Valsartan SIde Effects

FDA Warnings and Common Side Effects associated with Valsartan


From the time of its approval by the United States Food and Drug Administration (FDA) in 1996, Diovan (valsartan) was required to identify on its label a number of serious potential side effects associated with the drug, including a prominent warning to pregnant women that “[w]hen used in pregnancy during the second and third trimesters” drugs like valsartan “can cause injury and even death to the developing fetus.”

In addition to “Fetal/Neonatal Morbidity and Mortality”, the original prescribing information for Diovan (valsartan) also included a warning about the potential for “[e]xcessive reduction in blood pressure” as well as precautions involving impaired kidney and liver function. The revised 2018 label notes adverse reactions such as headache, dizziness, viral infection, fatigue, and abdominal pain in patients taking Diovan (valsartan) to treat their hypertension.

Potential Links Between Arbs and Cancer

Valsartan is categorized as an “angiotensin II receptor blocker (ARB)”, a category of drug that has been the subject of enhanced scrutiny by the United States Food and Drug Administration (FDA) going back nearly a decade, long before concerns over NDMA contamination prompted recalls of generic valsartan in the summer of 2018. In a series of Drug Safety Communications dating back at least until 2010, the FDA reported that it was exploring potential links between ARBs like valsartan and an increased risk of cancer.

Writing in a Drug Safety Communication dated July 15, 2010 , the FDA announced that it was “conducting a review of the class of medications known as angiotensin receptor blockers (ARBs) after a recently published study suggested they may be associated with a small increased risk in cancer.”

The FDA followed up on the 2010 communication by declaring in June 2011 declaring in June 2011 that it had “completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs)” and had “concluded that treatment with an ARB medication does not increase a patient’s risk of developing cancer.”

Risks of Using ARBs with Other Medications

However, less than a year after it purportedly had cleared angiotensin receptor blockers (ARBs) like valsartan of a suspected increase in cancer risk, the United States Food and Drug Administration (FDA) issued in April 2012 another Drug Safety Communication involving ARBs, this time warning of risks associated with using ARBs in conjunction with other medications.

“The US Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren and other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment,” the agency announced April 20, 2012. “These drug combinations should not be used (are contraindicated) in patients with diabetes.”

Relying on data from a clinical trial known as “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)”, the FDA noted, an increased risk of “kidney (renal) impairment, low blood pressure (hypotension), and high potassium blood levels (hyperkalemia)” in diabetes patients taking aliskiren in conjunction with an ARB or ACEI. The Drug Safety Communication further warned that “preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke).”

Consequently, the FDA announced, that the warning labels for the relevant drugs would be “updated based on preliminary data” from the ALTITUDE study.

If you or a loved one fears you have taken NDMA-contaminated valsartan, contact the experienced team of attorneys at now 1-888-612-8313 for a free valsartan lawsuit consultation with a licensed attorney!

Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article. 

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