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Katerzia Side Effects

Generic name: amlodipine

Medically reviewed by Drugs.com. Last updated on Oct 11, 2021.

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

For the Consumer

Applies to amlodipine: oral capsules, oral tablets

Side effects include:

Edema, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence. Edema, flushing, palpitations, and somnolence may be more common in women than men. Edema may be less frequent with concomitant ACE inhibitor or angiotensin II receptor antagonist therapy.

For Healthcare Professionals

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

General

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

Cardiovascular

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).[Ref]

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[Ref]

Nervous system

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[Ref]

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

Extrapyramidal syndrome may be associated with this drug.[Ref]

Gastrointestinal

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[Ref]

Dermatologic

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[Ref]

Other

Common (1% to 10%): Fatigue

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

Frequency not reported: Rigors, thirst[Ref]

Genitourinary

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[Ref]

Musculoskeletal

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

Very rare (less than 0.01%): Muscle weakness

Frequency not reported: Arthrosis, twitching[Ref]

Psychiatric

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[Ref]

Respiratory

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

Very rare (less than 0.01%): Cough

Frequency not reported: Epistaxis[Ref]

Ocular

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[Ref]

Metabolic

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

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

Frequency not reported: Anorexia[Ref]

Hematologic

Uncommon (0.1% to 1%): Purpura

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

Endocrine

Uncommon (0.1% to 1%): Gynecomastia[Ref]

Hepatic

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.[Ref]

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

Hypersensitivity

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

Frequently asked questions

References

1. "Product Information. Norvasc (amlodipine)." Pfizer U.S. Pharmaceuticals (2002):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.