Amlodipine Besylate

Commonly reported side effects of amlodipine include: edema. Other side effects include: fatigue, palpitations, and flushing. See below for a comprehensive list of adverse effects.

Applies to amlodipine: oral tablet

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
• 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
• 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

Applies to amlodipine: oral suspension, oral tablet, oral tablet disintegrating

The most commonly reported side effects include headache, edema, rash, fatigue, and dizziness.

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).

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

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

Headache occurred commonly during clinical trials, especially at the beginning of treatment.

Extrapyramidal syndrome may be associated with this drug.

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

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

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Tinnitus, asthenia, pain, malaise

Frequency not reported: Rigors, thirst

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

Uncommon (0.1% to 1%): Arthralgia, myalgia, muscle cramps, back pain

Very rare (less than 0.01%): Muscle weakness

Frequency not reported: Arthrosis, twitching

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

Uncommon (0.1% to 1%): Dyspnea, rhinitis

Very rare (less than 0.01%): Cough

Frequency not reported: Epistaxis

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

Uncommon (0.1% to 1%): Weight increase/decrease

Very rare (less than 0.01%): Hyperglycemia, increased appetite

Frequency not reported: Anorexia

Uncommon (0.1% to 1%): Purpura

Very rare (less than 0.01%): Leukopenia, thrombocytopenia

Uncommon (0.1% to 1%): Gynecomastia

Very rare (less than 0.01%): Hepatitis, jaundice, hepatic enzymes increased

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.

Very rare (less than 0.01%): Allergic reactions, angioedema