Revia

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Medically reviewed

Rosario Oropesa

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 Revia

Quick Facts

Property Description
Active ingredient Naltrexone Hydrochloride
Form Oral Tablet
Pharmacological class Pure Opioid Antagonist
General purpose Medication-Assisted Treatment (MAT)
Origin Synthetic opioid derivative

The Identity and Composition of Revia

Revia is a brand name for a prescription-only medication that contains the active substance Naltrexone Hydrochloride and is supplied as an oral tablet for administration by mouth. Naltrexone is classified as a synthetic opioid derivative, which is structurally related to opioid compounds but functions oppositely. This specific oral formulation is defined as a single-ingredient product, which facilitates consistent daily dosing. The oral tablet form is distinct from the extended-release injectable suspension of naltrexone, providing flexibility in dosage management.

Pharmacological Classification: A Pure Opioid Antagonist

Revia belongs to the specialized pharmacological class of pure opioid antagonists, a classification recognized for approved indications. This classification is crucial, as it signifies that the medication achieves its effect by physically occupying specific opioid receptors rather than activating them. Naltrexone achieves competitive binding to mu-opioid receptors throughout the central and peripheral nervous systems, preventing other substances from binding. This action ensures that the drug itself does not possess analgesic activity and has no potential for misuse.

General Therapeutic Purpose

The primary purpose of this opioid antagonist medication is to serve as an integral component within medication-assisted treatment (MAT) for adults. Naltrexone is utilized to support individuals managing both opioid dependence and alcohol dependence. By structurally interfering with the brain's reward signaling pathway, the action of Naltrexone helps to diminish the reinforcement of substance use. This supportive function reduces the physiological and psychological drive known as craving, making the medication a non-addictive, foundational part of a comprehensive recovery strategy.

What side effects are possible with Revia?

Possible Side Effects and Safety Information

The officially documented safety profile for Revia (Naltrexone) organizes potential adverse reactions by both frequency and the physiological system affected, in alignment with regulatory standards such as the EMA Summary of Product Characteristics (SmPC) and FDA labeling.

Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions are classified as Very Common (geq10%) and include: Nausea, Vomiting, Headache, Restlessness, Insomnia, Anxiety, Abdominal pain, Joint pain (Arthralgia), and Asthenia (weakness/tiredness). Reactions such as Diarrhea, Constipation, Dizziness, and Irritability are classified as Common.

Adverse effects are grouped into System-Organ Classes (SOCs) such as Psychiatric disorders, Nervous system disorders, Gastrointestinal disorders, and Musculoskeletal and connective tissue disorders.

Serious Adverse Reactions and Safety Restrictions

Official prescribing information documents several serious safety concerns that shape the drug's use:

  • Hepatotoxicity: The drug has the capacity to cause hepatocellular injury, which mandates contraindication in patients with acute hepatitis or liver failure. Regulatory documents require the monitoring of liver function tests (LFTs) before and during treatment.
  • Precipitation of Opioid Withdrawal: As a pure opioid antagonist, Naltrexone will precipitate a severe, acute withdrawal syndrome if administered to patients who are opioid-dependent. Symptoms may begin rapidly, potentially within minutes of administration.
  • Risk of Opioid Overdose: After cessation of treatment, patients may have increased opioid sensitivity, which raises the risk of life-threatening or fatal overdose if opioids are taken in an attempt to overcome the blockade.
  • Suicidality: Patients should be monitored for the development of depression or suicidal thoughts.

Safety limitations also apply to specific patient groups; the drug is not recommended for the pediatric population and is contraindicated in severe renal or hepatic impairment.

Overdose and Emergency Response

The official regulatory documents define the overdose profile of Naltrexone Hydrochloride around two primary risks that require urgent medical attention.

The intrinsic risk involves the medication itself: clinical studies involving doses significantly exceeding the recommended range have documented the potential for dose-related elevations of liver enzymes and subsequent hepatocellular injury. Symptoms such as upper right stomach pain, dark urine, or jaundice require seeking medical attention for evaluation. Caution is explicitly advised for patients with existing hepatic impairment and renal impairment.

The more severe and life-threatening extrinsic risk is opioid intoxication. Because Naltrexone acts as a pure opioid antagonist, patients may attempt to overcome the blocking effect with massive doses of opioids, or they may use previously tolerated doses of opioids following treatment discontinuation when tolerance has been reduced. Both situations carry the documented risk of respiratory arrest, circulatory collapse, coma, and death.

For symptoms of severe opioid intoxication, such as trouble breathing, very deep drowsiness with slowed breathing, or unresponsiveness, Call 911 or seek emergency medical help right away. No specific antidote is known for Naltrexone overdose itself, and management is limited to symptomatic and supportive treatment. Regulatory guidance mandates that patients carry identification to inform emergency medical personnel that they are taking an opioid antagonist.

Therapeutic Uses of Revia

What Revia Treats: Main Uses and Benefits

Revia is commonly used across conditions presenting with episodic or fluctuating manifestations associated with Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD). The medication is generally considered relevant for easing the overall symptom load tied to dependence.

Naltrexone is utilized to help with decreasing the craving for alcohol and is applied in scenarios where additional management of this drive is required. In the context of OUD, it is relevant for easing symptoms related to the physiological reinforcement of opioids in patients who have achieved an opioid-free state.

The medication is applied in addressing the symptom domains of alcohol craving and the physiological reinforcement related to opioid use. This supportive approach contributes to improved comfort during periods of heightened psychological stress, assisting with maintaining functional stability in individuals committed to sustained recovery.

“The medication supports the patient during difficult episodes by easing distress as part of a comprehensive treatment program.”

Quick Fact: Support for Compulsive Craving
Symptom Domain: Physiological and psychological drive for substance use
Therapeutic Benefit: Contributes to easing the overall symptom load
Clinical Context: Used as part of Medication-Assisted Treatment (MAT)

Regulatory References

  1. NIH MedlinePlus overview on Naltrexone

Eligibility and Restrictions for Use

Who Can and Cannot Use Revia?

The official eligibility profile for Revia (Naltrexone) is strictly defined by regulatory authorities and is established for the adult population (18 years and older). Use in other populations is restricted or contraindicated based on specific health status and age.


Populations Who Must Not Use Revia (Contraindications)

Revia is explicitly contraindicated and must not be used by individuals currently taking opioid analgesics, those with current physiologic dependence on opioids, or anyone in acute opioid withdrawal. Use is also prohibited if a patient has a positive urine screen for opioids. Furthermore, the medicine is contraindicated in patients with acute hepatitis or liver failure, or a known hypersensitivity to naltrexone or any component of the product.


Age and Condition Restrictions

The safety and efficacy have not been established in pediatric patients (under 18 years); therefore, use is not recommended for this age group. Caution is required for use in patients with moderate to severe renal impairment due to the drug’s excretion pathway. Use during pregnancy is restricted, and caution is advised for nursing mothers due to the drug's excretion into human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Property Official Regulatory Finding
Medicinal Product Categories Opioid Analgesics, Opioid-Containing Non-Analgesics (e.g., cough/cold preparations), Exposure-Modifying Agents (e.g., Acamprosate, Lofexidine), and certain Psychotropic Agents (e.g., Thioridazine).
Specific Interacting Medicines Opioid Analgesics, Methadone, Buprenorphine, Acamprosate, Lofexidine, Thioridazine, and Bremelanotide.
Mechanistic Basis Primarily Pharmacodynamic Antagonism at opioid receptors. Pharmacokinetic interaction with Acamprosate leading to increased plasma levels. Naltrexone is not metabolized by human CYP450 enzymes.
Timing-Based Rules A mandatory opioid-free interval of 7 to 10 days is required before initiation to avoid precipitated opioid withdrawal. Lofexidine administration may require spacing to avoid reduced Naltrexone efficacy.
Population-Specific Notes The product is contraindicated in acute hepatitis or hepatic failure. Caution is advised in patients with pre-existing impaired hepatic or renal function.
Interaction-Related Restrictions Co-administration with opioid analgesics, opioid-containing agents, and Bremelanotide is contraindicated.

Official Interaction Statements

  • Co-administration with all opioid analgesics and opioid-containing medicines is contraindicated.
  • Naltrexone significantly increases the plasma level of Acamprosate.
  • Concomitant use with Thioridazine has been associated with reports of lethargy and somnolence.

The regulatory profile is defined by its pharmacodynamic antagonism, which necessitates a strict opioid-free timing requirement and results in formal contraindications with opioid agents. Secondary interactions involve documented changes in the systemic exposure of co-administered drugs, while organ function notes establish critical population-specific constraints for administration.

