Aliskiren / Valsartan Side Effects

Applies to aliskiren/valsartan: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Discontinue aliskiren / valsartan as soon as possible when pregnancy is detected.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Serious side effects

Along with its needed effects, aliskiren / valsartan 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 / valsartan:

Less common

• bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• ear congestion
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• nausea
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Rare

• blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating

Incidence not known

• abdominal or stomach pain
• irregular heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nervousness
• numbness or tingling in the hands, feet, or lips
• shortness of breath
• weakness or heaviness of the legs

Other side effects

Some side effects of aliskiren / valsartan 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

• feeling of constant movement of self or surroundings
• sensation of spinning

For healthcare professionals

Applies to aliskiren / valsartan: oral tablet.

General

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.^[Ref]

Nervous system

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.^[Ref]

Gastrointestinal

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.^[Ref]

Immunologic

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.^[Ref]

Ocular

Ocular side effects reported for the aliskiren component have included periorbital edema without respiratory symptoms.^[Ref]

Genitourinary

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.^[Ref]

Local

Local side effects reported for the aliskiren component have included rash (1%).^[Ref]

Musculoskeletal

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.^[Ref]

Psychiatric

Psychiatric side effects reported for the valsartan component have included paresthesia.^[Ref]

Respiratory

Respiratory side effects reported for the valsartan component have included sinusitis and pharyngitis.^[Ref]

Hematologic

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.^[Ref]

Hepatic

Hepatic side effects have included elevations in blood urea nitrogen (BUN) and creatinine (less than 1%).^[Ref]

Metabolic

There have been postmarketing reports of peripheral edema associated with aliskiren.

Dermatologic

Postmarketing reports have included severe cutaneous adverse reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis.

Further information

Aliskiren/valsartan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer