Levazol

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Levazol

Method of action: Anthelmintic

Treatment option:

Medically reviewed

Marina Burgos

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 Levazol

Levazol: An Anthelmintic and Immunomodulatory Agent

Levazol is the trade name for the active pharmaceutical ingredient Levamisole, a synthetic drug notable for its dual classification as a powerful Nematocide/Anthelmintic and a systemic Immunomodulator. The compound is chemically categorized as an Imidazothiazole derivative. This dual function is critically important for its identity. Levamisole is recognized for its role in global public health for the treatment of parasitic infections. Its status reflects the compound's established utility for the clearance of susceptible parasitic roundworms.

The compound is produced through synthetic chemistry, distinguishing it from naturally derived medicines, and is designated as a prescription-only medicine (POM). It is prepared in several core formulations to suit diverse therapeutic needs, primarily the oral tablet and oral suspension for oral administration, alongside the solution for injection for parenteral use. The availability of multiple forms ensures clinical flexibility in patient management.

Composition and General Purpose

The pharmaceutical composition of Levazol utilizes Levamisole (typically as the hydrochloride salt) as the single active ingredient. The drug's unique dual therapeutic profile is a central differentiating factor from other anthelmintic agents.

The resulting general therapeutic purpose provides two distinct benefits. First, it acts to incapacitate specific parasitic worms, facilitating their expulsion from the body. Second, Levamisole exhibits a restorative property on the immune system, where it is recognized for its capacity to enhance the activity of T-cells and phagocytes in certain clinical contexts. This singular compound's ability to both address parasitic agents and contribute to the normalization of immune response defines the utility of Levazol in specific therapeutic settings.

Regulatory References

  1. World Health Organization (WHO)
  2. Levamisole on the WHO Essential Medicines List

What side effects are possible with Levazol?

Official Adverse Reaction Profile and Safety Characteristics

Levazol (Levamisole) has a safety profile officially characterized by a range of adverse reactions, which are grouped according to the body system affected and their reported frequency. The most serious concerns documented in regulatory information involve Blood and Lymphatic System Disorders and Nervous System Disorders, particularly when the medicine is administered over an extended period.

Systemic and Serious Adverse Reactions

The label documents specific serious adverse reactions. These include life-threatening hematological disorders such as Agranulocytosis (a severe drop in white blood cells) and Leukopenia. Neurological concerns officially listed include Encephalopathy-like syndrome and Vasculitis (inflammation of blood vessels).

Commonly reported effects involve the Gastrointestinal System (e.g., nausea, diarrhea, abdominal pain) and the Nervous System (e.g., dizziness, headache, fatigue).

Population and Exposure Safety Notes

The risk of severe adverse reactions, especially hematological toxicity, has been reported to be higher with prolonged, multiple-dose regimens (such as those used for immunomodulatory purposes) compared to single-dose anthelmintic use. Safety data also includes specific notes for vulnerable populations.

  • Pregnancy: Regulatory classification indicates the medicine is Suspected of damaging the unborn child.
  • Existing Blood Disorders: Use is restricted in patients with pre-existing blood disorders due to the established risk of severe hematological effects.

High-level safety constraints include the explicit warning that Levazol can produce an ANTABUSE-like effect when taken with alcohol, resulting in symptoms like flushing and nausea. These regulatory statements strictly define the medicine's official safety profile and required limitations.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Levazol (Levamisole) is officially documented in regulatory information as potentially presenting with a severe spectrum of clinical signs that may mimic the effects of nicotine or organophosphate poisoning. Immediate medical intervention is mandated in all cases of suspected overdose or accidental ingestion.

Documented Overdose Manifestations and Outcomes

Regulatory sources describe acute overdose manifestations predominantly affecting the nervous and gastrointestinal systems. Symptoms include neurological effects such as severe ataxia (lack of coordinated movement), muscle tremors, clonic convulsions (seizures), anxiety, and central nervous system depression. Gastrointestinal distress, including vomiting, nausea, abdominal pain, and colic, is also commonly documented. Severe systemic outcomes listed in official prescribing information include prostration and collapse. The toxicity profile also notes the potential for agranulocytosis to occur, especially with exposure to higher than recommended doses, which is considered a potentially life-threatening complication.

Required Emergency Actions

Due to the severity of documented outcomes, official labeling strictly mandates that medical advice must be sought immediately following a suspected overdose or if the patient feels unwell after accidental ingestion. Regulatory guidance requires individuals to Call a Poison Center or doctor/physician without delay. Because no specific antidote is known, clinical management focuses on symptomatic and supportive treatment. Regulatory documents also note that susceptibility to toxicity may be increased if underlying factors such as dehydration or physical stress are present.

Therapeutic Uses of Levazol

What Levazol Treats: Main Uses and Benefits

Levazol is commonly used for symptomatic relief across therapeutic domains where short-term symptomatic assistance is appropriate. It focuses on helping patients cope with the immediate burden of distressing manifestations rather than treating the underlying cause of a chronic condition. The main therapeutic benefits are generally realized during acute or unstable episodes.

The medication is considered relevant for managing symptoms associated with conditions presenting with systemic or localized discomfort and heightened physiological activity.

The medication is applied in clinical settings that involve acute or unstable symptom patterns, and is often used during phases when symptoms become more noticeable. This includes addressing groups of symptoms that may become intense or disruptive and situations requiring temporary assistance in symptom stabilization.


Quick Fact: Relief for Heightened Symptoms

Levazol provides support that helps ease the overall symptom burden and assists with maintaining functional stability when symptoms interfere with routine activities. This therapeutic support is relevant when patients experience symptom-driven clinical presentations, offering aid in managing conditions characterized by periods of heightened symptoms.

Regulatory References

  1. EMA therapeutic overview on Levamisole

Eligibility and Restrictions for Use

Levazol's eligibility is strictly defined by regulatory authorities and is based on specific patient populations and pre-existing health conditions.

Contraindications and Restrictions

Classification Population/Condition Restriction Details
Contraindicated Hypersensitivity Patients with known allergy to Levamisole or its components must not use the medicine.
Contraindicated Pre-existing Blood Disorders Prohibited for use in patients with a history of blood disorders (e.g., neutropenia) [Source 1.2, 2.3].
Contraindicated Recent Organophosphorus Exposure Must not be administered within 14 days of treatment with organophosphorus compounds [Source 2.3].
Not Recommended Severe Renal Impairment Use is not recommended due to increased risk of serious adverse effects [Source 2.6].
Use With Caution Liver Diseases Recommended to be used with caution in patients with a history of liver diseases [Source 2.3].

Age and Reproductive Eligibility

Levazol is generally considered acceptable for adults and children for approved anthelmintic uses. However, its safety and effectiveness for other uses (e.g., immunomodulatory) are not well-established in the pediatric population [Source 1.5].

For pregnant women and breastfeeding women, use is not recommended unless the prescribing physician determines it is essential to the patient's health [Source 2.3]. Regulatory documents often advise specific caution to avoid use during the third trimester of pregnancy [Source 1.1].

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Levazol

Interaction Scope

  • Medicinal product categories with documented interactions: Anticoagulants (coumarin derivatives), Anticonvulsants, Neurotoxic agents.
  • Specific interacting medicines (if explicitly listed): Warfarin, Phenytoin, and Organophosphorus Compounds.
  • Mechanistic basis of interactions (only if stated in label): Pharmacokinetic interaction resulting in inhibition of metabolism of coumarin derivatives; Pharmacodynamic interaction involving interference with alcohol (ethanol) metabolism.
  • Timing-based interaction rules (if applicable): A mandatory minimum 14-day separation is required between administration of Levazol and Organophosphorus Compounds.
  • Population-specific interaction notes (if applicable): No specific interaction cautions are explicitly defined in the regulatory interaction section for specific populations.
  • Interaction-related restrictions: Strictly prohibited co-administration of Levazol with Organophosphorus Compounds within a 14-day period. Consumption of alcohol (ethanol) is restricted due to the pharmacodynamic interaction risk.

Interaction Classifications (High-Level)

  • Interaction severity classification (as defined in official documents): Clinically significant interactions requiring either monitoring/dose adjustment or strict administration timing/prohibition.
  • Regulatory basis (EMA / FDA / etc.): Official prescribing documents and drug index information.
  • Interaction-context constraints (as defined in official documents): The constraint with Organophosphorus Compounds is an absolute time-based rule to prevent additive toxicity. The constraint with alcohol is a prohibition against co-consumption due to a specific and severe systemic reaction.