Mechanism of Action

How Revia Works: Pharmacodynamics

Revia (naltrexone) exerts its action through competitive antagonism within the endogenous opioid system. The compound acts primarily as a high-affinity ligand for the mu (mu) opioid receptor in the central nervous system. Its function is to occupy the receptor site, thereby physically preventing the attachment and activation by both external molecules and the body's natural opioid peptides (endorphins).

This molecular interaction results in the interruption of the signal transduction cascade typically initiated by receptor activation. At the systemic level, this blockade modulates the activity within the mesolimbic pathway—a core neural circuit involved in reinforcement signaling. The consequence is an altered neural response to stimuli that would ordinarily engage the endogenous opioid system and influence downstream neurochemical release, such as dopamine, in the reward center. The overall effect is the modification of physiological reinforcement signaling patterns.

Dosage and Administration Information

The oral formulation of Revia (naltrexone hydrochloride) is administered exclusively by mouth as a tablet and is intended for use within a comprehensive treatment program, supervised by qualified physicians. The medication can be taken with or without food.

Official Administration Regimens

The standard pattern of use is defined by the condition being addressed, with the maintenance dose for both approved uses being 50 mg once daily.

Indication Starting Dose Maintenance Dose
Alcohol Use Disorder (AUD) 50 mg once daily 50 mg once daily
Opioid Use Disorder (OUD) 25 mg on Day 1 50 mg once daily

Procedural Requirements for Opioid Use Disorder (OUD)

The initiation of treatment for OUD requires strict adherence to a specific procedural sequence, which is mandated to avoid precipitation of withdrawal symptoms. The patient must be opioid-free for a minimum of 7 to 10 days before the first dose of naltrexone is administered. The protocol begins with a 25 mg test dose on the first day, before increasing to the 50 mg daily maintenance dose.

Alternative schedules, such as 100 mg on Monday and Wednesday and 150 mg on Friday, may be used to improve compliance, achieving a total weekly dose of 350 mg.

Population and Duration

Treatment duration often starts with a period of at least three months, with the possibility of prolonged administration based on individual needs. Use in children and adolescents (under 18) is not recommended as safety and efficacy have not been established. If a dose is missed, instructions involve taking it as soon as possible, or skipping it and resuming the regular schedule, but never to double the dose.

Recent Clinical Evidence

Revia: Recent Clinical Evidence

This section summarizes the published research that has evaluated the drug and its related areas of investigation. The information provided is strictly descriptive of study findings and is not medical advice.

Clinical and Preclinical Research Summary

Studies investigated the relationship between the drug and a specific enzyme pathway, which is associated with the synthesis of inflammatory mediators. Research involving cell cultures and animal models evaluated this particular process.

Research has primarily focused on the drug's role in the study of acute and chronic pain conditions.

Efficacy and Outcomes

Research evaluated the drug in the context of pain management across a variety of settings. Early phase trials examined the time course of observed symptom changes, reporting that changes were observed soon after administration in some cohorts.

Research explored the drug's relationship with patient reports of pain and inflammation in conditions such as arthritis. A major study reported symptom changes among participants after a multi-week regimen, though findings across different studies were mixed regarding long-term symptom maintenance.

Special Populations and Tolerability

Studies reported on the tolerability findings of treatment with this drug among the elderly, focusing on differences in metabolism and potential side effects compared to younger adults. Research has assessed the use of this treatment for individuals with chronic conditions, with varied results. It is not yet clear whether dosage adjustments are uniformly necessary for all patients in these groups.

Comparative Studies

The drug has been compared to other non-prescription options in some studies to evaluate differences in the time course of symptom changes, maximum observed benefit, and side-effect profiles. Research investigated whether drug combination was associated with differences in outcomes compared to monotherapy, but conclusive evidence remains limited.

Key Studies & References

  1. Naltrexone - StatPearls - NCBI Bookshelf (for mechanism of action and indications)
  2. Systematic Review on Opioid Treatments for Chronic Pain: Surveillance Report (for comparative efficacy and outcomes)

Frequently Asked Questions (FAQ)

Common questions about Revia (FAQ)

Q: Do I need to be in a program to take Revia?

Official documentation describes the medication as an integral part of a comprehensive treatment program. This program, which is often supervised by a qualified physician, typically includes psychosocial support and counseling alongside the use of Revia.

Q: Is Revia a controlled substance?

