Deline

Quick links to important sections

Deline

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 Deline

Property Description
Active ingredient Desloratadine
Form Oral Solution, Film-coated Tablet, Tablet
Pharmacological class Second-Generation Antihistamine
General purpose Relief from Histamine-Mediated Symptoms
Origin Synthetic Compound (Active Metabolite)

Deline: What Type of Antihistamine Is It?

Deline is a proprietary medication containing the active ingredient Desloratadine, officially classified as a synthetic, second-generation antihistamine (H1-receptor antagonist). Its primary function is to act as a selective peripheral H1-receptor antagonist, blocking the effects of histamine, a natural chemical messenger released by the immune system in response to allergens.

This medication is designated as a second-generation compound, distinguishing it from older, first-generation drugs due to its pharmacological profile. The compound is designed to minimally cross the blood-brain barrier. The key conclusion for patients is that this design enables the essential non-sedating action, allowing individuals to manage the typical discomfort of allergy symptoms without the substantial drowsiness often associated with previous antihistamine types. Its general purpose is clinically recognized for providing effective relief by stabilizing the body's reaction during periods of histamine overproduction.


What Is the Composition and Origin of Deline?

The composition of Deline centers on the single, synthetic compound Desloratadine, classifying the product as a monotherapy medication. Desloratadine is derived as the principal active metabolite of the precursor compound, loratadine. Desloratadine is a highly selective H1-antagonist. The patient-friendly conclusion from this fact is that the drug is already in its fully active form when taken, which contributes to a direct and reliable action against the physical manifestations of allergic symptoms.

As a finished product, Deline is available for oral administration in several dosage forms, including the film-coated tablet, a standard tablet, and an oral solution. The solution form is frequently positioned for pediatric patients, featuring an aqueous vehicle which may be flavored to enhance compliance. This availability of liquid and solid dosage forms ensures accessibility for various patient groups, addressing a key practical requirement for managing chronic or seasonal allergic issues.

What side effects are possible with Deline?

Possible side effects and safety information

The safety profile of Deline (desloratadine), a second-generation antihistamine, is characterized by regulatory-classified adverse events reported during clinical development and post-marketing surveillance. In studies involving adults and adolescents, adverse effects were generally reported at rates similar to placebo.


Officially Classified Adverse Reactions

The following effects were reported in adult and adolescent patients aged 12 years and older as Common (may affect up to 1 in 10 people) in official regulatory documents:

  • Nervous System Disorders: Headache
  • Gastrointestinal Disorders: Dry mouth
  • General Disorders: Fatigue

Post-Marketing and Serious Adverse Reactions

Adverse reactions observed during post-marketing use are typically listed as Very Rare or Frequency Not Known and span several System Organ Classes (SOCs). Serious adverse reactions documented in regulatory sources include severe hypersensitivity reactions (such as anaphylaxis and angioedema) and effects on the Hepatobiliary Disorders (e.g., hepatitis, jaundice) and Cardiac Disorders (e.g., QT prolongation, arrhythmia).

Other notable SOC-classified effects include Nervous System Disorders (dizziness, seizures, insomnia), Psychiatric Disorders (hallucinations, aggression), and Metabolism and Nutrition Disorders (increased appetite, weight gain).


Safety Considerations for Special Populations

Official labeling advises caution for use in patients with severe renal insufficiency or severe hepatic impairment due to the potential for increased drug exposure. Specific adverse events, such as diarrhea, fever, and insomnia, were reported more frequently in infants (6 to 23 months) receiving the oral solution compared to placebo. An increased incidence of new-onset seizures has been reported in post-marketing safety data, advising caution in patients with a history of seizures.

Regulatory documents also note that while the influence on the ability to drive or use machinery is generally negligible, patients should be aware of the rare possibility of somnolence.

Overdose and Emergency Response

In cases of suspected overdose involving Deline (Desloratadine), regulatory authorities mandate that immediate medical attention must be sought.

Documented Overdose Presentations

Official labeling indicates that the adverse event profile observed in an overdose situation is generally similar to that seen with therapeutic doses, but the magnitude of the effects can be higher. In clinical trials, no clinically relevant effects were observed even with daily doses up to nine times the recommended strength.

However, post-marketing surveillance reports have documented the potential for more serious manifestations, which include:

  • CNS Effects: Increased somnolence, dizziness, insomnia, psychomotor hyperactivity, and seizures (reported in patients with and without a known seizure disorder).
  • Cardiac Effects: Tachycardia (fast heartbeat) and palpitations.
  • Gastrointestinal Effects: Nausea, vomiting, dyspepsia, and abdominal pain.

Population-specific notes highlight that the magnitude of effects may be increased in the pediatric population, with reports of abnormal behavior and aggression.

