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Sitavig Side Effects

Generic Name: acyclovir

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

For the Consumer

Applies to acyclovir: buccal mucosa tablet

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

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

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]

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

Local

Common (1% to 10%): Application site pain and application site irritation, local inflammation at injection site, phlebitis
Frequency not reported: Tissue necrosis[Ref]

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]

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

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

Very rare (less than 0.01%): Agitation, confusion, hallucinations, psychotic symptoms
Frequency not reported: Depression, insomnia
Postmarketing reports: Aggressive behavior[Ref]

Respiratory

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

References

1. "Product Information. Acyclovir (acyclovir)." West-Ward Pharmaceuticals Corporation (previously Roxane Laboratories Inc), Columbus, OH.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Sitavig (acyclovir)." Innocutis Holdings LLC, Charleston, SC.

5. "Product Information. Zovirax (acyclovir)." Mylan Pharmaceuticals Inc, Morgantown, WV.

Some side effects of Sitavig may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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