Onon

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Onon

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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 Onon

What is Onon? Defining the Medicinal Entity

Property Description
Active ingredient Pranlukast Hydrate
Form Capsules, Dry Syrup
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Origin Synthetic, Small Molecule drug

The medicine Onon is a prescription-required, orally administered drug manufactured by Ono Pharmaceutical Co., Ltd., that serves as a targeted maintenance treatment for conditions involving chronic inflammation of the airways and nasal passages. The drug's identity is defined by its sole active component, Pranlukast (specifically Pranlukast Hydrate), which positions it within the distinct pharmacological class of a Leukotriene Receptor Antagonist (LTRA). This approach is used for providing foundational control in respiratory maintenance.

Pranlukast is identified as a synthetic, small molecule drug, available as a single active ingredient product in forms suitable for oral administration, including Capsules and a flavored Dry Syrup. The Dry Syrup formulation is a distinguishing feature of Onon, developed to offer a convenient option, particularly for children and those who have difficulty swallowing tablets. This oral delivery method ensures systemic absorption, enabling the Pranlukast to circulate and provide consistent control over the biological processes driving inflammation throughout the respiratory system.

The general purpose of this therapy is to suppress the underlying triggers of chronic respiratory inflammation by interrupting the leukotriene pathway. The Pranlukast molecule acts as a competitive antagonist, selectively blocking the activity of powerful inflammatory mediators, the cysteinyl leukotrienes, at their receptor sites (CysLT1). This action establishes a therapeutic foundation for the ongoing management of conditions such as bronchial asthma and chronic allergic rhinitis.

Regulatory References

  1. National Library of Medicine (PubMed ID: 17265882)
  2. Pranlukast Hydrate Drug Information
  3. PMDA Draft Japanese Pharmacopoeia Monographs (Pranlukast)

What side effects are possible with Onon?

Possible Side Effects and Safety Information

The safety profile for Onon (Pranlukast Hydrate) is formally categorized by regulatory authorities, detailing adverse reactions based on their frequency and the body system affected. This regulatory framework defines the scope and severity of possible effects.


Frequency-Classified Adverse Reactions

Adverse events are generally categorized according to their reporting rate in clinical data:

  • Common Reactions (Typically 1% to <5%): These frequently documented events include gastrointestinal disturbances (such as nausea and abdominal discomfort) and effects on the nervous system (like headache and dizziness).
  • Less Common/Rare Reactions: These involve events that occur infrequently, such as specific blood disorders, and more pronounced skin reactions.

System-Organ Class and Serious Adverse Reactions

The official labeling groups effects by the body system affected, known as System-Organ Classes (SOC), highlighting specific safety concerns:

  • Hepatobiliary Disorders: The medicine is associated with elevations in liver enzymes (AST, ALT). Severe liver disorder, including jaundice, is documented as a serious adverse reaction.
  • Immune System/Hypersensitivity: The potential for Shock and Anaphylaxis is noted as a serious adverse reaction in regulatory documents.
  • Musculoskeletal and Connective Tissue Disorders: The risk of Rhabdomyolysis is listed as a serious, albeit rare, safety concern.

Regulatory Safety Considerations

The safety documentation includes specific limitations and population considerations. The drug is contraindicated in individuals with a known history of severe hypersensitivity to its components. Furthermore, caution is officially advised when using Pranlukast in patients with severe hepatic impairment due to the drug's metabolism and documented hepatobiliary risks. Regulatory data also suggest that the ratio of adverse reactions is highest in the elderly population, necessitating monitoring in this group.

Overdose and Emergency Response

Overdose Scope

Scope Element Official Regulatory Information
Documented overdose presentations: Clinical emergencies include Shock, Anaphylactoid reactions (such as breathing difficulty, cold sweat, or loss of consciousness), Convulsive seizures, and severe skin reactions like Stevens-Johnson syndrome.
Physiological systems affected: Systemic (Shock), Neurological (Seizures), Dermatological, and Hematologic (Aplastic Anaemia) systems are documented as being affected by severe clinical events.
Population-specific overdose notes: Children and adolescents require close monitoring for the onset of psychoneurotic symptoms or abnormal behavior, which necessitates prompt clinical evaluation.
When immediate medical help is required: Immediate medical help is required for the onset of any severe systemic symptoms, including severe respiratory distress, angioedema, or signs indicative of shock.

Overdose Classifications (High-Level)

Classification Element Official Regulatory Information
Severity classification: The regulatory documents define these events as clinically significant adverse reactions requiring immediate emergency intervention.
Overdose-context constraints: No specific antidote is documented for Pranlukast Hydrate in available regulatory information.

Resulting Overdose Structure

Official overdose statements:

  • The regulator mandates discontinuation of administration immediately upon observation of any severe clinical abnormality.
  • The official protocol for severe events emphasizes symptomatic and supportive measures, including the management of the airway, blood pressure, and fluid replacement.

Connection to the overall overdose profile (2–4 sentences): The regulatory documents define the emergency profile by listing severe systemic and allergic manifestations as the primary triggers for mandated help-seeking actions. This approach emphasizes the need for immediate, official supportive measures, as management is constrained by the confirmed absence of a specific pharmacological antidote. The required help-seeking conditions are directly tied to the observation of these life-threatening clinical signs.

Therapeutic Uses of Onon

Onon (pranlukast) is a therapeutic agent applied across domains where additional symptomatic support is needed for conditions characterized by periods of heightened symptoms in the respiratory system. The medication is used for managing specific conditions, including asthma (both chronic treatment and prophylaxis), supportive management of exercise-induced bronchoconstriction (EIB), and symptoms of allergic rhinitis (seasonal and perennial).

Quick Fact: May assist with symptoms related to physical discomfort

The medication is commonly used across conditions presenting with acute episodes. It is applied in addressing the symptoms related to systemic imbalance that accompany these manifestations, and may be part of symptomatic management alongside other established therapies. The patient benefit is that it provides support that helps ease the overall symptom burden in patients who experience symptoms that interfere with daily functioning. Additionally, the treatment generally supports comfort during symptomatic phases.

“This support helps maintain a sense of stability when symptoms are more noticeable and contributes to improved comfort during these symptomatic periods.”

Eligibility and Restrictions for Use

Eligibility and Non-Eligibility for Onon (Based on Official Regulatory Information)

Official government regulatory documents define who must not use the medicine, who can use it, and who requires special caution or dose adjustment. This information is critical for safe use.

Eligibility Status Population/Condition Regulatory Classification
Must Not Use Documented history of severe hypersensitivity to Clobazam or any component of the formulation. Contraindicated
Not Recommended Women who are pregnant or breastfeeding (lactating). Not Recommended
Requires Adjustment Geriatric patients (older adults), patients with renal impairment (kidney issues), or hepatic impairment (liver issues). Requires Dosage Adjustment
Requires Adjustment Patients identified as CYP2C19 poor metabolizers. Requires Dosage Adjustment
Use Established Pediatric patients 2 years of age and older who do not have a contraindication. Established

Use is prohibited for any patient with a severe hypersensitivity to the drug substance or its components. For all other specified populations—including the elderly and those with impaired liver or kidney function—the regulatory label requires a specific dose adjustment to manage risk and maintain appropriate drug exposure. Furthermore, the label explicitly designates use during pregnancy and lactation as not recommended due to the potential for harm to the fetus or infant, requiring careful consideration before use by females of reproductive potential.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Onon (Pranlukast Hydrate) is defined by its metabolic clearance, which primarily involves the cytochrome P450 enzymes CYP3A4 and CYP2C9. Regulatory documentation identifies pharmacokinetic interactions resulting from the co-administration of substances that interfere with these specific enzymes.

Co-administration with CYP3A4 inhibitors (such as certain antibiotics or antifungals) is officially documented to interfere with Pranlukast's clearance, which may lead to a measurable increase in its systemic plasma exposure. Conversely, co-administration with strong CYP inducers (including specific antiepileptic medicines) can accelerate the metabolism of Pranlukast, resulting in a decrease in its total plasma concentration.

The official labeling currently does not list any medicinal products as formally contraindicated due solely to interaction risk, nor are mandatory timing separation rules required. However, caution is advised for products known to modify these metabolic pathways. This includes certain non-medicinal substances, such as Grapefruit juice, which may increase exposure, and herbal inducers like St. John's Wort, which may reduce exposure. The consequences of these exposure-altering interactions are officially noted to be of greater clinical significance in patients with documented hepatic impairment.

Mechanism of Action

Pranlukast functions by targeting the Cysteinyl Leukotriene Type 1 ( CysLT1) receptor and interrupting the leukotriene signaling pathway. By acting as a competitive antagonist, the drug selectively prevents cysteinyl leukotrienes ( LTD4, LTC4, LTE4) from activating this receptor, leading to modulation of the physiological responses of the respiratory system.


Blocking Pathological Airway Constriction

This mechanistic domain covers the drug's direct action on the CysLT1 receptors located on airway smooth muscle cells. The blockade halts the intracellular signaling that would otherwise trigger muscle contraction. This action limits the pathological contraction of the bronchial smooth muscle, which modulates the diameter of the airways.


