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Tekturna Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tekturna (aliskiren) is a renin inhibitor, which is an anti-hypertensive (blood pressure lowering) medication, used to treat high blood pressure (hypertension). Common side effects of Tekturna include upset stomach, heartburn, diarrhea, lightheadedness, cough, itching or skin rash, headache, dizziness, tired feeling, back pain, joint pain or swelling, stuffy nose, or sore throat.
The usual recommended starting dose of Tekturna is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg. It may be prescribed with other antihypertensive agents. Tekturna may interact with atorvastatin, cyclosporine, furosemide, antifungal medications, potassium supplements, salt substitutes that contain potassium, or diuretics (water pills). Tell your doctor all medications and supplements you use. Tekturna is not recommended for use during pregnancy due to the risk for harm to a fetus. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Tekturna (aliskiren) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tekturna in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficult breathing; swelling of your face, lips, tongue, or throat.
If you have an allergic reaction to aliskiren you should not take it again.
Call your doctor at once if you have a serious side effect such as:
- feeling light-headed, fainting;
- nausea with slow uneven heart rate and a weak pulse;
- swelling around your eyes; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- stomach pain or upset, diarrhea, heartburn;
- itching or skin rash;
- headache, dizziness, tired feeling;
- back pain, joint pain or swelling; or
- stuffy nose, sore throat, cough.
Read the entire detailed patient monograph for Tekturna (Aliskiren Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tekturna Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), unusual change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tekturna (Aliskiren Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tekturna FDA Prescribing Information: Side Effects
Clinical Trials Experience
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions and Head and Neck Angioedema [see WARNINGS AND PRECAUTIONS]
- Hypotension [see WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Data described below reflect the evaluation of the safety of Tekturna in more than 6,460 patients, including over 1,740 treated for longer than 6 months, and more than 1,250 patients for longer than 1 year. In placebo controlled clinical trials, discontinuation of therapy due to a clinical adverse event, including uncontrolled hypertension, occurred in 2.2% of patients treated with Tekturna versus 3.5% of patients given placebo. These data do not include information from the ALTITUDE study which evaluated the use of aliskiren in combination with ARBs or ACEIs [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and Clinical Studies].
Angioedema: Two cases of angioedema with respiratory symptoms were reported with Tekturna use in the clinical studies. Two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of these angioedema cases in the completed studies was 0.06%.
In addition, 26 other cases of edema involving the face, hands, or whole body were reported with Tekturna use including 4 leading to discontinuation.
In the placebo controlled studies, however, the incidence of edema involving the face, hands, or whole body was 0.4% with Tekturna compared with 0.5% with placebo. In a long-term active-control study with Tekturna and hydrochlorothiazide (HCTZ) arms, the incidence of edema involving the face, hand or whole body was 0.4% in both treatment arms [see WARNINGS AND PRECAUTIONS].
Gastrointestinal: Tekturna produces dose-related gastrointestinal (GI) adverse reactions. Diarrhea was reported by 2.3% of patients at 300 mg, compared to 1.2% in placebo patients. In women and the elderly (age 65 years and older) increases in diarrhea rates were evident starting at a dose of 150 mg daily, with rates for these subgroups at 150 mg comparable to those seen at 300 mg for men or younger patients (all rates about 2.0% to 2.3%). Other GI symptoms included abdominal pain, dyspepsia, and gastroesophageal reflux, although increased rates for abdominal pain and dyspepsia were distinguished from placebo only at 600 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.
Cough: Tekturna was associated with a slight increase in cough in the placebo-controlled studies (1.1% for any Tekturna use versus 0.6% for placebo). In active-controlled trials with ACE inhibitor (ramipril, lisinopril) arms, the rates of cough for the Tekturna arms were about one-third to one-half the rates in the ACE inhibitor arms.
Seizures: Single episodes of tonic-clonic seizures with loss of consciousness were reported in 2 patients treated with Tekturna in the clinical trials. One of these patients did have predisposing causes for seizures and had a negative electroencephalogram (EEG) and cerebral imaging following the seizures (for the other patient EEG and imaging results were not reported). Tekturna was discontinued and there was no rechallenge.
Other adverse effects with increased rates for Tekturna compared to placebo included rash (1% versus 0.3%), elevated uric acid (0.4% versus 0.1%), gout (0.2% versus 0.1%) and renal stones (0.2% versus 0%).
Aliskiren's effect on ECG intervals was studied in a randomized, double-blind, placebo and active-controlled (moxifloxacin), 7-day repeat dosing study with Holter-monitoring and 12 lead ECGs throughout the interdosing interval. No effect of aliskiren on QT interval was seen.
Clinical Laboratory Findings
In controlled clinical trials, clinically relevant changes in standard laboratory parameters were rarely associated with the administration of Tekturna in patients with hypertension not concomitantly treated with an ARB or ACEI. In multiple-dose studies in hypertensive patients, Tekturna had no clinically important effects on total cholesterol, HDL, fasting triglycerides, or fasting glucose.
Blood Urea Nitrogen, Creatinine: In patients with hypertension not concomitantly treated with an ARB or ACEI, minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 7% of patients treated with Tekturna alone versus 6% on placebo [see WARNINGS AND PRECAUTIONS].
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.08 g/dL and 0.16 volume percent, respectively, for all aliskiren monotherapy) were observed. The decreases were dose-related and were 0.24 g/dL and 0.79 volume percent for 600 mg daily. This effect is also seen with other agents acting on the renin angiotensin system, such as angiotensin inhibitors and ARBs and may be mediated by reduction of angiotensin II which stimulates erythropoietin production via the AT1 receptor. These decreases led to slight increases in rates of anemia with aliskiren compared to placebo were observed (0.1% for any aliskiren use, 0.3% for aliskiren 600 mg daily, versus 0% for placebo). No patients discontinued therapy due to anemia.
Serum Potassium: In patients with hypertension not concomitantly treated with an ARB or ACEI, increases in serum potassium greater than 5.5 mEq/L were infrequent (0.9% compared to 0.6% with placebo) [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Serum Uric Acid: Aliskiren monotherapy produced small median increases in serum uric acid levels (about 6 micromol/L) while HCTZ produced larger increases (about 30 micromol/L). The combination of aliskiren with HCTZ appears to be additive (about 40 micromol/L increase). The increases in uric acid appear to lead to slight increases in uric acid-related AEs: elevated uric acid (0.4% versus 0.1%), gout (0.2% versus. 0.1%), and renal stones (0.2% versus 0%).
Creatine Kinase: Increases in creatine kinase of greater than 300% were recorded in about 1% of aliskiren monotherapy patients versus 0.5% of placebo patients. Five cases of creatine kinase rises, 3 leading to discontinuation and 1 diagnosed as subclinical rhabdomyolysis, and another as myositis, were reported as adverse events with aliskiren use in the clinical trials. No cases were associated with renal dysfunction.
The following adverse reactions have been reported in aliskiren postmarketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity: anaphylactic reactions and angioedema requiring airway management and hospitalization
Hepatic enzyme increase with clinical symptoms of hepatic dysfunction
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
Read the entire FDA prescribing information for Tekturna (Aliskiren Tablets)
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