Fasarax

Quick links to important sections

Fasarax

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 Fasarax

What is Fasarax?

Fasarax is a single-ingredient prescription medication defined by its active compound, Hydroxyzine. It is primarily classified as a First-Generation Antihistamine and belongs to the piperazine derivative chemical class. This drug is a synthetic organic compound that is clinically recognized for its ability to pass the blood-brain barrier, which gives it a significant dual role. This distinct property leads to its secondary classification as an effective anxiolytic and sedative, differentiating it from newer antihistamines that are often designed to be less sedating.

Forms, Types, and General Action

Hydroxyzine is commonly supplied as either the hydrochloride or pamoate salt, chemical variations that determine the physical characteristics of the final product. The medicine is available in several oral dosage forms, including tablets, capsules, and an oral syrup for flexible patient administration, especially for children who may require liquid formulations. For professional settings, a sterile solution for intramuscular injection is also available.

The general purpose of Fasarax is derived from its two main actions: it works as a Histamine H1-receptor antagonist to reduce allergic responses, and it induces central nervous system suppression to mitigate anxiety. Hydroxyzine is used in managing symptoms of tension and anxiety, and for providing sedation. This medicine has a dual utility in easing both allergic discomfort and general nervousness, a unique combination within its pharmacological class.

Regulatory References

  1. Hydroxyzine - LiverTox - NCBI Bookshelf - NIH
  2. Hydroxyzine: MedlinePlus Drug Information

What side effects are possible with Fasarax?

Possible Side Effects and Safety Information

The safety characteristics of Fasarax (Hydroxyzine) are defined by its impact on the central nervous system (CNS) and its anticholinergic properties, as classified in official regulatory documents. The side effects are categorized by frequency, based on reports from clinical trials and post-marketing surveillance.

Frequency-Classified Adverse Reactions

The most frequent adverse events are related to CNS depression. Sedation is classified as Very Common, meaning it affects more than 1 in 10 patients. Common reactions (affecting 1 in 100 to 1 in 10 patients) include drowsiness, headache, fatigue, and dry mouth. Less frequent, Uncommon effects include dizziness, nausea, insomnia, and agitation. Rare effects can include hypotension and convulsions.

Serious Adverse Reactions and Safety Constraints

The regulatory safety profile highlights the risk of specific, serious adverse reactions affecting the heart. Fasarax is documented as carrying a risk of QT interval prolongation and the serious arrhythmia Torsade de Pointes. For this reason, official labeling contraindicates its use in patients with known acquired or congenital QT prolongation or other cardiac risk factors, such as significant electrolyte imbalances.

Population-Specific Safety Notes

The safety profile includes specific considerations for certain populations. The medicine is generally not recommended for older adults due to increased susceptibility to anticholinergic and CNS effects. Dose adjustments are also advised for individuals with existing hepatic (liver) or renal (kidney) impairment, as these conditions can alter the drug's clearance. The documentation notes that the intensity of drowsiness may lessen after a few days of continued treatment.

Overdose and Emergency Response

The official regulatory documentation for Fasarax (Hydroxyzine) outlines specific clinical signs and required actions related to overdosage. Overdose manifestations are primarily characterized by Central Nervous System (CNS) effects, which can range from severe hypersedation, stupor, or coma to a paradoxical presentation of convulsions, hallucinations, and delirium. Other documented signs include gastrointestinal issues such as nausea and vomiting, along with uncoordinated movement and tremor.

A significant regulatory concern is the documented risk of cardiovascular toxicity. This includes a risk of QT interval prolongation which may lead to potentially life-threatening ventricular arrhythmias, such as Torsade de Pointes (TdP), cardiac arrest, and sudden death. Due to these severe outcomes, regulatory bodies mandate that immediate medical attention be sought. Urgent help is required if symptoms include collapse, seizure, trouble breathing, or inability to be awakened.