Resulting Interaction Structure

Official interaction statements:

  • Co-administration with Warfarin or other coumarin derivatives may increase the plasma concentration and effects of the anticoagulant.
  • Levazol may increase the effects of the anticonvulsant Phenytoin.
  • The drug must not be administered within 14 days before or after treatment with Organophosphorus Compounds.
  • Concurrent ingestion of alcohol (ethanol) is associated with the official risk of a "Antabuse"-like side effect (Disulfiram-like reaction).

Connection to the overall interaction profile (2–4 sentences):

The regulatory documents define the Levazol interaction structure through three key domains: pharmacokinetic interference leading to increased exposure of select concomitant medicines, a strict pharmacodynamic prohibition against concurrent alcohol use, and a mandatory 14-day timing separation requirement for co-treatment with Organophosphorus Compounds. This structure outlines both metabolic risk profiles and non-metabolic administration constraints as formally stated by government authorities.

Mechanism of Action

Targeted Parasite Neuromuscular Blockade

The anthelmintic action of Levazol is initiated by its function as a cholinergic agonist that specifically targets the L-subtype Nicotinic Acetylcholine Receptors ( nAChR) located on the body wall muscles of susceptible nematodes. This molecular interaction causes sustained depolarization, leading to the irreversible spastic paralysis of the parasite. This physiological outcome results in the worm becoming physically detached and expelled by host peristalsis.


Restoration of Depressed Cellular Immunity

Levazol exerts a separate, non-overlapping action by functioning as a restorative modulator of the host's cell-mediated immunity. This mechanism facilitates the restoration of function in depressed T-lymphocytes and phagocytic cells ( macrophages and neutrophils) in states of compromised immunity. The resulting physiological effect influences the cellular immune response profile. The effect is minimal or absent when the immune system is in an immunologically competent state.


Mechanistic Constraints and Target Specificity

The compound’s efficacy profile is dictated by the specificity of its targets. The neuromuscular action is limited by genetic mutations in parasite nAChR that can cause drug resistance, while the immunomodulatory action is contingent on a pre-existing state of immune depression, exerting minimal or no measurable physiological effect on immune cells in an immunologically competent state.

Dosage and Administration Information

Levazol is administered via the oral route, typically provided as a tablet or oral suspension, although a solution for injection is also an available formulation. The general use of the medicine is defined by two fundamentally different dosing patterns.

The primary use model involves a single-day course for certain acute applications. Under this regimen, the standard dose for adults falls within the range of 120 mg to 150 mg, administered once. The duration of this course is short-term, though a repeat administration may be utilized after 7 days in specific circumstances. Dosing for pediatric patients follows a separate rule based on a weight calculation (e.g., 3 mg per kilogram of body weight).

A separate, historical usage pattern involved a long-term, cyclic protocol used in combination with other agents. This regimen used a dose of 50 mg three times daily (TID) for three consecutive days, repeated on an intermittent schedule for up to one year.

Regardless of the regimen, the oral dose may be taken with or without food. For all usage, caution is applied for patients with existing hepatic or renal limitations. When a single dose is missed, clinical protocols generally indicate that a double dose should not be taken.

Recent Clinical Evidence

Research evidence / Overview of Studies for Levazol

The available research evidence for Levazol (Levamisole) focuses on its primary use in parasitic infections and studies that have explored its properties as an immunomodulator. The studies described here are the clinical evaluations referenced by regulatory and scientific bodies.


Evidence for Use in Parasitic Worm Clearance (Anthelmintic)

The available research for this use is assigned an Evidence Level: High by scientific bodies. Levazol was studied for the clearance of parasitic worms. This research base is the foundation for its inclusion on the World Health Organization's List of Essential Medicines.

This evidence comes largely from large-scale, short-term Randomized Controlled Trials (RCTs) and field efficacy studies. These studies primarily focused on populations in areas where parasitic worm infections are endemic. Researchers monitored outcomes related to the burden of infection, using measurements such as the Cure Rate (absence of parasite eggs after treatment) and the Egg Reduction Rate (ERR) (a measurement of parasite burden reduction).

The findings describe patterns observed in these studies, where trials monitored the expulsion of specific intestinal roundworms. This research highlights measurements of parasite burden reduction that were observed during the study period. This research base is assigned an Evidence Level: High by scientific bodies for this specific application, and it contributes to the broader evidence landscape of global deworming strategies.


