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

Applies to acyclovir: buccal mucosa tablet. Other dosage forms:

• capsule, powder for solution, solution, suspension, tablet

Serious side effects of Sitavig

Along with its needed effects, acyclovir (the active ingredient contained in Sitavig) 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 acyclovir:

Less common

• Canker sores
• pain in the gums
• sores, ulcers, or white spots on the tongue or inside the mouth

Other side effects of Sitavig

Some side effects of acyclovir 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

• Flushing or redness of the skin
• rash
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusually warm skin

For Healthcare Professionals

Applies to acyclovir: buccal tablet, compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral suspension, oral tablet.

General

The more commonly reported adverse reactions include malaise, nausea, vomiting, diarrhea, and headache.^[Ref]

Gastrointestinal

Nausea and vomiting are more frequent in elderly subjects.^[Ref]

Common (1% to 10%): Nausea, vomiting, diarrhea, abdominal pain, gingival pain (buccal tablet), aphthous stomatitis (buccal tablet)

Uncommon (0.1% to 1%): Sore throat

Postmarketing reports: Gastrointestinal distress^[Ref]

Renal

Renal pain may be associated with renal failure and crystalluria. Renal impairment is generally reversible but may progress to acute renal failure.^[Ref]

Rare (0.01% to 0.1%): Elevated blood urea nitrogen, elevated creatinine,

Very rare (less than 0.01%): Acute renal failure, renal pain

Frequency not reported: Crystalluria, renal impairment

Postmarketing reports: Renal failure, hematuria^[Ref]

Local

Severe local inflammatory reactions, including tissue necrosis, have occurred following infusion into extravascular tissues. Application site pain and application site irritation have occurred with the buccal tablets.^[Ref]

Common (1% to 10%): Application site pain and application site irritation, local inflammation at injection site, phlebitis

Frequency not reported: Tissue necrosis^[Ref]

Nervous system

Dizziness, somnolence, and coma more frequent in elderly subjects.^[Ref]

Common (1% to 10%): Headache, dizziness

Very rare (less than 0.01%): Ataxia, coma, convulsions, encephalopathy, dysarthria

Frequency not reported: Giddiness, shaking, taste disturbance, medication taste

Postmarketing reports: Decreased consciousness, delirium, paresthesia, seizure, tremors^[Ref]

Dermatologic

Common (1% to 10%): Erythema, rashes (including photosensitivity), pruritus, hives

Uncommon (0.1% to 1%): Urticaria, accelerated diffuse hair loss

Frequency not reported: Diaphoresis

Postmarketing reports: Alopecia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Cardiovascular

Frequency not reported: Palpitation, chest pain

Postmarketing reports: Hypotension, peripheral edema^[Ref]

Hematologic

Very rare (less than 0.01%): Anemia, leukopenia, thrombocytopenia, neutropenia

Frequency not reported: Hematologic changes including megaloblastic anemia

Postmarketing reports: Leukocyclastic vasculitis, lymphadenopathy, disseminated intravascular coagulation, hemolysis^[Ref]

Hepatic

Rare (0.01% to 0.1%): Reversible bilirubin and liver related enzymes

Very rare (less than 0.01%): Hepatitis, jaundice

Postmarketing reports: Hyperbilirubinemia^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis

Frequency not reported: Angioedema^[Ref]

Ocular

Frequency not reported: Pars planitis

Postmarketing reports: Visual abnormalities^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain

Postmarketing reports: Myalgia^[Ref]

Other

Common (1% to 10%): Lethargy, fatigue, fever

Frequency not reported: Vertigo

Postmarketing reports: Fever^[Ref]

Genitourinary

Frequency not reported: Menstrual abnormalities, abnormal urinalysis (characterized by an increase in formed elements in urine sediment) anuria, dysuria, hematuria^[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Frequency not reported: Thirst^[Ref]

Psychiatric

Very rare (less than 0.01%): Agitation, confusion, hallucinations, psychotic symptoms

Frequency not reported: Depression, insomnia

Postmarketing reports: Aggressive behavior^[Ref]

Hallucinations, psychosis, confusion, aggressive behavior, agitation may be more marked in older adults and those with renal impairment.^[Ref]

Respiratory

Rare (0.01% to 0.1%): Dyspnea^[Ref]