According to the Centers for Disease Control and Prevention (CDC), nearly half of American adults have high blood pressure. Medications are commonly used to control blood pressure to reduce the risk of cardiovascular-related diseases, such as heart attack, stroke, and kidney failure.
While effective, medications come with potential side effects. According to the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), adverse drug reactions are common. In this article, we will specifically discuss the safety profile of amlodipine, a medication commonly prescribed to lower blood pressure, to help patients make informed decisions about their treatment alongside their healthcare providers.
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What's Amlodipine?
Amlodipine is an FDA-approved medication for treating high blood pressure and coronary artery disease. It belongs to a class of drugs called calcium channel blockers (CCBs).
How Amlodipine Works in the Body
Calcium is needed for the muscles that surround blood vessels to contract. Amlodipine blocks calcium channels and, therefore, calcium entry into these cells. This lowers blood pressure by allowing the vessels to vasodilate (widen), which improves blood flow, reduces the heart's workload, and lowers blood pressure.
Common Uses of Amlodipine
Patients may take amlodipine for any of the following reasons:
FDA-Approved Indications
- Hypertension: High blood pressure
- Chronic Stable Angina: chest pain that occurs when the heart muscle does not receive enough oxygen
- Vasospastic Angina: a type of chest pain caused by a sudden narrowing of the coronary arteries due to spasms
- Coronary Artery Disease: the arteries that supply blood to the heart become narrowed or blocked
Off-Label Uses
- Diabetic Nephropathy: a type of kidney disease that occurs as a complication of diabetes mellitus
- Left Ventricular Hypertrophy: a heart condition in which the left ventricle (the heart's main pumping chamber) becomes thickened and enlarged
- Raynaud Phenomenon: excessive constriction of small blood vessels that restricts blood flow to the fingertips and toes
- Silent Myocardial Ischemia: Asymptomatic restriction of blood flow to the heart
- Group 1 Pulmonary Arterial Hypertension: a type of high blood pressure caused by the narrowing or blockage of blood vessels in the lungs
- Microvascular Angina: a type of chest pain that occurs from dysfunction of the smallest blood vessels that supply the heart muscle
- Kidney Transplant Recipients: amlodipine may be recommended as an antihypertensive agent for patients who have received a kidney transplant due to research suggesting it may protect the kidneys against immunosuppressive agents like cyclosporine
Common Side Effects of Amlodipine
Amlodipine's safety has been evaluated in over 11,000 patients. In general, amlodipine is well-tolerated at doses of up to 10 mg daily.
The most commonly reported side effects occur with doses higher than 10 mg daily and are mild to moderate in severity. They include:
- Edema (swelling)
- Dizziness
- Flushing
- Palpitations
- Fatigue
- Nausea
- Abdominal pain
- Headache
Strategies for Managing Side Effects
If you experience mild side effects, it's often helpful to:
- Rise slowly from a sitting or lying position to avoid dizziness.
- Drink plenty of water to stay hydrated and help with flushing.
- Take over-the-counter pain relievers for headaches, unless contraindicated.
- Elevate the legs and wear compression stockings to reduce swelling.
- Take your medication in the evening instead of the morning to help with daytime fatigue.
If side effects persist or worsen, talk to your prescribing doctor, who may be able to suggest additional management tips, lower your dose, or switch you to a different medication that may be better tolerated.
Severe Side Effects and Risks
Serious side effects that have been reported in 0.1-1% of patients in clinical trials include:
- Abnormal heart rhythms (arrhythmias), including ventricular tachycardia and atrial fibrillation
- Peripheral neuropathy (tingling, numbness, or burning pain in the hands, feet, arms, or legs)
- Muscle tremors
- Shortness of breath
- Low blood pressure (hypotension) and heart rate (bradycardia)
- Fainting
- Sexual dysfunction
- Allergic reactions
In rare cases, worsening chest pain and myocardial infarction (heart attack) may occur after starting amlodipine or increasing the dose. This risk is highest in patients with severe obstructive coronary artery disease. Despite these rare risks, clinical evidence supports the use of amlodipine to reduce the risk of adverse cardiovascular events, including heart attacks, in most people.
If you develop serious side effects, talk to your doctor as soon as possible.
Some side effects require immediate medical attention. If you experience symptoms that seem life-threatening, such as chest pain, very low blood pressure, and symptoms of severe allergic reactions, call 911.
Long-Term Health Concerns with Amlodipine
Long-term clinical trials and reviews have consistently shown that amlodipine is generally well-tolerated with a low incidence of severe adverse effects.
While postmarketing reports have noted instances of jaundice (yellowing of the skin and the whites of the eyes) and liver enzyme elevations, these occurrences are rare and typically not severe enough to preclude the use of amlodipine in most patients. However, caution is advised in patients with preexisting liver disease and severe hepatic impairment. Dose adjustments and routine liver function monitoring may be necessary.
Alternatives to Amlodipine
Alternative treatment options exist for those who experience bothersome side effects from amlodipine or cannot take the medication for other reasons. Work with your doctor to find the best treatment option based on individual needs.
Other Medications for Hypertension
Professional organizations like the American College of Cardiology (ACC) and American Heart Association (AHA) recommend four drug classes as initial therapy for most patients with hypertension requiring pharmacotherapy:
- Angiotensin-converting enzyme (ACE) inhibitors, such as lisinopril, block the ACE enzyme that produces a vasoconstricting hormone (called angiotensin II) with hypertensive effects.
- Angiotensin receptor blockers (ARBs), such as losartan, prevent angiotensin II from binding to its receptor.
- Other CCBs, such as diltiazem, may have a lower risk of edema than amlodipine.
- Thiazide-type diuretics, such as hydrochlorothiazide, block sodium reabsorption in the kidneys, which increases urine output and lowers blood pressure.
Non-Medication Approaches to Cardiovascular Health
A heart-healthy lifestyle is foundational for cardiovascular health, which is why the ACC and AHA recommend diet and exercise modifications as first-line treatment for cardiovascular disease. Specific recommendations are as follows:
Diet and Nutrition
Eat an anti-inflammatory diet that focuses on intake of the following nutrients:
In addition, patients should focus on limiting their intake of sodium to less than 2 grams and alcohol to no more than 1-2 drinks daily.
The Mediterranean and DASH diets are well-researched, and there is strong evidence to support their efficacy in reducing the risk of adverse cardiovascular events by improving cardiovascular metabolic health, lowering blood pressure, reducing inflammation, and promoting better lipid profiles.
Exercise
Patients should be encouraged to exercise:
- At least 150 minutes per week of moderate-intensity aerobic exercise, or
- At least 75 minutes per week of vigorous-intensity aerobic exercise, and
- 2-3 sessions per week of low-to-moderate intensity resistance training
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Conclusion
- Amlodipine is an effective FDA-approved medication for managing hypertension, angina, and coronary artery disease.
- Like any drug, amlodipine comes with potential side effects. From mild symptoms like dizziness to severe reactions such as low blood pressure or allergic responses, monitoring your body's response and consulting your healthcare provider regularly is important.
- Never stop or adjust your medication without first consulting a healthcare professional. If you're concerned about side effects or are exploring alternatives, your doctor can help you find a treatment plan that works best for you.
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