Evidence for Use in Immune System Modulation

Research also examined Levazol as a systemic Immunomodulator. This research is more complex and involves historical trials that studied whether Levazol was associated with outcomes in specific immune conditions. These studies included research on Nephrotic Syndrome and its use as an adjuvant in certain cancer therapies.

These studies used a variety of designs, including RCTs and smaller prospective trials, often over intermediate time intervals. They monitored outcomes related to systemic or functional imbalance, specifically measuring immunological biomarkers (like T-cell activity) and outcomes describing episodic or acute changes (like disease flares).

It is not yet clear whether the measured shifts in immune markers have long-term clinical relevance, particularly outside of the specific conditions studied historically. Because these types of research scenarios require prolonged administration to observe sustained outcomes, certainty remains low for widespread use, and long-term effects are not fully established.


What is Still Uncertain About Levazol Research

The evidence highlights what is known—and what is still uncertain—about Levazol. The primary area of uncertainty lies in the immune-modulatory uses, where data are still emerging for contemporary clinical applications, and findings were mixed across the different conditions. This means that certainty remains low when trying to generalize findings beyond the historically studied situations. The risk of resistance in parasitic species and limited data for previously unstudied special populations remain areas monitored by public health organizations.

Key Studies & References

  1. Levamisole - Electronic Essential Medicines List (EML)
  2. PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections (EMA Regulatory Review of Leukoencephalopathy Risk)

Frequently Asked Questions (FAQ)

Common questions about Levazol (FAQ)

Q: How quickly does Levazol start to work?

A: Levazol is absorbed rapidly into the body after it is taken, reaching its highest level in the blood within about 1.5 to 2 hours. For its primary use, the action on the parasitic worms is described as causing paralysis quickly. This rapid effect facilitates the expulsion of the worms, which usually happens within 24 hours of administration.

Q: Is there a generic version of Levazol available?

A: Levazol is a brand name for the active ingredient, which is Levamisole. According to global public health information, Levamisole is included in the World Health Organization's List of Essential Medicines. This generally supports the availability of Levamisole through generic formulations in many regions.

Q: What happens if I stop taking Levazol suddenly?

A: The most common and officially approved use for Levazol is a single, short-term dose, which is not a regimen that is suddenly stopped. For specialized intermittent protocols, regulatory documents mainly caution that the risk of serious side effects is primarily associated with prolonged or repeated high-dose regimens. Any change to a prescribed intermittent regimen is typically reviewed by a healthcare provider.

Q: Why is Levazol sometimes given for different conditions?

A: Levazol (Levamisole) is officially recognized for having a dual therapeutic profile in regulatory documents. Its established purpose is as an Anthelmintic (a drug for parasitic infections), but it also functions as a systemic Immunomodulator. This secondary property of restoring T-cell function led to its historical study and use in specific conditions involving compromised immunity.

Q: Is Levazol used for long-term treatment?

A: The primary, current use of Levazol involves a short, single-day course for acute conditions. While a historical regulatory labeling protocol did exist for a long-term, cyclic approach for immunomodulation, this use is associated with a higher risk of severe adverse reactions. Consequently, it is restricted or withdrawn in many major markets, though alternative-day regimens are still studied in highly specialized situations.

Q: Can Levazol be taken with pain relievers like ibuprofen?

A: Official regulatory interaction statements list specific drugs known to cause a serious interaction, such as Warfarin and Phenytoin, but do not explicitly list general, non-prescription pain relievers like Ibuprofen. Prescribing information generally advises informing a healthcare provider of all medicines taken, including non-prescription products, for interaction screening.

Q: Does Levazol have any warnings about liver problems?

A: Yes. Levazol is broken down in the liver, and official prescribing information advises it must be used with caution in patients with a history of liver diseases. Furthermore, the label lists elevated liver enzymes as a reported adverse effect, which can be an indicator of stress on the liver.

Q: Does Levazol have a black box warning?

A: The drug product Levazol does not currently carry a formal 'Black Box Warning' from the U.S. FDA, as its use has been restricted or withdrawn in that market. However, official safety documentation lists severe adverse reactions, including potentially life-threatening Agranulocytosis (a severe drop in white blood cells) and serious neurological events.

Q: How long does the effect of Levazol last?

A: The drug itself is rapidly cleared from the body, having an elimination half-life of approximately 3 to 4 hours. For the primary anthelmintic use, the drug’s systemic presence is brief, and the therapeutic outcome is supported by the rapid clearance of the parasite following the single dose.

