Tekturna Side Effects
Generic Name: aliskiren
Note: This page contains side effects data for the generic drug aliskiren. It is possible that some of the dosage forms included below may not apply to the brand name Tekturna.
It is possible that some side effects of Tekturna may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to aliskiren: oral tablet
As well as its needed effects, aliskiren (the active ingredient contained in Tekturna) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking aliskiren, check with your doctor immediately: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 aliskiren side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.
Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema
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)
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)
Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: 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.
Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness.
Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough
Rare (less than 0.1%): Hypotension
Uncommon (0.1% to 1%): Small decreases in hemoglobin and hematocrit
Postmarketing reports: Increased blood creatinine
Common (1% to 10%): Back pain
Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus
More about Tekturna (aliskiren)
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