Aclova

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Aclova

Quick Facts

Property Description
Active ingredient Aciclovir (Acyclovir)
Form Systemic (e.g., tablet, IV solution) and Topical (e.g., cream, ointment)
Pharmacological class Antiviral drug / Antiherpetic agent
General purpose Limiting viral replication and controlling infection spread
Origin Synthetic purine nucleoside analog

What Type of Medicine is Aclova (Aciclovir)?

Aclova is a prescription-only medication that contains the active ingredient Aciclovir (Acyclovir), a compound classified as an antiviral drug. The medicine specifically functions as an antiherpetic agent, meaning its primary therapeutic action is to target the family of viruses responsible for herpes-type infections.

The core substance, Aciclovir, is defined chemically as a synthetic purine nucleoside analog, making it a man-made compound designed to chemically mimic a natural building block of viral genetic material.


Forms, Composition, and General Antiviral Purpose

Aclova is supplied as a single-active-ingredient product in multiple dosage forms to facilitate both systemic and topical routes of administration. These forms include oral preparations like the tablet and capsule, and forms for localized application such as the cream and ointment. This variety in formulation ensures the active compound can be delivered effectively to various tissues.

The general purpose of this synthetic nucleoside analog is to limit the spread of target viral infections within the body. Aciclovir works by being preferentially activated in infected cells, where it causes viral DNA synthesis inhibition. This process restricts the virus's ability to replicate, which helps to control the underlying infectious cause. The drug's targeted approach relies on selective activation by viral enzymes.

What side effects are possible with Aclova?

Possible Side Effects and Safety Information

Aclova (obeticholic acid) carries the United States Food and Drug Administration's (FDA) strongest safety alert, a Boxed Warning, due to the risk of serious liver injury. Incorrect dosing, especially in patients with moderate to severe liver impairment, can significantly increase the risk of serious adverse reactions, including liver failure, liver transplant, and death.

Serious and Clinically Significant Adverse Reactions

The most critical safety concern is liver decompensation and liver failure. This medication is specifically contraindicated (should not be used) in patients with Primary Biliary Cholangitis (PBC) who have advanced cirrhosis of the liver. Serious liver injury has also been observed in patients without advanced cirrhosis. Monitoring of liver function is frequently required to detect worsening function or signs of disease progression.

Symptoms that may indicate a serious liver-related adverse reaction include:

  • Yellowing of the skin or eyes (jaundice)
  • Bloody or black stools or vomiting blood
  • Swelling in the abdomen
  • Mental status changes such as confusion or slurred speech

Common Adverse Reactions

The most commonly reported side effects include:

  • Severe pruritus (itching)
  • Fatigue
  • Abdominal pain or discomfort
  • Nausea and vomiting

Safety Monitoring and Limitations

Due to the significant risk of serious liver injury, Aclova requires careful and continuous safety monitoring, typically involving regular laboratory assessments of liver tests. The prescribing information mandates the permanent discontinuation of the drug if the patient progresses to advanced cirrhosis or develops clinically significant liver-related adverse reactions, such as acute-on-chronic liver disease. Adherence to the prescribed dosing regimen, which is based on the patient’s liver function, is essential for minimizing risk.

Overdose and Emergency Response

Documented Overdose Manifestations

Overexposure to systemic Aciclovir (Aclova) is officially documented to present with gastrointestinal symptoms, including nausea and vomiting. More serious manifestations involve the Central Nervous System (CNS), characterized by confusion, agitation, hallucinations, tremor, lethargy, and somnolence. Critical documented outcomes of overexposure involve the renal system.

Severe Outcomes and Required Actions

The most severe consequences listed in regulatory labeling are acute renal failure (or acute tubular necrosis) and the escalation of CNS effects to seizures and coma. Acute renal toxicity can be associated with the precipitation of Aciclovir crystals in the renal tubules, particularly following rapid intravenous administration or in dehydrated patients. For any suspected or known overdose, the government-mandated instruction is to seek immediate medical attention and contact a Poison Control Center immediately.

Management and Risk Considerations

Treatment is officially defined as symptomatic and supportive. Regulatory documents state that no specific antidote is known for Aciclovir overdose. However, hemodialysis is described as an effective procedural intervention for removing the drug from the blood, particularly in cases complicated by acute renal failure. Overdose risk is noted to be increased in specific populations. Regulatory information highlights that elderly patients and individuals with pre-existing renal impairment may be more susceptible to toxicity due to factors affecting drug clearance.

Therapeutic Uses of Aclova

What Aclova Treats: Main Uses and Benefits

The primary therapeutic use of the active compound in Aclova is focused on managing infections caused by the Herpes Simplex Virus (HSV) and the Varicella-Zoster Virus (VZV). It is commonly used to help decrease pain and support the healing of sores or blisters associated with these viral diseases, including Shingles (Herpes Zoster), Chickenpox (Varicella), Genital Herpes, and Cold Sores (Herpes Simplex Labialis).

Aclova is relevant in clinical settings that involve acute or unstable symptom patterns, serving as supportive symptomatic assistance. It helps address groups of symptoms that may appear suddenly, providing therapeutic benefit that may assist with easing the time to resolution of acute episodes. Furthermore, it is considered relevant in the management of severe infections in high-risk groups, such as HSV Encephalitis and Neonatal Herpes Simplex, and is used in suppressive therapy to help reduce the frequency and severity of recurrent herpes outbreaks.


Quick Fact: Focus on Symptom Management Description
Primary Symptom Focus Easing localized discomfort, burning, tingling, and sharp nerve pain.
Main Clinical Scenario Acute treatment of active flares or chronic suppressive therapy to help manage recurrence frequency.
Core Patient Benefit Supports maintenance of functional stability and contributes to improved comfort during symptomatic periods.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who can and cannot use Aclova? (Aciclovir)

The population eligibility for Aciclovir is strictly defined by regulatory documents, focusing on absolute prohibitions and conditional use requirements.

Contraindications and Restrictions

Category Eligibility Rule
Absolute Prohibition Patients with known hypersensitivity to aciclovir, valaciclovir, or any of the product’s excipients must not use this medicine. Certain oral formulations are contraindicated for patients with rare hereditary metabolic disorders (e.g., galactose intolerance).
Age-Related Use is established for adults and pediatric patients mathbf2 years and older (oral) or mathbf3 months and older (IV). Older adults are eligible but require dosage adjustment due to the high likelihood of reduced renal function, and must be monitored for neurological effects.
Organ Function Patients with impaired renal function are eligible but require mandatory dosage adjustment based on creatinine clearance to prevent drug accumulation. Use in patients with severe hepatic abnormalities requires caution.
Pregnancy/Lactation Use during pregnancy should be considered only if the potential benefit outweighs the unknown risk. Aciclovir is excreted in human milk, and caution is advised during breastfeeding.

Regulatory authorities require that patients receiving high-dose regimens maintain adequate hydration to mitigate the potential for renal toxicity.

What should I know about interactions with other medicines?

Aclova (Acyclovir) is primarily eliminated from the body through the kidneys via a process called active renal tubular secretion. Because of this, its potential interactions are mostly related to other medicines that share this same pathway or affect kidney health.

Potential Drug Interactions

Interacting Product Category Specific Medicines Mentioned Interaction Mechanism & Effect
Drugs Competing for Renal Clearance Probenecid (for gout), Cimetidine (for ulcers) These medicines can compete with Aclova for removal by the kidney. This competition may increase the concentration of Aclova in the bloodstream.
Nephrotoxic (Kidney-damaging) Drugs Amphotericin B, Cisplatin, Foscarnet, Cyclosporine, Tacrolimus, some Aminoglycoside antibiotics (e.g., Gentamicin) Concurrent use significantly increases the risk of renal impairment or kidney damage, requiring careful monitoring.
Immunosuppressant Mycophenolate Mofetil (used after organ transplants) Aclova has been shown to increase the exposure (Area Under the Curve) of the inactive metabolite of this medicine, which is relevant for transplant patients.
Antivirals Zidovudine There are reports of fatigue associated with the combined use of Aclova and Zidovudine.