Modulating Mucosal Edema and Cellular Trafficking

This domain addresses the drug's effect on vascular and cellular components. By blocking CysLT1 receptors on the vascular endothelium, the drug limits leukotriene-mediated fluid leakage into the tissue, which modulates mucosal fluid accumulation in the airways and nasal passages. Furthermore, this blockade attenuates the chemotactic signals that attract and activate inflammatory cells like eosinophils, which limits the cellular component of chronic tissue inflammation.


Mechanistic Constraints

The drug's mechanism is selective for the leukotriene pathway, and its effect is anti-constrictive rather than a direct, immediate relaxation of established muscle spasms. Therefore, this mechanism does not offer reversal for acute airway constrictions that may be mediated by other inflammatory signals, such as histamine.

Dosage and Administration Information

How Onon (Pranlukast Hydrate) is Used

The usage of Onon is defined by a structured, long-term administration pattern, following the established pattern for its role as a maintenance treatment. The medication is administered by the oral route and is not intended for acute or emergency use.


Official Administration Guidelines

Usage Parameter Instruction
Administration Route Oral (swallowed by mouth).
Standard Adult Dose 450 mg total per day.
Dosing Frequency The total dose is divided and taken twice daily (BID).
Timing Relative to Meals Doses are to be administered after breakfast and after dinner (postprandial).
Duration Pattern Designated for long-term, continuous maintenance therapy.
Available Forms Capsules (112.5 mg, 225 mg) and Dry Syrup (10% formulation).

Population-Specific and Procedural Rules

Onon dosing is adapted for specific patient groups. Pediatric patients require weight-based dosing, typically 7 mg/kg/day divided twice daily, which utilizes the Dry Syrup formulation for appropriate administration. This weight-based dosage must not exceed the maximum adult daily dose of 450 mg.

If a scheduled dose is missed, the standard procedure is to not take two doses at one time to catch up, but instead to simply continue with the next scheduled dose. If the Dry Syrup formulation is used, it is properly prepared by mixing it with water just prior to administration, ensuring the correct suspension is taken orally. This protocol ensures consistent drug concentration necessary for long-term management.

Recent Clinical Evidence

Research evidence / Overview of Studies for Onon


Research on Onon (Pranlukast) for Chronic Bronchial Asthma includes short-term randomized controlled trials (RCTs), open-label studies, and post-marketing surveillance. These studies have been used in research exploring how symptoms change over time in both adults and pediatric populations. Researchers primarily monitored physiological outcomes related to breathing function, such as the forced expiratory volume in 1 second (FEV1), along with patient-reported outcomes describing discomfort and symptom frequency. Pranlukast was also examined as an add-on therapy for patients already using inhaled corticosteroids.

For Allergic Rhinitis, evidence relies on short-term controlled trials and specific allergen challenge chamber studies. The research explored symptom changes by quantifying measurements of nasal congestion, sneezing, and discharge. Similarly, for Exercise-Induced Bronchoconstriction (EIB), acute, highly controlled studies were conducted to monitor immediate airway function measurements following a physical stressor in susceptible children and adolescents.

Long-Term Research and Evidence Gaps

While long-term open-label monitoring has tracked patients for up to two years, long-term effects are not fully established by extensive, multi-year, double-blind RCTs—the scientific standard for continued certainty.

The existing research highlights several gaps: comparative evidence is lacking for large-scale, long-term trials directly comparing Pranlukast to all other therapeutic options for asthma and rhinitis. Furthermore, evidence remains limited regarding patients with the most severe forms of asthma and in certain special groups, such as pregnant women.

Frequently Asked Questions (FAQ)

Common questions about Onon (FAQ)


Q: How quickly do people usually start to notice effects from Onon?

Regulatory documents describe Onon as a long-term, continuous maintenance therapy, not a medicine for immediate, acute relief. Its mechanism is designed to prevent future symptoms, which means the therapeutic benefit is established over time as part of maintenance therapy.


Q: Does Onon interact with common pain relievers like ibuprofen?

The way Onon is processed by the body involves specific liver enzymes, primarily CYP3A4 and CYP2C9. Medicines that interfere with these enzymes, including certain common over-the-counter pain relievers, may cause changes in the amount of Onon in the body. Patients should ensure their healthcare provider is aware of all concurrent medicines.


Q: Can Onon be taken with herbal supplements?

Official product information contains warnings that caution should be exercised regarding non-medicinal substances, particularly certain herbal supplements. Some herbal products, such as St. John's Wort, are officially noted as potentially being able to reduce the amount of the drug in the patient's system.


Q: What does the term 'contraindication' mean in the context of Onon?

