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Aliskiren / valsartan Side Effects

For the Consumer

Applies to aliskiren / valsartan: tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; mild flu-like symptoms; runny nose; sore throat; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur while taking aliskiren / valsartan:

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); burning, numbness, or tingling; change in the amount of urine produced; chest pain; fainting; frequent or painful urination; irregular heartbeat; muscle pain, weakness, or cramps; red, swollen, blistered, or peeling skin; shortness of breath; signs of infection (eg, fever, chills, persistent sore throat); sudden, unexplained weight gain; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness).

For Healthcare Professionals

Applies to aliskiren / valsartan: oral tablet

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]

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]

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]

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.

References

1. "Product Information. Diovan (valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

2. "Product Information. Tekturna (aliskiren)." Novartis Pharmaceuticals, East Hanover, NJ.

3. "Product Information. Valturna (aliskiren-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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