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Aliskiren / amlodipine Side Effects

For the Consumer

Applies to aliskiren / amlodipine: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Very bad dizziness or passing out.
  • Chest pain that is new or worse.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Stiff muscles, shakiness, or muscle movements that are not normal.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Cough.
  • Diarrhea.
  • Flu-like signs.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at

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, hyponatremia


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.

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.