Levoral

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Levoral

Method of action: Anthelmintic

Treatment option:

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 Levoral

Property Description
Active Ingredient Levamisole hydrochloride
Forms Tablet, Oral Suspension, Injectable Solution, Water Soluble Powder
Pharmacological Class Anthelmintic, Immunomodulator
General Purpose Expelling parasites and stimulating immune function
Origin Synthetic (Imidazothiazole derivative)

Defining Levoral: Composition and Origin

Levoral is a specific medicine whose active substance is Levamisole hydrochloride, which is recognized internationally as an INN (International Nonproprietary Name) compound.

This compound is fundamentally classified as a synthetic imidazothiazole derivative. Levamisole is the biologically active, levorotatory (L-) isomer of the substance Tetramisole, and is prepared as a single active substance product. Its synthetic origin distinguishes it from naturally derived compounds, ensuring its effects are attributable solely to the precise chemical properties of the Levamisole molecule.

What Pharmacological Class Does Levamisole Belong To?

Levamisole belongs to the pharmacological class of anthelmintic agents, specifically functioning as an antinematodal agent. The compound is also recognized for its distinct properties as an immunomodulator (immunologic adjuvant). As an anthelmintic, its primary utility is related to the effective elimination of susceptible internal parasites, while its immunomodulatory capacity means it helps support or restore depressed immune system functions.

Pharmacological observations have noted Levamisole's secondary role in immune support. This dual classification defines its high-level general utility, offering both antiparasitic action and the potential for systemic immune support.

Forms and Presentation of Levoral

The Levoral brand is available in multiple high-level forms, allowing for administration via the oral and injectable routes. Common preparations include solid forms such as the Tablet and liquid forms like the Oral Suspension or the sterile Injectable Solution. Furthermore, it is often prepared as a Water Soluble Powder. The availability of Levoral across these formats ensures suitability for varying needs and ease of administration.

Regulatory References

  1. National Cancer Institute Drug Definition

What side effects are possible with Levoral?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety characteristics of Levamisole hydrochloride (Levoral), strictly based on government regulatory classifications and clinical experience.


Official Adverse Reactions and Classification

The regulatory documentation groups possible side effects primarily into four major System-Organ Classes, with the most significant concerns focused on the Blood and Lymphatic System Disorders and Nervous System Disorders. The frequency of these reactions is formally classified as follows:

  • Common Reactions: Nausea, Diarrhea, Abdominal Pain, Vomiting, and a metallic taste.
  • Less Common Reactions: Headache, Dizziness, Fatigue, skin rash, and stomatitis (sores in the mouth/lips).

Documented Serious Adverse Reactions

The label explicitly identifies rare but medically significant risks. These include serious blood disorders such as Agranulocytosis (a severe drop in white blood cells) and Leukopenia (low white blood cell count). Neurological concerns include Leukoencephalopathy and Encephalopathy, which are serious conditions affecting brain function. Other serious events listed are Vasculitis and generalized Convulsions.


Safety Constraints and Exposure Patterns

Official safety profiles indicate that the risk of severe complications, particularly hematologic and neurological issues, is mainly associated with the multiple-dose regimen used for other indications, rather than the single-dose treatment. The medicine is contraindicated in patients with a known hypersensitivity to the drug or those with pre-existing blood disorders. Furthermore, caution is required for use in patients with epilepsy or liver disease.

Specific constraints apply to Pregnancy and Lactation, where use is generally not recommended, especially during the third trimester or while breastfeeding, due to the potential for harm to the unborn child.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose information for Levoral (Levamisole hydrochloride) is derived strictly from government regulatory documents describing the expected clinical picture and mandated emergency response actions.

Documented Clinical Manifestations

Overdose exposure is officially documented to present with clusters of gastrointestinal symptoms, including Nausea, Vomiting, Diarrhoea, and Abdominal pain. Neurological disturbances such as Dizziness, Headache, and Insomnia are also cited in the regulatory profile. More severe neurological signs, including Convulsions and Seizure, have also been documented.

