Amlodipine Side Effects and Contraindications
Contraindications
Amlodipine is contraindicated only in patients with known hypersensitivity to amlodipine. 1
This is the sole absolute contraindication listed in the FDA labeling. 1
Relative Contraindications and Cautions
While not absolute contraindications, amlodipine should not be used as routine treatment in patients with heart failure with reduced ejection fraction (HFrEF) due to potential adverse effects, though it may be considered for managing concurrent hypertension or ischemic heart disease in these patients as it showed neutral effects on morbidity and mortality in large trials. 2
Important Clinical Warnings:
- Rapid-release, short-acting dihydropyridines must be avoided without concomitant beta-blockade due to increased adverse potential, though this is less concerning with long-acting amlodipine. 3, 2
- Avoid use in patients with pulmonary edema or severe left ventricular dysfunction (this applies more to non-dihydropyridine calcium channel blockers, but caution is warranted). 3
Common Side Effects
Most Frequent Adverse Effects (Dose-Related):
Peripheral edema is the most common side effect, occurring in a dose-dependent manner: 1.8% at 2.5 mg, 3.0% at 5 mg, and 10.8% at 10 mg (compared to 0.6% with placebo). 1
- Edema occurs significantly more frequently in women (14.6%) than men (5.6%). 1
- Edema can manifest as lower extremity swelling, facial edema, or rarely bilateral upper extremity edema or generalized edema. 1, 4, 5
Other Common Side Effects (>1% incidence):
- 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
- Fatigue: 4.5% 1
- Nausea: 2.9% 1
- Headache 6
Less Common but Clinically Important Side Effects (<1% but >0.1%):
- Cardiovascular: Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, syncope, tachycardia 1
- Gastrointestinal: Gingival hyperplasia, constipation, dysphagia, diarrhea, pancreatitis 1, 7
- Dermatologic: Angioedema, erythema multiforme, pruritus, rash 1
- Musculoskeletal: Muscle cramps, myalgia, arthralgia 1
- Neurologic: Paresthesia, tremor, vertigo, somnolence 1
- Psychiatric: Sexual dysfunction, insomnia, nervousness, depression 1
- Hematologic: Leukopenia, purpura, thrombocytopenia 1
Postmarketing Reports:
- Gynecomastia (rare) 1
Key Clinical Considerations
- Discontinuation rates due to adverse effects are low (approximately 1.5%), similar to placebo. 1
- Amlodipine does not cause clinically significant changes in serum lipids, glucose, electrolytes, or renal function. 1
- The drug is well-tolerated and does not cause postural hypotension or cardiac conduction disturbances typical of other calcium channel blockers. 8, 9
- Edema incidence appears lower in pediatric populations compared to adults, though monitoring remains important. 4
- Amlodipine is considered safe for breastfeeding with a relative infant dose of 1.7%-4.3%. 6
Important Pitfall
When initiating amlodipine or increasing the dose, patients may rarely experience worsening angina or myocardial infarction—if this occurs, immediate medical attention is required. 1