What are the side effects of Norvasc (amlodipine)?

Side Effects of Norvasc (Amlodipine)

Peripheral edema is the most common side effect of amlodipine, occurring in up to 10.8% of patients taking the 10mg dose. 1

Common Side Effects

• Peripheral edema: Occurs in a dose-dependent manner (1.8% at 2.5mg, 3.0% at 5mg, and 10.8% at 10mg) 1

  • More common in women (14.6%) than men (5.6%) 1
  • Caused by precapillary/postcapillary pressure imbalance due to arterial dilation with minimal effect on venous tone 2
  • Typically affects lower limbs, particularly feet and ankles 2
  • Not associated with fluid retention or volume overload 2

• Dizziness: Occurs in 1.1-3.4% of patients (dose-dependent) 1

• Flushing: Occurs in 0.7-2.6% of patients (dose-dependent) 1

  • More common in women (4.5%) than men (1.5%) 1

• Palpitations: Occurs in 0.7-4.5% of patients (dose-dependent) 1

  • More common in women (3.3%) than men (1.4%) 1

• Fatigue: Reported in 4.5% of patients 1

• Nausea: Reported in 2.9% of patients 1

• Abdominal pain: Reported in 1.6% of patients 1

• Somnolence (drowsiness): Reported in 1.4% of patients 1

  • More common in women (1.6%) than men (1.3%) 1

• Headache: Common side effect, though interestingly a meta-analysis found reduced headache incidence with amlodipine compared to placebo (7.9% vs 10.9%), particularly at lower doses 3

Less Common Side Effects (<1%)

• Cardiovascular: Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis 1

• Neurological: Hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo 1

• Gastrointestinal: Anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia 1

• Musculoskeletal: Arthralgia, arthrosis, muscle cramps, myalgia 1

• Psychiatric: Sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization 1

• Respiratory: Dyspnea, epistaxis 1

• Dermatological: Angioedema, erythema multiforme, pruritus, rash (erythematous and maculopapular) 1

  • Rare cases of hyperpigmentation of oral mucosa and skin have been reported 4

• Special senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus 1

• Urinary: Micturition frequency, micturition disorder, nocturia 1

• Other: Dry mouth, increased sweating, hyperglycemia, thirst, leukopenia, purpura, thrombocytopenia 1

• Post-marketing: Gynecomastia (reported infrequently) 1

Special Considerations

• Elderly patients: Greater antihypertensive effects due to decreased baroreceptor response and age-related increase in drug exposure 5

  • Should initiate at lower doses and titrate cautiously 5

• Heart failure: Amlodipine is reasonably well tolerated in patients with mild LV dysfunction 5

  • Should be avoided in patients with pulmonary edema or severe LV dysfunction 5

• Concomitant medications:

  • Can be used with nitroglycerin 1
  • Has minimal effect on myocardial contractility or cardiac conduction compared to other calcium channel blockers 6

• Children: Edema may be less common in pediatric patients compared to adults, but cases of generalized edema have been reported 7

Risk Reduction Strategies

• Dose optimization: Lower doses (2.5-5mg) result in significantly lower rates of edema compared to higher doses (10mg) 3

  • Consider starting at the lowest effective dose, particularly in elderly patients 5

• Monitoring: Watch for early signs of peripheral edema, especially in the ankles and feet 2

• Patient education: Inform patients about potential side effects and when to contact their healthcare provider 1

• Alternative options: If edema is problematic, consider alternative antihypertensive medications or combination therapy that allows for lower amlodipine dosing 2