Aliskiren/Hydrochlorothiazide Side Effects

Please note - some side effects for Aliskiren/Hydrochlorothiazide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aliskiren/Hydrochlorothiazide - for the Consumer

Aliskiren/Hydrochlorothiazide

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 Aliskiren/Hydrochlorothiazide:

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

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

Side Effects by Body System

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. 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. 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 re-challenge.

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.

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.

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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