Aliskiren / amlodipine Side Effects

Some side effects of aliskiren / amlodipine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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

Cardiovascular side effects associated with aliskiren have included extremely rare cases of hypotension (0.1%) and angioedema (0.06%) involving the face, hands, or whole body.

Cardiovascular side effects associated with amlodipine have included palpitation (up to 4.5%). Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, and vasculitis have been reported in less than 1% but greater than 0.1% of patients. Cardiac failure, extrasystoles, and pulse irregularity have been reported in less than 0.1% of patients. Angina and myocardial infarction have occasionally been reported; however, these reactions could not be distinguished from coexisting disease states or medications. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, especially in patients with severe obstructive coronary artery disease.

Dermatologic

Dermatologic side effects associated with aliskiren have included rash (1%). Postmarketing reports have included severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis.

Dermatologic side effects associated with amlodipine have included rash and erythematous rash in up to 2% of patients. Angioedema, erythema multiforme, increased sweating, maculopapular rash, and pruritus have been reported in less than 1% but greater than 0.1% of patients. Alopecia, dermatitis, skin discoloration, skin dryness, and urticaria have been reported in less than 0.1% of patients. Amlodipine-associated lichen planus and telangiectasia have been rarely reported.

Endocrine

Endocrine side effects associated with amlodipine have included gynecomastia during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects associated with aliskiren appear to be dose related. These have included diarrhea (2.3%), abdominal pain, dyspepsia, and gastroesophageal reflux.

Gastrointestinal side effects associated with amlodipine have included nausea (2.9%), dysphagia (up to 2%), and abdominal pain (1.6%). Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, and vomiting have been reported in less than 1% but greater than 0.1% of patients. Gastritis, increased appetite, loose stools, and taste perversion have been reported in less than 0.1% of patients. At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge.

General

In general, aliskiren is well tolerated with an adverse event profile similar to placebo. Most adverse effects reported were mild to moderate in severity.

Amlodipine is generally well-tolerated at dosages up to 10 mg per day. Most side effects reported were of mild or moderate severity and were dose-related. Headache and edema are the most common side effects.
Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Genitourinary

Genitourinary side effects associated with amlodipine have included micturition disorder, micturition frequency, and nocturia in less than 1% but greater than 0.1% of patients. Dysuria and polyuria have been reported in less than 0.1% of patients.

Hematologic

Hematologic side effects associated with amlodipine have included leukopenia, purpura, and thrombocytopenia in less than 1% but greater than 0.1% of patients.

Hypersensitivity

Hypersensitivity side effects associated with aliskiren have included cases of angioedema involving the face, hands, and body with or without respiratory symptoms. Periorbital edema without respiratory symptoms were also reported as possible angioedema and resulted in discontinuation. There have been postmarketing reports of angioedema requiring airway management and hospitalization associated with aliskiren.

Hypersensitivity side effects associated with amlodipine have included allergic reaction (less than 1% but greater than 0.1%).

Hepatic

Hepatic side effects associated with amlodipine have included jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) during postmarketing experience. In some instances, these cases were severe enough to require hospitalization.

Metabolic

Metabolic side effects associated with aliskiren have included elevated uric acid (0.4%), gout (0.2%), and renal stones (0.2%). There have been postmarketing reports of peripheral edema associated with aliskiren.

Metabolic side effects associated with amlodipine have included hyperglycemia, thirst, weight decrease, and weight gain in less than 1% but greater than 0.1% of patients. New-onset diabetes has been reported. A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition.

Musculoskeletal

Musculoskeletal side effects associated with amlodipine have included myalgia (up to 2%). Arthralgia, arthrosis, and muscle cramps have been reported in less than 1% but greater than 0.1% of patients. Hypertonia, muscle weakness, and twitching have been reported in less than 0.1% of patients.

Nervous system

Nervous system side effects associated with aliskiren have included headache, dizziness, fatigue, and single episodes of tonic-clonic seizures with loss of consciousness.

Nervous system side effects associated with amlodipine have included headache (7.3%), dizziness (up to 3.4%), and somnolence (up to 1.6%). Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor, and vertigo have been reported in less than 1% but greater than 0.1% of patients. Ataxia and migraine have been reported in less than 0.1% of patients. Myoclonus has been reported.

Other

Other side effects associated with aliskiren have included back pain.

Other side effects associated with amlodipine have included edema (up to 14.6%), flushing (up to 4.5%), fatigue (4.5%), back pain (up to 2%), and tinnitus. During studies in patients with documented coronary artery disease, the most common side effect was peripheral edema. Asthenia, hot flushes, malaise, pain, and rigors have been reported in less than 1% but greater than 0.1% of patients. Cold and clammy skin and parosmia have been reported in less than 0.1% of patients.

Ocular

Ocular side effects associated with amlodipine have included abnormal vision, conjunctivitis, diplopia, and eye pain in less than 1% but greater than 0.1% of patients. Abnormal visual accommodation and xerophthalmia have been reported in less than 0.1% of patients.

Psychiatric

Psychiatric side effects associated with amlodipine have included male sexual dysfunction (up to 2%). Abnormal dreams, anxiety, depersonalization, depression, female sexual dysfunction, insomnia, and nervousness have been reported in less than 1% but greater than 0.1% of patients. Agitation, amnesia, and apathy have been reported in less than 0.1% of patients.

Renal

Renal side effects associated with amlodipine have been reported rarely. At least one case of interstitial nephritis has been reported. Increased blood creatinine has been associated with the aliskiren component.

Respiratory

Respiratory side effects associated with aliskiren have included nasopharyngitis, upper respiratory tract infection, and cough.

Respiratory side effects associated with amlodipine have included epistaxis (up to 2%) and dyspnea (less than 1% but greater than 0.1%). Coughing and rhinitis have been reported in less than 0.1% of patients. 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.

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