Important Contextual Notes

Due to Aclova’s relatively wide therapeutic window, the documented increases in blood concentrations with cimetidine or probenecid generally do not require a dosage adjustment. However, renal function must be monitored closely when Aclova is used with other potentially kidney-damaging medicines. For topical forms of Aclova (creams, ointments), the risk of systemic drug interactions is considered low due to minimal absorption into the bloodstream.

Mechanism of Action

Enzyme-Driven Activation and Viral Selectivity

The drug's action is fundamentally reliant on a highly selective activation process within the infected host cell, initiated by the viral enzyme Thymidine Kinase (TK). This enzyme transforms the inactive Aciclovir into its monophosphate form. Subsequent cellular kinases complete the cascade, yielding the pharmacologically active inhibitor, Aciclovir Triphosphate (ACV-TP). This mechanism ensures that the necessary chemical conversion occurs primarily within virus-infected cells, directing action toward the viral replication pathway.


Irreversible DNA Chain Termination

The activated metabolite, ACV-TP, targets the Viral DNA Polymerase enzyme. It functions as a competitive inhibitor and an obligate chain terminator. ACV-TP is incorporated into the growing viral DNA strand but lacks the chemical group necessary for further chain elongation. This action immediately halts the virus’s ability to successfully replicate its DNA, resulting in the non-production of new, functional viral particles.


️ Mechanism Limitations

Constraints on this mechanism include its lack of activity against non-replicating viral DNA residing in nerve ganglia, where the required activating enzyme is not expressed. Furthermore, viral strains with deficient or altered Thymidine Kinase exhibit resistance, as the initial phosphorylation essential for the drug's mechanism is compromised.

Dosage and Administration Information

How to Use Aclova: Administration Overview

Aclova (Aciclovir) is administered via three primary, distinct routes: oral (tablets, capsules, or suspension), intravenous (IV) infusion for severe systemic conditions, and topical (cream) for localized use. Treatment initiation is time-critical; for acute episodes, administration begins at the earliest sign or symptom of the outbreak.

Oral dosing schedules are condition-dependent, requiring administration five times daily (at specific intervals, often omitting the night dose) during acute treatment, or twice daily for chronic suppressive therapy. These regimens are followed for a specific duration, typically a short course of 5 to 10 days.

Administration Conditions and Adjustments

For oral forms, the medicine may be taken with or without food. However, systemic administration involves consideration of specific patient factors. Because the drug is eliminated primarily by the kidneys, it is standard for the dose and interval to be modified for older adults and patients with impaired renal function, based on the patient's creatinine clearance. A supplemental dose is also applied after each hemodialysis session.

IV administration involves proper dilution and is administered slowly as an infusion over at least one hour to mitigate procedural complications. Topical application is restricted to external skin areas, avoiding contact with mucous membranes.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Aclova

The information below summarizes the clinical research and evidence structure for the active ingredient in Aclova (Aciclovir), focusing on how the medicine has been studied and what the official research sources report. This overview is based on findings from trials and systematic reviews, without providing any clinical advice or treatment recommendations.


Evidence for Acute Treatment of Herpes Simplex Virus (HSV) Infections

The evidence for managing acute episodes of Genital Herpes and Cold Sores (Herpes Simplex Labialis) primarily comes from short-term Randomized Controlled Trials (RCTs) and meta-analyses. Researchers explored the use of Aciclovir in the context of acute episodes of these conditions, in both systemic (oral/IV) and topical forms, including which outcomes related to healing time and symptom duration the studies monitored.