Required Emergency Actions

The management of Desloratadine overdose should be handled by a healthcare professional. Official guidance requires that standard measures to remove unabsorbed active substance should be considered.

Symptomatic and supportive treatment is recommended by regulatory authorities. It is formally stated that no specific antidote is known for Desloratadine. Additionally, the drug is not eliminated by hemodialysis.

Therapeutic Uses of Deline

Deline is commonly used to help with symptoms related to heightened physiological activity across multiple therapeutic domains. It is primarily applied for conditions involving episodic or fluctuating manifestations of allergy, where additional symptomatic support is needed.

Managing Seasonal and Year-Round Upper Respiratory Symptoms

Deline is generally used in addressing allergic rhinitis, a condition characterized by periods of heightened symptoms, including persistent sneezing, rhinorrhea (runny nose), and nasal congestion. It helps address symptom clusters that may become intense or disruptive during peak seasons or due to perennial exposure. This provides support that helps ease the overall symptom burden.

Control of Chronic Hives and Dermatological Itching

The medication is relevant for easing difficult-to-tolerate skin discomfort, primarily in the management of Chronic Idiopathic Urticaria (CIU), or long-term hives. It provides symptomatic support that helps ease distressing skin symptoms by controlling severe pruritus (itching) and reducing the size and frequency of wheals (hives/welts). This may assist with maintaining functional stability and supports general well-being during symptomatic phases.

Supporting Ocular Comfort and Daytime Function

Deline also helps manage ocular symptoms, such as itchy eyes and excessive tearing, that interfere with daily functioning. The non-sedating action generally helps patients receive supportive relief for all domains without the substantial cognitive strain associated with older compounds. This contributes to improved day-to-day comfort, especially when maintaining performance is relevant.


Category of Use: Support for Multi-Domain Symptoms Deline is commonly used to help with the full range of histamine-driven allergic symptoms, offering supportive relief across the nasal, ocular, and dermatological domains.

Regulatory References

  1. NIH MedlinePlus overview of Desloratadine

Eligibility and Restrictions for Use

Official Eligibility Profile: Who Can and Cannot Use Deline?

The population eligibility for Deline is defined by governmental regulatory documents, establishing absolute exclusions and conditions that require restricted use.

Category Official Regulatory Classification
Populations for whom use is contraindicated Patients with known hypersensitivity to desloratadine, its precursor loratadine, or any ingredient in the formulation.
Populations for whom use is not recommended Pregnant women and breastfeeding women (as desloratadine is excreted into breast milk). Safety and effectiveness are not established for infants less than 6 months of age.
Age-related eligibility Approved for Adults and Adolescents 12 years of age and older. Use is established for children from 6 months of age (for specific formulations).
Eligibility-related restrictions Use requires caution in patients with a medical or familial history of convulsions or seizure disorders.
Organ Function Restrictions Use requires caution in adults with severe renal impairment or hepatic impairment due to altered drug clearance.

The official profile specifies these constraints across age groups, physiological states, and medical history. These statements formally define who is excluded from using the medicine and the conditions under which the medicine must be administered with caution.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Deline

Property Value
Medicinal product categories with documented interactions Antifungals, Macrolide Antibiotics, Histamine H2-Receptor Antagonists, and Selective Serotonin Reuptake Inhibitors.
Specific interacting medicines (if explicitly listed) Ketoconazole, Erythromycin, Azithromycin, Cimetidine, Fluoxetine.
Mechanistic basis of interactions Pharmacokinetic interaction resulting in increased plasma concentrations (AUC and Cmax) of desloratadine and its active metabolite.
Timing-based interaction rules None. No mandatory administration timing rules requiring separation are documented in the regulatory label.
Population-specific interaction notes Increased exposure is documented in patients with Severe Renal Impairment and Hepatic Impairment. Higher concentrations are also observed in a subset of the population identified as slow metabolizers.
Interaction-related restrictions No specific drug-drug combinations are formally prohibited (contraindicated) based on interaction risks in the monotherapy label.
Property Value
Interaction severity classification Interactions are classified as resulting in increased exposure without leading to clinically relevant changes in the safety profile (e.g., ECG or vital signs).
Regulatory basis FDA Prescribing Information, EMA Summary of Product Characteristics (SmPC), and national health authority monographs.
Interaction-context constraints Food and Grapefruit Juice have no effect on drug bioavailability. Alcohol co-administration does not potentiate alcohol-mediated CNS impairment.

Official Interaction Statements:

  • Co-administration with Ketoconazole, Erythromycin, Azithromycin, Cimetidine, and Fluoxetine results in a pharmacokinetic interaction characterized by an increase in the plasma concentrations of Desloratadine.
  • Despite documented increased drug exposure, formal regulatory studies determined that there were no clinically relevant changes observed in the safety profile.
  • The regulatory label explicitly states that food and grapefruit juice do not affect the bioavailability of the medicine, and alcohol does not potentiate CNS impairment.
  • Exposure (AUC) to Desloratadine is significantly increased in patients diagnosed with severe renal impairment and hepatic impairment.

Connection to the overall interaction profile

The official interaction profile is structured around defined pharmacokinetic outcomes, showing that while co-administration with specific agents increases plasma exposure, this effect is not associated with documented, clinically significant changes to the safety profile. No restrictions are placed on administration with food, grapefruit juice, or alcohol, and no mandatory timing separation rules are required for interacting medicines.

Mechanism of Action

Deline is a fixed-dose combination product containing the components Acebrophylline and Acetylcysteine. The mechanism involves two distinct pathways that converge to modulate lung function.

Acebrophylline acts as a phosphodiesterase (PDE) inhibitor, primarily targeting PDE enzymes within bronchial smooth muscle cells. Inhibition of PDE prevents the breakdown of cyclic adenosine monophosphate (cAMP) to AMP. The consequent intracellular accumulation of cAMP activates Protein Kinase A (PKA), which ultimately leads to a reduction in the phosphorylation of myosin light chain kinase. This intracellular cascade results in a decrease in cytosolic calcium concentration, culminating in relaxation of the airway smooth muscle and subsequent dilation of the bronchi and bronchioles. Additionally, Acebrophylline modulates the release of inflammatory mediators.

Acetylcysteine functions as a mucolytic agent. It interacts directly with the disulfide bonds present in the mucopolysaccharide fibers of respiratory mucus. This interaction causes the bonds to break, leading to depolymerization of the mucoproteins. The resulting decrease in mucus viscosity and elasticity facilitates its clearance from the respiratory tract. The system-level physiological consequence of this dual mechanism is the concurrent modulation of airway resistance via smooth muscle relaxation and improved mucociliary clearance.

Dosage and Administration Information

How to Use Deline: Administration Guidelines

This section outlines established administration protocols for Deline (desloratadine), focusing strictly on how the medicine is used.


Administration Scope

The method for taking Deline is by the oral route. The medication is formulated as film-coated tablets, orally disintegrating tablets (ODTs), and an oral solution.

Feature Administration Instruction
Standard Adult Dose 5 mg taken once daily.
Timing in Relation to Meals May be administered with or without food.
Frequency Pattern Once daily (OD) for all approved indications.
Duration Pattern Use may be intermittent (short-term, as symptoms are present) or persistent (long-term, for chronic conditions).

Population-Specific Use and Preparation

Dosage adjustments exist for specific patient populations. For adults with renal or hepatic impairment, a starting dose of 5 mg every other day is utilized to manage systemic exposure.

Pediatric Dosing is determined by age, typically utilizing the oral solution formulation; for example, infants aged 6 to 11 months are administered 1 mg once daily.

Administration instructions specify that the oral solution is measured using a calibrated device. ODTs are handled carefully, placed on the tongue to disintegrate, and taken immediately after removal from the blister. If a dose is missed, it is taken as soon as it is remembered, with subsequent doses returning to the regular once-daily schedule.

These instructions establish a standardized framework for the use of Deline, outlining the dose and method of administration.

Recent Clinical Evidence

Research evidence / Overview of Studies for Deline

Evidence for Symptom Relief in Allergic Rhinitis

Research for Deline was studied for conditions characterized by fluctuating or episodic manifestations such as allergic rhinitis (hay fever) and relies on various types of studies. Researchers primarily used short-term, randomized, placebo-controlled trials (RCTs) to explore how symptoms change over time. These studies were conducted across large groups of adults and adolescents. In these trials, researchers primarily monitored patient-reported outcomes describing perceived discomfort. Outcomes measured included the Total Symptom Score (TSS) and Total Nasal Symptom Score (TNSS), which monitored outcomes related to systemic or functional imbalance like sneezing and nasal itching. Research was studied for outcomes linked to inflammatory or irritative states, but findings indicate limited insight into long-term functional changes.


Evidence for Management of Chronic Hives (Urticaria)

Research exploring Deline was studied for chronic hives, or Chronic Idiopathic Urticaria (CIU), primarily used medium-term RCTs, typically conducted over four to six weeks. These trials focused on adult and adolescent populations, as well as children who had conditions involving periods of heightened symptoms. Studies monitored several key measurement axes. They examined outcomes related to physical discomfort, such as the change in the Pruritus (itching) Severity Score, and the overall Urticaria Activity Score (UAS). Studies report how symptoms evolved in the observed populations during the study period. However, follow-up durations were limited, and data for long-term effects are not fully established past the typical six-week trial duration in controlled settings.


Examining Long-Term Studies and Follow-up Data

The majority of high-quality evidence used to explore outcomes related to physical discomfort is derived from short-term controlled trials. Long-term effects are not fully established by randomized controlled trials. When examining long-term data, researchers rely mainly on observational settings and post-marketing surveillance reports. These studies describe patterns in the general population when the compound was observed in daily-life settings over extended periods. Therefore, there is limited information for long-term outcomes, and the sustained pattern of measured change after the study period concludes is not fully established.


Gaps in the Evidence and Areas of Uncertainty

Studies contribute to the broader evidence landscape regarding what has been observed so far, but there are several areas where the evidence base remains limited. Data for certain groups remain insufficient, including those with severe symptoms or very older adults. Evidence quality varies across studies, particularly when research examines objective markers, such as inflammatory cell levels. The clinical significance of changes measured in these biomarkers is not fully understood. Comparative evidence is lacking for many clinical settings.

Key Studies & References

  1. Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994) - ClinicalTrials.gov NCT00757562
  2. Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472) - ClinicalTrials.gov NCT00805324

Frequently Asked Questions (FAQ)

Common questions about Deline (FAQ)


Q: How does Deline differ from similar medications for the same condition?

As a second-generation antihistamine, Deline is described as different from older (first-generation) medications because it is designed to be non-sedating. Official product information notes it minimally crosses the blood-brain barrier, which is why substantial drowsiness is not commonly associated with its use. The medication is also an active form (metabolite) of another compound, loratadine, which contributes to a reliable action against the physical manifestations of allergic symptoms.


Q: Does Deline only treat the symptoms, or does it address the underlying cause?

Official documents describe Deline's action as blocking the effects of histamine. Histamine is the natural chemical messenger in the body that causes allergy symptoms. By acting as a selective peripheral H1-receptor antagonist, the medication is described as relieving these physical symptoms mediated by histamine.


Q: Is Deline a brand name, and are there generic versions available?

Deline is the proprietary brand name for the active ingredient desloratadine. Regulatory documents specify the drug’s composition and active component. However, official regulatory product information does not typically list or guarantee the current availability of generic alternatives on the market.


Q: Are there any specific vitamins, supplements, or herbal remedies that interact with Deline?

The official interaction map explicitly details drug interactions with certain prescription medicines, such as Erythromycin and Cimetidine. However, the regulatory documentation does not generally provide specific information regarding interactions with most vitamins, supplements, or herbal remedies.


Q: Does Deline interact with common over-the-counter pain relievers (like ibuprofen or acetaminophen)?

Official product information focuses on pharmacokinetic interactions documented with specific prescription compounds. The regulatory list of interacting medicines does not explicitly mention common over-the-counter pain relievers like ibuprofen or acetaminophen.


Q: Are there specific medical conditions (like heart disease or diabetes) that might prevent someone from using Deline?

Official labeling defines conditions that require caution or exclude use. The official labeling states that Deline is contraindicated for individuals with known hypersensitivity to the drug or its precursor, loratadine. Additionally, use requires caution in patients with a medical history of convulsions or a diagnosis of severe renal or hepatic impairment.


Q: What were the main outcomes or success rates cited in the original clinical trials for Deline?

Clinical trials for Deline focused on measuring changes in patient-reported symptom severity scores. For chronic hives, for example, researchers measured the Urticaria Activity Score (UAS). Studies report changes in these scores consistent with observed symptom relief, but a single overall 'success rate' is not typically quantified in the regulatory summaries.


Q: Why do some patients report feeling no change while taking Deline?

Studies and official product information indicate that individual responses to the medication can vary. It is noted that a subset of the population is classified as slow metabolizers, which can result in altered exposure (drug concentration) in the blood.

How should Deline be stored and disposed of?

Storage and Disposal Conditions for Deline

The storage of Deline (desloratadine) must align strictly with the official regulatory labeling to ensure stability and safety.

Required Storage and Handling

Condition Regulatory Requirement
Temperature Do not store above 30 C (86 F) and keep from freezing
Protection Must be protected from light and stored away from excess moisture
Container Rule Keep the medicine in its container and tightly closed
Child Safety Mandatory to keep out of the sight and reach of children

Official Disposal Instructions

Any unused or expired product must be disposed of in accordance with local requirements to prevent environmental contamination. The best method is to use a community drug take-back program. If one is unavailable, the medicine can be discarded in household trash after being mixed with an undesirable substance (e.g., dirt or coffee grounds) and sealed in a container, following the procedure recommended by the FDA. Do not throw away any medicines via wastewater.

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

Available in countries:

Equivalent of Deline found in:

A-Z Index: