperidone should be used at the lowest effective quantity for the shortest possible duration. It is also crucial to avoid concomitant use with other medications that prolong the QT interval or inhibit the CYP3A4 enzyme, as this can increase the concentration of domperidone in the body.

Hormonal Side Effects: The Role of Prolactin

Domperidone's dopamine-blocking effect also impacts prolactin levels, a hormone involved in milk production. Since the pituitary gland, which produces prolactin, is outside the blood-brain barrier, domperidone can increase prolactin levels. This effect is sometimes leveraged off-label to increase breast milk supply, but it can also cause unintended hormonal side effects.

Hormonal side effects include:

  • Galactorrhea: The production and discharge of breast milk in both men and women.
  • Gynecomastia: Breast enlargement in men.
  • Breast pain or tenderness: Affecting both men and women.
  • Menstrual irregularities: Irregular periods or even cessation of menstruation (amenorrhea) in women.
  • Decreased libido: Reduced sexual desire.

These side effects are typically reversible upon discontinuation of the medication.

Comparison of Domperidone vs. Metoclopramide Side Effects

Domperidone and metoclopramide are both dopamine antagonists used for gastrointestinal issues, but their side effect profiles differ due to their ability to cross the blood-brain barrier.

Side Effect Category Domperidone Metoclopramide
Central Nervous System (CNS) Minimally crosses the blood-brain barrier; fewer CNS effects like drowsiness, anxiety, or extrapyramidal symptoms at standard usage. Crosses the blood-brain barrier more readily; higher risk of CNS side effects including drowsiness, restlessness, anxiety, and extrapyramidal symptoms.
Cardiovascular Associated with a quantity-dependent risk of QT prolongation and potential serious cardiac events, particularly in high-risk patients. Can also cause cardiovascular effects, but the risk profile differs; generally considered to have a different cardiac safety profile.
Hormonal (Prolactin) Increases prolactin levels, which can lead to galactorrhea, breast tenderness, and menstrual irregularities. Also increases prolactin levels, with similar potential for hormonal side effects.
Gastrointestinal Common side effects include dry mouth, abdominal cramps, and diarrhea. Common side effects include diarrhea and nausea.

Regulatory Status and Safety Precautions

Domperidone’s availability and approved uses vary significantly across the globe. It is not approved by the FDA for any human use in the United States due to the cardiac risks. In contrast, it is available by prescription in many countries, such as Canada, the UK, and Australia, and over-the-counter in others like Mexico and Italy, albeit with specific restrictions on the quantity and duration.

Given the potential for serious cardiac side effects, especially at higher quantities and in certain patient populations, several precautions are necessary when taking domperidone:

  • Adherence to prescribed quantity: Never exceed the recommended quantity.
  • Limited duration of use: Treatment is typically for a short period.
  • Avoid high-risk populations: Use with caution or avoid in elderly patients, those with heart conditions, or existing electrolyte imbalances.
  • Monitor drug interactions: Inform your doctor of all other medications, especially CYP3A4 inhibitors (certain antibiotics and antifungals) or other QT-prolonging drugs.
  • Report symptoms promptly: Seek immediate medical attention if you experience palpitations, dizziness, or fainting.

For more information on the FDA's position regarding domperidone, consult their official information page.

Conclusion: Navigating Domperidone's Side Effects

Dry mouth stands out as the most common side effect associated with domperidone, a typically mild and manageable inconvenience for most users. However, patients and healthcare providers must not overlook the other potential adverse reactions, ranging from headaches and gastrointestinal upset to more serious hormonal and cardiovascular issues. Strict adherence to prescribing guidelines, which often include using the lowest effective quantity for the shortest duration, is critical for mitigating serious cardiac risks. The varying regulatory status of domperidone across different countries underscores the need for patient awareness and informed discussion with a healthcare provider to ensure safe and effective treatment.

Frequently Asked Questions

Dry mouth, while the most common side effect of domperidone, is generally not considered serious. It is typically mild and often goes away on its own. Chewing sugar-free gum or sucking on sugar-free sweets can help alleviate the discomfort.

Yes, domperidone is associated with rare but serious heart-related side effects, including QT prolongation, arrhythmia, and cardiac arrest. This risk is higher with higher daily quantities, in patients over 60, and those with pre-existing heart conditions.

The US Food and Drug Administration (FDA) has not approved domperidone for human use due to concerns over its cardiac risks, including arrhythmia and sudden death. The FDA has issued warnings, particularly regarding its unapproved use for increasing breast milk production.

Domperidone increases the level of the hormone prolactin by blocking dopamine receptors. Elevated prolactin can cause hormonal side effects such as galactorrhea (unusual milk production), breast enlargement in men (gynecomastia), breast tenderness, and menstrual irregularities in women.

Yes, domperidone is metabolized by the CYP3A4 enzyme, so combining it with drugs that inhibit this enzyme (like certain antifungals and antibiotics) can increase the risk of serious side effects. It should also be avoided with other medications that prolong the QT interval.

Most mild and common side effects, such as dry mouth or headache, may improve as your body adjusts to the medication or after discontinuation. More serious side effects, including hormonal or cardiac issues, may require immediate medical attention.

Following regulatory changes in many countries, the typical recommended maximum daily quantity for domperidone has been adjusted to minimize the risk of serious cardiac events.

References

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Medical Disclaimer

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