Amlodipine Side Effects

Brand Names: Norvasc

Please note - some side effects for Amlodipine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Amlodipine - for the Consumer

Amlodipine/Benazepril

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Benazepril:

Dizziness; headache; persistent, dry cough.

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine/Benazepril:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, hands, eyes, throat, face, lips, or tongue; unusual hoarseness); blisters or sores in the mouth, nose, throat, or on the genitals; dark urine; decreased urination; fainting; fever, chills, or persistent sore throat; irregular, fast, or slow heartbeat; loss of appetite; muscle cramps, pain, or weakness; new or worsening chest pain (eg, longer, more often, more severe); pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, diarrhea, or vomiting; severe stomach pain; swelling of the hands, feet, or ankles; symptoms of a heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting); tender, bleeding, or swollen gums; unexplained weight gain; unusual bruising or bleeding; unusual weakness or fatigue; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amlodipine/Atorvastatin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Atorvastatin:

Constipation; diarrhea; dizziness; drowsiness; flushing; gas; headache; nausea; stomach upset or pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine/Atorvastatin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced or increased urination; changes in vision; dark urine; fainting; fast, slow, or irregular heartbeat; increased frequency, duration, or severity of chest pain; joint pain; muscle aches, pain, tenderness, or weakness, especially with fever, unusual tiredness, or general body discomfort; numbness of an arm or leg; pale stools; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; sharp or crushing chest, jaw, or left arm pain; sudden leg pain; sudden, severe or persistent headache, vomiting, or dizziness; sudden shortness of breath; swelling of your feet or legs; tender, bleeding, or swollen gums; unexplained weight gain; worsening angina pain (eg, longer, more often, more severe); yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amlodipine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine:

Dizziness; drowsiness; fatigue; flushing; headache; muscle cramps; nausea; stomach pain; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fainting; fast, slow, or irregular heartbeat; pounding in the chest; severe or persistent dizziness; shortness of breath; swelling of the feet or legs; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting); tender, bleeding, or swollen gums; worsening angina pain (eg, longer, more often, more severe); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amlodipine/Valsartan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Valsartan:

Dizziness; sore throat or discomfort when swallowing; stuffy nose; upper respiratory tract infection (head or chest cold).

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine/Valsartan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; chest, jaw, or left arm pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; numbness and tingling of an arm or leg; severe or persistent dizziness; severe or persistent muscle pain or aches; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amlodipine/Olmesartan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Olmesartan:

Dizziness; flushing.

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine/Olmesartan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; fainting; fast or irregular heartbeat; light-headedness; numbness of an arm or leg; severe or persistent dizziness; severe or persistent muscle pain or aches; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amlodipine/Valsartan/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Valsartan/Hydrochlorothiazide:

Dizziness; headache; indigestion; light-headedness; mild back pain; muscle spasms; nausea; sore throat or discomfort when swallowing; stuffy nose; tiredness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine/Valsartan/Hydrochlorothiazide:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes (eg, decreased vision clearness); burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe joint); mental or mood changes (eg, depression); numbness of an arm or leg; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; sudden, severe headache; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual thirst, tiredness, or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amlodipine/Olmesartan/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amlodipine/Olmesartan/Hydrochlorothiazide:

Dizziness; headache; light-headedness; muscle spasms; nausea; sore throat; stuffy or runny nose; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Amlodipine/Olmesartan/Hydrochlorothiazide:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling sensation; burning or painful urination; change in the amount of urine produced; confusion; dark urine; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe); loss of appetite; mental or mood changes; muscle pain, weakness, or cramps; new or worsening chest pain (eg, longer, more often, more severe); pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent dry mouth; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of a heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden headache or vomiting; sudden vision changes); tender, bleeding, or swollen gums; unusual bruising or bleeding; unusual restlessness or sluggishness; unusual thirst, tiredness, or weakness; vision changes (eg, blurred vision, decreased vision clearness, double vision); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Amlodipine Side Effects - for the Professional

Amlodipine

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Amlodipine besylate tablets have been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Amlodipine besylate tablets were well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Amlodipine besylate tablets were of mild or moderate severity. In controlled clinical trials directly comparing Amlodipine besylate tablets (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Amlodipine besylate tablets due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects that occurred in a dose related manner are as follows:

Adverse Event	2.5 mg N=275	5 mg N=296	10 mg N=268	Placebo N=520
Edema	1.8	3	10.8	0.6
Dizziness	1.1	3.4	3.4	1.5
Flushing	0.7	1.4	2.6	0
Palpitation	0.7	1.4	4.5	0.6

Other adverse experiences that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

	Placebo-Controlled Studies
	Amlodipine (%) (N=1730)	Placebo (%) (N=1250)
Headache	7.3	7.8
Fatigue	4.5	2.8
Nausea	2.9	1.9
Abdominal Pain	1.6	0.3
Somnolence	1.4	0.6

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Amlodipine treatment as shown in the following table:

Adverse Event	Amlodipine Besylate		Placebo
	Male=% (N=1218)	Female=% (N=512)	Male=% (N=914)	Female=% (N=336)
Edema	5.6	14.6	1.4	5.1
Flushing	1.5	4.5	0.3	0.9
Palpitations	1.4	3.3	0.9	0.9
Somnolence	1.3	1.6	0.8	0.3

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.

Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal: anorexia, constipation, dyspepsia, 1dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

General: allergic reaction, asthenia, 1back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System: arthralgia, arthrosis, muscle cramps, 1myalgia.

Psychiatric: sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Respiratory System: dyspnea, 1epistaxis.

Skin and Appendages: angioedema, erythema multiforme, pruritus, 1rash, 1rash erythematous, rash maculopapular.

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.

Urinary System: micturition frequency, micturition disorder, nocturia.

Autonomic Nervous System: dry mouth, sweating increased.

Metabolic and Nutritional: hyperglycemia, thirst.

Hemopoietic: leukopenia, purpura, thrombocytopenia. 1These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies. The following events occurred in <0.1% of patients: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia. Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina. Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine. In the CAMELOT and PREVENT studies [see Clinical Studies (14.4)], the adverse event profile was similar to that reported previously, with the most common adverse event being peripheral edema.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of Amlodipine.

Amlodipine besylate tablets have 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.

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Side Effects by Body System - for Healthcare Professionals

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.

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.

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.

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.

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.

Hematologic

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

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.

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.

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

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.

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.

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.

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.

Hypersensitivity

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

Endocrine

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

Endocrine side effects have included gynecomastia during postmarketing experience.

Renal

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

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