Note: This document contains side effect information about amlodipine / perindopril. Some dosage forms listed on this page may not apply to the brand name Prestalia.

Summary

Common side effects of Prestalia include: cough. Continue reading for a comprehensive list of adverse effects.

Applies to amlodipine / perindopril: oral tablet.

Serious side effects of Prestalia

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

• 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
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back or neck
• stomach pain
• sweating
• unusual tiredness or weakness
• vomiting
• weakness or heaviness of the legs

Other side effects of Prestalia

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]