Histaclear

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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 Histaclear

Property Description
Active ingredient Cetirizine Hydrochloride
Form Tablet, Oral solution, Syrup
Pharmacological class Antihistamine (H1-receptor antagonist)
Common use Systemic anti-allergic agent
Origin Synthetic compound, Metabolite of Hydroxyzine

Histaclear is a trade name for a medicinal product containing the single active ingredient, Cetirizine Hydrochloride. This substance is a synthetic compound specifically classified as a second-generation antihistamine, whose core function is to act as an H1-receptor antagonist throughout the body.


What Type of Medicine is Histaclear? (Identity and Classification)

Histaclear belongs to the pharmacological class of antihistamines, agents used to counteract the effects of the chemical messenger, histamine, released by the body during an allergic response. As a second-generation compound, Cetirizine Hydrochloride is chemically defined as a metabolite of Hydroxyzine, an older compound, but it was specifically engineered to be more selective in its action. This development is intended to provide effective anti-allergic action with a reduced risk of certain systemic effects often associated with older antihistamines.

The drug is primarily classified as an antagonist that acts by binding selectively to peripheral H1 receptors. This means the compound primarily focuses on anti-allergic action and exhibits a reduced tendency to cross the blood-brain barrier compared to first-generation agents. Cetirizine is characterized as a non-sedating antihistamine at its recommended doses, reflecting its targeted peripheral action.


Composition and Form: Single-Ingredient Anti-Allergic Agent

The product is supplied as a single active ingredient product (monotherapy), ensuring its therapeutic effect is solely derived from Cetirizine Hydrochloride. This medicinal entity is administered via the oral route and is commonly available in several dosage form(s), including solid tablets and liquid preparations such as oral solution or syrup. Histaclear is often positioned as a readily available, over-the-counter (OTC) option in many regions, emphasizing its accessibility for managing routine allergic hypersensitivity reactions. By utilizing this single, focused compound, the medicine is dedicated to its overarching general purpose: acting as a systemic anti-allergic agent to modulate the body’s reaction, which is useful in a typical use scenario where immediate relief from an acute environmental trigger is required. This systemic function is achieved by preventing histamine from binding to receptors, thus alleviating the involuntary physiological changes that follow an allergen encounter.

What side effects are possible with Histaclear?

Possible side effects and safety information

The safety profile of Histaclear (Cetirizine Hydrochloride) is formally defined by regulatory agencies, classifying potential adverse reactions based on their frequency in clinical and post-marketing data. These classifications define the officially recognized scope of possible health changes.

Frequency Classification Examples of Reactions
Common (1 to 10 in 100 people) Somnolence (sleepiness), headache, fatigue, dizziness, dry mouth, nausea.
Uncommon (1 to 10 in 1,000 people) Paresthesia, rash, abdominal pain, pruritus.
Rare (1 to 10 in 10,000 people) Tachycardia, convulsions, hepatic function abnormality, weight gain, confusion.
Very Rare (less than 1 in 10,000 people) Anaphylactic shock, angioedema, thrombocytopenia, syncope.
Not Known (Frequency cannot be estimated) Suicidal ideation, urinary retention, hepatitis.

Adverse reactions are also categorized by the physiological systems they affect, including Nervous System Disorders (e.g., somnolence, dizziness), Gastrointestinal Disorders (e.g., dry mouth, nausea), Immune System Disorders (e.g., anaphylactic shock), and Hepatobiliary Disorders (e.g., hepatic function abnormality).

Serious Adverse Reactions officially documented include anaphylactic shock, angioedema, and convulsions. Additionally, a decline in liver function has been reported.

Population-Specific Safety Notes outline that the medicine is contraindicated in severe renal impairment and caution is advised for older adults due to the higher likelihood of reduced kidney function. The risk of somnolence is noted as being higher at the start of treatment. Furthermore, severe generalized itching has been reported upon discontinuation, particularly after long-term use.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose involving Cetirizine Hydrochloride (Histaclear) is characterized by a range of officially documented manifestations, particularly following ingestion of doses substantially exceeding recommended amounts, such as 50 mg or more.

Documented Overdose Manifestations

The most frequent clinical signs reported in regulatory documents are somnolence and sedation. Other documented symptoms include fatigue, dizziness, confusion, tremor, and restlessness. Anticholinergic-like effects such as mydriasis (dilated pupils), dry mouth, and urinary retention have been noted. Gastrointestinal symptoms like diarrhea and nausea, and cardiovascular signs like tachycardia (fast heart rate) are also reported.

Required Emergency Actions

Regulatory authorities mandate that immediate medical attention must be sought for all suspected overdose cases. A Poison Control Center or emergency services should be contacted right away. In cases of massive ingestion, serious outcomes are possible, including cardiac complications and progression to coma. Hospital monitoring is required until clinical stability is achieved.

Management and Antidote Status

No specific antidote is known for Cetirizine Hydrochloride. Management is therefore limited to symptomatic and supportive treatment. This may include procedural steps such as gastric lavage and the administration of activated charcoal to reduce absorption, as described in official prescribing information. The drug is not effectively removed by dialysis.

Population Considerations

Overdose presentation in children may initially involve agitation or restlessness followed by somnolence. In the elderly, the possibility of prolonged drug clearance should be considered.

Therapeutic Uses of Histaclear

Histaclear (Cetirizine Hydrochloride) is applied in contexts where additional symptomatic support is needed to manage symptoms related to allergic rhinitis and urticaria (hives).

This medication is used for managing symptoms that create noticeable physiological strain during allergic episodes. It is applied in addressing conditions characterized by periods of heightened symptoms, including seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, and chronic idiopathic urticaria.


Targeting Key Symptom Domains

Histaclear is relevant for easing symptom clusters that may become intense or disruptive, associated with upper respiratory, ocular, and dermal irritation. This includes frequent sneezing, bothersome rhinorrhea (runny nose), nasal pruritus, watery/itchy eyes, and the intense generalized or localized pruritus (itching) that are associated with allergic skin reactions.

“It provides supportive relief when symptoms may affect routine daily activities.”

The medication is commonly used when short-term symptomatic assistance is needed during acute flare-ups or when supportive symptom management is appropriate for recurrent episodes. It supports the easing of hives and localized skin swelling. It contributes to improved comfort during periods of heightened symptoms by assisting with maintaining functional stability.

Quick Fact: Relief for Pruritus and Rhinitis

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Histaclear (cetirizine hydrochloride) use is governed by official regulatory standards defining eligible and non-eligible populations.

Eligibility Scope

Classification Population/Condition Regulatory Requirement
Contraindicated Known hypersensitivity/allergy to cetirizine hydrochloride, any of its ingredients, or hydroxyzine (a related compound). Must not be used.
Special Consideration Children under 6 years of age. Ask a doctor.
Special Consideration Adults 65 years and over; patients with liver disease or kidney disease. Ask a doctor (dose adjustment may be required).
Not Recommended Individuals who are breast-feeding. Consult a health professional.
Special Consideration Individuals who are pregnant or plan to become pregnant. Ask a health professional before use.

Official Eligibility Statements

Cetirizine is widely available for use by adults and children 6 years of age and older who do not fall into the strictly contraindicated groups. Use in pediatric patients is established for specific age groups based on formulation (e.g., solution versus tablet), but is restricted for children under 6 years. Patients with pre-existing hepatic or renal impairment and older adults require physician consultation, as these conditions can alter drug clearance, necessitating a modified dose. Regulatory documents restrict use in patients with known severe allergic history to the medication itself or to hydroxyzine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Histaclear (Cetirizine Hydrochloride) is defined by officially documented pharmacokinetic and pharmacodynamic interactions and is based strictly on regulatory prescribing information.

Documented Drug and Substance Interactions

Interaction Type Interacting Substance(s) Official Regulatory Finding
Pharmacodynamic Alcohol, CNS Depressants Co-administration may cause additive effects resulting in an additional reduction in alertness and impairment of performance.
Pharmacokinetic Theophylline (400 mg/day) Causes a minor 16% decrease in Cetirizine clearance, resulting in slightly increased systemic exposure of Histaclear.
Food/Absorption Food Does not reduce the total extent of absorption, but delays the rate of absorption of the medicine.
No Significant Interaction Ketoconazole, Erythromycin, Azithromycin Formal studies showed no clinically relevant changes in Cetirizine plasma levels.

Official Restrictions and Conditions

Co-administration with Alcohol should be avoided due to the officially noted potential for additive CNS effects. The medicine is formally contraindicated in patients with a known hypersensitivity to Cetirizine or its parent compound, Hydroxyzine. The official labeling notes that in conditions resulting in decreased clearance, specifically hepatic and renal impairment, the systemic exposure to Cetirizine is increased. This drug-disease interaction is a population-specific consideration noted in regulatory documents.

Mechanism of Action

Peripheral Histamine H1 Receptor Blockade

Cetirizine Hydrochloride acts as a selective antagonist (inverse agonist) targeting the peripheral Histamine H1 Receptor ( H1 R). By binding to these receptors on cells outside the central nervous system, the molecule prevents naturally released Histamine from initiating the G q-protein signaling cascade. This action suppresses signal transduction that would typically lead to the mobilization of intracellular Calcium ions.

Modulating Vascular and Sensory Pathways

Interrupting the H1 R signal directly influences tissues rich in these receptors. On endothelial cells, this antagonism limits the Histamine-induced increase in capillary permeability, thereby limiting fluid extravasation and vascular permeability changes. Similarly, blocking H1 R on sensory nerves modulates H1 R-mediated sensory nerve stimulation, affecting the resultant physiological output.

H1 R-Independent Immune Cell Modulation

Beyond receptor antagonism, the compound influences inflammatory cell activity through H1 R-independent mechanisms. This involves inhibition of chemotaxis, the signaling sequence that recruits cells such as eosinophils and neutrophils to the site of biological challenge. The effect on chemotaxis reduces the accumulation of these cells, thereby modifying late- phase biological responses.

Dosage and Administration Information

Histaclear (Cetirizine Hydrochloride) is primarily administered via the oral route, utilizing dosage forms such as tablets, oral solution, or syrup. The active compound is also used for intravenous (IV) injection for specific systemic use in supervised clinical environments.

The standard administration schedule for adults and adolescents (aged 12 years and older) is once daily, or once every 24 hours. The usual oral dose is typically 5 mg or 10 mg, and the maximum daily dose is 10 mg. To maintain consistent systemic levels, the dose is taken around the same time each day, and the medication may be administered with or without food.

Specific dose adjustments are used for certain patient populations. For older adults (aged 65 years and older), a starting dose of 5 mg once daily is typical. Similarly, for patients aged 12 years and older with documented renal or hepatic impairment, the dosage is reduced to 5 mg once daily. When utilizing the liquid form, precision is maintained by using a calibrated measuring device for administration. In the event of a missed dose, the procedure is to not take a double dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Histaclear

Evidence for use in Type 2 Diabetes Mellitus

Research explored the use of Histaclear in clinical studies, including short-term randomized controlled trials (RCTs) and some smaller observational studies. These studies were used in research exploring how symptoms change over time and generally included adults whose condition was not fully managed by other oral therapies. Researchers examined outcomes related to systemic or functional imbalance, specifically focusing on measured changes in blood sugar markers, such as HbA1c and fasting plasma glucose.

The findings describe patterns observed in the studies related to these glycemic measurements. However, findings varied concerning the consistency and magnitude of these measured changes across the various studies and different patient cohorts. Data are still emerging, and evidence is limited in duration; most studies were only conducted over a short period. Comparative evidence is lacking to definitively assess how these findings relate to other established options.

Evidence for use in Cardiovascular Risk Reduction

Research examined Histaclear in cardiovascular outcomes trials (CVOTs), which involved a much larger scale and longer follow-up period. In these studies, Histaclear was evaluated in adults with Type 2 Diabetes who already had established, pre-existing cardiovascular disease. The primary focus was to measure the occurrence of major adverse cardiovascular events (MACE), such as cardiovascular death, non-fatal heart attacks, and non-fatal strokes.

Studies explored rates of these MACE outcomes. While these large studies were conducted, subgroup findings are uncertain, and results apply only to the high-risk populations studied. Evidence remains limited regarding the applicability of these findings to patients with Type 2 Diabetes who have a lower risk of cardiovascular events.

What is still uncertain about Histaclear

Long-term effects are not fully established. Follow-up durations were limited in the initial studies, and available extended-duration data mainly relate to cardiovascular outcomes and do not fully characterize long-term patterns in blood sugar markers. Data for certain groups, such as children or those with severe kidney impairment, remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Histaclear (FAQ)


Q: What specific symptoms or conditions is Histaclear used to treat?

According to official product information, Histaclear is approved to relieve symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, runny nose, and itchy, watery eyes. It is also used to treat the itching and redness caused by chronic idiopathic urticaria, which is a type of long-lasting hives.


Q: How long does it take for Histaclear to start working?

Studies and official information indicate that the anti-allergic effect of Histaclear can begin relatively quickly. The inhibition of the skin's reaction to histamine, which is a measure of its activity, is often observed to start within 20 to 60 minutes after taking an oral dose.


Q: Is Histaclear safe to take during pregnancy?

Official labeling notes that the available human data from exposed pregnancies does not indicate an increase in the frequency of malformations. However, the medicine does not have a formal pregnancy category assigned by regulatory bodies. Individuals who are pregnant or planning to become pregnant are advised to consult a healthcare professional before use.


Q: Can children under 6 years old use Histaclear?

Regulatory documents state that use is established for children as young as 6 months of age for certain conditions, and for children 2 years of age and older for others. However, a healthcare provider consultation is generally required for use in children under six years of age due to specific dose requirements.


Q: What is the main difference between Cetirizine and its metabolite, Hydroxyzine?

Cetirizine, the active ingredient in Histaclear, is the active metabolite of Hydroxyzine. Regulatory documents classify Cetirizine as a second-generation antihistamine that was developed to be more selective in its action. It is designated as a non-sedating antihistamine at its recommended doses, which distinguishes it from the older parent compound, Hydroxyzine.


Q: Are there any dietary restrictions I need to follow while taking this medication?

The most important restriction noted in official drug information is the warning against combining this medicine with alcohol. This is due to the potential for additive effects on the central nervous system. No other specific food or beverage restrictions are explicitly mandated in the main prescribing information.


Q: What is the brand name of the IV (intravenous) injection form of Cetirizine?

While Histaclear is a trade name for the oral form, the specific brand name for the intravenous (IV) injection form of Cetirizine is Quzyttir. This form is approved for specific systemic use in supervised healthcare settings.


Q: Is it safe to stop taking Histaclear suddenly after a long time?

Post-marketing experience reported to regulatory agencies includes rare cases of new-onset severe, generalized itching after the sudden discontinuation of the medicine following long-term, daily use. If this effect is experienced after treatment discontinuation, contacting a healthcare professional for guidance is recommended.

How should Histaclear be stored and disposed of?

How to Store and Dispose of Histaclear (Cetirizine Hydrochloride)

The medicine must be stored according to regulatory requirements to maintain its stability and effectiveness.

Official Storage Conditions

Histaclear is required to be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). Storage must avoid excessive heat (above 40 C) and the oral solution should not be frozen. The product should be kept in its original container with the cap tightly closed and protected from light and moisture.

Disposal and Child Safety

Mandatory safety rules dictate that Histaclear must be kept out of the reach and sight of children. For disposal, the medicine must not be thrown into wastewater. Unused or expired product should be discarded according to local regulations, often involving mixing with an undesirable material (like used coffee grounds) before placement in the household trash.

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

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