Summary
Commonly reported side effects of amlodipine include: edema. Other side effects include: fatigue, palpitations, and flushing. Continue reading for a comprehensive list of adverse effects.
Applies to amlodipine: oral capsules, oral tablets.
Side effects include:
Edema, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence. Edema, flushing, palpitations, and somnolence may be more common in women than men. Edema may be less frequent with concomitant ACE inhibitor or angiotensin II receptor antagonist therapy.
For Healthcare Professionals
Applies to amlodipine: oral liquid, oral suspension, oral tablet, oral tablet disintegrating.
General
The most commonly reported side effects include headache, edema, rash, fatigue, and dizziness.[Ref]
Cardiovascular
Myocardial infarction, chest pain, and arrhythmia (e.g., bradycardia, ventricular tachycardia, atrial fibrillation) cannot be distinguished from the natural history of the underlying disease.
Edema occurred in 14.6% of female patients given this drug compared to 5.6% of male patients, and was more likely to occur in patients given the 10 mg dose (compared to the 5 and 2.5 mg doses).[Ref]
Very common (10% or more): Edema (up to 14.6%)
Common (1% to 10%): Palpitations, ankle edema
Uncommon (0.1% to 1%): Hypotension, chest pain
Very rare (less than 0.01%): Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia, atrial fibrillation), vasculitis, cardiac failure, pulse irregularity, extrasystoles, hot flush
Frequency not reported: Tachycardia, peripheral ischemia, postural hypotension[Ref]
Nervous system
Common (1% to 10%): Somnolence, dizziness, headache
Uncommon (0.1% to 1%): Tremor, taste perversion/dysgeusia, syncope, hypoesthesia, paresthesia
Very rare (less than 0.01%): Hypertonia, peripheral neuropathy, ataxia, migraine, amnesia, parosmia
Frequency not reported: Extrapyramidal syndrome, postural dizziness, vertigo[Ref]
Headache occurred commonly during clinical trials, especially at the beginning of treatment.
Extrapyramidal syndrome may be associated with this drug.[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain, nausea
Uncommon (0.1% to 1%): Vomiting, dyspepsia, altered bowel habits (including diarrhea and constipation), dry mouth
Very rare (less than 0.01%): Pancreatitis, gastritis, gingival hyperplasia, loose stools
Frequency not reported: Dysphagia, flatulence[Ref]
Dermatologic
Common (1% to 10%): Flushing
Uncommon (0.1% to 1%): Alopecia, skin discoloration, increased sweating/hyperhidrosis, pruritus, rash, exanthema
Very rare (less than 0.01%): Erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke edema, photosensitivity, skin dryness, cold and clammy skin, dermatitis[Ref]
Other
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Tinnitus, asthenia, pain, malaise
Frequency not reported: Rigors, thirst[Ref]
Genitourinary
Uncommon (0.1% to 1%): Micturition disorder, nocturia, increased urinary frequency, impotence
Very rare (less than 0.01%): Dysuria, polyuria
Frequency not reported: Male/female sexual dysfunction[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Arthralgia, myalgia, muscle cramps, back pain
Very rare (less than 0.01%): Muscle weakness
Frequency not reported: Arthrosis, twitching[Ref]
Psychiatric
Uncommon (0.1% to 1%): Insomnia, mood changes (including anxiety), depression
Rare (0.01% to 0.1%): Confusion
Frequency not reported: Abnormal dreams, depersonalization, nervousness, apathy, agitation[Ref]
Respiratory
Uncommon (0.1% to 1%): Dyspnea, rhinitis
Very rare (less than 0.01%): Cough
Frequency not reported: Epistaxis[Ref]
Ocular
Uncommon (0.1% to 1%): Visual disturbance (including diplopia)
Very rare (less than 0.01%): Abnormal visual accommodation, xerophthalmia
Frequency not reported: Abnormal vision, conjunctivitis, eye pain[Ref]
Metabolic
Uncommon (0.1% to 1%): Weight increase/decrease
Very rare (less than 0.01%): Hyperglycemia, increased appetite
Frequency not reported: Anorexia[Ref]
Hematologic
Uncommon (0.1% to 1%): Purpura
Very rare (less than 0.01%): Leukopenia, thrombocytopenia[Ref]
Endocrine
Uncommon (0.1% to 1%): Gynecomastia[Ref]
Hepatic
Increased hepatic enzymes were mostly consistent with cholestasis.
Some cases of hepatitis, jaundice, and/or hepatic enzyme elevations were severe enough to require hospitalization; however, the association with this drug was uncertain in most cases.[Ref]
Very rare (less than 0.01%): Hepatitis, jaundice, hepatic enzymes increased[Ref]
Hypersensitivity
Very rare (less than 0.01%): Allergic reactions, angioedema[Ref]
