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The following information is not a substitute for the knowledge and judgement of a healthcare professional. It should not be construed to indicate that use of the drug
is safe, appropriate, or effective for you. Always consult with your doctor, nurse, or pharmacist before taking medication.

Amlodipine Side Effects

Overview Side Effects Dosage Interactions For Professionals More

Pregnancy Warnings
Some side effects of amlodipine may not be reported. AlwaysBreastfeeding
consult yourWarnings
doctor or healthcare specialist for medical advice. You may also
report side effects to the FDA.
User Reviews

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For the Consumer
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Applies to amlodipine: oral tablet, oral tablet disintegrating
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Along with its needed effects, amlodipine may cause some unwanted effects. Although not all of these side effects may occur, if they do
occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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

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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 side effects of amlodipine may occur that usually do not need medical attention. These side effects may go away during treatment as
your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these
side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any
questions about them:

Less common

Acid or sour stomach

belching
heartburn
indigestion
lack or loss of strength
muscle cramps

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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

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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.

Other

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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.

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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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