Aliskiren / valsartan Side Effects
Not all side effects for aliskiren / valsartan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to aliskiren / valsartan: oral tablet
In addition to its needed effects, some unwanted effects may be caused by aliskiren / valsartan. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking aliskiren / valsartan:Less common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- difficult, burning, or painful urination
- difficulty breathing
- ear congestion
- frequent urge to urinate
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- nasal congestion
- runny nose
- sore throat
- trouble sleeping
- unusual tiredness or weakness
- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- Abdominal or stomach pain
- irregular heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- numbness or tingling in the hands, feet, or lips
- shortness of breath
- weakness or heaviness of the legs
Some of the side effects that can occur with aliskiren / valsartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Less common
- Feeling of constant movement of self or surroundings
- sensation of spinning
For Healthcare Professionals
Applies to aliskiren / valsartan: oral tablet
Genitourinary side effects have included urinary tract infection (1.4%). Genitourinary side effects reported for the aliskiren component have included elevated uric acid (0.4%), gout (0.2%), and renal stones (0.2%). Genitourinary side effects reported for the valsartan component have included impotence.
Nervous system side effects have included fatigue (2.6%) and vertigo (1.1%). Nervous system side effects reported for the aliskiren component have included headache, dizziness, fatigue, cough, and tonic-clonic seizures in two patients, one of which had a history of seizures and the other had no history given.
Gastrointestinal side effects have included diarrhea (1.4%). Gastrointestinal side effects reported for the aliskiren component have included diarrhea which increased with increasing dosage and was higher in elderly women, abdominal pain, dyspepsia, and gastroesophageal reflux.
Immunologic side effects have included nasopharyngitis (2.6%) and upper respiratory tract infection (1.1%). Immunologic side effects reported for the aliskiren component have included nasopharyngitis and upper respiratory tract infection. There have been postmarketing reports of angioedema requiring airway management and hospitalization associated with aliskiren.
Ocular side effects reported for the aliskiren component have included periorbital edema without respiratory symptoms.
General side effects reported for the aliskiren component have included angioedema (0.06%), and edema involving the face, hands, or whole body (0.4%), and cough (1.1%). General side effects reported for the valsartan component have included cough (2.6%), and angioedema.
Local side effects reported for the aliskiren component have included rash (1%).
Musculoskeletal side effects reported for the aliskiren component have included back pain. Musculoskeletal side effects reported for the valsartan component have included asthenia and muscle cramps.
Psychiatric side effects reported for the valsartan component have included paresthesia.
Respiratory side effects reported for the valsartan component have included sinusitis and pharyngitis.
Hematologic side effects have included small mean decreases from baseline in red blood cell (RBC) count, hemoglobin, and hematocrit in both monotherapy and combination therapy.
Postmarketing hematologic side effects have included increased blood creatinine.
Hepatic side effects have included elevations in blood urea nitrogen (BUN) and creatinine (less than 1%).
There have been postmarketing reports of peripheral edema associated with aliskiren.
Postmarketing reports have included severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis.
More about aliskiren/valsartan
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