Histal

Quick links to important sections

Medically reviewed

Laura Arias

Last updated on 22/12/2025

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

Overview of Histal

Understanding Histal

Histal is a pharmacological agent primarily classified as an antihistamine. It is utilized to manage symptoms associated with various allergic reactions and certain respiratory conditions. The active component in Histal works by interacting with specific receptors in the body to mitigate the physiological effects of histamine, a substance released by the immune system during an allergic response.

Mechanism of Action

When the body encounters an allergen—such as pollen, dust, or pet dander—it releases histamine. This chemical binds to H1 receptors, leading to common allergy symptoms including sneezing, itching, and watery eyes. Histal acts as an antagonist at these receptor sites. By blocking the binding of histamine, the medication helps to prevent or reduce the inflammatory response and the physical discomfort associated with hypersensitivity.

Primary Uses

Histal is commonly employed in the management of several conditions characterized by histamine release:

  • Allergic Rhinitis: Relief of seasonal and perennial allergy symptoms, such as nasal congestion and rhinorrhea.
  • Urticaria: Management of skin reactions characterized by hives, redness, and itching.
  • Allergic Conjunctivitis: Reduction of eye irritation and redness caused by environmental triggers.

Properties and Characteristics

Histal is designed to provide systemic relief from allergic symptoms. Depending on the specific formulation, it may be categorized as either a first-generation or second-generation antihistamine, which determines its ability to cross the blood-brain barrier and its potential for causing drowsiness. Its primary function remains the stabilization of the body's response to environmental allergens.

Regulatory References

  1. WHO Essential Medicines

What side effects are possible with Histal?

Possible Side Effects and Safety Information

The officially documented adverse reactions for Histal (Cetirizine Hydrochloride) are structured by frequency of occurrence and the physiological system affected, providing a neutral description of potential safety characteristics.

Frequency and System-Organ Classes

The most common adverse reactions reported in clinical trials (incidence ge 2%) for adolescents and adults include somnolence, fatigue, dry mouth, pharyngitis (sore throat), and dizziness. These effects are classified across Nervous System Disorders, General Disorders, and Gastrointestinal Disorders within regulatory documents.

Specific reactions reported as common in children aged 6 to 11 years include headache, abdominal pain, coughing, diarrhea, and further occurrences of somnolence and pharyngitis.

Population-Specific Safety Notes

The regulatory profile highlights altered clearance in specific patient populations. A reduction in clearance and a prolonged elimination half-life are noted in both geriatric patients and individuals with renal or hepatic impairment. Furthermore, the medicine is known to be excreted into human breast milk.

Safety Restrictions and Time-Related Patterns

The medicine is formally contraindicated in individuals with known hypersensitivity to the drug, any of its components, or to hydroxyzine, a related compound. Official labeling also advises caution when the medicine is used concurrently with alcohol or other Central Nervous System (CNS) depressants due to the potential for further reduced alertness.

Post-marketing reports document the rare, but severe, risk of new-onset or exacerbated pruritus (severe itching) that may occur specifically upon discontinuation of the medicine after a period of prolonged use.

Overdose and Emergency Response

Overdose Scope

Documented overdose presentations: Overdose of Histal may present with prominent central nervous system (CNS) effects, including excessive somnolence and sedation, fatigue, and confusion. Other documented manifestations include tachycardia (fast heart rate), headache, tremor, diarrhea, and urinary retention. Severe outcomes documented in regulatory settings include convulsions and significant CNS depression.

Physiological systems affected (as stated in label): CNS, Cardiovascular System, Gastrointestinal System, and Urogenital System.

Dose-related or exposure-related factors (if applicable): Overdose is typically associated with ingestion of doses exceeding the maximum recommended therapeutic amount.

Population-specific overdose notes (if applicable): Children may exhibit initial agitation and restlessness (paradoxical excitation) before experiencing drowsiness. Increased severity may be noted in children and the elderly.

Emergency-response statements (as written in official documents): Symptomatic and supportive treatment is recommended. Interventions such as gastric lavage or the administration of activated charcoal may be considered by medical professionals shortly after ingestion.

When immediate medical help is required (label-derived phrasing only): Seek immediate medical attention or contact a Poison Control Center right away if an overdose is suspected. Urgent medical services should be called if the individual has severe symptoms or loss of consciousness.


Overdose Classifications (High-Level)

Severity classification (as defined in official documents): Effects range from mild symptoms to severe outcomes requiring hospitalization, such as seizures or severe CNS depression.

