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Aliskiren / amlodipine Side Effects

Not all side effects for aliskiren / amlodipine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aliskiren / amlodipine: oral tablet

In addition to its needed effects, some unwanted effects may be caused by aliskiren / amlodipine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking aliskiren / amlodipine:

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
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • diarrhea
  • dizziness
  • fever
  • headache
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with aliskiren / amlodipine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • itching skin
  • lack or loss of strength
  • muscle cramps
  • rash
  • stomach discomfort or upset
Incidence not known
  • Swelling of the breasts or breast soreness in both females and males

For Healthcare Professionals

Applies to aliskiren / amlodipine: oral tablet


Rare (less than 0.1%): Hypotension

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]


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)

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]


Postmarketing reports: Gynecomastia[Ref]


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

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]


Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia
Rare (less than 0.1%): Dysuria, polyuria[Ref]


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


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

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


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


Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema

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]


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

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

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

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]


Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain
Rare (less than 0.1%): Abnormal visual accommodation, xerophthalmia[Ref]


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


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


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

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]


Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus[Ref]


1. "Product Information. Tekamlo (aliskiren-amlodipine)." Novartis Pharmaceuticals, East Hanover, NJ.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.