Атаракс

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Атаракс

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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 Атаракс

Quick Facts

Property Description
Active Ingredient Hydroxyzine
Primary Form Tablet, Oral solution, IM solution
Pharmacological Class First-generation antihistamine, Anxiolytic
General Purpose Relieves itching and nervous tension
Origin Synthetic (Piperazine derivative)

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

The medicinal compound Hydroxyzine is classified primarily as a first-generation antihistamine and a miscellaneous anxiolytic, belonging to the synthetic chemical family of piperazine derivatives and diphenylmethane derivatives. This classification defines the drug's nature as a potent agent with effects targeting both allergic responses and the Central Nervous System (CNS).

The crucial defining characteristic of Hydroxyzine is its ability to readily cross the blood-brain barrier. This property is key to its dual categorization as a CNS depressant that helps manage nervous agitation. This sedative effect is clinically recognized, setting it apart from newer antihistamines designed to be non-drowsy. It is classified under the Anatomical Therapeutic Chemical (ATC) code N05BB01, which groups it with other psycholeptics that are not benzodiazepines.

Hydroxyzine: Composition and High-Level Purpose

Hydroxyzine is supplied as a single-ingredient product, most commonly as the dihydrochloride salt in solid tablet or liquid oral solution forms, as well as a sterile solution for intramuscular injection. This ensures flexibility for administration via both the oral and intramuscular routes. The primary clinical benefit of the compound is its documented ability to provide symptomatic relief from anxiety and nervous tension.

By blocking the effects of histamine, the medicine aids in relieving generalized pruritus (itching). Concurrently, its action on the CNS helps achieve a generalized decrease in psychomotor tension, providing a state of relaxation used to manage anxiety and nervous tension, such as managing short-term situational nervousness.

Regulatory References

  1. Hydroxyzine - LiverTox - NCBI Bookshelf

What side effects are possible with Атаракс?

Possible Side Effects and Safety Information

Hydroxyzine’s safety profile, as documented in official regulatory sources like the FDA and EMA, is defined by its effects on the Central Nervous System (CNS), anticholinergic properties, and specific cardiovascular risks. Adverse reactions are classified by frequency and grouped into System-Organ Classes (SOC).

Frequency-Classified Adverse Reactions

The most frequently reported effects are classified as Common in regulatory labeling. These include drowsiness, dry mouth, and fatigue. The sedation effect is noted as typically transitory in regulatory documents, meaning it may lessen with continued therapy or dose adjustment. Less frequent, or Uncommon, reactions may involve confusion, disorientation, or tachycardia.

Serious Safety Considerations

The most serious regulatory safety concern is the risk of QT interval prolongation and the associated life-threatening ventricular arrhythmia, Torsade de Pointes (TdP). This risk has led to specific safety limitations. Serious skin reactions, such as Acute Generalized Exanthematous Pustulosis (AGEP), have also been documented in post-marketing reports.

Regulatory Restrictions and Population Safety

Official labeling imposes explicit restrictions on use:

  • Contraindications: The medicine is strictly contraindicated for individuals with a known prolonged QT interval or those with uncompensated risk factors for TdP.
  • Older Adults: Use in geriatric patients is generally not recommended due to increased sensitivity to sedation and anticholinergic effects, and a reduction in the drug's elimination.
  • Pregnancy: The medication is contraindicated during early pregnancy due to inadequate safety data.

These constraints establish the framework for understanding the medicine's risk profile, emphasizing that the primary safety limitation is determined by the serious, albeit rare, cardiac risk, while common effects are typically related to the expected CNS activity.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory profile for Hydroxyzine overdosage is defined by potential effects on the central nervous system and the cardiovascular system, necessitating specific emergency actions. Immediate medical attention must be sought upon any suspected overdose. General supportive care, including frequent monitoring of vital signs and close patient observation, is officially indicated.

Documented Manifestations and Severe Outcomes

Category Officially Documented Findings
Common Clinical Signs Hypersedation is the most common manifestation, alongside reports of convulsions, stupor, nausea, and vomiting.
Severe Outcomes The primary risk is cardiotoxicity, specifically the risk of QT prolongation and the dangerous ventricular arrhythmia Torsade de Pointes.
Population Note Elderly patients are officially noted as more susceptible to CNS effects, including increased confusion and over-sedation.

Emergency Management and Monitoring

Overdose management is strictly symptomatic and supportive, as no specific antidote is known for Hydroxyzine. Due to the severe cardiotoxicity risk, continuous ECG monitoring is recommended in the official protocols.

