Aliskiren / Amlodipine Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 12, 2024.

Applies to aliskiren / amlodipine: oral tablet.

Important warnings This medicine can cause some serious health issues

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, you should not use aliskiren and amlodipine together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

You should not take aliskiren and amlodipine if you are also using cyclosporine or itraconazole.

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.

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.

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

Medical Disclaimer