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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.For the Consumer
Applies to aliskiren: oral tablet
Oral route (Tablet; Pellet)
When pregnancy is detected, discontinue aliskiren as soon as possible, since drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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:
Incidence not known
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:
For Healthcare Professionals
Applies to aliskiren: oral tabletHypersensitivity
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.
Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: AngioedemaGastrointestinal
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.
Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)
Postmarketing reports: Nausea, vomitingDermatologic
Common (1% to 10%): Rash
Rare (less than 0.1%): Angioedema (involving the face, hands, or whole body)
Postmarketing reports: Severe cutaneous adverse reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis)Metabolic
Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema, hyponatremiaNervous 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.
Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness.Respiratory
Frequency not reported: Nasopharyngitis, upper respiratory tract infection, coughCardiovascular
Rare (less than 0.1%): HypotensionHematologic
Uncommon (0.1% to 1%): Small decreases in hemoglobin and hematocrit
Postmarketing reports: Increased blood creatinineMusculoskeletal
Common (1% to 10%): Back painOther
Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus
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