Procedural steps documented in regulatory information include immediate gastric lavage and the administration of activated charcoal. Hypotension may be managed with vasopressors; however, Epinephrine must not be used, as the drug is documented to counteract its pressor effect. Furthermore, the possibility of co-ingestion of multiple agents must be considered during management.

Therapeutic Uses of Атаракс

What Atarax Treats: Main Uses and Benefits

The medication is used across multiple therapeutic domains, primarily offering symptomatic support for both nervous tension and allergic symptoms. It is commonly used to address generalized anxiety, manage nervous restlessness, and is relevant for easing chronic, severe itching (pruritus) associated with allergic skin conditions.


Symptomatic Support for Anxiety and Nervous Tension

This medication is relevant in contexts marked by increased discomfort or tension, specifically addressing symptom clusters like worry and irritability that interfere with daily functioning. This supportive relief generally contributes to improved comfort during periods of heightened symptoms. It is also applied when short-term symptomatic assistance is needed in clinical settings, such as before or after surgical procedures.

Managing Disruptive Allergic and Chronic Itching

Atarax is applied across domains where additional symptomatic support is needed, primarily focusing on symptoms related to inflammatory or irritative states and is commonly used across conditions presenting with acute or episodic manifestations. The medication assists with maintaining functional stability and provides support that helps ease the overall symptom burden.


Quick Fact: Relief for Nervous Agitation and Itching

Therapeutic Area Primary Symptom Axis Contextual Use
Anxiolysis Heightened physiological activity Short-term relief of nervous tension
Anti-pruritic Inflammatory or irritative states Chronic allergic itching and hives

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility Profile for Atarax

The eligibility for Atarax (Hydroxyzine) is defined by official regulatory documentation, outlining populations who can use the medicine and those who are strictly prohibited from use.

Eligibility Status Key Population Constraints
Contraindicated Known Hypersensitivity to hydroxyzine or its metabolites; Prolonged QT interval or specific cardiac arrhythmias; Early pregnancy (first trimester); Patients taking certain QT/QTc-prolonging drugs.
Use with Restriction Older adults (geriatric population) are not recommended for use; Nursing mothers should not take the medicine.

Condition-Specific Eligibility Rules: Use must be avoided in severe liver disease and requires careful adjustment for impaired renal function. Caution is mandated for patients with comorbidities like angle-closure glaucoma, certain forms of urinary retention, and pre-existing seizure disorders (epilepsy), which are susceptible to the drug’s properties. The medicine is approved for use in both adults and the pediatric population (children under and over 6 years) under labeled conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information emphasizes two primary areas of interaction for hydroxyzine (Атаракс): additive central nervous system (CNS) depression and the risk of cardiac rhythm changes.

1. CNS Depressants and Alcohol

Interacting Product Category Official Regulatory Constraint Implication/Mechanism
Alcohol Use is strictly contraindicated. Potentiation of CNS effects, increasing sedation and impairment.
CNS Depressants (e.g., narcotics, barbiturates, general anesthetics, meperidine) The dose of the concomitant CNS depressant must be reduced when co-administered with hydroxyzine. Hydroxyzine potentiates the effects of these agents, increasing the risk of over-sedation.

2. QT-Prolonging and Metabolism-Affecting Drugs

Interacting Product Category Official Regulatory Constraint Implication/Mechanism
QT-Prolonging Medicines (e.g., certain antiarrhythmics, antipsychotics, antidepressants, antibiotics) Concomitant use is strictly contraindicated. Risk of additive QT interval prolongation, which can lead to life-threatening ventricular arrhythmia (Torsades de Pointes).
CYP3A4/5 Inhibitors (Potent) Use with caution is required. May reduce the elimination of hydroxyzine, leading to increased drug levels in the blood and heightened risk of QT prolongation.

Additional regulatory constraints include using caution with drugs that lower heart rate (bradycardia-inducing) or decrease potassium levels (hypokalaemia-inducing), as these factors also elevate the risk of dangerous heart rhythm changes. Hydroxyzine also counteracts the pressor action of epinephrine, which is a consideration in an emergency setting. The overall interaction profile is defined by restrictions and warnings related to these two major pharmacodynamic concerns.

Mechanism of Action

Атаракс (hydroxyzine) functions primarily as a histamine H1 receptor inverse agonist. The compound crosses the blood-brain barrier, exerting its highest affinity and activity at both peripheral and central H1 receptors. By acting as an inverse agonist, it not only occupies the binding site but also actively stabilizes the receptor in an inactive conformation, reducing constitutive Gq-protein signaling mediated by the H1 receptor. This antagonism of histamine's excitatory actions in the central nervous system modulates neuronal activity, resulting in a systemic physiological state of decreased alertness and reduced central nervous system arousal. Hydroxyzine also exhibits secondary, weaker interaction as an antagonist at the serotonin 5-HT2A receptor, the dopamine D2 receptor, and the muscarinic acetylcholine receptors. Its primary H1 antagonism also inhibits histamine-induced increases in capillary permeability and smooth muscle contraction in peripheral tissues.

Dosage and Administration Information

How to Use Hydroxyzine (Atarax): Administration Guidelines

Hydroxyzine administration follows specific protocols detailing its route, dosing, frequency, and population-specific adjustments.


Administration Scope and Routes

Hydroxyzine is approved for two primary administration routes: Oral and Intramuscular (IM). Oral forms include tablets, typically 10 mg, 25 mg, and 50 mg strengths, and an oral solution. The IM injection is for parenteral use in acute or specialized care settings and must not be administered intravenously (IV) or subcutaneously (SC).

Oral forms may be taken without regard to meals. If using the liquid solution, it must be shaken well before measuring the dose.

Official Dosing Regimens

Dosing schedules are specific to the clinical context. For adults managing pruritus (itching), the typical dose is 25 mg taken three to four times daily. For anxiety and tension, adult doses range from 50 mg to 100 mg up to four times daily, with the maximum total daily dose defined by established clinical standards. The drug's efficacy as an anxiolytic is not established for continuous use beyond four months.


Population-Specific Adjustments

Established guidelines mandate dose adjustments for specific patient groups:

  • Older Adults: Treatment begins at the low end of the dosing range, with the maximum daily dose limited to 50 mg.
  • Impaired Organ Function: A reduction in the total daily dose is required for patients with documented renal or hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of Studies for Атаракс


Evidence for Use in Generalized Anxiety and Nervous Tension

Research into the evidence base for this medicine's use in Generalized Anxiety Disorder (GAD) was studied, exploring short-term symptom patterns. The evidence base primarily consists of short-term Randomized Controlled Trials (RCTs) and comprehensive evidence reviews, such as those conducted by Cochrane, focusing on adults. These studies research examined how anxiety symptoms changed over defined time intervals, often compared against a placebo or other agents evaluated alongside the medicine.

Systematic analyses of these studies findings describe patterns observed in the studies where the medicine was included, and reported measurements of change in anxiety scores were compared to placebo groups over the limited study durations.

Evidence for Use in Chronic Pruritus (Itching)

The research for this context was studied, exploring outcomes linked to inflammatory or irritative states, such as chronic urticaria (hives) and specific dermatoses. Research explored patient-reported outcomes describing perceived discomfort, primarily measuring changes in itch severity scores and the patterns of allergic reactions.

Studies reported how symptoms evolved in the observed populations across short- to intermediate-term observation periods. Research explores this context for symptoms of allergic pruritus. The regulatory scope is established based on the available clinical data.

Evidence for Acute Use and Sedation

This evidence base includes single-dose clinical studies focusing on episodes where symptoms become more noticeable, specifically to evaluate the sedative effect and its role in acute nervous tension before medical or surgical procedures. Adults and children was observed in studies related to this acute application.

What is Still Uncertain About Атаракс

The most significant gap is the lack of systematic data for long-term use (more than four months) for managing anxiety symptoms. The main body of evidence related to the anxiety context is limited to short-term follow-up durations. Additionally, regarding older adults (aged 65 and over), regulatory documentation indicates that data for certain groups remain insufficient for defining the response pattern compared to younger subjects.

Key Studies & References

  1. Label: HYDROXYZINE HYDROCHLORIDE tablet (DailyMed - NIH)

Frequently Asked Questions (FAQ)

Common questions about Атаракс (FAQ)

Q: How does Атаракс differ from benzodiazepines?

A: According to official classification, hydroxyzine (Атаракс) is defined as a first-generation antihistamine and a type of anxiolytic, which means it is not a benzodiazepine. The two classes differ in how they work in the brain; hydroxyzine primarily blocks histamine receptors, while benzodiazepines enhance the effects of gamma-aminobutyric acid (GABA) receptors.

Q: Can Атаракс be used for sleep issues or just anxiety?

A: Official information indicates that this medication is approved for its sedative properties, which can help relieve anxiety and tension before and after general anesthesia. Its sedative properties are sometimes noted for short-term sleep issues due to its calming effects, in addition to its primary use for anxiety and itching.

Q: Is Атаракс a controlled substance?

A: No. Regulatory authorities, such as the U.S. Drug Enforcement Administration (DEA), do not classify hydroxyzine (Атаракс) as a controlled substance. Its status as a non-controlled substance indicates a different potential for abuse or dependence compared to scheduled medications.

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

A: Clinical summaries state that the sedating and calming effects of hydroxyzine typically have a rapid onset. The initial effects are often reported to begin within 15 to 30 minutes following oral administration.

Q: If I stop taking Атаракс suddenly, what might happen?

A: Regulatory documents note that abrupt cessation of hydroxyzine, especially after long-term or high-dose use, is not recommended. Sudden stopping may be associated with discontinuation symptoms such as increased anxiety, tremors, or insomnia.

Q: Does Атаракс cause weight gain?

A: Weight gain is not commonly listed as a frequent or major side effect in the official product information for hydroxyzine. Although some older antihistamines can cause changes in appetite, major regulatory labels do not typically highlight weight gain for this medication.

Q: Is Атаракс addictive or habit-forming?

A: Official information indicates that hydroxyzine is generally considered to have a very low potential for abuse, dependence, or addiction. This is consistent with its classification as a non-controlled substance.

Q: What should I do if I miss a dose of Атаракс?

A: Official product information describes the standard guidance for a missed dose when the medicine is taken on a regular schedule. This guidance involves taking the dose when remembered unless it is near the time for the next dose, in which case the missed dose is omitted. The guidance also states that a double dose is not to be taken.

Q: Are there generic versions of Атаракс available?

A: Yes, hydroxyzine is available in various FDA-approved generic forms. The active ingredient can be found as hydroxyzine hydrochloride (the salt form in Атаракс) and hydroxyzine pamoate, both of which have generic equivalents.

Q: Is it possible to develop a tolerance to the effects of Атаракс?

A: Regulatory documents and clinical data suggest that tolerance to the sedative or calming effects of the drug may potentially develop over time. Official product information concerning anxiety relief notes that efficacy has not been established for continuous use extending beyond four months.

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

A: Official regulatory interaction warnings primarily focus on substances that cause central nervous system depression, alcohol, and drugs that affect heart rhythm. Regulatory documents do not specifically list an interaction with common Nonsteroidal Anti-inflammatory Drugs (NSAIDs) like ibuprofen.

Q: What does official information say about stopping Атаракс after long-term use?

A: Official information states that abrupt discontinuation of the medication following long-term or high-dose use is not recommended. This is to minimize the possibility of discontinuation symptoms, which may include a return of anxiety or trouble sleeping.

Q: What is the difference between Атаракс and Vistaril?

A: Atarax and Vistaril are two different brand names for the same core active compound, hydroxyzine. The distinction lies in the chemical salt form used: Atarax contains hydroxyzine hydrochloride, and Vistaril contains hydroxyzine pamoate. Both forms are approved by regulatory bodies for the same indications.

Q: Does Атаракс affect laboratory test results?

A: Official product information describes that hydroxyzine can interfere with the results of certain laboratory tests. Specifically, it may affect the outcomes of allergy skin tests, and its use may need to be discontinued for a specified period before testing is performed.

Q: Can Атаракс cause nightmares or unusual dreams?

A: While specific effects like nightmares or unusual dreams are not commonly listed, post-marketing reports sometimes note their occurrence. Regulatory documents do list other central nervous system effects, such as confusion or disorientation, as possible uncommon adverse reactions.

Q: Does regulatory information mention any known withdrawal symptoms for Атаракс?

A: Regulatory documentation, particularly post-marketing safety reports, indicates that discontinuation symptoms may occur following cessation, especially after high-dose use. These symptoms can include nervousness, insomnia, and tremors.

Q: How common is headache listed as a side effect of Атаракс?

A: Headache is listed in some regulatory post-marketing data as a potential side effect. However, compared to common effects like drowsiness and dry mouth, headache is typically categorized as an uncommon or less frequent adverse reaction in the official product information.

How should Атаракс be stored and disposed of?

Storage and Disposal Requirements for Atarax (Hydroxyzine)

Official regulatory labeling dictates that hydroxyzine tablets must be stored at Controlled Room Temperature, specifically defined as 20 C to 25 C (68 F to 77 F). Storage must avoid excess heat and moisture. The product must be dispensed and stored in a tight container with a child-resistant closure and must always be kept out of the reach of children.

For liquid forms, storage requires a light-resistant container. Any broken or torn packaging, such as a damaged blister, should not be used. Disposal of unused or expired medicine and its container must be carried out strictly in accordance with all applicable local, regional, and national regulations for pharmaceutical waste.

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

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