Q: Can Levazol cause weight gain or weight loss?

A: Levazol is not commonly associated with weight gain in regulatory documents. However, official safety information describes rapid weight loss (e.g., five pounds in one week) as a symptom that has been reported and may warrant assessment by a healthcare provider.

Q: Is it normal to feel tired after taking Levazol?

A: Yes. According to official product information, fatigue and drowsiness are listed among the commonly reported side effects. These are classified as general nervous system effects that patients may experience. Concerns about the severity of any side effect are typically reviewed by a prescribing doctor.

Q: Can I take Levazol with my blood pressure medication?

A: Official regulatory documents list known interactions with specific drugs like Warfarin and Phenytoin, but they do not list a blanket restriction or warning regarding common classes of blood pressure medication. All concurrent medications are generally reviewed by the prescribing healthcare provider before Levazol is administered.

Q: Are there any foods or drinks I should avoid while taking Levazol?

A: The single most important restriction defined in regulatory documents is the strict prohibition of alcohol (ethanol). Concurrent ingestion carries a high risk of a severe 'Antabuse'-like systemic reaction. Aside from alcohol, official instructions state that the medicine can be taken with or without food, and no other food or drink is generally restricted.

Q: Does Levazol need to be taken at a specific time of day?

A: For the typical single-dose regimen, the specific time of day is not critical. For specialized, intermittent dosing protocols, the dose is usually taken once daily, often in the morning, with the primary goal being to take it at the same time on the days it is prescribed to maintain a consistent schedule.

Q: Does taking Levazol affect lab test results?

A: Yes. Levazol is known to be associated with the risk of severe hematological disorders (blood problems), such as agranulocytosis. Consequently, monitoring of complete blood counts (CBCs) is typically performed as part of the management of patients taking this medication, as the drug can significantly impact these lab results.

Q: Is Levazol a controlled substance?

A: No. Levazol (Levamisole) is officially classified as a prescription-only medicine (POM) but is not scheduled as a controlled substance under the U.S. Controlled Substances Act (CSA) or similar regulatory bodies internationally.

Q: Can Levazol cause issues with my stomach or digestion?

A: Yes. Gastrointestinal (GI) disturbances are listed in official documents as commonly reported adverse reactions. These issues may include nausea, diarrhea, vomiting, and abdominal pain or cramping.

Q: Are there different strengths of Levazol available?

A: Yes. According to official dosage guides and product information, Levazol is commonly available for human use in different strengths, typically as 50 mg tablets and 150 mg tablets. It is also available in different formulations, such as oral suspensions.

Q: Why is Levazol's mechanism of action described as [specific mechanism jargon]?

A: The anthelmintic mechanism is described using jargon like 'cholinergic agonist' because Levazol chemically acts like the body’s natural signal, acetylcholine. It selectively targets and continuously stimulates specific receptors on the parasite’s muscles, which results in spastic paralysis and expulsion.

Q: Is the research on Levazol ongoing?

A: Yes. While its long-term use has been restricted in many countries, Levazol remains the subject of ongoing clinical research. Studies are currently exploring its potential role in specific combination therapies for advanced cancers and maintaining remission in immune disorders like Nephrotic Syndrome.

Q: Can Levazol affect my mood or mental health?

A: Yes. Levazol has reported effects on the nervous system. Official safety documents list psychiatric side effects, including mood changes and anxiety. More serious neurological events, such as confusion or psychosis, have also been reported, particularly with the higher or prolonged dosing regimens.

How should Levazol be stored and disposed of?

Levazol (Levamisole) must be stored and disposed of according to strict requirements outlined in official regulatory documentation to ensure stability and public safety.

Storage Requirement Official Condition
Temperature Range Store at controlled room temperature (20 C to 25 C), with acceptable excursions up to 30 C.
Protection Keep from freezing. Protect from moisture and direct light.
Container Rule Keep the immediate container tightly closed and in its original packaging.
Child Safety Store out of the sight and reach of children and pets; store locked up.

Official disposal instructions strictly mandate that unused or expired Levazol must not be disposed of in household waste or wastewater (e.g., flushed down the toilet). The product must be discarded in accordance with local pharmaceutical waste disposal requirements or returned to an approved disposal plant.

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

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