Aliskiren and valsartan Side Effects

Please note - some side effects for Aliskiren and valsartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral tablet

Genitourinary

Genitourinary side effects have included urinary tract infection (1.4%). Genitourinary side effects reported for the aliskiren component have included elevated uric acid (0.4%), gout (0.2%), and renal stones (0.2%). Genitourinary side effects reported for the valsartan component have included impotence.

Nervous system

Nervous system side effects have included fatigue (2.6%) and vertigo (1.1%). Nervous system side effects reported for the aliskiren component have included headache, dizziness, fatigue, cough, and tonic-clonic seizures in two patients, one of which had a history of seizures and the other had no history given.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (1.4%). Gastrointestinal side effects reported for the aliskiren component have included diarrhea which increased with increasing dosage and was higher in elderly women, abdominal pain, dyspepsia, and gastroesophageal reflux.

Immunologic

Immunologic side effects have included nasopharyngitis (2.6%) and upper respiratory tract infection (1.1%). Immunologic side effects reported for the aliskiren component have included nasopharyngitis and upper respiratory tract infection. There have been postmarketing reports of angioedema requiring airway management and hospitalization associated with aliskiren.

Ocular

Ocular side effects reported for the aliskiren component have included periorbital edema without respiratory symptoms.

General

General side effects reported for the aliskiren component have included angioedema (0.06%), and edema involving the face, hands, or whole body (0.4%), and cough (1.1%). General side effects reported for the valsartan component have included cough (2.6%), and angioedema.

Local

Local side effects reported for the aliskiren component have included rash (1%).

Musculoskeletal

Musculoskeletal side effects reported for the aliskiren component have included back pain. Musculoskeletal side effects reported for the valsartan component have included asthenia and muscle cramps.

Psychiatric

Psychiatric side effects reported for the valsartan component have included paresthesia.

Respiratory

Respiratory side effects reported for the valsartan component have included sinusitis and pharyngitis.

Hematologic

Hematologic side effects have included small mean decreases from baseline in red blood cell (RBC) count, hemoglobin, and hematocrit in both monotherapy and combination therapy.

Postmarketing hematologic side effects have included increased blood creatinine.

Hepatic

Hepatic side effects have included elevations in blood urea nitrogen (BUN) and creatinine (less than 1%).

Metabolic

There have been postmarketing reports of peripheral edema associated with aliskiren.

Dermatologic

Postmarketing reports have included severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis.

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