Sitavig Side Effects Center

Last updated on RxList: 11/10/2021
Sitavig Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Sitavig?

Sitavig (acyclovir) is an antiviral medication prescribed to treat recurrent cold sores.

What Are Side Effects of Sitavig?

Common side effects of Sitavig include:

  • headache
  • pain or irritation at the site of application
  • dizziness
  • tiredness
  • mouth or gum pain
  • mouth sores
  • skin rash or
  • redness

Dosage for Sitavig

Sitavig is available as one 50 mg buccal tablet that is applied to the upper gum region inside the mouth.

What Drugs, Substances, or Supplements Interact with Sitavig?

Drug interactions are unlikely.

Sitavig During Pregnancy and Breastfeeding

Sitavig has not been studied in pregnant or breastfeeding women.

Additional Information

Our Sitavig (acyclovir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Sitavig Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising or bleeding, purple or red pinpoint spots under your skin;
  • changes in behavior;
  • confusion, hallucinations; or
  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • mild skin pain;
  • rash, itching;
  • nausea, vomiting, diarrhea;
  • headache; or
  • mouth pain while using an acyclovir buccal tablet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sitavig (Acyclovir Buccal Tablets)


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Sitavig Professional Information


Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The overall safety of SITAVIG was assessed in 378 adult subjects having at least 4 herpes labialis episodes the previous year.

One randomized, double-blind, placebo-controlled trial was conducted in patients with recurrent herpes labialis (cold sores). In this trial, 378 HSV infected subjects used SITAVIG as a single dose, and 397 subjects used placebo.

Selected treatment emergent adverse events without regard to causality and reported in at least 1% of patients can be seen in Table 1.

Table 1 Selected Treatment Emergent Adverse Events reported in at least 1% of patients

N = 378
N = 397
Nervous System Disorders
Gastrointestinal system Disorders
Gingival Pain1%0.3%
Aphthous Stomatitis1%0
Administration Site Conditions
Application Site Pain1%1%
Application Site Irritation1%0
Skin and Subcutaneous Disorders

The treatment emergent adverse events considered related to treatment that occurred in greater than or equal to 1% of patients included headache (1% SITAVIG vs. 2% placebo) and application site pain (1% both arms). There was no discontinuation of SITAVIG due to adverse drug reactions. Most treatment related adverse events were mild or moderate in severity. One report of headache from both treatment arms was classified as severe.

Read the entire FDA prescribing information for Sitavig (Acyclovir Buccal Tablets)

© Sitavig Patient Information is supplied by Cerner Multum, Inc. and Sitavig Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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