Aliskiren Side Effects

Brand Names: Tekturna

Please note - some side effects for Aliskiren may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aliskiren - for the Consumer

Aliskiren

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aliskiren:

Mild diarrhea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, or tongue; hoarseness); symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); trouble swallowing.

Aliskiren/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aliskiren/Hydrochlorothiazide:

Cough; dizziness; flu-like symptoms (eg, headache, muscle or joint aches, tiredness); mild diarrhea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urination; fainting; fever, chills, or persistent sore throat; increased thirst; irregular heartbeat; muscle pain or cramps; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea or stomach pain; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; unusually dry mouth; yellowing of the eyes or skin.

Side Effects by Body System

Hypersensitivity

Two cases of angioedema with respiratory symptoms were reported with aliskiren use in clinical studies, and two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of angioedema cases in completed studies was 0.06%. Twenty-six other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including four which led to discontinuation. In the placebo controlled studies, the incidence of edema involving the face, hands or whole body was 0.4% with aliskiren compared with 0.5% with placebo.

Hypersensitivity side effects 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.

Gastrointestinal

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

In women and the elderly (65 years of age or older), increases in diarrhea rates were evident starting at a dose of 150 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.

Dermatologic

Dermatologic side effects have included rash (1%).

Metabolic

Metabolic side effects have included elevated uric acid (0.4%), gout (0.2%), and renal stones (0.2%).

Nervous system

Episodes of tonic-clonic seizures were reported in two patients treated with aliskiren in the clinical trials. One patient had predisposing causes for seizures and a negative electroencephalogram (EEG) and cerebral imaging following the seizures (the other patient's EEG and imaging results were not reported). Aliskiren was discontinued and there was no re-challenge.

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

Respiratory

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

Other

Other side effects have included back pain.

Cardiovascular

Cardiovascular side effects have included extremely rare cases of hypotension (0.1%) and angioedema (0.06%).

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.

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