These trials were relevant in assessing short-term or episodic symptom patterns and focused on measuring the time required for lesions to heal completely and the duration of acute localized symptoms. Research highlights changes observed in measured outcomes during the study period, and studies document patterns related to how symptoms evolved in the observed populations. Findings describe patterns observed in the studies related to patient-reported outcomes describing perceived discomfort.


Evidence for Treatment of Varicella-Zoster Virus (VZV) Infections (Shingles and Chickenpox)

The evidence base for acute management of Herpes Zoster (Shingles) and Chickenpox is documented in multiple RCTs and analyses. Studies explored the use of Aciclovir for conditions characterized by fluctuating or episodic manifestations. Research primarily focused on outcomes linked to the timeframe of rash and lesion healing and measuring the duration and intensity of acute pain during periods of heightened symptom activity.

Research describes that study results reflect the specific conditions under which they were conducted, including the requirement to initiate study treatment within a short timeframe (e.g., within 72 hours of rash onset) to observe the reported patterns.


Evidence for Suppressive and Preventive Use

For patients experiencing frequent recurrent outbreaks, Aciclovir was evaluated in research exploring chronic suppressive therapy. The evidence for this use primarily comes from long-term RCTs with follow-up durations extending for six months or more. These studies monitored outcomes reflecting daily functioning or activity level in conditions involving periods of heightened symptoms.

Aciclovir was also evaluated in research contexts involving prophylaxis (prevention) of viral reactivation in high-risk groups, such as immunocompromised patients. These studies focused on observing rates of viral shedding and clinical reactivation over defined time intervals.


What is Still Uncertain About Aclova Research

While a large body of evidence exists, the research highlights what is known and what is still uncertain across several areas:

  • Comparative Evidence: Comparative evidence is lacking in some areas, particularly concerning the difference in measured outcomes when compared to newer antiviral treatments that have since become available.
  • Long-Term Pain Outcomes: Research exploring the resolution of long-term pain (PHN) documented patterns of varied outcomes, and certainty remains low regarding the influence of Aciclovir in preventing or resolving this specific, long-term complication.

Key Studies & References

  1. Public Assessment Report Scientific discussion Aciclovir Accord 200 mg, 400 mg and 800 mg tablets (aciclovir) NL/H
  2. Acyclovir - StatPearls - NCBI Bookshelf

Frequently Asked Questions (FAQ)

Common questions about Aclova (FAQ)


Q: Is Aclova the same kind of medicine as [similar common drug name]?

A: Aclova contains the active ingredient Aciclovir, which is classified as an antiviral drug and a synthetic purine nucleoside analogue. According to official documents, this means the compound is man-made to chemically mimic a natural building block of viral genetic material, targeting only virus-infected cells.


Q: Do any common foods or drinks interfere with Aclova?

A: The official product information states that the oral forms of Aclova may be taken with or without food. Unlike some other medications, common regulatory warnings do not typically list specific restrictions for common foods or beverages when taking this medicine.


Q: Does Aclova interact with pain relievers like Tylenol or Advil?

A: The official label does not typically list major interactions between Aciclovir and acetaminophen (Tylenol). However, some regulatory sources advise caution when Aciclovir is used with certain Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen (Advil), as both medicines rely on the kidneys for clearance, which can potentially increase the risk profile.


Q: Is it important to take Aclova at the exact same time every day?

A: Official administration guidelines stress the need for administration at specific, regular intervals throughout the day. Regular administration is described in official guidelines to help maintain consistent concentrations of the active ingredient, supporting the goal of antiviral control.


Q: How quickly should someone expect to notice the effects of Aclova?

A: Clinical studies do not provide a specific number of hours for onset of effects. Research focuses on measuring outcomes like the time required for lesions to heal and the reduction in the overall duration of symptoms. Clinical study protocols typically required initiation of treatment at the earliest sign of an outbreak to measure the reported outcomes.


Q: Are there any specific organs or body systems that Aclova affects most?

A: Aclova is eliminated primarily by the kidneys, making renal (kidney) function the key factor for how the medicine clears the body. Official sources note that dosage modifications are necessary for individuals with impaired kidney function. Potential neurological effects, such as confusion or dizziness, are also noted in certain populations.


