Tekturna HCT Side Effects

Generic name: aliskiren / hydrochlorothiazide

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.

Some side effects of Tekturna HCT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to aliskiren / hydrochlorothiazide: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking aliskiren / hydrochlorothiazide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hydrochlorothiazide and aliskiren and call your doctor at once if you have a serious side effect such as:

• eye pain, vision problems;

• feeling like you might pass out;

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

• urinating less than usual, or not at all;

• joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); 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 of aliskiren / hydrochlorothiazide may include:

• dizziness, spinning sensation;

• diarrhea, stomach pain, indigestion;

• tired feeling;

• flu symptoms; or

• dry cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to aliskiren / hydrochlorothiazide: oral tablet

General

In general, aliskiren is well tolerated with an adverse event profile similar to placebo. Most adverse effects reported were mild to moderate in severity.

Hypersensitivity

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.

Hypersensitivity side effects associated with aliskiren have included cases of angioedema involving the face, hands, and body with or without respiratory symptoms. Periorbital edema without respiratory symptoms were also reported as possible angioedema and resulted in discontinuation. There have been postmarketing reports of angioedema requiring airway management and hospitalization associated with aliskiren.
Hypersensitivity side effects associated with hydrochlorothiazide have included purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, and anaphylactic reactions.

Metabolic

Metabolic side effects associated with aliskiren monotherapy and combination therapy with hydrochlorothiazide have included elevated uric acid, gout, and renal stones. There have been postmarketing reports of peripheral edema associated with aliskiren. Metabolic side effects associated with hydrochlorothiazide have included hyperglycemia, glycosuria, and hyperuricemia. Serum electrolyte abnormalities including hypokalemia (2.2%) and hyperkalemia (0.8%) have been reported in clinical trials using aliskiren-hydrochlorothiazide.

Gastrointestinal

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.

Gastrointestinal side effects associated with aliskiren appear to be dose related. These have included diarrhea (2.3%), abdominal pain, dyspepsia, and gastroesophageal reflux. Gastrointestinal side effects associated with hydrochlorothiazide have included pancreatitis, cramping, gastric irritation, and sialadenitis. In placebo-controlled clinical trials, diarrhea (1.6%) was reported in patients receiving the combination product.

Cardiovascular

Cardiovascular side effects associated with aliskiren have included extremely rare cases of hypotension (0.1%) and angioedema (0.06%).

Dermatologic

Dermatologic side effects associated with aliskiren have included rash (1%). Erythema multiforme including Stevens-Johnson syndrome, and exfoliative dermatitis including toxic epidermal necrolysis have been associated with hydrochlorothiazide therapy.

Nervous system

Nervous system side effects associated with aliskiren have included headache, dizziness, fatigue, and single episodes of tonic-clonic seizures with loss of consciousness. Restlessness has been associated with hydrochlorothiazide. In placebo-controlled clinical trials, dizziness (2.3%), vertigo (1.2%), and asthenia (1.2%) were reported in patients receiving the combination product.

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.

Hepatic

Hepatic side effects associated with hydrochlorothiazide have included jaundice (intrahepatic cholestatic jaundice). Occasional elevations (greater than 150%) of ALT (SGPT) were observed in 1.2% of patients treated with aliskiren-hydrochlorothiazide.

Renal

Renal side effects including renal failure, renal dysfunction, and interstitial nephritis have been associated with hydrochlorothiazide. Elevations of BUN and creatinine have also been reported when using aliskiren-hydrochlorothiazide.

Hematologic

Hematologic side effects associated with hydrochlorothiazide have included aplastic anemia, thrombocytopenia, agranulocytosis, leukopenia, and hemolytic anemia. A greater than 20% decrease in hemoglobin and hematocrit were observed in less than 0.1% and 0.1%, respectively, in patients treated with aliskiren-hydrochlorothiazide.

Postmarketing hematologic side effects have included increased blood creatinine.

Musculoskeletal

Musculoskeletal side effects including muscle spasm have been associated with hydrochlorothiazide treatment. In placebo-controlled clinical trials, arthralgia (1.0%) was reported in patients receiving the combination product.

Ocular

Ocular side effects including transient blurred vision and xanthopsia have been associated with hydrochlorothiazide. Ocular side effects reported postmarketing have included idiosyncratic reactions to the hydrochlorothiazide component resulting in acute transient myopia and acute angle-closure glaucoma.

Respiratory

Respiratory side effects associated with aliskiren have included nasopharyngitis, upper respiratory tract infection, and cough. In placebo-controlled clinical trials, cough (1.3%) was reported in patients receiving the combination product.

Other

Other side effects associated with aliskiren have included back pain. Other side effects associated with hydrochlorothiazide have included weakness. In placebo-controlled clinical trials, influenza (2.3%) was reported in patients receiving the combination product.

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