Drug Safety-related Labeling Changes (SrLC)

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DIOVAN (NDA-021283)


Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/12/2019 (SUPPL-53)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Fetal Toxicity

Additions and/or revisions underlined:

Diovan can cause fetal harm when administered to a pregnant woman.  Use of drugs that act …

6 Adverse Reactions

6.1 Clinical Trials Experience

Pediatric Hypertension

Newly added information:

The most common adverse reaction in children less than 6 years old was hyperkalemia.

Hyperkalemia was mainly observed in children with underlying renal disease.

7 Drug Interactions


Extensively changed; please refer to label for complete information.

8 Use in Specific Populations

PLLR conversion for subsections below; please refer to label for complete information

8.1 Pregnancy

8.2 Lactation

Newly added information to the below subsection:
8.5 Geriatric Use

Exposure (measured by AUC) to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)


Newly added information:

Lactation:  Advise women not to breastfeed during treatment with Diovan.

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue Diovan until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Hyperkalemia: Advise patients not to use salt substitutes without consulting their healthcare provider


What should I tell my doctor before taking DIOVAN?

Tell your doctor about all of your medical conditions, including if you:

  • are breastfeeding. It is not known if DIOVAN passes into your breast milk or effects your breastfed baby or milk production. Do not breastfeed while you are taking DIOVAN.

02/03/2017 (SUPPL-50)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Studies Experience

Pediatric Hypertension

Additions and/or revisions underlined:

… A causal relationship to Diovan has not been established. In a second study of  6-months duration in 75 children aged 1 to 5 years, there were no deaths; one case of marked liver transaminase elevations occurred following 6 months of treatment.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information

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