Tekturna Side Effects

Generic Name: aliskiren

Please note - some side effects for Tekturna 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 of Tekturna - for the Consumer

Tekturna

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 Tekturna:

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

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Tekturna HCT

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 Tekturna HCT:

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

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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. 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%).

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 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 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.