Azeflo

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Azeflo

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Azeflo

Quick Facts

Property Description
Active Ingredients Azelastine Hydrochloride, Fluticasone Propionate
Form Aqueous Suspension Nasal Spray
Pharmacological Class Antihistamine and Intranasal Corticosteroid Combination
General Purpose Suppression of immediate allergy response and inflammation
Origin Synthetic

What is Azeflo?

Azeflo is a prescription-only, fixed-dose combination product designed for targeted intranasal administration as an aqueous suspension nasal spray. Its primary differentiating feature is the simultaneous delivery of two distinct synthetic pharmacological agents—an antihistamine and a corticosteroid—which provides enhanced therapeutic benefits compared to monotherapy. The combination formulation is commonly prescribed for symptoms such as persistent sneezing and nasal congestion, which are characteristic of inflammatory nasal conditions.

What Type of Medicine is Azeflo?

Pharmacologically, Azeflo is classified as a dual-action medicine, merging an H1-receptor Antagonist (Azelastine) with an Intranasal Corticosteroid (Fluticasone). This specific fixed-dose formulation provides an effective strategy for managing both the allergic and inflammatory components of conditions like rhinitis, compared to either agent used alone. This combination approach provides a rapid and sustained method for managing complex nasal discomfort.

Composition and Dual Mechanism

The two Active Ingredients are Azelastine Hydrochloride and Fluticasone Propionate. Azelastine, the antihistamine component, is designed to provide rapid relief by blocking the effects of histamine, a core inflammatory mediator. Fluticasone, a synthetic glucocorticoid, exerts an anti-inflammatory effect by binding to receptors to suppress the release of various inflammatory chemical messengers in the nasal lining. This dual-action strategy is designed to ensure the medicine addresses both the immediate allergic reaction and the underlying chronic tissue swelling by combining a topical antihistamine with an intranasal steroid.

What side effects are possible with Azeflo?

Possible Side Effects and Safety Information

Official regulatory documents classify the medicine's adverse reactions based on their frequency in clinical studies. The profile is characterized by common local nasal events and specific systemic considerations related to the intranasal corticosteroid component.

Frequency Category Representative Adverse Reaction
Very Common Epistaxis (Nosebleed)
Common Dysgeusia (Unpleasant taste), Headache
Uncommon Nasal irritation, Sneezing, Nasal dryness
Very Rare Glaucoma, Cataract, Somnolence (Drowsiness)

Side effects are grouped by system-organ classes, primarily affecting Respiratory, Thoracic, and Mediastinal Disorders (local irritation, nasal dryness) and Nervous System Disorders (headache, dizziness). The adverse reaction of dysgeusia, often reported as an unpleasant taste, is linked to the medicine's flow down the throat.

Serious adverse reactions, though rare, are officially documented. These include the potential for Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and the development of glaucoma or cataracts, concerns that are associated with the systemic absorption of any intranasal corticosteroid. Instances of nasal septal perforation have also been reported, particularly associated with long-term use.

Safety statements include specific considerations for certain populations. The growth of children receiving prolonged treatment should be monitored. Patients with severe hepatic impairment may experience increased systemic exposure to the components. Furthermore, official labeling advises caution regarding use in patients with recent nasal trauma or ulcers due to the potential for impaired wound healing, and notes the risk of increased systemic effects when used concurrently with certain CYP3A4 inhibitors.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory information for Azeflo (Azelastine and Fluticasone) outlines distinct risks associated with acute, single-event overdosage versus chronic exposure to high doses.


Documented Overdose Manifestations

Acute overdose, particularly from incidental oral uptake, may cause disturbances of the Central Nervous System (CNS), with symptoms documented as drowsiness and confusion. Severe acute manifestations may include tachycardia (increased heart rate), hypotension (low blood pressure), and coma.

Chronic overdosage, defined as prolonged use at dosages higher than recommended, carries a risk of systemic effects from the corticosteroid component. These include signs of hypercorticism and adrenal suppression (HPA axis effects), which may result in serious long-term conditions such as Cushing's syndrome, cataracts, and glaucoma.

Emergency Actions Mandated by Regulators

Regulatory guidance requires users to seek medical help or contact a poison control center or emergency room at once for suspected acute overdose or accidental ingestion. Immediate action is advised even if there are no signs of discomfort or poisoning. General supportive measures should be employed if overdosage is suspected, as no known specific antidote is available.

Special Considerations

For pediatric patients, chronic high-dose exposure carries an officially documented risk of growth retardation. Furthermore, monitoring is required for chronic high-dose users, where additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Therapeutic Uses of Azeflo

What Azeflo Treats: Main Uses and Benefits

Azeflo is commonly used to provide supportive symptomatic relief for conditions presenting with acute or disruptive symptom patterns, namely Seasonal Allergic Rhinitis (hay fever) and perennial allergic rhinitis. This therapeutic approach is typically applied across domains where additional symptomatic support is needed.

The medication helps address symptom clusters that may become intense or disruptive, specifically targeting symptoms related to inflammatory or irritative states. These include frequent sneezing, watery discharge, and chronic nasal congestion. It is applied in clinical settings where acute manifestations of allergy interfere with daily functioning.

“This therapeutic approach is relevant for managing symptoms that interfere with daily comfort and create noticeable functional strain.”

By providing support that helps ease the overall symptom burden, Azeflo contributes to improved comfort during periods of heightened symptoms, assisting with maintaining functional stability when symptoms interfere with routine activities. It is used in situations involving certain distressing symptoms that require robust supportive relief.

Quick Fact: Relief for Rhinitis Symptoms
Primary Target Nasal congestion, sneezing, and watery discharge.
Symptom Scope Focus on allergic and inflammatory symptoms.
Usage Context Conditions involving recurrent or episodic manifestations.

Regulatory References

  1. NIH DailyMed guidance

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Azeflo — Official Regulatory Information


Eligibility Scope

Category Eligibility Rule (Strictly Regulatory Statement)
Populations for whom use is allowed Adult and pediatric patients 6 years of age and older.
Populations for whom use is not recommended Children younger than 6 years of age (Safety and effectiveness have not been established).
Populations for whom use is contraindicated Patients with known hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any other ingredient in the product.

Eligibility Classifications (High-Level)

  • Age-Related Eligibility: The medicine is indicated for individuals 6 years of age and older. Use is not established in younger children.
  • Condition-Specific Restrictions: Caution is required in patients with recent nasal ulcers, nasal surgery, or nasal trauma; use should be avoided until healing is complete. Caution is also advised in the presence of certain existing infections (e.g., tuberculosis, ocular herpes simplex) due to the immunosuppressive effect of the corticosteroid component.
  • Pregnancy and Lactation Status: Use during pregnancy is advised only if the potential benefit justifies the potential risk to the fetus (Risk Category C or B3 by older classifications). It is unknown if the components are excreted in human breast milk, necessitating a decision to discontinue nursing or discontinue the drug.

Resulting Eligibility Structure

Official eligibility is structured by an absolute exclusion for patients with hypersensitivity and a minimum approved age of 6 years. Use is limited or conditional for patients with compromised nasal tissue, certain infections, or pre-existing conditions like glaucoma or cataracts.

What should I know about interactions with other medicines?

Azeflo contains azelastine hydrochloride and fluticasone propionate, and its interaction profile is defined by both components. Two primary categories of interactions are documented in regulatory information.

Interactions Causing Increased Drowsiness

Concurrent use with alcohol or other Central Nervous System (CNS) depressants should be avoided. The azelastine component can cause somnolence, and combining it with other substances that slow brain activity, such as certain pain medicines, anti-anxiety drugs, or other sedating antihistamines, can lead to a further decrease in alertness and impairment of CNS performance.

Interactions Affecting Fluticasone Levels

Fluticasone propionate is primarily cleared from the body by the liver enzyme cytochrome P450 (CYP) 3A4. Medicinal products that are potent inhibitors of this enzyme can increase fluticasone propionate blood levels. This increased systemic exposure may lead to adverse effects, including Cushing syndrome and adrenal suppression.

  • Ritonavir (used to treat HIV) is a strong inhibitor of CYP3A4, and its coadministration with Azeflo is not recommended.
  • Other potent CYP3A4 inhibitors, such as ketoconazole (used for fungal infections) and cobicistat-containing products, are expected to increase fluticasone levels. Caution should be used with the coadministration of these products.

Mechanism of Action

Rapid Antagonism of Histamine Signaling

This domain describes the rapid kinetics of action governed by Azelastine. It involves the selective blockade of H1 receptors on sensory nerve endings and vascular tissue, a mechanism that competitively inhibits the binding of endogenous histamine. This molecular event interrupts the neurogenic and vascular cascade, resulting in reduced afferent sensory nerve stimulation and decreased plasma exudation across the endothelial layer.


Genomic Modulation of Chronic Inflammation

The mechanism for sustained physiological effect is driven by Fluticasone, which acts as an agonist for the intracellular Glucocorticoid Receptor ( GR). This complex enters the cell nucleus to modulate gene transcription, a process known as transrepression, which suppresses the production of a broad range of pro-inflammatory mediators like cytokines and leukotrienes. This genomic action modulates the transcription of pro-inflammatory genes, correlating with a subsequent decrease in tissue edema and inflammatory cellular influx.


Dual-Phase Mechanistic Synergy

Azeflo's mechanism is characterized by the complementary interaction of its two components, which address distinct temporal phases of the underlying biological response. Azelastine provides immediate pathway interference by directly blocking peripheral receptor activity, while Fluticasone provides sustained pathway regulation via long-term genetic control. This synergy results in the modulation of both the rapid, acute receptor signaling and the sustained, genomic regulation of tissue inflammation.

Dosage and Administration Information

Administration Instructions for Azeflo

Azeflo (Azelastine) is administered exclusively via the intranasal route using a spray pump.


Dosing Schedule and Frequency

The frequency pattern is typically twice daily, though a once-daily option is available for certain adult regimens. Dosing varies by age group and the indication:

Age Group Indication Recommended Dose (0.1% or 0.15% concentration) Frequency
Children 6 months to 5 years Perennial Allergic Rhinitis 1 spray per nostril Twice daily
Children 2 to 11 years Seasonal Allergic Rhinitis 1 spray per nostril Twice daily
Adults and Adolescents (12+ years) Seasonal Allergic Rhinitis 1 or 2 sprays per nostril Twice daily OR 2 sprays per nostril once daily (0.15% only)
Adults and Adolescents (12+ years) Perennial Allergic Rhinitis 2 sprays per nostril Twice daily

Procedural Steps

Preparation is required to ensure proper function. Before initial use, the device must be primed by releasing 6 sprays or until a fine mist is visible. If the spray has not been used for three or more days, it must be reprimed with 2 sprays or until a fine mist appears.

  • Administration: Gently insert the tip into the nostril, avoiding spraying into the nasal septum, and actuate the pump rapidly and firmly while sniffing gently. Repeat in the other nostril, and again for a second spray if required by the recommended dose.
  • Special Condition: It is an explicit procedural requirement to avoid spraying Azeflo into the eyes.

These instructions establish the precise dosage, frequency, and preparation steps required for the use of Azeflo as an intranasal spray, forming the basis for the medication use protocol.

Recent Clinical Evidence

Research evidence / Overview of studies for Azeflo

Evidence for Use in Seasonal Allergic Rhinitis (SAR)

Scientific research related to the combination product and seasonal allergic rhinitis comes from short-term, randomized controlled trials (RCTs). These studies research examined adults and adolescents who were experiencing moderate to severe symptoms of this condition characterized by fluctuating or episodic manifestations. The study outcomes examined primarily focused on patient-reported outcomes describing perceived discomfort, such as changes in the Total Nasal Symptom Score (TNSS). Studies compared measurements of the combined TNSS across the combination product group, monotherapy groups, and placebo.

Comparing Combination Therapy to Monotherapies and Placebo

Clinical trials research examined the combination product against its single-component medicines and placebo. These comparisons were relevant in trials assessing short-term or episodic symptom patterns, usually lasting about 14 days. The comparison trials research explored whether the combination product was observed in a different pattern of symptom score changes compared to the individual components or placebo. This evidence contributes to the broader evidence landscape by showing how the dual-action approach was measured in specific trial settings.


Evidence for Use in Perennial Allergic Rhinitis (PAR)

For perennial allergic rhinitis, evidence includes randomized controlled trials and open-label studies that was evaluated in adults with persistent, non-seasonal symptoms. The study outcomes examined centered on tracking changes in the Total Nasal Symptom Score and monitoring outcomes reflecting daily functioning or activity level. The trials studies monitored changes in symptom scores in the observed populations across the longer treatment course. However, comparative evidence is lacking in the way of large, long-term trials that directly compare the combination against an inactive spray (placebo) over a full year for persistent symptoms.


What Remains Uncertain and Research Gaps

The scientific evidence highlights what is known — and what is still uncertain. There is limited information for long-term outcomes that track sustained symptom changes or measured effects over periods much longer than one year. Research data for certain groups remain insufficient when evaluating the combination product specifically in non-allergic or chronic rhinitis. Additionally, subgroup findings are uncertain in children aged 6 to 11, where some measured results were not clearly distinguishable from placebo, indicating that evidence quality varies across studies for this group.

Frequently Asked Questions (FAQ)

Common questions about Azeflo (FAQ)

Q: How quickly does Azeflo start to relieve allergy symptoms?

A: Studies show that the antihistamine component, Azelastine, is designed to provide rapid relief for some nasal allergy symptoms. According to clinical data, the onset of action is typically observed within 30 minutes of administration.


Q: What are the most common side effects of using Azeflo?

A: Official regulatory documents based on clinical trials indicate that the most common adverse reactions reported by patients include an unpleasant or bitter taste (dysgeusia), headache, and nosebleeds (epistaxis).


Q: Can using Azeflo cause nosebleeds?

A: Yes, nosebleeds (epistaxis) were reported as a very common adverse reaction in clinical studies. This finding is documented in the product's official safety information.


Q: Is it normal to taste the Azeflo spray after using it?

A: Experiencing an unpleasant taste, known medically as dysgeusia, is common when using this product. This is a common side effect reported in clinical trials and is often linked to the flow of the medication down the throat.


Q: How long can I safely use Azeflo for chronic allergies?

A: Specific safety data for use beyond a year is limited, and official documents note that patients on long-term treatment should be monitored. For patients using an intranasal corticosteroid for an extended duration, official labeling advises monitoring for potential side effects, including changes in vision or damage to the nasal lining.


Q: Does Azeflo interact with common allergy medications like Zyrtec or Claritin?

A: Official regulatory information advises caution when using Azeflo with other Central Nervous System (CNS) depressants, which includes certain other sedating antihistamines. Combining these substances may increase the risk of drowsiness or reduced mental alertness.


Q: What happens if I stop using Azeflo suddenly?

A: Sudden discontinuation after prolonged use may rarely cause symptoms of steroid withdrawal in susceptible individuals. This is related to the corticosteroid component's potential effects on the adrenal system.


Q: Are there potential long-term effects from continuous use of Azeflo?

A: As with any intranasal corticosteroid, continuous long-term use is associated with a small risk of serious but rare systemic effects. These effects include potential issues with the adrenal glands, vision problems like Glaucoma or Cataracts, and, rarely, nasal septal perforation.


Q: Does Azeflo cause dry mouth or throat?

A: Dry mouth or throat are not listed as common adverse reactions. However, the product is associated with nasal dryness and irritation, and the unpleasant taste side effect confirms flow into the throat.


Q: Is Azeflo the same as Flonase or Nasonex?

A: No, Azeflo is not the same as Flonase (fluticasone) or Nasonex (mometasone). Azeflo is a combination product containing two active ingredients: an antihistamine (azelastine) and a corticosteroid (fluticasone). Flonase and Nasonex are single-ingredient nasal corticosteroid sprays.


Q: Will Azeflo make me drowsy or tired?

A: Yes, drowsiness, or somnolence, is a documented possible side effect associated with the antihistamine component. Official warnings state that due to the risk of drowsiness (somnolence), patients should be cautious when engaging in activities requiring complete mental alertness.


Q: Can Azeflo be used for non-allergy sinus congestion?

A: Based on regulatory labeling, the product is specifically indicated only for the treatment of nasal symptoms associated with Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis (SAR and PAR). Its use for other types of congestion is not covered by the official indications.


Q: Why do people sometimes say Azeflo has a funny smell or taste?

A: The perception of a funny or unpleasant taste is a very common side effect reported in clinical trials. This is known as dysgeusia and is linked to the azelastine component of the spray.


Q: Does Azeflo help with eye watering and itchy eyes too?

A: Although the official indications focus on nasal symptoms, the antihistamine component is known to address allergy symptoms, which can include itchy or watery eyes.


Q: Is Azeflo safe to use during pregnancy? (General question, not personalized)

A: Official information advises that the drug should be used during pregnancy only if the potential benefit justifies any potential risk to the fetus. No adequate and well-controlled human studies have been conducted regarding its use during pregnancy.


Q: Can Azeflo be used while breastfeeding? (General question, not personalized)

A: It is unknown whether the active components of Azeflo are excreted into human breast milk. Official labeling states a decision must be made whether to discontinue nursing or discontinue the medication, weighing the potential benefits.


Q: What's the difference between Azeflo and just an intranasal steroid?

A: Azeflo is a dual-action spray because it combines two types of medicine: an antihistamine (azelastine) and an intranasal corticosteroid (fluticasone). A standard intranasal steroid is a single-ingredient product containing only the corticosteroid component.


Q: Does Azeflo make you feel shaky or anxious?

A: While the medication can cause side effects related to the nervous system, such as headache and drowsiness, feelings of shaking or anxiety are not commonly listed adverse reactions in official regulatory documents.


Q: What are the signs of an allergic reaction to Azeflo?

A: Regulatory warnings list possible signs of a hypersensitivity reaction (allergic reaction), which may include swelling (angioedema), rash, hives, or breathing difficulty. These are considered rare but serious adverse events.


Q: Has Azeflo been studied in teenagers?

A: Yes, the product is officially indicated for use in adolescents aged 12 years and older for both seasonal and perennial allergic rhinitis, meaning this age group was included in clinical trials for the product's approval.


Q: Is it common to feel tired after starting Azeflo?

A: Drowsiness (somnolence) is a possible side effect associated with the antihistamine component. Official warnings state that due to the risk of drowsiness, activities requiring full mental alertness should be approached with caution.


Q: Does Azeflo have any effects on blood sugar levels?

A: Because the product contains a corticosteroid, there is a theoretical potential for systemic effects like hypercorticism, particularly with prolonged use. In susceptible individuals, this may be associated with changes in glucose metabolism.


Q: Is Azeflo safe for people with liver or kidney issues? (General question)

A: Official regulatory information advises caution for patients with severe hepatic (liver) impairment because this can lead to increased systemic exposure to the medication's components. Regulatory documents do not typically list specific major warnings regarding kidney impairment.


Q: What kind of research supports the combination of ingredients in Azeflo?

A: The combination of ingredients is supported by controlled clinical trials. These studies compared the combination product's effect on nasal symptom scores against the single active components and a placebo in patients with allergic rhinitis.


Q: Is it better to use Azeflo in the morning or at night?

A: The product is typically prescribed for use twice daily (morning and evening). Official prescribing information indicates that the specific timing guidance should be followed as directed by a healthcare professional.


Q: Does Azeflo help with post-nasal drip?

A: Yes, the product is indicated for the symptoms of Allergic Rhinitis, and is used to help manage symptoms such as post-nasal drip.


Q: Are there warnings about driving or operating machinery while using Azeflo?

A: Yes, official warnings state that due to the risk of drowsiness, patients should be cautious when engaging in hazardous occupations, such as driving or operating machinery.


Q: Does Azeflo cause headaches?

A: Yes, headache is a documented side effect of Azeflo. It is classified as a common adverse reaction reported by patients in clinical trials.

How should Azeflo be stored and disposed of?

How to Store and Dispose of Azeflo?

To ensure product stability, Azeflo (azelastine hydrochloride/fluticasone propionate) nasal spray must be stored according to official regulatory requirements.

Storage Conditions

The medicine must be stored at room temperature, generally between 15 C and 30 C (59 F and 86 F). It is mandatory to not refrigerate or freeze the spray. The product must be kept in its original, closed container, stored in an upright position, and protected from light and moisture.

Stability and Safety

The medicine has a defined in-use shelf life: it must be discarded 6 months after its first opening or after 120 metered sprays, whichever comes first. Always keep the medicine out of the sight and reach of children.

Disposal Instructions

There are no special requirements for disposal stated in some regulatory documents. The product should not be disposed of via household wastewater. Consult a pharmacist or healthcare professional for instructions on how to properly discard any unused or expired medicine, often through community drug take-back programs.

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

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