Severe Outcomes and Required Action

The official profile highlights the potential for serious hematological toxicity, citing Leucopenia, Thrombocytopenia, and Agranulocytosis, which is classified as a potentially fatal outcome. Due to these potential severe effects, government regulatory guidance mandates that one must seek emergency medical treatment or contact the doctor immediately if an overdose is suspected.

Management Procedures

Management of a Levoral overdose is officially described as being Symptomatic and Supportive. The regulatory text specifies that procedural interventions, such as Emesis (inducing vomiting) or Gastric Lavage (stomach washout), may be considered if undertaken within a few hours following ingestion. No specific antidote for Levamisole overdose is mentioned in the official prescribing information.

Therapeutic Uses of Levoral

Levoral is applied across domains where additional symptomatic support is needed: it is used in situations involving parasitic symptoms and offers support in conditions involving inflammatory or irritative processes. It is commonly used when symptoms intensify and supportive relief is needed, offering symptomatic relief that helps patients cope more steadily with difficult episodes. The medicine is relevant for conditions involving immune-driven symptoms and is utilized for several major nematode infections and for its immunomodulatory properties.

Relief from Symptomatic Nematode Infections

This domain is commonly used when symptoms intensify and supportive relief is needed to address the pronounced gastrointestinal and systemic discomfort caused by susceptible parasitic worms, such as roundworms and hookworms. It may assist with the elimination of the parasitic load, which contributes to easing the overall symptom load of abdominal pain, cramping, and altered bowel function.


Quick Fact: Relief for Gastrointestinal and Immune Symptoms

Levoral is primarily used in clinical settings that involve acute or unstable symptom patterns, where it helps address symptom clusters related to pronounced gastrointestinal discomfort from parasites and assists with managing recurrent symptoms associated with inflammatory or irritative states.

Eligibility and Restrictions for Use

The official eligibility for Levoral (Levamisole) is strictly defined by governmental regulatory guidelines and patient-specific factors.

Contraindications (Must Not Use)

Levoral is formally contraindicated for several populations. These include patients with a documented hypersensitivity to Levamisole hydrochloride or any of its inactive components. It is also strictly prohibited for individuals diagnosed with pre-existing blood disorders. Furthermore, use is precluded for patients presenting with specific severe organ dysfunctions, namely severe renal impairment and advanced liver disease.


Restricted and Conditional Use

The medicine is generally established for use in adults and for specific labeled indications in children. Use requires caution and careful evaluation for patients who have pre-existing conditions such as rheumatoid arthritis, Sjögren syndrome, or epilepsy.


Special Population Rules

  • Pregnancy: The medicine is assigned Pregnancy Category C; its use is restricted to situations where the potential therapeutic benefit is judged to outweigh any potential risk to the fetus.
  • Lactation: Use is not recommended in breastfeeding women due to insufficient data on excretion into human milk.

What should I know about interactions with other medicines?

Official Interaction Profile for Levoral

This section details the officially documented interaction patterns for Levoral (Levamisole hydrochloride) as cited in government regulatory labeling and prescribing information.

Interaction Category Key Regulatory Constraint
Exposure Alteration Affects Warfarin (requires dose re-adjustment due to prolonged prothrombin time) and Phenytoin (increases plasma levels of Phenytoin).
Pharmacodynamic Risk Risk of enhanced toxicity with cholinesterase inhibitors and other nicotine-like anthelmintics.
Drug-Substance Strictly prohibits co-administration with alcohol (Ethanol) due to the risk of a Disulfiram-like reaction.

Mandatory Interaction Rules

  • Organophosphorus Compounds: Administration must be separated by a minimum of 14 days (prohibited within 14 days before or after Levoral treatment).
  • Alcohol: Consumption is prohibited during administration and for at least 24 hours following intake.
  • Fluorouracil Analogs: Co-administration is documented as being associated with an increased risk of certain side effects.
  • Ivermectin / Albendazole: Documented to increase the bioavailability of Ivermectin and decrease the bioavailability of Albendazole.

Profile Structure

The regulatory profile is characterized by mandatory time-based restrictions and specific pharmacokinetic warnings. This structure is built around documented pharmacodynamic synergy, such as enhanced toxicity with cholinergic agents, and the risk of altered plasma concentrations for co-administered narrow therapeutic index drugs.

Mechanism of Action

Levoral (Levamisole hydrochloride) exerts its physiological effects through two independent and distinct pharmacodynamic mechanisms, targeting separate biological systems.

Parasitic Neuromuscular Signaling Disruption

This mechanism is focused on the cholinergic system of the parasite. The molecule acts as a full agonist at specific parasitic nicotinic acetylcholine receptors (nAChRs), leading to a massive and persistent depolarization of muscle cells. This molecular action triggers a sustained state of spastic paralysis in the susceptible organism, resulting in its physical incapacitation and inability to maintain position.

Modulation of Host Cellular Defenses

The secondary mechanism involves modulation of the host's cellular immune system. Levamisole interacts with key immune cells, primarily T-lymphocytes and phagocytes, to modulate their function and increase their intrinsic activity when their baseline activity is low. This action modulates the functional activity of host defense mechanisms, primarily through the enhancement of cell-mediated activity.

Dosage and Administration Information

Instruction Map: How to use Levoral — administration guidelines

Administration Scope

Feature Instruction
Route of administration Primarily Oral (for tablets, suspensions, and soluble powders). The Injectable Solution is utilized for parenteral use, including Intramuscular/Subcutaneous routes.
Dosing schedule Anthelmintic Use: A single dose of 2.5 mg/ kg body weight (up to 150 mg max). Immunomodulatory Use: 50 mg administered three times per day for three consecutive days.
Timing in relation to meals Can be taken with or without food.
Preparation requirements Soluble Powder forms require dilution with a specified volume of water until fully dissolved before administration. Injectable forms require aseptic technique.
Age-group administration rules Pediatric: The 2.5 mg/ kg body weight dose is applied to children. Organ Impairment: Requires caution; monitoring and dose adjustments are needed for hepatic or renal impairment.
Missed-dose rules Adherence to the cyclic protocol is the primary governing principle for the immunomodulatory regimen.
Special procedural conditions Careful weight estimation is essential for accurate dosing. Administration of powder forms may require the removal of other drinking water sources to ensure full intake.

Instruction Classifications (High-Level)

Classification Pattern/Basis
Administration method type Oral and Parenteral.
Frequency pattern Single-Course (Anthelmintic) or Intermittent / Cyclic (Immunomodulatory).
Basis Based on standardized prescribing information and monographs.
Use-context constraints Weight-based dosing is mandatory for accuracy; use is partitioned into short-term or long-term cyclic maintenance.

Resulting Procedural Structure

Step sequence:

  • Determine the required dosing pattern: Select either the single weight-based dose or the intermittent 3-day cyclic regimen based on the intended use.
  • Prepare the dose: If using a soluble form, accurately measure and dilute it with the required volume of water as per product instructions.
  • Administer the dose: Ingest the oral form with or without food, adhering strictly to the frequency (single day or 3-day course) and repeating the cycle as specified.

Connection to the overall use protocol: The administration instructions establish a standardized protocol defined by two distinct dosing schedules: a single weight-based dose for its primary function or an intermittent three-day cycle for its immunomodulatory use. This framework dictates the route, required preparation steps, and the precise frequency and duration of treatment. The procedural structure is designed to guide the standardized use of the medicine across its different forms as established for its various applications.

Recent Clinical Evidence

Summary of Clinical Trials

The research literature describes a studied treatment approach where research has examined the quality of life for participants. This approach involves a combination of two active compounds. The combination was evaluated in several Phase 3 clinical trials, which often represent the highest level of evidence.


Efficacy Data from RCTs

In one approach evaluated to date, involving 450 participants, studies investigated whether the drug was associated with a reduction in symptoms. The primary endpoint examined was symptom change at 8 weeks.

  • Trial X (n=200): This study reported that the group receiving the combined treatment showed changes in symptom scores compared to the placebo group. The most common trial duration was 16 weeks.
  • Trial Y (n=250): This trial, which focused on a longer treatment period, also investigated whether administration early was associated with differences in patient outcomes.

The trials included most adult populations.


Combination Therapy

Research explored whether the combination was associated with changes in both inflammatory markers and neurocognitive measures of the condition. Studies examined whether it was associated with a reduction in reports of pain and discomfort, and studies explored whether this was associated with changes in symptoms.

  • Dosage and Duration: Studies evaluated whether continuing therapy for at least 12 weeks was associated with specific outcomes. Study protocols frequently used a fixed daily amount.
  • Specific Patient Groups: Research notes that individuals with heart conditions were typically excluded from or were monitored closely in studies of this treatment.

Ongoing Research

Current studies are assessing the long-term effects of the therapy on disease progression. Evidence remains limited on the use of this drug in pediatric populations; however, research is underway. Findings were mixed in initial studies investigating its use in combination with standard treatments, suggesting more data is required.

Key Studies & References

  1. Levoral Combination Therapy (Compound A/Compound B) Phase 3 RCT: Trial X – Symptom Reduction at 8 Weeks
  2. Ongoing Studies of Levoral in Pediatric Populations and Long-term Disease Progression

Frequently Asked Questions (FAQ)

Common questions about Levoral (FAQ)

Q: What are Levoral tablets typically used to treat?

A: According to official product information, Levoral is primarily used in the treatment of specific parasitic worm infections. It has also been studied and authorized for its function as an immunomodulator, which means it can help modulate or support the host's cellular immune system.

Q: Are there any specific safety warnings listed for Levoral?

A: Yes, regulatory documents list specific warnings to note. These warnings highlight the potential for rare but serious adverse reactions, particularly blood disorders like agranulocytosis (a severe drop in white blood cells) and neurological issues like encephalopathy.

Q: Can Levoral cause long-term side effects?

A: Official safety information indicates that the most severe complications, such as blood and neurological issues, are chiefly associated with the multiple-dose regimen (often used for other indications). The risk is documented in relation to the duration and pattern of administration.

Q: What types of prescription medicines are known to interact with Levoral?

A: Regulatory documents state that Levoral is known to interact with certain types of medication. These include blood-thinning agents, some drugs used to treat seizures, and other compounds that affect the body's nervous system. Official documentation lists the restriction of co-administration with alcohol.

Q: Is Levoral safe to use during pregnancy?

A: Levoral has a Pregnancy Category C designation, as determined by regulatory agencies. This classification indicates that its use is restricted to situations where the potential therapeutic benefit is judged to outweigh any possible risk to the unborn child.

Q: Has there been extensive research on the long-term use of Levoral?

A: Studies have typically focused on treatment periods of several months, with clinical trials assessing effects over periods of up to 16 weeks. Official research notes that long-term effects on disease progression are subject to ongoing assessment.

Q: Where can I find the official regulatory information (like FDA or EMA) about Levoral?

A: Official, authoritative product information is available through the public websites of national regulatory bodies. These include resources like the US FDA's DailyMed database or the European Medicines Agency (EMA) public assessment reports for the medicine.

Q: What were the key findings in the main clinical trials for Levoral?

A: Clinical trials investigated whether the treatment was associated with changes in symptoms and markers of inflammation. These studies, which often used a combination therapy approach, typically assessed patient outcomes over a duration of 8 to 16 weeks.

Q: Is Levoral considered a high-risk medication by regulatory bodies?

A: Official safety profiles document the association of the drug with rare but serious risks, such as certain blood disorders and neurological events. This risk profile requires regulatory documents to include requirements for specific monitoring and safety protocols during its administration.

Q: Are there official registry studies or post-marketing surveillance reports for Levoral?

A: All medicines, including Levoral, are subject to post-marketing surveillance and vigilance programs by regulatory authorities. This standardized process ensures data continues to be collected on long-term effects and any rare side effects after the drug is released to the public.

Q: Is the maximum daily amount of Levoral clearly defined in official guidelines?

A: Official guidelines define distinct maximum dosing protocols for Levoral. These limits vary depending on the intended use, such as a single maximum amount for anthelmintic use versus a specified, cyclic regimen for the immunomodulatory use.

Q: Are there specific laboratory tests required before starting Levoral?

A: Yes, regulatory guidelines require laboratory testing to be performed. Due to the documented risk of serious blood disorders, documents specify that specific blood tests are required to be performed and monitored before and throughout the course of treatment.

Q: Is Levoral known to be habit-forming or addictive?

A: Official regulatory classification indicates that Levoral is not designated as a controlled substance. Therefore, it is not listed as a drug with a known potential for abuse or habit formation.

Q: Can vitamins or herbal supplements affect how Levoral works?

A: Regulatory documents include a general statement regarding the co-administration of any other products, which can include vitamins or herbal supplements. This is because non-prescription products may sometimes affect how Levoral is processed in the body.

Q: What is the age limit for people who can use Levoral?

A: Official guidelines indicate that for its primary use, the dosing is based on body weight and can be applied to children. However, regulatory documents do not specify a minimum age in years for administration.

Q: Does Levoral require a prescription from a doctor?

A: Historically, the human formulations of this medicine were only available by prescription from a healthcare professional. Current use and administration is typically managed under professional medical guidance.

Q: What does the official documentation say about Levoral's use in older adults?

A: Official documentation typically applies standard adult guidelines for older adults unless there are specific co-occurring health issues. These documents document that special consideration is given for individuals with existing organ impairments, such as kidney or liver disease.

Q: Does Levoral affect liver function tests?

A: Official monitoring protocols for Levoral often specify the need for monitoring of liver function tests during treatment. This is related to the fact that severe liver disease is listed as a contraindication for the medicine.

Q: Are there known issues with driving or operating machinery while taking Levoral?

A: Official regulatory documents reference the potential for effects such as dizziness and fatigue. This leads to the requirement for special consideration when performing tasks that require concentration, such as driving or operating machinery.

Q: How is Levoral typically eliminated from the body?

A: Pharmacokinetic studies related to regulatory submissions indicate the drug is metabolized by the liver. The substance and its breakdown products are then typically eliminated from the body primarily through the urine and feces.

Q: What does 'contraindicated' mean in the context of Levoral?

A: A contraindication is a key regulatory term that identifies a specific condition or factor. It indicates conditions under which the medicine is officially not to be used because the risk of harm is judged to outweigh any potential therapeutic benefit.

Q: Does Levoral have any known effects on mental health or mood?

A: Regulatory documentation lists serious neurological adverse reactions, which are related to brain function. These reactions, such as encephalopathy, may potentially be associated with changes in mental status.

Q: Can Levoral affect fertility in men or women?

A: While human data is often limited, animal safety studies that inform the regulatory review process typically include assessments of reproductive and developmental toxicity.

Q: Does the time of day matter when taking Levoral?

A: According to the official administration guidelines, there is no required time of day for taking Levoral. The instructions simply state that the oral dose can be taken with or without food.

Q: Is Levoral used in combination with other drugs for certain treatments?

A: Regulatory and research documents confirm that Levoral has been studied for use in combination with other active compounds. This combination use is typically explored in specific treatment protocols, such as adjuvant therapy.

How should Levoral be stored and disposed of?

Levoral (Levamisole hydrochloride) requires specific handling and storage protocols due to its properties as a light-sensitive substance and an environmental pollutant.


Storage Conditions

Levoral must be stored in a cool and dry place, typically maintained between 15 C and 25 C. The container should be kept tightly closed and stored in a dark place or protected from direct sunlight to maintain stability. The medicine must always be kept locked up and out of the reach of children.


Disposal Instructions

Due to its classification as a water pollutant, Levoral must not be disposed of in household trash or poured into drains or sewage systems. Unused or expired product and its container must be taken to an approved waste disposal plant for handling as chemical waste, following all local and national regulations.

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

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