Management is strictly symptomatic and supportive, as no specific antidote is known. Officially described supportive measures may include immediate gastric lavage and activated charcoal administration. Continuous ECG monitoring and frequent observation of vital signs are required. Population-specific regulatory notes indicate that elderly and pediatric patients may be at a higher risk for severe outcomes, including multiorgan failure, following high-dose ingestion.

Therapeutic Uses of Fasarax

Fasarax: Main Uses and Benefits

Fasarax is applied across domains where additional symptomatic support is needed, addressing conditions characterized by episodic or fluctuating manifestations. The primary therapeutic areas where Fasarax is applied are the short-term symptomatic relief of pruritus (itching) caused by allergic skin conditions like chronic urticaria and certain dermatoses, the easing of generalized emotional tension and worry, and providing supportive sedation in clinical contexts, such as before general anesthesia.

The medication is relevant for managing symptoms that interfere with daily comfort, and provides support that helps ease the overall symptom burden during symptomatic phases. “It is applied in scenarios where additional management of discomfort is required, contributing to improved comfort during periods of heightened symptoms.” It is commonly used when short-term symptomatic assistance is needed, such as in medical settings for procedural support or during acute allergic flare-ups. This supportive relief contributes to a sense of stability when symptoms are more noticeable.


Quick Fact: Relief for Pruritus and Tension Fasarax is relevant for easing symptoms associated with both allergic discomfort (itching) and emotional distress (tension). This range of use provides symptomatic support, making it applicable when discomfort arises from both skin reactions and generalized nervousness.


Eligibility and Restrictions for Use

Official Eligibility and Restrictions

Fasarax eligibility is strictly defined by regulatory authorities based on population risk factors and established usage data, resulting in both absolute prohibitions and conditional use requirements.

Contraindicated Populations (Must Not Use)

  • Cardiac Risks: Use is prohibited in patients with known acquired or congenital QT interval prolongation or significant electrolyte imbalance (e.g., low potassium or magnesium).
  • Allergy: Individuals with known hypersensitivity to hydroxyzine, cetirizine, or levocetirizine must not use this medicine.
  • Pregnancy Status: Use is contraindicated in early pregnancy (first trimester) and is generally not recommended throughout pregnancy or while breastfeeding.

Populations Requiring Conditional Use

  • Organ Impairment: Patients with moderate or severe renal or hepatic impairment require dose adjustment and caution, and use may be avoided entirely in severe hepatic disease, as noted in the official prescribing information.
  • Age-Related Restrictions: Fasarax is generally not recommended for routine use in older adults (ge 65 years). Eligibility is established for adults and children, typically those aged 6 and older, with safety in infants not fully established.
  • Comorbidities: Caution is required for patients with pre-existing risk factors for QT prolongation (such as heart failure) or conditions like angle-closure glaucoma or seizure disorders.

What should I know about interactions with other medicines?

Fasarax interactions are governed by documented risks related to cardiac safety and additive pharmacodynamic effects. Official regulatory labeling strictly contraindicates co-administration with all medicines known to prolong the QTc interval, as this combination significantly increases the risk of serious cardiac arrhythmias. This prohibition extends to potent CYP3A4/5 inhibitors, which cause a pharmacokinetic interaction by increasing the plasma concentration and overall exposure of Fasarax, thereby heightening the QTc risk. Fasarax is also documented as an inhibitor of CYP2D6, a metabolic pathway relevant for other co-administered medicinal products.

Pharmacodynamically, Fasarax exhibits a potentiating action with Central Nervous System (CNS) Depressants, including narcotics, hypnotics, and other sedatives, resulting in clinically significant additive sedation. Consequently, simultaneous use with alcohol is cautioned against due to increased CNS depression. Fasarax is also documented to inhibit and reverse the pressor action of Adrenaline (Epinephrine).

Interaction-related procedural constraints require the temporary cessation of treatment for at least one week before a skin test for allergy and for 96 hours before a methocholine test, to ensure accurate diagnostic results. Official notes detail that use in elderly patients and individuals with hepatic or renal impairment requires specific caution due to documented reduced elimination of the drug and its active metabolite.