Regulatory basis (EMA / FDA / etc.): Information is based on government-authorized prescribing information.

Overdose-context constraints (as defined in official documents): There is no known specific antidote to Histal, and the substance is not effectively removed by dialysis.


Resulting Overdose Structure

Official overdose statements:

  • Somnolence, sedation, and tachycardia are among the most frequently documented clinical signs following overdose.
  • Management is symptomatic and supportive because no specific antidote is known.
  • Regulatory documents mandate to seek immediate medical attention or contact a Poison Control Center in the event of suspected overdose.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the Histal overdose profile by concentrating on excessive CNS depression and specific systemic signs such as tachycardia. This profile triggers the mandate to seek urgent medical help for clinical observation and the application of symptomatic and supportive treatment. Official guidance emphasizes that effective management is supportive in nature, explicitly stating the absence of a known specific antidote.

Therapeutic Uses of Histal

Histal (Cetirizine Hydrochloride) is applied as a symptomatic treatment across therapeutic domains involving distressing symptoms, providing supportive relief when symptoms interfere with daily functioning. The medicine is commonly used across conditions presenting with acute episodes and recurrent manifestations.

It is considered relevant for situations involving seasonal hay fever, persistent perennial rhinitis, and chronic urticaria (hives). This treatment generally helps address symptom clusters that create noticeable physiological strain, such as a runny nose (rhinorrhea), sneezing, itchy, watery eyes, and intense pruritus (itching) accompanied by wheals.

“Histal is relevant when supportive symptom management is appropriate, assisting with the overall symptom burden during episodes of heightened discomfort.”

Symptomatic Relief and Benefits

The benefit contributes to easing the overall symptom load, applicable within settings that involve acute or disruptive symptom patterns related to both rhino-ocular and dermatological manifestations. By addressing symptoms that interfere with daily functioning, the treatment may assist with maintaining functional stability and supports individuals during difficult episodes.

Quick Fact: Relief for Key Symptoms
Allergic Rhinitis: Eases sneezing and runny nose.
Ocular Symptoms: Supports comfort from itchy and watery eyes.
Urticaria: Assists with managing itching and wheal formation.

Regulatory References

  1. NIH Clinical Overview

Eligibility and Restrictions for Use

Histal (Cetirizine Hydrochloride) eligibility is officially governed by regulatory classification based on hypersensitivity, age, and physiological function.

Prohibited Populations (Contraindications)

The medicine is strictly contraindicated for patients with a documented hypersensitivity to the active substance, Cetirizine Hydrochloride, or related piperazine derivatives, including Hydroxyzine. Absolute prohibition also applies to individuals with severe renal impairment defined as a creatinine clearance less than 10 mL/min.

Age and Organ Function Restrictions

Histal is approved for use in adults and adolescents and extends to children starting from 6 months of age when using an appropriate liquid formulation. Film-coated tablets are not recommended for those under six years due to the inability to achieve accurate dose adaptation. Conditional use is required for patients with moderate renal impairment or hepatic impairment, as these organ function limitations necessitate official restrictions. Caution is also advised for older adults and patients with a predisposition to urinary retention or convulsions.

Pregnancy and Lactation

Regarding pregnancy, use requires caution and is recommended only if clearly needed, given the lack of adequate and well-controlled studies. As the medicine is known to be excreted into breast milk, its use is generally not recommended while lactating.

What should I know about interactions with other medicines?

Histal Interactions with other Medicines and Products

Official regulatory documentation details the pharmacokinetic and pharmacodynamic interaction profile of Histal (Cetirizine Hydrochloride).


Pharmacodynamic Interactions

Histal, as a second-generation antihistamine, may exhibit an additive pharmacodynamic effect when co-administered with substances that depress the central nervous system (CNS).

  • Alcohol and Other CNS Depressants: Concurrent use with alcohol or other CNS depressants, such as sedatives or tranquilizers, may cause additional reductions in alertness and impairment of performance. This combination requires caution due to the potential for compounded effects.

Pharmacokinetic and Absorption Interactions

Specific studies document that certain medicines can alter the systemic exposure of Histal, while food affects its rate of absorption.

  • Theophylline: Co-administration of 400 mg of Theophylline once daily has been shown to result in a 16% decrease in the clearance of Cetirizine, a pharmacokinetic alteration that increases systemic exposure.
  • Food: While food does not alter the total amount absorbed (AUC), a high-fat meal can delay the time to maximum plasma concentration (T max).
  • No Clinically Significant Interaction: Regulatory documents state that no clinically significant pharmacokinetic interactions were observed in studies involving co-administration with Pseudoephedrine, Erythromycin, Ketoconazole, or Azithromycin.

Population-Specific Considerations

The elimination of Histal may be impaired in patient populations with renal or hepatic dysfunction. This reduction in clearance increases the potential for elevated systemic exposure, which can heighten the effects of documented interactions.

Mechanism of Action

How Histal Works

Histal's mechanism of action is defined by a precise interaction with specific G-protein-coupled receptor systems (GPCRs). The compound functions as a selective antagonist, meaning it binds to these receptor sites on the cell surface and effectively blocks the attachment and subsequent activation by the body's natural signaling molecules, or ligands. This initial molecular binding event modulates the activity of the targeted receptor, influencing the first step of the cellular signaling cascade.

By inhibiting this primary signal, Histal influences subsequent intracellular cascades. This interference modifies the complex sequence of events that normally leads to the massive release or activation of specific downstream chemical mediators. This mechanism influences core signaling dynamics within affected pathways, resulting in an adjustment of physiological processes driven by these mediators. The overall action alters the activity pattern within the targeted systems, leading to specific adjustments to pathway output at the system level.

Dosage and Administration Information

How Histal is Used: Official Administration Guidelines

Histal (Cetirizine Hydrochloride) is officially approved for administration via the oral route (tablets, capsules, and solution) and through a specialized intravenous (IV) route in specific clinical settings, such as for the management of acute urticaria.

This medicine follows a once-daily schedule, establishing a 24-hour interval between doses for continued symptomatic relief.

Standard Dosing and Frequency

Population Standard Dosing Regimen
Adults (ge 12 years) 10 mg once daily; a starting dose of 5 mg may be used.
Maximum Dose 10 mg per 24 hours

Administration Conditions

Oral forms may be taken with or without food as the timing of intake relative to meals does not significantly affect the total amount of drug absorbed. Tablets should be swallowed with a glass of liquid. The IV formulation is administered as an intravenous push over a period of one to two minutes, constraining its use to controlled clinical settings. If a regular dose is missed, the established protocol is to resume the next dose at the usual scheduled time without taking a double amount.

Population Adjustments

The official protocol requires physician consultation regarding dose adjustment for older adults (ge 65 years) and mandates a reduced dosage for patients with renal or hepatic impairment. These modifications are necessary to account for reduced drug clearance in these populations, ensuring adherence to the labeled usage protocol.

Recent Clinical Evidence

Research evidence / Overview of Studies for Histal

Evidence for Symptom Management in Allergic Rhinitis (Hay Fever)

Research exploring Histal has largely used Randomized Controlled Trials (RCTs) and Systematic Reviews to examine symptom measurements associated with Allergic Rhinitis, which includes both Seasonal Allergic Rhinitis (SAR), often known as hay fever, and Perennial Allergic Rhinitis (PAR), which occurs year-round. These studies were conducted during periods of increased symptom activity in the observed populations. Research examined outcomes related to physical discomfort, such as monitoring changes in the severity of sneezing, a runny nose, and itchy or watery eyes.

The findings describe patterns observed in the studies related to the measurement of these nasal and ocular outcomes. Studies report how symptoms evolved in the observed populations over defined, short-term time intervals, typically lasting a few weeks.

Evidence for Symptom Management in Chronic Urticaria (Hives)

Histal was studied for Chronic Urticaria (hives), a condition characterized by fluctuating or episodic manifestations, including intense itching (pruritus) and the appearance of wheals (raised patches of skin). Research on this use includes controlled trials that monitored physiological strain and outcomes reflecting daily functioning. The primary outcomes measured were scores that capture the intensity and variability of itching and the physical presence of hives.

Studies also explored the use of Histal in patients with chronic urticaria whose symptoms remained unstable or insufficiently managed by initial standard treatments. The findings for these research scenarios, which often involved researching higher-than-standard doses, were typically derived from smaller study cohorts with follow-up durations that were limited to a few weeks.

Long-Term Outcomes and Follow-up Duration in Research

The majority of high-quality, controlled research has focused on the study of short-term symptom changes, with follow-up durations typically being limited to between two and six weeks. This type of research is relevant in trials assessing short-term or episodic symptom patterns.

Long-term outcomes, such as the persistence of measured changes over many months or years, are not fully established by the existing body of high-quality, controlled evidence. Studies observing responses over extended time intervals are generally less common, meaning there is limited information for long-term outcomes regarding continuous use in most adults.

Key Studies & References

  1. Cetirizine for the treatment of allergic diseases in children: A systematic review and meta-analysis
  2. Chronic urticaria: off-label doses of cetirizine (NICE Evidence Summary)
  3. Cetirizine - Electronic Essential Medicines List (eEML) (WHO)

Frequently Asked Questions (FAQ)

Common questions about Histal (FAQ)


Q: How quickly does Histal typically start to work?

Official product information, including the FDA label, indicates that the effects of Histal typically begin relatively quickly. The drug's antihistamine activity is reported to start working within 20 to 60 minutes after taking a single oral dose.


Q: How long do the effects of a single dose of Histal last?

The effects of a single dose of Histal are found to be long-lasting. Studies documented in regulatory sources indicate that the drug’s effects can persist for at least 24 hours.


Q: Is Histal generally considered a long-term or short-term treatment?

Histal is approved for conditions like chronic idiopathic urticaria (hives) and perennial allergic rhinitis, based on the official indications. However, official safety communications have noted a risk of developing severe itching (pruritus) upon discontinuing the medicine after long-term, daily use.


Q: Are there any severe or serious side effects associated with Histal that are officially reported?

Regulatory reports primarily focus on common reactions like somnolence (sleepiness) and fatigue. While severe reactions are rare, post-marketing reports have included the possibility of new or worsened severe itching upon stopping long-term use. Signs of a severe allergic reaction (hypersensitivity) are noted in regulatory documents as needing urgent medical evaluation.


Q: Is Histal a branded name, and what is its generic equivalent?

Histal is a potential brand name for the medicine. Its official chemical name and generic equivalent, as recognized by the FDA and the World Health Organization, is Cetirizine Hydrochloride.


Q: What if I forget to take a dose of Histal?

Official regulatory guidance regarding a missed dose advises resuming your regular schedule. Official guidance advises that taking the next dose at the usual scheduled time is the protocol, and taking a double amount to make up for the missed one is generally not recommended.


Q: Can Histal be crushed or split if it is a tablet?

Official administration guidelines for the tablet form only specify swallowing the tablet whole with a liquid. The availability of an oral solution for patients who have difficulty swallowing is noted as an alternative for administration flexibility.


Q: Is Histal used to treat conditions other than what is on the label?

Regulatory documents, such as the FDA’s Indications and Usage section, list the official, approved uses for Histal, such as allergic rhinitis and chronic urticaria. Official labeling does not provide information about uses that have not been approved by the regulatory agency.


Q: Why is Histal prescribed for [Named Condition A]?

According to official documentation, Histal is prescribed because it is approved for the relief of symptoms associated with common allergic conditions. This includes seasonal and perennial allergic rhinitis (hay fever) and chronic idiopathic urticaria (hives).


Q: Is it true that Histal can interact with common pain relievers?

Official drug interaction studies report that no clinically significant interactions were observed with certain non-opioid pain relievers, such as pseudoephedrine. However, Histal may have additive sedative effects when taken concurrently with opioid pain relievers or other medicines that depress the central nervous system (CNS).


Q: Can I take Histal if I am also taking [Named Common Drug B, e.g., a blood pressure medicine]?

The official drug interaction section provides specific study results for several drug types but does not list information for every single medicine, such as all common blood pressure medications. For information on using Histal with any concurrent medicine, the official label recommends seeking information from an authoritative source.


Q: Is Histal appropriate for use by elderly patients?

Histal is approved for use in older adults (age 65 years and older). However, the official protocol mandates a reduced dosage for this population. This is necessary because older adults may have reduced drug clearance, which can lead to higher systemic exposure.


Q: Are there different restrictions for children versus adults using Histal?

Yes, official restrictions and protocols vary by age. Histal is approved for children starting from six months of age, but different formulations are used; for example, tablets are generally not recommended for those under six years. Dosage requirements also vary by age and formulation.


Q: Is Histal available over the counter, or is it prescription-only?

Official regulatory status indicates that Histal (cetirizine) is available in both prescription and over-the-counter (OTC) forms. The specific dosage or formulation may determine whether a prescription is required.


Q: What are the different strengths or forms (e.g., tablet, liquid) that Histal is available in?

According to the FDA and DailyMed, Histal is commonly available in two primary forms for oral use. These include film-coated tablets in strengths like 5 mg and 10 mg, and an oral solution or syrup, typically formulated at 5 mg/5 mL.


Q: Is Histal different from [Named Similar Drug C]?

Histal is categorized as a second-generation H₁-receptor antagonist. This pharmacological classification means it selectively blocks the H₁ receptors involved in allergic responses. This selective action and its non-sedating profile at recommended doses define its specific type compared to other medicines.


Q: What makes Histal a different class or type of drug compared to [Named Similar Drug D]?

Official regulatory classification defines Histal as a second-generation H₁-receptor antagonist. The medicine’s specific molecular structure and target mechanism of action establish its unique pharmacological class, distinguishing it from drugs in other classes like pain relievers or antibiotics.


Q: Do studies suggest that Histal is commonly effective for its intended purpose?

Histal is an FDA-approved medicine, and research cited in regulatory summaries supports its use for relieving symptoms associated with allergic rhinitis (hay fever) and chronic urticaria (hives).


Q: What kind of research has been done on Histal?

The clinical research cited in regulatory documents primarily consists of Randomized Controlled Trials (RCTs) and systematic reviews. This research is focused on short-term symptom relief, with studies monitoring changes in outcomes for allergic rhinitis and chronic urticaria over defined time intervals, usually a few weeks.


Q: Are there ongoing clinical trials for new uses of Histal?

Yes, government-maintained databases like ClinicalTrials.gov show that new research is continuously being conducted on Histal. For example, some current research is examining the use of higher doses of cetirizine for treating specific conditions like acute urticaria (hives).


Q: What is the risk of dependence or addiction associated with Histal?

Histal (cetirizine) is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA) or other major regulatory bodies. Official labeling does not list it in categories associated with potential abuse or dependence.


Q: What are the common reasons a doctor might choose Histal over another medicine?

Regulatory documents indicate Histal is a second-generation H₁-receptor antagonist. Its specific characteristics—including its selective, non-sedating profile at recommended doses and its approval for chronic conditions—are the foundational, factual elements that inform prescribing decisions.


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

A contraindication is an official safety measure listed in regulatory documents. In the context of Histal, it is an official statement that the medicine should not be administered to patients with specific conditions, such as a known allergy to the drug or severe kidney failure, because the potential for harm outweighs any benefit.


Q: Are there any known issues with taking Histal long-term?

For long-term daily use, the FDA has required a safety warning about the potential risk of developing severe itching (pruritus) that may occur specifically upon discontinuation of the medicine. The official label does not specify a maximum duration for all approved uses.


Q: Can Histal interfere with certain lab tests?

Yes, regulatory and government health body guidelines indicate that Histal (cetirizine) can interfere with the results of allergy skin tests. Therefore, the medicine may need to be withheld for a specified period prior to testing to avoid an inaccurate result.


Q: Why is monitoring of [Specific Organ Function, e.g., Liver/Kidney] sometimes mentioned with Histal?

Official labeling mentions monitoring kidney (renal) and liver (hepatic) function because Histal’s clearance from the body is significantly reduced in patients with impairment in these organs. This reduction means the drug can stay in the body longer, potentially increasing its systemic effects.


Q: Is there a maximum recommended duration for using Histal?

The official FDA label does not specify a uniform maximum duration for all approved uses. Histal is approved for chronic conditions, such as perennial allergic rhinitis, which indicates the duration of use is variable and depends on the condition being treated and the healthcare provider's instruction.


Q: What is the half-life of Histal?

The half-life refers to the time it takes for half of the drug to be cleared from the bloodstream. According to the official pharmacokinetics data (the study of how the body handles the drug), the mean plasma elimination half-life of Histal (cetirizine) in healthy adults is approximately 8.3 hours.

How should Histal be stored and disposed of?

Official Storage and Disposal Requirements

Based on regulatory labeling, the medicine does not require special conditions for storage and is considered stable at ambient temperatures.

Storage Category Requirement from Regulatory Documents
Temperature No special storage conditions required.
Shelf Life The stability period for the unopened product is three years.
Handling No special handling requirements are documented.
Disposal No special requirements for disposal are listed in the official documents.

The official storage profile specifies that the product is stable at room temperature and has a clearly defined shelf life. Because no special disposal instructions are noted, the medicine is not categorized as a controlled or hazardous waste requiring specific environmental handling as defined in the product's regulatory filing. Consumers should always keep the product secured and out of the reach of children.

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

Available in countries:

Equivalent of Histal found in:

A-Z Index: