Tekturna Side Effects
Generic name: aliskiren
Medically reviewed by Drugs.com. Last updated on Jul 3, 2024.
Note: This document provides detailed information about Tekturna Side Effects associated with aliskiren. Some dosage forms listed on this page may not apply specifically to the brand name Tekturna.
Applies to aliskiren: oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, lips, tongue, or throat while you are using this medicine.
Dizziness or lightheadedness may occur while you are using this medicine, especially if you have been taking a diuretic (water pill). Do not drive or do anything else that could be dangerous until you know this medicine affects you. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, stop using this medicine until you have talked to your doctor.
Check with your doctor right away if you become sick while taking this medicine, especially if you have severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink of plenty of water during exercise or hot weather.
This may cause serious kidney problems, including kidney failure. Check with your doctor right away if you have a decrease in how much or how often you urinate.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.
You should not use this medicine (unless your doctor specifically tells you to) if you are also receiving cyclosporine (Gengraf®, Neoral®, Sandimmune®) or itraconazole (Sporanox®).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.
Serious side effects of Tekturna
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 side effects
- body aches or pain
- chills
- cough
- diarrhea
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
Rare side effects
- ankle, knee, or great toe joint pain
- blood in the urine
- joint pain, 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
- pain in the groin or genitals
- sharp back pain just below the ribs
- swelling of the feet or lower legs
- vomiting
Incidence not known
- blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- itching
- 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
Other side effects of Tekturna
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 side effects
- back pain
- belching
- dizziness
- heartburn
- indigestion
- muscle aches
- rash
- stomach discomfort, upset, or pain
For healthcare professionals
Applies to aliskiren: oral tablet.
Hypersensitivity adverse events
- Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
- Postmarketing reports: Angioedema[Ref]
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.[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)
- Postmarketing reports: Nausea, vomiting[Ref]
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.[Ref]
Dermatologic
- 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)[Ref]
Metabolic
- Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
- Postmarketing reports: Peripheral edema, hyponatremia[Ref]
Nervous system
- Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness.[Ref]
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.[Ref]
Respiratory
- Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough[Ref]
Cardiovascular
- Rare (less than 0.1%): Hypotension[Ref]
Hematologic
- Uncommon (0.1% to 1%): Small decreases in hemoglobin and hematocrit
- Postmarketing reports: Increased blood creatinine[Ref]
Musculoskeletal
- Common (1% to 10%): Back pain
Other
- Rare (less than 0.1%): Parosmia
- Frequency not reported: Tinnitus[Ref]
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References
1. (2007) "Product Information. Tekturna (aliskiren)." Novartis Pharmaceuticals
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Frampton JE, Curran MP (2007) "Aliskiren: A Review of its Use in the Management of Hypertension." Drugs, 67, p. 1767-1792
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Further information
Tekturna side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.