Amlodipine and perindopril

Name: Amlodipine and perindopril

What is amlodipine and perindopril?

Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Perindopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Perindopril also widens blood vessels and also prevents the body from retaining water.

Amlodipine and perindopril is a combination medicine used to treat high blood pressure (hypertension).

Amlodipine and perindopril may also be used for purposes not listed in this medication guide.

Amlodipine and perindopril side effects

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • swelling in your hands or feet, rapid weight gain;

  • little or no urinating;

  • new or worsened chest pain;

  • fever, chills, sore throat, body aches, flu symptoms;

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • swelling;

  • cough;

  • dizziness; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For the Consumer

Applies to amlodipine / perindopril: oral tablet

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

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Incidence not known
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • bloody urine
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • decreased frequency or amount of urine
  • difficult breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast or irregular heartbeat
  • increased thirst
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back or neck
  • sweating
  • unusual tiredness or weakness
  • weakness or heaviness of the legs

Some side effects of amlodipine / perindopril 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
  • Cough
  • dizziness
  • headache
Incidence not known
  • Diarrhea
  • rash

For Healthcare Professionals

Applies to amlodipine / perindopril: oral tablet

General

The most common side effects were edema, cough, headache, and dizziness.[Ref]

Nervous system

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

Amlodipine:
Common (1% to 10%): Headache, dizziness, somnolence
Uncommon (0.1% to 1%): Syncope, hypoesthesia, neuropathy peripheral, paraesthesia, tremor, dysgeusia, postural dizziness
Rare (0.01% to 0.1%): Amnesia, migraine
Very rare (less than 0.01%): Hypertonia
Frequency not reported: Extrapyramidal syndrome

Perindopril:
Common (1% to 10%): Headache, dizziness, drowsiness, paraesthesia, dysgeusia
Very rare (less than 0.01%): Stroke[Ref]

Other

Common (1% to 10%): Edema peripheral, vertigo, fatigue, lethargy

Amlodipine:
Very common (10% or more): Edema peripheral (13.2%)
Common (1% to 10%): Edema, fatigue
Uncommon (0.1% to 1%): Vertigo, asthenia, malaise, pain, tinnitus, gynecomastia
Rare (less than 0.1%): Ataxia

Perindopril:
Common (1% to 10%): Vertigo, tinnitus, asthenia
Uncommon (0.1% to 1%): Edema peripheral, atypical chest pain
Postmarketing reports: Falls, serositis, fever[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea

Amlodipine:
Uncommon (0.1% to 1%): Cough, dyspnea, epistaxis, rhinitis
Rare (less than 0.1%): Parosmia

Perindopril:
Very common (10% or more): Cough (up to 12%)
Common (1% to 10%): Dyspnea, epistaxis
Uncommon (0.1% to 1%): Bronchospasm
Very rare (less than 0.01%): Rhinitis, eosinophilic pneumonia[Ref]

Cardiovascular

Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Bradycardia, peripheral coldness

Amlodipine:
Common (1% to 10%): Palpitations, flushing
Uncommon (0.1% to 1%): Arrhythmia, bradycardia, chest pain, peripheral ischemia, tachycardia, vasculitis, hot flushes, postural hypotension, hypotension, vasculitis
Rare (0.01% to 0.1%): Myocardial infarction, angina pain, cardiac failure, pulse irregularity, extrasystoles, cold and clammy skin

Perindopril:
Common (1% to 10%): Palpitations, impaired peripheral circulation, flushing, hypotension, discomfort on exertion
Very rare (less than 0.01%): Angina pectoris, myocardial infarction, arrhythmia, vasculitis
Postmarketing reports: Cardiac arrest[Ref]

Dermatologic

Common (1% to 10%): Eczema
Frequency not reported: Rash

Amlodipine:
Uncommon (0.1% to 1%): Erythema multiforme, pruritus, rash, rash erythematosus, rash maculopapular, sweating increased, purpura, alopecia, hyperhidrosis, exanthema, skin discoloration
Rare (0.01% to 0.1%): Skin dryness, dermatitis, urticaria
Very rare (less than 0.01%): Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity

Perindopril:
Common (1% to 10%): Pruritus, rash, exanthema
Uncommon (0.1% to 1%): Hyperhidrosis, urticaria
Very rare (less than 0.01%): Erythema multiforme
Postmarketing reports: Bullous pemphigoid, pemphigus, psoriasis, exfoliative dermatitis[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea
Frequency not reported: Nausea

Amlodipine:
Common (1% to 10%): Abdominal pain, nausea
Uncommon (0.1% to 1%): Constipation, dysphagia, diarrhea, flatulence, vomiting, gingival hyperplasia, dry mouth, dyspepsia, altered bowel habits
Rare (less than 0.1%): Loose stools, gastritis

Perindopril:
Common (1% to 10%): Abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation
Uncommon (0.1% to 1%): Dry mouth[Ref]

Genitourinary

Common (1% to 10%): Erectile dysfunction

Amlodipine:
Uncommon (0.1% to 1%): Sexual dysfunction, micturition frequency, micturition disorder, nocturia, impotence
Rare (less than 0.1%): Dysuria

Perindopril:
Uncommon (0.1% to 1%): Impotence[Ref]

Hematologic

Amlodipine:
Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia
Very rare (less than 0.01%): Neutropenia

Perindopril:
Uncommon (0.1% to 1%): Leukopenia
Very rare (less than 0.01%): Agranulocytosis or pancytopenia, thrombocytopenia, hemolytic anemia in patients with a congenital glucose-6-phosphate dehydrogenase deficiency, decrease in hemoglobin and hematocrit
Postmarketing reports: Anemia, leucocytosis, eosinophilia, elevated erythrocyte sedimentation rate[Ref]

Hepatic

Amlodipine:
Uncommon (0.1% to 1%): Pancreatitis
Rare (less than 0.1%): Hepatitis, jaundice, hepatic enzyme elevations

Perindopril:
Common (1% to 10%): ALT elevated
Uncommon (0.1% to 1%): AST elevated
Rare (0.01% to 0.1%): Serum bilirubin elevated
Very rare (less than 0.01%): Pancreatitis, hepatitis
Postmarketing reports: Hepatic failure, jaundice[Ref]

Immunologic

Amlodipine:
Uncommon (0.1% to 1%): Allergic reaction, angioedema
Very rare (less than 0.01%): Quincke's edema

Perindopril:
Uncommon (0.1% to 1%): Allergic reactions, angioedema
Postmarketing reports: Positive antinuclear antibody[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia

Amlodipine:
Uncommon (0.1% to 1%): Anorexia, weight gain, weight decrease, hyperglycemia, thirst
Rare (less than 0.1%): Increased appetite

Perindopril:
Frequency not reported: Hypoglycemia, hyperkalemia
Postmarketing reports: Symptomatic hyponatremia[Ref]

Musculoskeletal

Frequency not reported: Joint swelling

Amlodipine:
Common (1% to 10%): Ankle swelling
Uncommon (0.1% to 1%): Back pain, rigors, arthralgia, arthrosis, muscle cramps, myalgia
Rare (less than 0.1%): Muscle weakness, twitching

Perindopril:
Common (1% to 10%): Back pain, muscle cramps
Postmarketing reports: Arthralgia/arthritis, myalgia[Ref]

Ocular

Amlodipine:
Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain, visual disturbances
Rare (less than 0.1%): Dry eyes, abnormal visual accommodation

Perindopril:
Common (1% to 10%): Visual disturbances[Ref]

Psychiatric

Amlodipine:
Uncommon (0.1% to 1%): Insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization, mood changes
Rare (less than 0.1%): Apathy, agitation, confusion

Perindopril:
Uncommon (0.1% to 1%): Mood changes, sleep disturbances
Very rare (less than 0.01%): Depression, confusion, hallucinations[Ref]

Renal

Perindopril:
Uncommon (0.1% to 1%): Renal impairment
Very rare (less than 0.01%): Acute renal failure
Frequency not reported: Blood urea increased, serum creatinine increased
Postmarketing reports: Nephritis[Ref]

Some side effects of amlodipine / perindopril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Not recommended

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