Amlodipine Side Effects
Amlodipine is generally well-tolerated, with peripheral edema being the most common side effect, occurring in a dose-dependent manner (1.8% at 2.5mg, 3% at 5mg, and 10.8% at 10mg), along with other vasodilatory effects like flushing, dizziness, and headache. 1
Common Side Effects (>1% incidence)
The FDA-approved labeling identifies the following most frequent adverse reactions from controlled trials 1:
- Peripheral edema: Dose-dependent (1.8-10.8%), significantly more common in women (14.6%) than men (5.6%) 1
- Fatigue: 4.5% vs 2.8% placebo 1
- Dizziness: 1.1-3.4% (dose-related) 1
- Flushing: 0.7-2.6% (dose-related), more common in women (4.5%) than men (1.5%) 1
- Palpitations: 0.7-4.5% (dose-related), more common in women (3.3%) than men (1.4%) 1
- Nausea: 2.9% vs 1.9% placebo 1
- Abdominal pain: 1.6% vs 0.3% placebo 1
- Somnolence: 1.4% vs 0.6% placebo 1
Less Common but Notable Side Effects (<1% but >0.1%)
The following adverse events have been reported in clinical trials or post-marketing surveillance 1:
Cardiovascular: Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, syncope, tachycardia 1
Neurological: Hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo 1
Gastrointestinal: Constipation, diarrhea, dysphagia, pancreatitis, vomiting, gingival hyperplasia 1
Musculoskeletal: Arthralgia, muscle cramps, myalgia 1
Dermatologic: Angioedema, erythema multiforme, pruritus, rash 1
Other: Sexual dysfunction, insomnia, nervousness, depression, dyspnea 1
Important Clinical Considerations
Gender differences: Women experience significantly higher rates of edema (14.6% vs 5.6%), flushing (4.5% vs 1.5%), and palpitations (3.3% vs 1.4%) compared to men 1
Pediatric population: Amlodipine-related edema appears less common in children than adults, though generalized edema can occur and requires monitoring 2. Common pediatric side effects include headache, dizziness, and flushing 3
Cardiovascular safety: Unlike short-acting dihydropyridines (e.g., immediate-release nifedipine), amlodipine does not cause reflex tachycardia or adverse cardiovascular events due to its gradual onset and long half-life 3, 4. Amlodipine is reasonably well-tolerated in patients with mild left ventricular dysfunction 3
Metabolic neutrality: Amlodipine does not cause clinically significant changes in serum potassium, glucose, lipids, uric acid, or renal function 1, 5, 6
Renal effects: Amlodipine demonstrates renoprotective effects, particularly when combined with ARBs, and can increase eGFR even in CKD patients 3
Rare but Serious Adverse Events
Post-marketing surveillance has identified gynecomastia as a rare adverse event 1. Hematologic effects including leukopenia, purpura, and thrombocytopenia have been reported in <1% of patients 1
Discontinuation Rates
Only approximately 1.5% of patients discontinued amlodipine due to adverse reactions in controlled trials, which was not significantly different from placebo (about 1%) 1