Amlodipine Side Effects

Not all side effects for amlodipine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to amlodipine: oral tablet, oral tablet disintegrating

In addition to its needed effects, some unwanted effects may be caused by amlodipine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking amlodipine:

More common
  • Swelling of the ankles or feet
Less common
  • Difficult or labored breathing
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • tightness in the chest
  • wheezing
Rare
  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • chills
  • cold and clammy skin
  • cold sweats
  • confusion
  • dark yellow urine
  • cough
  • diarrhea
  • dilated neck veins
  • dizziness or lightheadedness when getting up from a lying or sitting position
  • extra heartbeats
  • extreme fatigue
  • fainting
  • fever
  • itching of the skin
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • numbness and tingling of the face, fingers, or toes
  • pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
  • painful or difficult urination
  • pale, bluish-colored, or cold hands or feet
  • pinpoint red or purple spots on the skin
  • red, irritated eyes
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness, soreness or itching skin
  • shakiness in the legs, arms, hands, or feet
  • slow or irregular heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sores, welting, or blisters
  • sudden sweating
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swollen glands
  • trembling or shaking of the hands or feet
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weak or absent pulses in the legs
  • weakness in the arms, hands, legs, or feet
  • weight gain
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach pain
  • clay-colored stools
  • diarrhea
  • headache
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with amlodipine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle cramps
  • sleepiness or unusual drowsiness
  • stomach discomfort, upset, or pain
Rare
  • Abnormal dreams
  • anxiety
  • back pain
  • bad unusual or unpleasant (after) taste
  • bleeding gums
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloating
  • bloody nose
  • burning feeling in the chest or stomach
  • burning while urinating
  • burning, dry, or itching eyes
  • change in color of the treated skin
  • change in sense of smell
  • change in taste
  • changes in vision
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cracked, dry, or scaly skin
  • decreased sexual performance or desire
  • depression
  • difficulty with moving
  • difficulty with swallowing
  • discharge, excessive tearing
  • double vision
  • dry mouth
  • dryness of the skin
  • excess air or gas in the stomach or intestines
  • excessive muscle tone
  • eye pain
  • feeling of constant movement of self or surroundings
  • feeling of unreality
  • feeling unusually cold
  • flushed, dry skin
  • fruit-like breath odor
  • full feeling
  • general feeling of discomfort or illness
  • hair loss or thinning of the hair
  • headache, severe and throbbing
  • hearing loss
  • hyperventilation
  • increased appetite
  • increased hunger
  • increased sweating
  • increased thirst
  • increased urge to urinate during the night
  • increased urination
  • irritability
  • irritation in the mouth
  • lack of feeling or emotion
  • loose stools
  • loss of memory
  • muscle pains or stiffness
  • muscle tension or tightness
  • muscle weakness
  • nervousness
  • pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • passing gas
  • problems with memory
  • redness and swelling of the gums
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • runny nose
  • seeing double
  • sensation of spinning
  • sense of detachment from self or body
  • shakiness and unsteady walk
  • shivering
  • sleeplessness
  • sneezing
  • stuffy nose
  • sweating
  • swollen joints
  • tenderness in the stomach area
  • thirst
  • trouble in holding or releasing urine
  • trouble sleeping
  • twitching
  • unable to sleep
  • uncaring
  • unexplained weight loss
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • waking to urinate at night
  • weight loss
Incidence not known
  • Swelling of the breasts or breast soreness in both females and males

For Healthcare Professionals

Applies to amlodipine: oral tablet

General

Amlodipine is generally well-tolerated at dosages up to 10 mg per day. Most side effects reported were of mild or moderate severity and were dose-related. Headache and edema are the most common side effects.

Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.[Ref]

Other

Other side effects have included edema (up to 14.6%), flushing (up to 4.5%), fatigue (4.5%), and back pain (up to 2%). During studies in patients with documented coronary artery disease, the most common side effect was peripheral edema. Asthenia, hot flushes, malaise, pain, and rigors have been reported in less than 1% but greater than 0.1% of patients. Cold and clammy skin and parosmia have been reported in less than 0.1% of patients.[Ref]

Cardiovascular

Cardiovascular side effects have included palpitation (up to 4.5%). Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, and vasculitis have been reported in less than 1% but greater than 0.1% of patients. Cardiac failure, extrasystoles, and pulse irregularity have been reported in less than 0.1% of patients. Angina and myocardial infarction have occasionally been reported; however, these reactions could not be distinguished from coexisting disease states or medications. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, especially in patients with severe obstructive coronary artery disease.[Ref]

Nervous system

Nervous system side effects have included headache (7.3%), dizziness (up to 3.4%), and somnolence (up to 1.6%). Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor, and vertigo have been reported in less than 1% but greater than 0.1% of patients. Ataxia and migraine have been reported in less than 0.1% of patients. Myoclonus has been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (2.9%), dysphagia (up to 2%), and abdominal pain (1.6%). Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, and vomiting have been reported in less than 1% but greater than 0.1% of patients. Gastritis, increased appetite, loose stools, and taste perversion have been reported in less than 0.1% of patients. At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge.[Ref]

Hematologic

A case study reports a 34-year-old woman with a history of chronic renal failure secondary to glomerulonephritis, who was started on amlodipine for uncontrolled hypertension. Three days later the patient developed severe thrombocytopenia. After discontinuation of the drug, the platelet count returned to normal.[Ref]

Hematologic side effects have included leukopenia, purpura, and thrombocytopenia in less than 1% but greater than 0.1% of patients.[Ref]

Hepatic

Hepatic side effects have included jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) during postmarketing experience. In some instances, these cases were severe enough to require hospitalization.[Ref]

Metabolic

Metabolic side effects have included hyperglycemia, thirst, weight decrease, and weight gain in less than 1% but greater than 0.1% of patients. New-onset diabetes has been reported. A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 2%). Arthralgia, arthrosis, and muscle cramps have been reported in less than 1% but greater than 0.1% of patients. Hypertonia, muscle weakness, and twitching have been reported in less than 0.1% of patients.

Psychiatric

Psychiatric side effects have included male sexual dysfunction (up to 2%). Abnormal dreams, anxiety, depersonalization, depression, female sexual dysfunction, insomnia, and nervousness have been reported in less than 1% but greater than 0.1% of patients. Agitation, amnesia, and apathy have been reported in less than 0.1% of patients.

Dermatologic

Dermatologic side effects have included rash and erythematous rash in up to 2% of patients. Angioedema, erythema multiforme, increased sweating, maculopapular rash, and pruritus have been reported in less than 1% but greater than 0.1% of patients. Alopecia, dermatitis, skin discoloration, skin dryness, and urticaria have been reported in less than 0.1% of patients. Amlodipine-associated lichen planus and telangiectasia have been rarely reported. At least one case of amlodipine-associated bullous pemphigoid (with erythema multiforme-like clinical features) has been reported.[Ref]

A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine. The rash resolved upon substitution with nifedipine.[Ref]

Ocular

Ocular side effects have included abnormal vision, conjunctivitis, diplopia, and eye pain in less than 1% but greater than 0.1% of patients. Abnormal visual accommodation and xerophthalmia have been reported in less than 0.1% of patients.

Respiratory

Respiratory side effects have included epistaxis (up to 2%) and dyspnea (less than 1% but greater than 0.1%). Coughing and rhinitis have been reported in less than 0.1% of patients. Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.[Ref]

Genitourinary

Genitourinary side effects have included micturition disorder, micturition frequency, and nocturia in less than 1% but greater than 0.1% of patients. Dysuria and polyuria have been reported in less than 0.1% of patients.[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 1% but greater than 0.1%).[Ref]

Endocrine

Endocrine side effects have included gynecomastia during postmarketing experience.[Ref]

In one case, a patient's gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent.[Ref]

Renal

Renal side effects have been reported rarely. At least one case of interstitial nephritis has been associated with amlodipine therapy.[Ref]

References

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24. Packer M, Oconnor CM, Ghali JK, Pressler ML, Carson PE, Belkin RN, Miller AB, Neuberg GW, Frid D, Wertheimer JH, Cropp A "Effect of amlodipine on morbidity and mortality in severe chronic heart failure." N Engl J Med 335 (1996): 1107-14

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35. Southward J, Irvine E, Rabinovich M "Probable amlodipine-induced angioedema." Ann Pharmacother 43 (2009): 772-6

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