Side Effects of Amlodipine
The most common side effects of amlodipine are peripheral edema (leg/ankle swelling), dizziness, flushing, and fatigue, with edema being dose-related and occurring in up to 10.8% of patients at the 10 mg dose. 1
Most Common Adverse Effects
Dose-Related Side Effects
The FDA-approved labeling from controlled clinical trials demonstrates clear dose-dependent patterns for key adverse effects 1:
- Peripheral edema: 1.8% at 2.5 mg, 3.0% at 5 mg, and 10.8% at 10 mg (compared to 0.6% with placebo) 1
- Dizziness: 1.1% at 2.5 mg, 3.4% at 5 mg and 10 mg (compared to 1.5% with placebo) 1
- Flushing: 0.7% at 2.5 mg, 1.4% at 5 mg, and 2.6% at 10 mg 1
- Palpitations: 0.7% at 2.5 mg, 1.4% at 5 mg, and 4.5% at 10 mg 1
Non-Dose-Related Common Side Effects
Additional adverse effects occurring in >1% of patients include 1:
- Fatigue: 4.5% (compared to 2.8% with placebo) 1
- Nausea: 2.9% (compared to 1.9% with placebo) 1
- Abdominal pain: 1.6% 1
- Somnolence: 1.4% 1
The American College of Cardiology confirms that headache, flushing, and dizziness are additional potential side effects 2.
Gender-Specific Considerations
Women experience significantly higher rates of certain side effects compared to men 1:
- Edema: 14.6% in women vs. 5.6% in men 1
- Flushing: 4.5% in women vs. 1.5% in men 1
- Palpitations: 3.3% in women vs. 1.4% in men 1
Less Common but Clinically Important Side Effects
Cardiovascular Effects (<1% but >0.1%)
- Arrhythmias (including ventricular tachycardia and atrial fibrillation) 1
- Bradycardia 1
- Syncope 1
- Peripheral ischemia 1
Neurological Effects
Gastrointestinal Effects
Dermatological Effects
Other Systems
- Sexual dysfunction (both male and female) 1
- Muscle cramps and myalgia 1
- Gynecomastia (postmarketing reports) 1
Pediatric Population
In pediatric patients, amlodipine demonstrates a similar but distinct side effect profile 3:
- Fatigue (most common) 3
- Headache 3
- Facial flushing 3
- Dizziness 3
- Edema occurs less frequently in children compared to adults 4, though generalized edema can occur and requires monitoring 4
Important Clinical Caveats
Edema Management
Peripheral edema from amlodipine is due to vasodilation, not fluid retention, and can be treated with diuretics 1. This edema is a direct consequence of the drug's mechanism of action on vascular smooth muscle 5, 6.
Worsening Angina
Rarely, when first starting amlodipine or increasing the dose, patients may experience worsening angina or even myocardial infarction 1. If this occurs, immediate medical attention is required 1.
Heart Failure Considerations
The European Society of Cardiology notes that amlodipine may be used for angina or hypertension in patients with compensated heart failure if not controlled by other therapy 7. However, all calcium channel blockers may precipitate heart failure in predisposed patients 7.
Laboratory Values
Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests, including serum potassium, glucose, lipids, uric acid, or renal function 1. This represents an advantage over some other cardiovascular agents 6.
Discontinuation Rate
Only approximately 1.5% of patients discontinue amlodipine due to adverse reactions, which is not significantly different from placebo 1. This reflects the generally favorable tolerability profile of the medication 5, 6.