Aliskiren / amlodipine Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 29, 2022.

Applies to aliskiren/amlodipine: oral tablet

Cardiovascular

Aliskiren:

Rare (less than 0.1%): Hypotension

Amlodipine:

Common (1% to 10%): palpitations

Uncommon (0.1% to 1%): Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, vasculitis

Rare (less than 0.1%): Myocardial infarction, angina^[Ref]

Dermatologic

Aliskiren:

Common (1% to 10%): Rash

Rare (less than 0.1%): Angioedema (involving the face, hands, or whole body)

Postmarketing reports: Severe cutaneous adverse reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis)

Amlodipine:

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

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

Rare (less than 0.1%): Alopecia, dermatitis, skin discoloration, skin dryness, urticaria, lichen planus, telangiectasia^[Ref]

Endocrine

Amlodipine:

Postmarketing reports: Gynecomastia^[Ref]

Gastrointestinal

Aliskiren:

Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)

Postmarketing reports: Nausea, vomiting

Amlodipine:

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

Uncommon (0.1% to 1%): Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, vomiting

Rare (less than 0.1%): Gastritis, increased appetite, loose stools, taste perversion, dysgeusia^[Ref]

Genitourinary

Amlodipine:

Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia

Rare (less than 0.1%): Dysuria, polyuria^[Ref]

Hematologic

Amlodipine:

Uncommon (0.1% to 1%): Leukopenia, purpura, thrombocytopenia^[Ref]

Hypersensitivity

Aliskiren:

Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms

Postmarketing reports: Angioedema

Amlodipine:

Uncommon (0.1% to 1%): Allergic reaction^[Ref]

Hepatic

Amlodipine:

Postmarketing reports: Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)-Some cases were severe enough to require hospitalization^[Ref]

Metabolic

Aliskiren:

Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones

Postmarketing reports: Peripheral edema, hyponatremia

Amlodipine:

Uncommon (0.1% to 1%): Hyperglycemia, thirst, weight loss, weight gain

Very rare (less than 0.01%): Acute porphyria exacerbation

Frequency not reported: New-onset diabetes^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Asthenia, rigors

Amlodipine:

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Arthralgia, arthrosis, muscle cramps

Rare (less than 0.1%): Hypertonia, muscle weakness, twitching, ataxia^[Ref]

Nervous system

Aliskiren:

Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness

Amlodipine:

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

Uncommon (0.1% to 1%): Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor

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

Ocular

Amlodipine:

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

Rare (less than 0.1%): Abnormal visual accommodation, xerophthalmia^[Ref]

Psychiatric

Amlodipine:

Rare (less than 0.1%): Abnormal dreams, anxiety, depersonalization, depression, insomnia, nervousness, agitation, amnesia, apathy^[Ref]

Renal

Amlodipine:

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

Respiratory

Aliskiren:

Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough

Amlodipine:

Common (1% to 10%): Epistaxis

Uncommon (0.1% to 1%): Dyspnea

Rare (less than 0.1%): Coughing, rhinitis

Postmarketing reports: Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.^[Ref]

Other

Rare (less than 0.1%): Parosmia

Frequency not reported: Tinnitus^[Ref]

Further information

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

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