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Aliskiren / amlodipine Side Effects

For the Consumer

Applies to aliskiren / amlodipine: oral tablet

Along with its needed effects, aliskiren/amlodipine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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

Rare

  • 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 side effects of aliskiren / amlodipine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

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]

References

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.

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