Tekturna HCT Side Effects

Please note - some side effects for 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.

Side Effects of Tekturna HCT - for the Consumer

Tekturna HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tekturna HCT:

Cough; dizziness; flu-like symptoms (eg, headache, muscle or joint aches, tiredness); mild diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur when using Tekturna HCT:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); decreased urination; eye pain; fever, chills, or persistent sore throat; increased thirst; irregular heartbeat; muscle pain or cramps; red, swollen, blistered, or peeling skin; severe or persistent nausea or stomach pain; shortness of breath; symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness); unusual bruising or bleeding; unusual tiredness or weakness; unusually dry mouth; vision changes (eg, decreased vision clearness); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Tekturna HCT Side Effects - for the Professional

Tekturna HCT

Clinical Studies Experience

The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Risk of fetal/neonatal morbidity and mortality [see Warnings and Precautions (5.1)].
  
• Head and neck angioedema [see Warnings and Precautions (5.2)].
  
• Hypotension in volume- and/or salt-depleted patients [see Warnings and Precautions (5.3)].

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.

Tekturna HCT

Tekturna HCT has been evaluated for safety in more than 2,700 patients, including over 700 treated for 6 months and 190 for over 1 year. In placebo-controlled clinical trials, discontinuation of therapy due to a clinical adverse event (including uncontrolled hypertension) occurred in 2.7% of patients treated with Tekturna HCT versus 3.6% of patients given placebo.

Adverse events in placebo-controlled trials that occurred in at least 1% of patients treated with Tekturna HCT and at a higher incidence than placebo included dizziness (2.3% vs. 1%), influenza (2.3% vs. 1.6%), diarrhea (1.6% vs. 0.5%), cough (1.3% vs. 0.5%), vertigo (1.2% vs. 0.5%), asthenia (1.2% vs. 0%), and arthralgia (1% vs. 0.5%).

Aliskiren

Aliskiren has been evaluated for safety in 6,460 patients, including 1,740 treated for longer than 6 months, and 1,250 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 aliskiren, versus 3.5% of patients given placebo.

Two cases of angioedema with respiratory symptoms were reported with aliskiren 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 aliskiren 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 aliskiren compared with 0.5% with placebo. In a long-term active-controlled study with aliskiren and HCTZ arms, the incidence of edema involving the face, hands, or whole body was 0.4% in both treatment arms.

Aliskiren 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) 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% 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.

Aliskiren was associated with a slight increase in cough in the placebo-controlled studies (1.1% for any aliskiren use vs. 0.6% for placebo). In active-controlled trials with ACE inhibitor (ramipril, lisinopril) arms, the rates of cough for the aliskiren arms were about one-third to one-half the rates in the ACE inhibitor arms.

Other adverse reactions with increased rates for aliskiren compared to placebo included rash (1% vs. 0.3%), elevated uric acid (0.4% vs. 0.1%), gout (0.2% vs. 0.1%), and renal stones (0.2% vs. 0%).

Single episodes of tonic-clonic seizures with loss of consciousness were reported in two patients treated with aliskiren in the clinical trials. One patient had 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. Aliskiren was discontinued and there was no rechallenge in either case.

The following adverse events occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with aliskiren, but also occurred at about the same or greater incidence in patients receiving placebo: headache, nasopharyngitis, dizziness, fatigue, upper respiratory tract infection, back pain and cough.

No clinically meaningful changes in vital signs or in ECG (including QTc interval) were observed in patients treated with aliskiren.

Hydrochlorothiazide

Other adverse reactions that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body As A Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia;

Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Metabolic: hyperglycemia, glycosuria, hyperuricemia

Musculoskeletal: muscle spasm

Nervous System/Psychiatric: restlessness

Renal: renal failure, renal dysfunction, interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: transient blurred vision, xanthopsia

Clinical Laboratory Test Abnormalities

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Tekturna HCT.

Blood Urea Nitrogen (BUN)/Creatinine: Elevations (greater than 50% increase) in BUN and creatinine occurred in 11.8% and 0.9%, respectively, of patients taking Tekturna HCT, and 7% and 1.1%, respectively, of patients given placebo in short-term controlled clinical trials. No patients were discontinued due to an increase in either BUN or creatinine.

Hemoglobin and Hematocrit: A greater than 20% decrease in hemoglobin and hematocrit were observed in <0.1% and 0.1%, respectively, of patients treated with Tekturna HCT, compared with 0% in placebo-treated patients. No patients were discontinued due to anemia.

Liver Function Tests: Occasional elevations (greater than 150%) in ALT (SGPT) were observed in 1.2% of patients treated with Tekturna HCT, compared with 0% in placebo-treated patients. No patients were discontinued due to abnormal liver function tests.

Serum Uric Acid: Uric acid related abnormalities were more commonly observed in patients treated with Tekturna HCT, compared with placebo; 2.2% versus 0% had a uric acid increase >50% from baseline; gout and renal stones were less commonly observed.

Serum Electrolytes: [see Warnings and Precautions (5.9).]

Post-Marketing Experience

The following adverse reactions have been reported in aliskiren post-marketing 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: angioedema requiring airway management and hospitalization

Peripheral edema

Blood creatinine increased

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Side Effects by Body System - for Healthcare Professionals

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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