Q: What is the difference between Aclova and a placebo in clinical trials?

A: Studies show that when compared to a placebo (an inactive substance), study results demonstrated a reduction in the time needed for lesions to heal. Furthermore, research indicates that Aclova was associated with shortened duration of symptoms and reduced the frequency of recurrent episodes in study populations.


Q: Does Aclova need to be tapered off, or can I stop taking it suddenly?

A: For a standard course of treatment, the medicine is typically not tapered off. Official patient information advises that it is important to finish the full prescribed course of the medication, even if symptoms improve, to support the goal of fully managing the underlying infection.


Q: What happens in the body if Aclova is stopped suddenly?

A: If the medicine is stopped prematurely, official documents note that the underlying viral infection may not be fully managed. Stopping the prescribed course of Aclova too soon, or skipping doses, may result in symptoms returning or make the viral infection more challenging to manage in the future.


Q: Does Aclova affect sleep patterns?

A: Regulatory documentation and official information have noted side effects that may be associated with altered sleep patterns. These reported adverse events include feelings of dizziness, tiredness, or general drowsiness.


Q: Is Aclova associated with any eye or vision issues?

A: Official safety documentation advises patients to be aware of and report any visual abnormalities or sudden vision changes. These symptoms are noted in safety documentation as potential signs of severe adverse events.


Q: What specific warnings about driving or operating machinery are on the Aclova label?

A: Official regulatory information advises caution when driving or operating machinery. The medicine may cause side effects, such as dizziness, tiredness, or drowsiness, which could potentially affect performance of such activities.


Q: Is there a maximum duration of use for Aclova?

A: For Aciclovir (the active ingredient), chronic suppressive therapy has been studied for periods of up to 12 months. Official guidance suggests that therapy should be periodically interrupted (e.g., every 6 to 12 months) to assess the disease status.


Q: Are there any official reports of Aclova recalls or safety alerts?

A: Official safety bodies, such as the FDA and EMA, routinely monitor medicines and issue updates. For the active ingredient, major regulatory communications have included safety alerts related to potential neurological side effects and guidelines for proper administration.


Q: Why does the packaging for Aclova have a specific warning about sun exposure?

A: The active ingredient, Aciclovir, can cause photosensitivity, which means it can make the skin more sensitive to the sun and increase the risk of sunburn. Official documentation includes statements on limiting sun exposure, wearing protective clothing, and using sunscreen while the medicine is being used.


Q: What does the FDA say about Aclova's long-term safety?

A: Long-term safety research for Aciclovir has focused on its suppressive use for up to 12 months. Note that a different, similarly named drug that sometimes uses the name Aclova (Obeticholic acid) carries a strong FDA Boxed Warning due to the risk of serious liver injury, requiring continuous monitoring of liver function.


Q: What misunderstandings do people commonly have about Aclova's purpose?

A: A common point of clarity noted in patient education materials is that Aclova (Aciclovir) is specifically designed to treat viral infections. It is important to understand that this medicine will not treat colds, the flu, or infections caused by bacteria.


Q: Is Aclova approved in countries outside of the US?

A: Yes, the active ingredient Aciclovir is widely recognized and is listed on the World Health Organization’s List of Essential Medicines. It is approved and marketed under various names in countries outside of the US, including those regulated by the European Medicines Agency (EMA) and Health Canada.

How should Aclova be stored and disposed of?

Storage and Disposal of Aclova (Aciclovir)


Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, generally below 25°C or 30°C.
Prohibited Do not refrigerate the cream formulation.
Protection Keep the product in its original, tightly closed container and protect from light and moisture.
Child Safety Must be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired Aclova must be handled according to regulatory standards. Do not dispose of the medicine via wastewater or household waste. The product must be disposed of in accordance with local requirements for pharmaceutical waste, often by returning it to a pharmacy or drug take-back program.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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Equivalent of Aclova found in:

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