Delortan

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Delortan

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 Delortan

Quick Facts

Property Description
Active ingredient Desloratadine
Form Film-coated tablet, oral solution / syrup
Pharmacological class Second-generation antihistamine
Common use Allergy symptoms (high-level purpose)
Origin Synthetic compound (active metabolite)

What Type of Medicine is Delortan?

Delortan is a pharmaceutical preparation classified as a second-generation non-sedating antihistamine, containing the single active ingredient Desloratadine. This synthetic compound is recognized as the major active metabolite of Loratadine, confirming its advanced pharmacological status. It is positioned as a long-acting selective H₁-receptor antagonist. This specific action is clinically recognized for providing effective, sustained control over allergic manifestations.


Composition and Available Forms

The composition of Delortan is a single-ingredient product, featuring only Desloratadine along with pharmaceutical excipients. The medicine is designed for the oral route of administration and is offered in patient-appropriate dosage forms including the solid film-coated tablet and a liquid oral solution or syrup. The liquid formulation is a key differentiating factor, making it suitable for pediatric patients or others who require precise liquid dosing.


What is Delortan's General Purpose?

The general purpose of Delortan is to achieve symptomatic relief by acting as a selective peripheral H₁-receptor antagonist. This mechanism interrupts the action of histamine, the key chemical mediator released during an allergic reaction. This specific action allows the medicine to effectively control allergic manifestations such as itching, swelling, and increased mucous secretion. This active ingredient is used for its anti-allergic properties in providing control over allergic discomfort.

Regulatory References

  1. EMA: Desloratadine EPAR Overview

What side effects are possible with Delortan?

Possible Side Effects and Safety Information for Delortan

Adverse Reactions Summary

In clinical trials, undesirable effects with Delortan (desloratadine) at the recommended dose were reported in a small percentage of patients (3%) in excess of those treated with placebo. The most frequent adverse reactions observed were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%). In adolescents, headache was the most common side effect.

Serious and Post-Marketing Adverse Reactions

Post-marketing surveillance has identified very rare cases of serious adverse reactions, including severe allergic reactions (e.g., anaphylaxis and angioedema) and seizures. Other very rare events include hepatitis, elevated liver enzymes, jaundice, hallucinations, psychomotor hyperactivity, and cardiac events like tachycardia and palpitations.

Adverse reactions reported with a frequency classified as Not Known (cannot be estimated from available data) include weight gain, increased appetite, depressed mood, abnormal/aggressive behavior, and photosensitivity.

Safety Restrictions and Precautions

  • Contraindications: The medicine is contraindicated in individuals with known hypersensitivity to the active substance, any excipients, or to loratadine.
  • Population-Specific Caution: Caution is recommended in patients with pre-existing severe renal or hepatic impairment. Due to an observed increased incidence of new-onset seizures, Delortan should be administered with caution to patients, particularly young children, with a personal or family history of seizures.
  • Pregnancy and Breast-feeding: Use during pregnancy and breast-feeding is generally not recommended as a precautionary measure.
  • Alcohol Interaction: While clinical trials suggest no potentiation of performance impairment, cases of alcohol intolerance and intoxication have been reported during post-marketing use, and caution is advised with concomitant alcohol intake.
  • Driving/Machine Use: Although most people do not experience drowsiness, patients are advised to assess their individual response before engaging in activities requiring mental alertness, such as driving or operating machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the overdose profile for Delortan (desloratadine) as typically resulting in symptoms similar to those experienced with therapeutic doses, but potentially with a higher magnitude of effects. Clinical studies evaluating multi-dose exposure up to nine times the recommended daily dose (45 mg) did not show any clinically relevant serious effects.


Immediate Actions

Urgent medical attention must be sought immediately in the event of any suspected overdose, even if no symptoms are currently present. Contact a Poison Control Centre, doctor, or pharmacist right away. This applies to all individuals, including the pediatric population.

Management and Monitoring

Management of an overdose is primarily symptomatic and supportive. Following an acute overexposure, healthcare providers will consider standard clinical measures to remove any unabsorbed drug from the body. Because desloratadine is not eliminated by haemodialysis, its removal from the bloodstream via this method is ineffective in the overdose context. Continued monitoring and supportive care are essential until the individual's condition is stable. The general adverse event profile observed in overdosage is similar to that documented for recommended therapeutic use.

Therapeutic Uses of Delortan

What Delortan Treats: Main Uses and Benefits

Delortan is a medication commonly used to provide symptomatic relief and assists in addressing fluctuating symptoms in situations involving allergic discomfort. Its application is relevant in therapeutic contexts where supportive relief for specific allergic conditions is sought, particularly Allergic Rhinitis (including Hay Fever) and Chronic Idiopathic Urticaria (hives). It is used to support these two main therapeutic domains.

This medication helps address the group of symptoms that cluster in the nasal, ocular, and cutaneous domains. Specifically, it assists with managing sneezing, runny nose, nasal congestion, itchy eyes, and the distressing itching and associated swelling of hives. This support is typically applied in situations where discomfort is driven by exposure to inhalant allergens or chronic internal allergic processes.

“The application of this medication is aimed at easing the impact of disruptive symptom manifestations on routine activities and general comfort.”

This use contributes to easing day-to-day comfort during periods of heightened symptoms and helps maintain a sense of stability when symptoms are more noticeable, by easing the overall symptom load of persistent allergic discomfort.

Quick Fact: Support for Allergic Symptoms
Primary Focus Nasal, Ocular, and Skin Manifestations
Usage Scenario Seasonal Episodes and Chronic Management
Patient Benefit Supports coping with difficult episodes

Regulatory References

  1. NIH DailyMed overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Delortan?

The eligibility to use Delortan is determined by official population rules established in government regulatory documents.

Eligibility Status Populations/Conditions
Contraindicated Patients with known hypersensitivity to Desloratadine or to the related drug, Loratadine. Certain tablet formulations are also contraindicated in patients with rare hereditary problems like total lactase deficiency.
Approved Age Groups Use is established for adults and adolescents ge 12 years. The oral solution is approved for children ge 6 months of age.

Conditional Use and Restrictions

Official labeling requires caution and may necessitate dosage adjustment (conditional use) for adults with severe renal impairment or severe hepatic impairment. Use is officially not established for infants under 6 months of age. Caution is also advised when administering the medicine to patients with a personal or familial history of seizures.

Pregnancy and Lactation Status

Delortan use during pregnancy is not recommended as a precautionary measure. For breastfeeding women, a decision must be made to either discontinue nursing or discontinue the medication, as the substance is excreted into breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Delortan (Desloratadine) is defined by officially documented pharmacokinetic changes resulting from co-administration with other medicines and conditions that alter systemic exposure.

Pharmacokinetic Interaction Patterns

Interacting Medicine Official Regulatory Finding
Ketoconazole, Erythromycin Co-administration leads to an increase in the plasma concentrations of Desloratadine and its active metabolite.
Cimetidine, Azithromycin Co-administration is documented to increase systemic exposure (AUC/Cmax).
Fluoxetine Documented to increase plasma concentrations of Desloratadine and its active metabolite.

Despite these documented increases in drug exposure, controlled clinical studies found no clinically relevant changes in the safety profile of Desloratadine when co-administered with these prescription medicines.


Restrictions and Other Substance Interactions

Administration of Delortan is restricted if a patient has known hypersensitivity to the product, to the active ingredient, or to its parent compound, Loratadine. There are no formally documented timing requirements, and the dose may be taken with or without food as its bioavailability is not affected. Regarding alcohol, clinical trials indicate that Desloratadine does not potentiate the performance-impairing effects of alcohol. However, post-marketing surveillance reports recommend caution with concomitant alcohol intake due to reported cases of alcohol intolerance and intoxication.

Furthermore, official prescribing information notes that overall drug exposure is significantly increased in patients with severe renal impairment and hepatic impairment, which affects the pharmacokinetic profile in these specific populations.

Mechanism of Action

Selective H1 Receptor Antagonism

Delortan (desloratadine) functions as a selective peripheral H1 receptor antagonist . The molecule competes with naturally released histamine for binding sites on H1 receptors located primarily on vascular endothelial cells, smooth muscle cells, and mast cells. This competitive interaction prevents histamine from coupling to the receptor, thereby suppressing the initiation of the Gq protein signaling sequence and subsequent intracellular calcium mobilization.

Modulation of Inflammatory Mediator Cascade

Inhibition of H1 receptor activation modifies early molecular steps that shape downstream physiological events in peripheral tissues. By blocking this initial signaling cascade, the molecule attenuates the consequences of excessive histamine-mediated signaling, which includes modifying the threshold for increased vascular permeability and contraction of specific smooth muscle groups. This pathway modulation contributes to the regulation of exaggerated physiological responses.

Minimal Central Nervous System Engagement

The molecule exhibits poor affinity for transport across the blood-brain barrier. This limited passage results in minimal interaction with central H1 receptors, thereby focusing the pharmacodynamic effect predominantly on targeted peripheral signaling pathways.

Dosage and Administration Information

How to Use Delortan: Official Administration Guidelines

Delortan (desloratadine) is administered through the oral route. Its usage pattern is based on a fixed once-daily frequency for all approved indications and standard populations. The medicine may be taken with or without food, offering flexibility in the timing of the daily dose.


Standard Dosing and Frequency

The standard prescribed dose for adults and adolescents aged 12 years and over is 5 mg once daily. Dosing for younger pediatric patients is lower, reflecting age-based requirements:

  • Ages 6 to 11 years: 2.5 mg once daily.
  • Ages 12 months to 5 years: 1.25 mg once daily.

Administration Requirements

Dosage Form Procedural Requirement
Film-coated tablet Must be swallowed whole, typically with water.
Oral solution/syrup Requires a calibrated measuring device to ensure the exact 1.0 mg to 2.5 mg volume is administered.
Orally-disintegrating tablet (ODT) Must be placed on the tongue to dissolve and should be taken immediately after removal from its packaging.

Duration and Special Populations

Treatment duration varies based on the pattern of the allergic condition being addressed. For intermittent conditions (e.g., symptoms occurring less than four days per week), use may be a short course, initiated upon the appearance of symptoms and stopped once they are resolved. For persistent conditions, continuous daily use is the model for the duration of the exposure period.

In adult patients with hepatic or renal impairment, the initial dosing frequency is reduced to 5 mg every other day. If a dose is missed, the instruction is to take it as soon as possible, then return to the regular schedule, without taking a double dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Delortan

Evidence for Symptom Relief in Allergic Rhinitis

The initial research for Delortan was used in studies exploring how symptoms change over time for conditions where symptoms may vary in intensity, such as seasonal and perennial allergic rhinitis (AR). This evidence base includes a large number of short-term, placebo-controlled clinical trials and subsequent systematic reviews. Researchers examined outcomes related to physical discomfort by measuring changes in standard symptom scales, including runny nose, sneezing, nasal congestion, and eye-related itching or tearing. Studies also explored outcomes reflecting daily functioning or activity level.

Research highlights changes measured during the study period, reporting how symptoms evolved in the observed populations, which included Adults and Adolescents. Findings describe patterns observed in these studies, reporting that symptom scores evolved differently in the measured population compared to when a placebo was administered. The evidence contributes to understanding symptom patterns during those short-term periods of heightened symptom activity.

Evidence for Symptom Relief in Chronic Urticaria

Delortan was evaluated in research contexts involving fluctuating or unstable symptoms linked to chronic idiopathic urticaria (CIU), a condition presenting with cycles of stability and flare-ups. Key research involved controlled trials and observational studies where researchers monitored outcomes related to physical discomfort in the skin. Studies explored outcomes capturing phases of heightened symptom activity by measuring specific changes in itching intensity and the characteristics of the hives (size and number) in Adults with chronic CIU. Research contributes to understanding symptom patterns and short-term changes in both the intensity of the itching and the appearance of the hives.

Where Research Gaps and Uncertainty Remain

The evidence highlights what is known and what is still uncertain. One main limitation is the lack of extensive, controlled research exploring very long-term outcomes. As noted, follow-up durations were limited in many core trials, meaning data for the full duration of symptom patterns over time is limited. Furthermore, systematic reviews have noted some heterogeneity (variability) in the specific design and patient groups included in the older research. Research does not indicate whether an individual will respond similarly to the group patterns observed.

Frequently Asked Questions (FAQ)

Common questions about Delortan (FAQ)

Q: What medical conditions is Delortan used to treat?

According to official regulatory documents, Delortan is indicated for the relief of symptoms associated with allergic rhinitis, which includes both seasonal (e.g., hay fever) and perennial forms. It is also used for the symptomatic treatment of chronic idiopathic urticaria, a condition often characterized by hives or itching that occurs without a known cause.

Q: Which other drugs should not be taken with Delortan due to interactions?

Regulatory information states that Delortan is strictly contraindicated if a patient has a known hypersensitivity to the drug or to its parent compound, Loratadine. Although some other medicines (like Ketoconazole and Erythromycin) may increase the level of Delortan in the blood, official labeling indicates that these drugs are not typically cited as contraindications.

Q: What should I do if I experience a serious or severe side effect?

Serious adverse reactions, such as swelling of the face, throat, or tongue, difficulty breathing, or seizures, have been reported in post-marketing surveillance. Regulatory guidance suggests that if a serious reaction occurs, the medication should be stopped. Official labeling states that severe allergic reactions or other serious adverse events warrant immediate contact with emergency services or a healthcare professional.

Q: Is Delortan available over-the-counter (OTC) or only by prescription?

The availability of Delortan is subject to local regulatory laws and may vary. In the United States, it is typically available by prescription only. However, in certain other regions, specific formulations or lower-dose packages may be approved for sale over-the-counter (OTC) without a prescription.

How should Delortan be stored and disposed of?

How to Store and Dispose of Delortan?

The storage and disposal of Delortan (desloratadine) must strictly adhere to regulatory requirements to ensure product stability and safety.

Storage Requirements

Delortan tablets must be stored below 30°C, and the oral solution should be stored below 25°C and must not be frozen. All forms require protection from moisture and light. The medicine must be kept in its original package/container and the oral solution bottle should be kept tightly closed. A mandatory instruction is to keep the medicine out of the sight and reach of children.

Disposal Instructions

Any unused or expired product must be disposed of in accordance with local requirements. Delortan must not be thrown into wastewater or household waste unless specifically advised by a local take-back scheme. Proper disposal is required to prevent environmental contamination.

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

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