Summary

More frequently reported side effects include: edema, fatigue, and headache. Continue reading for a comprehensive list of adverse effects.

Applies to amlodipine / atorvastatin: oral tablet.

Serious side effects

Along with its needed effects, amlodipine/atorvastatin 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 / atorvastatin:

More common

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

Rare

• Chest pain or discomfort
• dilated neck veins
• extra heartbeats
• irregular breathing
• irregular heartbeat or pulse
• swelling of the face, fingers, feet, or lower legs
• weight gain

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• dark-colored urine
• diarrhea
• fever
• joint or muscle pain
• muscle cramps, spasms, or stiffness
• red, irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur while taking amlodipine / atorvastatin:

Symptoms of overdose

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• sweating

Other side effects

Some side effects of amlodipine / atorvastatin 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:

More common

• Body aches or pain
• congestion
• difficulty with moving
• headache
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• runny or stuffy nose
• tender, swollen glands in the neck
• voice changes

Less common

• Accidental injury
• acid or sour stomach
• belching
• bloated or full feeling
• difficulty having a bowel movement (stool)
• excess air or gas in the stomach or intestines
• general feeling of discomfort or illness
• heartburn
• indigestion
• lack or loss of strength
• loss of appetite
• nausea
• passing gas
• shivering
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• trouble sleeping
• vomiting

Rare

• Anxiety
• bad, unusual, or unpleasant (after) taste
• blistering, crusting, irritation, itching, or reddening of the skin
• burning feeling in the chest or stomach
• burning while urinating
• change in near or distance vision
• change in taste
• change in the color of the skin
• cold and clammy skin
• cracked, dry, scaly skin
• difficulty in focusing eyes
• dry mouth
• dryness of the eyes
• excessive muscle tone
• frequent urination
• hair loss or thinning of the hair
• increased appetite
• increased volume of pale, dilute urine
• irritability
• lack of feeling or emotion
• loose stools
• loss of memory
• muscle tension, tightness, or weakness
• problems with memory
• restlessness
• severe and throbbing headache
• shakiness and unsteady walk
• sneezing
• tenderness in the stomach area
• transient, mild, or pleasant aromatic odor
• trembling, or other problems with muscle control or coordination
• twitching
• uncaring
• unsteadiness
• welts

For Healthcare Professionals

Applies to amlodipine / atorvastatin: oral tablet.

General

The most common side effect of amlodipine was edema. The most common side effects of atorvastatin were diarrhea, nasopharyngitis, and arthralgia.^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, nausea

Uncommon (0.1% to 1%): Flatulence

Amlodipine:

Common (1% to 10%): Nausea, abdominal pain, constipation, dyspepsia

Uncommon (0.1% to 1%): Dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia, dry mouth, flatulence, altered bowel habits

Frequency not reported: Gastritis, loose stools

Atorvastatin:

Very common (10% or more): Diarrhea (up to 14.1%)

Common (1% to 10%): Dyspepsia, nausea, abdominal pain, constipation, flatulence

Uncommon (0.1% to 1%): Abdominal discomfort, vomiting

Rare (less than 0.1%): Eructation^[Ref]

Respiratory

Common (1% to 10%): Respiratory tract infection

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

Amlodipine:

Common (1% to 10%): Epistaxis, respiratory tract infection

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

Frequency not reported: Coughing

Atorvastatin:

Very common (10% or more): Nasopharyngitis (up to 12.9%)

Common (1% to 10%): Pharyngolaryngeal pain, respiratory tract infection, rhinitis

Uncommon (0.1% to 1%): Pharyngitis, asthma

Rare (less than 0.1%): Sinusitis

Frequency not reported: Epistaxis, interstitial lung disease^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, myalgia

Uncommon (0.1% to 1%): Leg cramps

Amlodipine:

Common (1% to 10%): Back pain, myalgia, arthralgia

Uncommon (0.1% to 1%): Arthrosis, muscle cramps, leg cramps

Frequency not reported: Muscle weakness, twitching

Atorvastatin:

Very common (10% or more): Arthralgia (up to 11.7%)

Common (1% to 10%): Pain in extremity, musculoskeletal pain, muscle spasms, myalgia, back pain

Uncommon (0.1% to 1%): Creatine kinase elevations 10 times the upper limit of normal or greater, leg cramps, neck pain

Rare (less than 0.1%): Myositis, myopathy, muscle fatigue

Frequency not reported: Joint swelling, blood creatine phosphokinase increased

Postmarketing reports: Rhabdomyolysis, tendon rupture, immune-mediated necrotizing myopathy^[Ref]

Other

Common (1% to 10%): Accidental injury, asthenia, pain

Uncommon (0.1% to 1%): Vertigo

Amlodipine:

Very common (10% or more): Edema (up to 10.8%)

Common (1% to 10%): Fatigue, accidental injury, asthenia, pain

Uncommon (0.1% to 1%): Vertigo, malaise, rigors, tinnitus, gynecomastia

Atorvastatin:

Common (1% to 10%): Accidental injury, asthenia

Uncommon (0.1% to 1%): Pain, vertigo, deafness, malaise

Rare (less than 0.1%): Tinnitus, pyrexia

Postmarketing reports: Fatigue, gynecomastia^[Ref]

Cardiovascular

Common (1% to 10%): Palpitation, vasodilation, peripheral edema

Uncommon (0.1% to 1%): Hypertension

Amlodipine:

Common (1% to 10%): Flushing, palpitation, peripheral edema

Uncommon (0.1% to 1%): Arrhythmia, bradycardia, chest pain, peripheral ischemia, tachycardia, vasculitis, hot flushes, vasodilation, hypotension, postural hypotension

Frequency not reported: Cardiac failure, pulse irregularity, extrasystoles, myocardial infarction

Atorvastatin:

Common (1% to 10%): Hypertension, palpitation

Uncommon (0.1% to 1%): Vasodilation

Postmarketing reports: Chest pain, peripheral edema^[Ref]

Hepatic

Common (1% to 10%): GGT increased, ALT increased, AST increased

Amlodipine:

Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased, pancreatitis

Postmarketing reports: Jaundice, hepatic enzyme elevations, hepatitis

Atorvastatin:

Common (1% to 10%): Transaminase elevations 3 times the upper limit of normal or greater twice within 4 to 10 days

Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased

Rare (less than 0.1%): Pancreatitis, hepatitis, cholestasis

Frequency not reported: Transaminases increased, liver function test abnormal, blood alkaline phosphatase increased

Postmarketing reports: Fatal and non-fatal hepatic failure^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Paresthesia

Amlodipine:

Common (1% to 10%): Dizziness, somnolence, headache

Uncommon (0.1% to 1%): Syncope, hypoesthesia, neuropathy peripheral, paresthesia, tremor, postural dizziness

Frequency not reported: Ataxia, hypertonia, migraine, amnesia, parosmia, taste perversion

Postmarketing reports: Extrapyramidal disorder

Atorvastatin:

Common (1% to 10%): Hemorrhagic stroke, headache, dizziness

Uncommon (0.1% to 1%): Hypoesthesia, paresthesia

Rare (less than 0.1%): Peripheral neuropathy

Postmarketing reports: Cognitive impairment, amnesia, dysgeusia^[Ref]

Immunologic

Common (1% to 10%): Flu syndrome

Uncommon (0.1% to 1%): Allergic reaction

Amlodipine:

Common (1% to 10%): Allergic reaction

Uncommon (0.1% to 1%): Flu syndrome

Atorvastatin:

Common (1% to 10%): Flu syndrome

Uncommon (0.1% to 1%): Allergic reaction, infection, influenza

Rare (less than 0.1%): Hypersensitivity, anaphylaxis^[Ref]

Dermatologic

Common (1% to 10%): Rash

Amlodipine:

Common (1% to 10%): Rash, rash erythematous

Uncommon (0.1% to 1%): Angioedema, erythema multiforme, pruritus, rash maculopapular, sweating increased, purpura, alopecia

Frequency not reported: Skin discoloration, urticaria, skin dryness, dermatitis, cold and clammy skin

Atorvastatin:

Uncommon (0.1% to 1%): Rash, pruritus, urticaria

Rare (less than 0.1%): Angioedema, alopecia

Postmarketing reports: Angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, insomnia

Amlodipine:

Uncommon (0.1% to 1%): Insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization, mood changes

Frequency not reported: Apathy, agitation

Atorvastatin:

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Depression, nightmare^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary frequency

Amlodipine:

Common (1% to 10%): Male sexual dysfunction, urinary frequency

Uncommon (0.1% to 1%): Female sexual dysfunction, micturition frequency, micturition disorder, nocturia

Frequency not reported: Dysuria, polyuria

Atorvastatin:

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Urinary frequency, erectile dysfunction

Rare (less than 0.1%): White blood cells urine positive^[Ref]

Metabolic

Amlodipine:

Uncommon (0.1% to 1%): Anorexia, weight gain, weight decrease, hyperglycemia, thirst

Frequency not reported: Increased appetite

Atorvastatin:

Common (1% to 10%): Diabetes

Uncommon (0.1% to 1%): Anorexia

Rare (less than 0.1%): Hypoglycemia

Frequency not reported: Hyperglycemia

Postmarketing reports: Weight increased^[Ref]

Ocular

Amlodipine:

Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain

Frequency not reported: Abnormal visual accommodation, xerophthalmia

Atorvastatin:

Uncommon (0.1% to 1%): Vision blurred^[Ref]

Hematologic

Amlodipine:

Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia

Atorvastatin:

Postmarketing reports: Thrombocytopenia^[Ref]