Aliskiren / Amlodipine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 23, 2024.

Applies to aliskiren / amlodipine: oral tablet.

Get emergency medical help if you have any of these signs of an allergic reaction while taking aliskiren / amlodipine: hives; vomiting, severe stomach pain; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

• chest pain or pressure, pain spreading to your jaw or shoulder;

• little or no urinating; or

• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling.

Common side effects may include:

• swelling in your hands, ankles, or feet;

• dizziness, tired feeling;

• cough;

• diarrhea;

• stomach pain, upset stomach; or

• flu symptoms (fever, chills, body aches).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:

For healthcare professionals

Applies to aliskiren / amlodipine: oral tablet.

Cardiovascular adverse events

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

Aliskiren/amlodipine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer