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
Along with its needed effects, aliskiren (the active ingredient contained in Tekturna) 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:Less common
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- Ankle, knee, or great toe joint pain
- blood in the urine
- joint pain
- joint stiffness or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of bladder control
- loss of consciousness
- lower back or side pain
- nausea and vomiting
- pain in the groin or genitals
- sharp back pain just below the ribs
- swelling of the feet or lower legs
- Blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- joint or muscle pain
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- sores, ulcers, or white spots in the mouth or on the lips
- tingling of the hands or feet
- unusual weight gain or loss
Some side effects of aliskiren 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
- back pain
- muscle aches
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to aliskiren: oral tablet
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.
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 side effects have included rash (1%). Postmarketing reports have included severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis.
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.
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 side effects have included nasopharyngitis, upper respiratory tract infection, and cough.
Other side effects have included back pain.
Cardiovascular side effects have included extremely rare cases of hypotension (0.1%) and angioedema (0.06%).
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.
Postmarketing hematologic side effects have included increased blood creatinine.
More about Tekturna (aliskiren)
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