Tekturna Side Effects

Generic name: aliskiren

Note: This document contains side effect information about aliskiren. Some of the dosage forms listed on this page may not apply to the brand name Tekturna.

Some side effects of Tekturna 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: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking aliskiren (the active ingredient contained in Tekturna) hives; severe stomach pain; difficult breathing; swelling of your face, lips, tongue, or throat.

If you have an allergic reaction to aliskiren you should not take it again.

Call your doctor at once if you have a serious side effect such as:

• feeling light-headed, fainting;

• nausea with slow uneven heart rate and a weak pulse;

• swelling around your eyes; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of aliskiren may include:

• stomach pain or upset, diarrhea, heartburn;

• itching or skin rash;

• headache, dizziness, tired feeling;

• back pain, joint pain or swelling; or

• stuffy nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to aliskiren: oral tablet

Hypersensitivity

Two cases of angioedema with respiratory symptoms were reported with aliskiren (the active ingredient contained in Tekturna) 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. There have been postmarketing reports of angioedema requiring airway management and hospitalization. Periorbital edema without respiratory symptoms were also reported as possible angioedema and resulted in discontinuation.

Gastrointestinal

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.

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

Dermatologic

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

Metabolic

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

Nervous system

Episodes of tonic-clonic seizures were reported in two patients treated with aliskiren (the active ingredient contained in Tekturna) 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 rechallenge.

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 (the active ingredient contained in Tekturna) is well tolerated with an adverse event profile similar to placebo. Most adverse effects reported were mild to moderate in severity.

Hematologic

Postmarketing hematologic side effects have included increased blood creatinine.

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