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Valturna Side Effects

Generic name: aliskiren / valsartan

Note: This document contains side effect information about aliskiren / valsartan. Some dosage forms listed on this page may not apply to the brand name Valturna.

Applies to aliskiren/valsartan: oral tablet.

Warning

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 of Valturna

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

Rare

Incidence not known

Other side effects of Valturna

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

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. 2001;PROD.

2. Product Information. Tekturna (aliskiren). Novartis Pharmaceuticals. 2007.

3. Product Information. Valturna (aliskiren-valsartan). Novartis Pharmaceuticals. 2009.

Further information

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.