For Healthcare Professionals Applies to amlodipine: oral tablet.
Agitation, amnesia, and apathy have been reported in less than 0.1% of patients. 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.
In the event that any of these side effects do occur, they may require medical attention. In addition to its needed effects, some unwanted effects may be caused by amlodipine.
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.
You should check with your doctor immediay if any of these side effects occur when taking amlodipine:
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. Most side effects reported were of mild or moderate severity and were dose-related. Headache and edema are the most common side effects. Amlodipine is generally well-tolerated at dosages up to 10 mg per day.
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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 plaet count returned to normal.
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In some instances, these cases were severe enough to require hospitalization. Hepatic side effects have included jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) during postmarketing experience.
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.
Dysuria and polyuria have been reported in less than 0.1% of patients. Genitourinary side effects have included micturition disorder, micturition frequency, and nocturia in less than 1% but greater than 0.1% of patients.
At least one case of interstitial nephritis has been associated with amlodipine therapy. Renal side effects have been reported rarely.
Pregnancy Category C Risk cannot be ruled out.
Hypersensitivity side effects have included allergic reaction (less than 1% but greater than 0.1%).
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.
Applies to amlodipine: oral tablet, oral tablet disintegrating.
Data sources include Micromedex (updated Sep 26th, 2014), Cerner Multum (updated Oct 16th, 2014), Wolters Kluwer (updated Oct 9th, 2014) and others. To view content sources and attributions, refer to our editorial policy.
Calcium channel blockers have been suggested as possibly unsafe in patients with this condition. Metabolic side effects have included hyperglycemia, thirst, weight decrease, and weight gain in less than 1% but greater than 0.1% of patients. A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. New-onset diabetes has been reported.
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Side effects can be reported to the FDA here. You should always consult a doctor or healthcare professional for medical advice. Not all side effects for amlodipine may be reported.
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. 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. 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. Cardiovascular side effects have included palpitation (up to 4.5%).
Gastrointestinal side effects have included nausea (2.9%), dysphagia (up to 2%), and abdominal pain (1.6%). At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge. Gastritis, increased appetite, loose stools, and taste perversion have been reported in less than 0.1% of patients. 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.
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Some of the side effects that can occur with amlodipine may not need medical attention. Your health care professional may also be able to l 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:. As your body adjusts to the medicine during treatment these side effects may go away.
CSA Schedule N Not a controlled drug.
In one case, a patient's gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent.
Availability Rx Prescription only.
Hematologic side effects have included leukopenia, purpura, and thrombocytopenia in less than 1% but greater than 0.1% of patients.
Asthenia, hot flushes, malaise, pain, and rigors have been reported in less than 1% but greater than 0.1% of patients. Other side effects have included edema (up to 14.6%), flushing (up to 4.5%), fatigue (4.5%), and back pain (up to 2%). Cold and clammy skin and parosmia have been reported in less than 0.1% of patients. During studies in patients with documented coronary artery disease, the most common side effect was peripheral edema.
Endocrine side effects have included gynecomastia during postmarketing experience.
Myoclonus has been reported. Ataxia and migraine have been reported in less than 0.1% of patients. 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.
Approval History Calendar Drug history at FDA.
Amlodipine-associated lichen planus and angiectasia have been rarely reported. Alopecia, dermatitis, skin discoloration, skin dryness, and urticaria have been reported in less than 0.1% of patients. 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. At least one case of amlodipine-associated bullous pemphigoid (with erythema multiforme-like clinical features) has been reported.
The rash resolved upon substitution with nifedipine. A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine.
Amlodipine 5 mg side effects