Aliskiren / hydrochlorothiazide Side Effects
Some side effects of 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.
For the Consumer
Applies to aliskiren / hydrochlorothiazide: oral tablet
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:Less common
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- runny nose
- sore throat
- trouble sleeping
- unusual tiredness or weakness
- Difficulty with swallowing
- fast heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shortness of breath
- skin rash
- tightness in the chest
Get emergency help immediately if any of the following symptoms of overdose occur while taking aliskiren / hydrochlorothiazide:Symptoms of overdose
- decreased urine output
- dry mouth
- increase in heart rate
- increased thirst
- irregular heartbeat
- muscle cramps
- numbness, tingling, pain, or weakness in the hands or feet
- rapid breathing
- sunken eyes
- swelling of the face, ankles, or hands
- weak pulse
- weakness and heaviness of the legs
- wrinkled skin
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:Less common
- Difficulty with moving
- feeling of constant movement of self or surroundings
- lack or loss of strength
- muscle stiffness
- sensation of spinning
For Healthcare Professionals
Applies to aliskiren / hydrochlorothiazide: oral tablet
In general, aliskiren is well tolerated with an adverse event profile similar to placebo. Most adverse effects reported were mild to moderate in severity.
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 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.
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 side effects associated with aliskiren have included extremely rare cases of hypotension (0.1%) and angioedema (0.06%).
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 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 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 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 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 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 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 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 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.
More aliskiren/hydrochlorothiazide resources
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