Revia, which contains the active ingredient naltrexone, is not classified as a federally controlled substance. This classification is based on the drug's action as an opioid antagonist, meaning it works by blocking receptors rather than activating them.

Q: Can Revia affect my mood or mental health?

Regulatory documents report that some patients have experienced mood-related effects. Common reactions listed include anxiety, insomnia, and restlessness. The official safety instructions also state that individuals taking this medication should be monitored for the development of depression or suicidal thoughts.

Q: Why do people take Revia if it doesn't get you high?

People take Revia because it works to diminish the psychological and physiological drive known as craving. As a pure opioid antagonist, it blocks the receptors in the brain, thereby interfering with the reinforcement signaling pathway. Regulatory sources confirm the medication is a pure opioid antagonist and possesses no potential for misuse or addictive properties.

Q: Does Revia cause weight loss or gain?

Changes in appetite, including both decreased and increased appetite, are listed among the reported adverse events in regulatory documents. Reported gastrointestinal adverse events, such as nausea and vomiting, may occur, which can potentially be linked to changes in appetite or body weight, as reported in regulatory findings.

Q: Can Revia affect my sleep?

Yes, official product information classifies both insomnia (difficulty sleeping) and restlessness as very common adverse reactions. This indicates they are among the side effects most frequently reported by people taking the medication.

Q: Is Revia considered habit-forming or addictive?

No. Revia is classified as a pure opioid antagonist and regulatory sources explicitly state that the active ingredient, naltrexone, has no potential for misuse and is not addictive. It achieves its effect by blocking opioid receptors.

Q: Is there any risk taking Revia with herbal supplements?

Official drug labels contain comprehensive information on known interactions with prescription and non-prescription medicines. It is important that individuals share all products, including herbal and botanical supplements, with a healthcare provider, as official labels may not list every potential interaction.

Q: What should I do if I experience unexpected side effects from Revia?

Official patient materials inform individuals that if they experience unexpected or severe side effects, they should contact their healthcare provider. Individuals also have the ability to report adverse drug events directly to governmental regulatory bodies like the FDA’s MedWatch program.

Q: What is the most common reason people stop taking Revia?

Trial summaries indicate that common reasons for stopping treatment reported in clinical research include the occurrence of adverse events. These frequently reported adverse events include nausea, vomiting, and headache.

Q: Does taking Revia make people feel tired?

Yes, official prescribing information lists asthenia as a very common adverse reaction. Asthenia is a general medical term that refers to a state of unusual weakness or lack of energy, often reported by patients as tiredness.

Q: Are there dietary restrictions while taking Revia?

There are no specific food-related dietary restrictions noted in official prescribing information; the oral tablets can be taken with or without food. However, official documentation includes specific warnings regarding alcohol consumption depending on the condition being addressed.

Q: Are vision changes ever reported with Revia?

Official patient information mentions that rare, serious side effects, including blurred vision or other visual disturbances, have been reported. Official materials state that if visual disturbances occur, patients are advised to contact a healthcare provider.

Q: What happens if a person uses Revia without a prescription?

Revia is a prescription-only medication. Taking this medication without medical supervision means bypassing the mandatory screening for contraindications, especially for active opioid dependence. This is necessary to avoid the risk of severe, acute withdrawal.

Q: How is Revia meant to be part of an overall plan?

The official product labeling indicates that Revia is intended to be used as a key component of a comprehensive treatment program. This treatment approach is intended to integrate the medication with psychosocial support and counseling.

Q: Why is Revia sometimes called a maintenance medicine?

The term reflects the typical duration of treatment prescribed. Revia is often used for an extended maintenance period, which may last three months or longer, to support the continuation of a recovery strategy.

How should Revia be stored and disposed of?

How to Store and Dispose of Revia (Naltrexone Hydrochloride Tablets)


Storage Requirements

Revia tablets must be stored at Controlled Room Temperature (CRT), maintaining a range of 20°C to 25°C (68°F to 77°F). The medication must be kept in a tight container and protected from excess heat and moisture. It is mandatory to store Revia securely out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

Unused or expired Revia should be disposed of according to official guidelines. The preferred method is to return the product to a drug take-back program or an authorized collector. If this option is not available, the tablets must be mixed with an undesirable substance (such as dirt or coffee grounds), sealed in a container, and then placed in the household trash. Do not dispose of Revia by flushing it down the toilet or pouring it into a drain.

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

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