In official medical terms, a contraindication is a factor or condition that absolutely prohibits the use of a medicine because the risk of serious harm outweighs any potential benefit. For Onon, this prohibition applies to individuals with a documented history of severe hypersensitivity or allergic reaction to any of its components.


Q: What is the maximum duration of use described in official labeling for Onon?

Official regulatory documents classify the drug for prophylactic and long-term, continuous maintenance therapy for chronic conditions. The regulatory labeling does not designate a fixed maximum duration for use.


Q: Does the efficacy of Onon vary by age or race?

Regulatory information addresses use in different age groups by requiring weight-based dosing for children and dose adjustments for older adults. Official regulatory documents do not contain statements regarding variation in the drug's efficacy based on race.


Q: Why is Onon sometimes called a certain name by doctors?

The name Onon is a brand name for the active ingredient, which is Pranlukast Hydrate. Healthcare providers may refer to the medicine by its active ingredient, or by other trade names used in different regions, such as Azlaire.


Q: Can Onon be stopped suddenly, or is a taper usually described?

Regulatory documents do not prescribe a specific schedule for discontinuing the medication. Clinical experience suggests that discontinuing the medication may lead to the return of original symptoms, which is why the drug is intended for continuous long-term use.


Q: Is it common to feel tired when starting Onon?

Official product information lists both sleepiness (somnolence) and fatigue as possible adverse reactions that users may experience when taking the drug.


Q: Does Onon have a known interaction with alcohol?

Official regulatory warnings state that caution should be exercised regarding the use of alcohol, particularly for patients with underlying liver conditions. This is due to the way the drug is metabolized in the liver and the potential for alcohol to worsen central nervous system side effects like dizziness.


Q: Has Onon been approved in countries outside of the US?

The active ingredient, Pranlukast, is approved and used in multiple countries. Onon is the specific trade name used in Japan, and it is also marketed under other trade names in different regions internationally.


Q: Are there generic versions of Onon available?

Official regulatory product listings confirm the availability of generic formulations of the active ingredient, Pranlukast, in certain markets.


Q: Does Onon affect sleep patterns?

Official drug information lists sleepiness (somnolence) as a possible adverse reaction.


Q: Does Onon require special lab tests to monitor its effects?

Official warnings note the potential for a serious, albeit rare, adverse reaction involving the liver. Due to this risk, the monitoring of certain laboratory values, such as liver function tests, is often advised for patients on long-term treatment.


Q: Is there a list of common allergic reactions to Onon?

Official adverse reaction reports list rash, itching, and hives as common allergic reactions. Severe, systemic allergic reactions, such as anaphylaxis, are also noted as rare but serious possibilities in the official documents.


Q: Is Onon known to affect mental clarity or focus?

Side effects listed in the official documentation include dizziness, headache, and sleepiness. These reactions can potentially affect a patient's mental alertness and overall ability to focus.


Q: Is it normal to feel a change in appetite after starting Onon?

While not listed as a common side effect, official safety information notes that loss of appetite is an initial symptom of a serious, albeit rare, adverse reaction such as liver disorder.


Q: Is the 'half-life' of Onon considered short or long?

The drug’s elimination half-life—the time it takes for half of the drug to be cleared from the system—is reported in pharmacokinetics data as approximately 1.5 hours, which is generally classified as short.


Q: What are the official guidelines regarding driving or operating machinery while taking Onon?

Official regulatory documentation states that caution is necessary regarding activities that require full mental alertness, such as driving a vehicle or operating complex machinery. This warning is due to the documented potential for side effects like sleepiness and dizziness.


Q: Can taking Onon affect the results of other medical tests?

The drug is associated with changes in certain laboratory values, which would be reflected in medical test results. Official safety information specifically notes the possibility of elevated liver enzymes and thrombocytopenia (a reduction in blood platelets).


Q: Is it possible to develop a tolerance to Onon over time?

Clinical studies, including those monitoring patients for up to five years, have specifically looked for signs of tolerance (also called tachyphylaxis). These studies reported that a rapidly diminishing response to the drug was not recognized during the monitoring period.

How should Onon be stored and disposed of?

The official storage and disposal instructions for Onon (Pranlukast Hydrate) are defined by regulatory documents to ensure product stability and safety. The medication must be stored below 30 C and actively kept away from direct sunlight, heat, and moisture.

Requirement Official Statement
Temperature Store below 30 C
Protection Keep away from direct sunlight, heat, and moisture
Child Safety Store out of the reach of children
Disposal Discard the remainder; Do not store them

Disposal of unused or expired product must follow official guidelines. Patients are instructed to consult their pharmacy or medical institution for proper handling and to ensure disposal is in accordance with local regulations.

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

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