Note: This document contains side effect information about aliskiren / hydrochlorothiazide. Some of the dosage forms listed on this page may not apply to the brand name Tekturna HCT.
Applies to aliskiren/hydrochlorothiazide: oral tablet
Oral route (Tablet)
When pregnancy is detected, discontinue aliskiren / hydrochlorothiazide 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 / hydrochlorothiazide 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 / hydrochlorothiazide:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking aliskiren / hydrochlorothiazide:
Symptoms of overdose
Some side effects of aliskiren / hydrochlorothiazide 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:
Applies to aliskiren / hydrochlorothiazide: oral tablet
Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema
Uncommon (0.1% to 1%): Rash
Rare (less than 0.1%): Anaphylaxis
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.
Frequency not reported: Edema, peripheral edema
Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema, hyponatremia
Very common (10% or more): Mild hypokalemia (decrease of 0.5 mEq/L) occurs in up to 50% of patients, and may predispose patients to cardiac arrhythmias
Common (1% to 10%): Metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, elevated serum uric acid levels
Very rare (less than 0.01%): Hot flushes
Frequency not reported: Edema, peripheral edema, glucose intolerance, a potentially deleterious effect on the lipid profile (i.e., increased serum cholesterol)
Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)
Postmarketing reports: Nausea, vomiting
Uncommon (0.1% to 1%): Nausea, vomiting, diarrhea
In women and the elderly (65 years of age or older) receiving aliskiren therapy, 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%): 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)
Rare (less than 0.1%): Erythema annular centrifugum, acute eczematous dermatitis, morbilliform and leukocytoclastic vasculitis, phototoxic dermatitis
Frequency not reported: Subacute cutaneous lupus erythematosus like reaction
Uncommon (0.1% to 1%): Malaise, pain
Frequency not reported: Fatigue
Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness
Frequency not reported: Cerebrovascular insufficiency associated with hydrochlorothiazide-induced plasma volume contraction, cognitive and neurologic impairment (i.e., confusion, somnolence, feeling dazed)- Symptoms resolved following discontinuation of hydrochlorothiazide.
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.
Common (1% to 10%): Occasional elevations (greater than 150% from baseline) in ALT (SGPT)
Rare (less than 0.1%): Interstitial nephritis
Rare (less than 0.1%): Renal insufficiency, renal failure, renal dysfunction, interstitial nephritis
Rare (less than 0.1%): Immune-complex hemolytic anemia, aplastic anemia, thrombocytopenia
Uncommon (0.1% to 1%): Asthenia, rigors
Uncommon (0.1% to 1%): Myalgias, chills, muscle spasms, preservation of mineral bone density in older patients
Frequency not reported: Transient blurred vision, acute transient myopia, acute angle-closure glaucoma, xanthopsia
Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough
Frequency not reported: Acute noncardiogenic pulmonary edema (these cases are thought to be due to idiosyncrasy or a hypersensitivity mechanism)
Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus
Common (1% to 10%): Rash that is histologically identical to subacute cutaneous lupus
Frequency not reported: Allergic vasculitis, hemolytic anemia
Rare (less than 0.1%): Hypotension
Frequency not reported: Cardiac arrhythmias (including ventricular ectopy and complete AV heart block), hypotension, orthostatic hypotension (more common in the elderly)
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Tekturna Hct