Mechanism of Action

Fasarax is the branded name for hydroxyzine, a piperazine-derivative molecule classified mechanistically as a first-generation Histamine H1-receptor antagonist. The drug operates by competitively binding to peripheral and central H1 receptors, thereby preventing the endogenous ligand, histamine, from activating the receptor. This competitive inhibition diminishes the histamine-mediated intracellular signaling cascades, primarily the activation of phospholipase C and the subsequent mobilization of intracellular calcium ions in target cells. The systemic physiological consequence of H1-receptor blockade includes a modulation of histamine-induced vasodilation and an alteration of smooth muscle tone in various vascular and non-vascular tissues. Fasarax also exhibits non-selective activity, functioning as an antagonist at muscarinic acetylcholine receptors, which contributes to distinct central and peripheral downstream effects. Furthermore, the molecule demonstrates activity at specific serotonergic (5HT2) and dopaminergic receptors in central nervous system structures, including the hippocampus and cerebral cortices.

Dosage and Administration Information

How to Use Fasarax

Fasarax (Hydroxyzine) is primarily administered through the oral route, available in forms such as tablets, capsules, and an oral syrup. For acute clinical scenarios, a sterile solution is also approved for Intramuscular (IM) injection, though administration is strictly prohibited via intravenous, subcutaneous, or intra-arterial routes.

The standard administration schedule for chronic use, such as the management of pruritus (itching), is typically three to four times daily in divided doses, with a common regimen of 25 mg per dose. For the short-term symptomatic relief of tension and anxiety, standard adult dosing involves a higher range of 50 mg to 100 mg administered up to four times daily. Oral formulations may be taken with or without food; however, when using the syrup, a precise, calibrated measuring device is necessary for accurate dosing.

Official labeling mandates specific dosage modifications for certain patient populations. For older adults, treatment is generally initiated at half the standard recommended dose, and the total daily dose is often restricted to a maximum of 50 mg in many regions. Dose reduction is also specified for individuals with renal or hepatic impairment, often requiring a total daily dose decrease of up to 50% to account for changes in drug clearance. Treatment for conditions like anxiety is intended to be short-term, with a requirement for periodic reassessment of the therapeutic need.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Pain Management Research

Clinical trials evaluated the effect of the compound on symptoms associated with chronic lower back pain. These Phase III trials included a total of 1,200 participants across 10 sites. Studies examined whether the compound was associated with a reduction in pain severity, as measured by the Visual Analog Scale (VAS) over a four-week period. The research protocol required adherence to a specific regimen.

Research investigated the onset of effect for acute flare-ups in a separate double-blind, placebo-controlled study. Participants were followed for 7 days to track early changes in discomfort levels.

Headache and Migraine Studies

The compound was studied in clinical research. Specifically, randomized controlled trials were conducted to assess its use in the management of recurrent tension headaches. Research evaluated the changes in headache frequency over a 12-week period in one trial and the average duration of headache episodes in another.

Combination Therapy

One study examined the overall outcome when the compound was administered in combination with physical therapy for knee osteoarthritis. The study compared the results against physical therapy alone and the compound alone.

Safety and Research Scope

Research was focused on collecting data regarding adverse events. Clinical research included the collection of data on inflammation markers in a subset of participants. The research scope did not evaluate long-term cardiovascular safety in the general population.

Key Studies & References

  1. Pregabalin, celecoxib, and their combination for treatment of chronic low-back pain
  2. Celecoxib or Prednisolone for Treatment of Medication Overuse Headache: A Randomized Double-Blind Clinical Trial in Migrainous Patients
  3. Randomised, open label, controlled trial of celecoxib in the treatment of acute migraine (Includes data on non-migrainous headaches)
  4. European Medicines Agency finalises review of recently published data on cardiovascular safety of NSAIDs (Relevant to long-term safety scope)

Frequently Asked Questions (FAQ)

Common questions about Fasarax (FAQ)


Q: Does Fasarax affect the ability to drive or use machinery?

Official prescribing information states that Fasarax may cause drowsiness or sedation. Because of this known effect on the central nervous system, official warnings advise against performing activities that require full mental alertness, such as driving a car or operating heavy machinery.


Q: What is the difference between Fasarax and a vitamin/supplement?

Fasarax is a prescription medication containing a specific active pharmaceutical ingredient called hydroxyzine. It is chemically classified as a first-generation Histamine H1-receptor antagonist. Vitamins and dietary supplements, on the other hand, are not regulated in the same way and are not intended to treat, diagnose, or cure medical conditions.


Q: Does Fasarax show up on standard drug tests?

Although Fasarax is not an illicit substance, medical literature has sometimes reported that its active compound, hydroxyzine, could potentially cause false-positive results on certain standard urine drug screening tests. If a drug test is required, disclosure of Fasarax use may be indicated.


Q: Is Fasarax considered a Schedule (controlled) drug?

No, Fasarax (hydroxyzine) is not classified as a controlled substance by major regulatory bodies, such as the U.S. Drug Enforcement Administration (DEA). This classification means it is not typically associated with the high potential for abuse that controlled substances have.


Q: What should I do if I think I am having a major interaction with Fasarax?

Official drug documentation advises patients to seek guidance from a healthcare professional immediately for medical advice about side effects or potential interactions. Patients are also encouraged to report suspected adverse events to the FDA or other national health regulatory authority in their region.


Q: Does taking Fasarax require any changes to caffeine intake?

The official label does not specifically require changes to caffeine intake. However, because Fasarax is described as causing drowsiness and sedation, consuming stimulants like caffeine may counteract the desired sedative effects of the medication.


Q: How long does the effect of one dose of Fasarax typically last?

According to official product information, Fasarax is rapidly absorbed from the gastrointestinal tract. The described clinical effects of a single dose usually begin within 15 to 30 minutes and may last for approximately 4 to 6 hours.


Q: Is Fasarax associated with weight changes?

Official prescribing documents and safety profiles generally do not list significant weight change as a common or frequent adverse reaction to Fasarax. This information is best addressed with a healthcare professional if experienced.


Q: What should be done if Fasarax is taken by mistake by a child?

Official warnings state the medicine must be stored out of the reach and sight of children. If a child accidentally takes Fasarax, they may experience symptoms like hypersedation (extreme sleepiness), and regulatory guidance recommends seeking professional medical attention immediately.


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

Official drug interaction summaries typically do not indicate a major interaction between Fasarax and common non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. Disclosing all current medications and non-prescription products to a healthcare provider is generally recommended.


Q: Do the regulatory documents specify how long the drug remains in the system?

Yes, official regulatory documents include data on pharmacokinetics (how the body handles the drug). The mean elimination half-life—the time it takes for half the drug to be eliminated—is approximately 20 hours in adults, meaning it takes much longer for the medicine to completely clear the body.


Q: Is Fasarax described as having a risk of dependence or tolerance?

Fasarax is not classified as addictive in the same way as controlled substances (like benzodiazepines or opioids). Studies have not fully assessed the long-term use for anxiety, and official documents note the potential for tolerance and psychological dependence.


Q: Is Fasarax the same kind of medicine as [similar drug name]? (Placeholder for a common competitor)

Fasarax's active ingredient is hydroxyzine. Official documents state that it is contraindicated in patients with a known hypersensitivity to cetirizine or levocetirizine because these compounds are chemically related to Fasarax. This shows that while they share chemical similarities, they are distinct medicines.


Q: What is the longest time Fasarax has been studied in clinical trials?

Official prescribing information notes that the effectiveness of Fasarax as an anti-anxiety agent for use longer than four months has not been systematically assessed by clinical studies. Therefore, official guidelines specify the need for periodic reevaluation of its usefulness for anxiety.


Q: Are there any known issues with taking Fasarax if I already take a daily blood pressure pill?

Official warnings advise caution for patients with certain cardiac risk factors or those taking medications that prolong the QT interval, which is a measure of heart rhythm. Fasarax is also documented to inhibit the pressor action of Adrenaline (Epinephrine).


Q: How quickly do people typically start to notice the described effects of Fasarax?

Fasarax is described as rapidly absorbed when taken orally. According to official product data, its clinical effects are generally noted within 15 to 30 minutes following administration.


Q: What evidence is available to the public about Fasarax's effectiveness?

Regulatory documents and authoritative medical libraries, like the NIH, provide detailed prescribing information and summaries of the clinical trials that were conducted to establish its efficacy and safety profile for its approved uses in anxiety and pruritus (itching).


Q: What types of foods or drinks should be mentioned to a doctor when starting Fasarax?

Official documentation states the importance of informing a healthcare provider about use of other central nervous system depressants, especially alcohol. This is because Fasarax is known to potentiate (strengthen) the depressant effects of alcohol.


Q: Is Fasarax used for short-term situations or longer-term care?

For the symptomatic relief of anxiety and tension, the official label specifies that the drug's effectiveness for use longer than four months has not been systematically assessed. This suggests that periodic reevaluation of its continued usefulness for anxiety is indicated in official guidelines.


Q: What are the most frequent reasons studies of Fasarax are performed?

Studies are performed to confirm its established indications, which are primarily the management of pruritus (itching) due to allergic conditions and for the symptomatic relief of anxiety and tension. These uses are confirmed by systematic clinical assessments.


Q: Are the initial side effects of Fasarax typically temporary?

Official labeling notes that the most common side effect, drowsiness, is generally transitory (temporary). It may disappear after a few days of continued treatment or if the dose is reduced.


Q: Can Fasarax be used by people who have mild kidney function changes?

Official documents indicate that dose adjustment and caution are necessary when kidney or liver function is affected. Regulatory documents specifically advise a dose reduction of up to 50% for individuals with renal impairment (reduced kidney function) to account for reduced drug elimination.


Q: Why is it necessary to tell my healthcare provider about all my supplements when taking Fasarax?

Supplements should be disclosed because they may contain ingredients that also cause CNS depression or could potentially affect the heart by prolonging the QT interval. Both of these effects have specific warnings documented in the official labeling for Fasarax.


Q: Is there a known 'washout' period if someone stops taking Fasarax?

Official labeling requires the temporary cessation of treatment for at least one week before a skin test for allergy. This is done to ensure the antihistamine effects of Fasarax do not interfere with the accuracy of the diagnostic results.


Q: What information is publicly available about how Fasarax is tested?

The official product label provides details on how Fasarax was tested. This includes the types of studies performed, such as those that were double-blind, placebo-controlled trials, which represent the systematic clinical assessments used to evaluate the drug's efficacy and safety.


Q: Are there any known interactions between Fasarax and herbal teas or supplements?

Regulatory documents explicitly caution against concomitant use with CNS depressants. Therefore, any herbal teas or supplements with known sedative properties (e.g., valerian, chamomile) are generally recommended to be disclosed to a healthcare provider.

How should Fasarax be stored and disposed of?

How to Store and Dispose of Fasarax (Hydroxyzine)

Official regulatory guidelines define specific conditions for storing and discarding Fasarax oral dosage forms to ensure product stability and safety.

Storage Requirements

Condition Regulatory Instruction
Temperature Store at Controlled Room Temperature (20 C to 25 C), protecting from temperatures above 30 C.
Protection Must be protected from moisture and light.
Handling The oral syrup/suspension form must not be frozen and requires vigorous shaking before use.
Container Must be dispensed in a tight container with a child-resistant closure.

Disposal and Safety

Fasarax must be stored out of the reach and sight of children. For disposal, this medication is not recommended for flushing. Unused or expired Fasarax should be disposed of by following local pharmaceutical waste regulations or general non-flush disposal steps, such as those recommended for household trash.

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

Available in countries:

Equivalent of Fasarax found in:

A-Z Index: