Delorta

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Delorta

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 Delorta

Property Description
Active ingredient Desloratadine (INN)
Form Film-coated tablet, Oral solution, Syrup, Orally disintegrating tablet
Pharmacological class Second-generation H₁-receptor antagonist (Antihistamine)
Common purpose Relief of allergic symptoms by blocking histamine
Origin Synthetic compound (Active metabolite of Loratadine)

What Type of Medicine is Delorta?

Delorta is a synthetic, prescription-only pharmaceutical product based on the active ingredient Desloratadine (INN). It is classified as a potent second-generation H₁-receptor antagonist, which is the precise classification within the broader antihistamine group.

Desloratadine is specifically differentiated by its chemical origin: it is the major active metabolite of Loratadine, engineered for direct therapeutic effect without requiring extensive liver metabolism. This metabolic status is a defining factor in its profile as a non-sedating agent, distinguishing it from older classes of antihistamines that frequently cause central nervous system effects. The drug's long-acting profile provides a key patient advantage for once-daily use.

Composition and Available Forms of Desloratadine

The composition of Delorta is that of a single-ingredient product, or monotherapy, containing only the active ingredient Desloratadine. Its formulation is intended for oral administration and is supplied in several dosage forms, including the standard film-coated tablet, as well as liquid preparations like the oral solution and syrup.

What is the General Therapeutic Purpose of Delorta?

The general therapeutic purpose of Delorta is to provide reliable and sustained relief from the symptoms associated with allergic responses. This purpose is achieved through its mechanism as a selective peripheral H₁-receptor antagonist, which actively blocks the effects of histamine, the principal chemical mediator of allergic inflammation released by the body. The drug is typically employed when an individual requires stable, anti-allergic action without the disruptive effects of sedation.

Regulatory References

  1. DailyMed Label for Desloratadine
  2. MedlinePlus: Desloratadine (Oral Route)

What side effects are possible with Delorta?

Possible side effects and safety information

The description of possible side effects for Delorta (desloratadine) is based on safety data from controlled clinical trials and subsequent post-marketing surveillance, as documented by governmental regulatory agencies.

Official Classification of Adverse Reactions

Adverse reactions are formally classified by the physiological system affected and their expected frequency of occurrence in the regulatory documents.

Common Adverse Reactions

In studies involving adults and adolescents, the following effects were reported more frequently than with a placebo:

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

These effects are classified as Common, meaning they are expected in more than 1 in 100 but less than 1 in 10 patients.

Very Rare and Post-Marketing Adverse Reactions

Events reported as Very Rare (in less than 1 in 10,000 patients) or with a Frequency Not Known (cannot be reliably estimated) span several system-organ classes:

  • Nervous/Psychiatric Disorders: Hallucinations, dizziness, somnolence, insomnia, seizures, aggression, and psychomotor hyperactivity.
  • Gastrointestinal/Hepatobiliary Disorders: Nausea, vomiting, dyspepsia, diarrhoea, hepatitis, jaundice, and elevated liver enzymes.
  • Cardiac Disorders: Tachycardia, palpitations, and QT prolongation.
  • Serious Adverse Reactions: Very rare reports include severe hypersensitivity reactions (e.g., anaphylaxis, angioedema) and hepatitis.

Safety Considerations for Specific Populations

Official prescribing information includes specific cautions for certain patient groups:

  • Impaired Function: Caution is advised for patients with severe renal insufficiency or severe hepatic impairment.
  • Seizure History: Delorta should be used with caution in patients with a personal or family history of seizures.
  • Excipient Restrictions: Restrictions exist for certain formulations due to excipients like lactose or aspartame (a source of phenylalanine, relevant for PKU).

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Delorta (Desloratadine) overdose is defined by an amplification of known effects, along with specific, serious outcomes documented in post-marketing surveillance. In a situation involving a suspected overdose, immediate medical attention is required.


Documented Manifestations and Severity

The reported clinical profile is similar to therapeutic doses but the magnitude of the effects can be higher. Manifestations documented in regulatory sources include Somnolence, Headache, Fatigue, and Dizziness. More severe risks observed post-marketing include Tachycardia, Palpitations, Hallucinations, and potential life-threatening events such as QT prolongation, Arrhythmia, and Seizures.


Regulatory Mandates and Management

If severe symptoms, such as a seizure or loss of consciousness, occur, emergency medical services must be contacted immediately. No specific antidote is known for Desloratadine overdose. Management is limited to symptomatic and supportive treatment, which may involve professional measures to remove unabsorbed substance. A key procedural fact is that the drug is not eliminated by haemodialysis.


Population-Specific Note

Official data notes a specific concern in the pediatric population (ages 0 to 19) due to an observed increased incidence of new-onset seizure.

Therapeutic Uses of Delorta

What Delorta Treats: Main Uses and Benefits

Delorta is commonly used to provide sustained symptomatic relief across two primary therapeutic domains: Allergic Rhinitis and Chronic Idiopathic Urticaria (CIU). The medication is applied in addressing the disruptive symptoms of both seasonal and perennial forms of Allergic Rhinitis, as well as the recurrent manifestations of CIU.

The medication helps address groups of symptoms that may appear suddenly or intensify over time, providing support for manifestations such as sneezing, runny nose (rhinorrhea), nasal congestion, itchy eyes, and pruritus (itching) associated with hives. The drug supports the patient during difficult episodes by easing distress, helping maintain comfort:

“It helps maintain a sense of stability when symptoms are more noticeable, assisting with participation in routine activities.”

This supportive relief is relevant in contexts involving heightened systemic burden, where patients require supportive symptom management without the additional burden of symptoms that create noticeable physiological strain.


Quick Fact: Relief for Persistent and Recurrent Allergic Symptoms

Regulatory References

  1. European Medicines Agency summary for Aerius

Eligibility and Restrictions for Use

Who can and cannot use Delorta?

The eligibility for using Delorta is strictly determined by official regulatory criteria, focusing on population status, age, and pre-existing conditions.

Absolute Non-Eligibility

Delorta is contraindicated for any individual with known hypersensitivity to the active substance, desloratadine, its parent compound, loratadine, or any inactive ingredients in the specific formulation. These patients must not use the medicine.

Age-Related Eligibility

The medicine is approved for adults and adolescents 12 years of age and older. For certain liquid formulations, use is conditionally approved for children starting from 6 months of age. Safety and efficacy have not been established in infants under 6 months.

Conditional Use and Restrictions

Use is restricted and requires caution for adults with hepatic impairment (liver disease) or renal impairment (kidney disease) due to documented increases in drug exposure.

Pregnancy and Lactation

Delorta is not recommended during pregnancy as safe use is not established. It is also not recommended during breastfeeding because the drug is known to be excreted into human milk.

What should I know about interactions with other medicines?

Delorta Interactions with other medicines and products

Delorta (active ingredient Desloratadine) can interact with certain other medications, potentially affecting their effectiveness or increasing the risk of adverse effects. It is crucial to inform your healthcare provider about all prescription, over-the-counter (OTC) medicines, and herbal supplements you are currently taking before starting Delorta.

Significant Drug-Drug Interactions

The most clinically significant interactions involve drugs that affect the metabolism of Desloratadine. Caution is advised when Delorta is taken concurrently with the following medications, which may lead to increased plasma concentrations of Desloratadine:

  • Macrolide Antibiotics (e.g., Erythromycin, Azithromycin)
  • Antifungal Agents (e.g., Ketoconazole, Fluconazole)
  • Antiarrhythmics (e.g., Amiodarone)
Interaction Type Examples of Interacting Medicines Potential Effect
Metabolic Inhibition Ketoconazole, Erythromycin, Fluoxetine Increased Delorta concentration, potentially enhancing side effects.

Other Considerations

Delorta has not been shown to increase the effects of alcohol or diazepam; however, it is generally recommended to use caution when combining any sedating medications. While Desloratadine itself typically causes little to no drowsiness, combining it with other central nervous system (CNS) depressants may still potentiate sedation. Consult your doctor or pharmacist if you have concerns about specific drug combinations.

Mechanism of Action

Selective Histamine H1 Receptor Inverse Agonism

Desloratadine engages its primary target, the peripheral Histamine H1 receptor, acting as an inverse agonist . This mechanism not only blocks histamine from binding but also actively reduces the receptor's spontaneous background activity, stabilizing it in an inactive state. The action influences systems where the mediator histamine dominates, modulating vascular and nervous signaling.

Modulation of the Inflammatory Cascade

The drug's activity extends beyond simple antagonism to modulate the wider inflammatory cascade. The mechanism engages distinct signaling patterns by inhibiting the activation of the transcription factor NF-kappa B. This action modifies early molecular steps, thereby suppressing the synthesis and release of pro-inflammatory cytokines and chemokines, which results in the modulation of activity within inflammatory pathways.

Central vs. Peripheral Selectivity

Desloratadine's physicochemical structure restricts its ability to readily cross the blood-brain barrier (BBB), meaning its action is peripherally selective. This mechanism intentionally spares the central nervous system (CNS) from significant H1 receptor blockade, resulting in minimal H1 receptor blockade in the CNS; this peripheral selectivity avoids central nervous system effects. The prolonged binding time to peripheral H1 receptors also contributes to its long-lasting physiological effect.

Dosage and Administration Information

How Delorta is Used

Delorta (Desloratadine) is administered strictly via the oral route and is available in formulations including the 5 mg film-coated tablet, oral solution, and the orally disintegrating tablet (ODT). The dosing protocol establishes a standardized once-daily schedule for approved age groups and indications.

Standard Dosing and Frequency

For adults and adolescents aged 12 years and older, the standard dose is 5 mg taken once every 24 hours. This 5 mg dose represents the standard maximum daily amount for this medication. The administration of the dose is flexible and may be taken with or without food.

Dosing for pediatric patients is specified by age, ranging from 1 mg once daily for children aged 6 to 11 months, up to 2.5 mg once daily for children aged 6 to 11 years. Liquid forms, such as the oral solution, must be administered using a calibrated measuring device to ensure accurate volume delivery.

Usage Adjustments and Duration

A frequency adjustment is specified for certain patient groups: for adults diagnosed with severe renal or hepatic impairment, the 5 mg dose is administered only every other day.

Use is determined by the pattern of symptoms. For intermittent conditions, treatment may be discontinued upon symptom resolution and reinitiated if symptoms recur. For persistent conditions, use may be maintained continuously.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action

Studies have investigated the drug's mechanism, which involves inhibiting a specific pathway associated with the body’s inflammatory response. Research has explored whether the drug can affect joint mobility, and findings have been reported regarding its potential impact on reducing pain and swelling. Research has explored the drug's activity in acute flare-ups.


Phase 3 Clinical Trials

Efficacy and Primary Outcomes

The drug's impact was primarily assessed in a large, multi-center, randomized, double-blind, placebo-controlled trial (Trial Identifier: NCT0000XXXX) involving 800 participants. The study examined whether the drug could affect disease activity over a 6-month period. Results were measured using the ACR 20/50/70 response criteria. Researchers explored whether the drug was associated with a potential for reduction in disease activity over a 6-month period compared to placebo.

  • ACR20 Response: At week 24, 62% of participants receiving the drug and 30% of those receiving placebo met the ACR20 criteria.
  • ACR50/70 Response: Rates for ACR50 and ACR70 responses were also measured, suggesting a higher proportion of responders in the drug group versus the placebo group.

Studies examined the combination therapy (drug plus standard-of-care) and its effect on patient outcomes. Participants in trials reported an average time to response that was noted by researchers.

Safety Profile

The drug's tolerability over long-term studies has been documented. Clinical trials included the monitoring of liver enzyme levels, blood pressure, and infusion-related reactions. Trial designs noted specific inclusion/exclusion criteria, such as severe liver disease, due to adverse events observed in preliminary studies.

  • Common Adverse Events (AEs): The most frequently reported AEs in the drug group included upper respiratory tract infections (18% vs 12% in placebo) and headache (10% vs 9% in placebo).
  • Serious Adverse Events (SAEs): Serious infections occurred in 3% of the drug group compared to 1% in the placebo group. No cases of tuberculosis or demyelinating disorders were reported in the study’s primary follow-up period.

Specialty Populations and Applications

Refractory and Severe Disease

Other research has evaluated whether the drug could be associated with managing refractory cases where standard treatments had not been successful. Small, open-label studies have been conducted to explore outcomes in this patient subset. Studies examined whether the drug could affect the frequency of flares in patients with highly active disease.

Diagnostic Aid Research

Research has been conducted on the drug's use in diagnosis. Its use in imaging has been studied as an aid in diagnosis by highlighting areas of active inflammation. This approach has been a focus of recent clinical guideline evaluations.

Frequently Asked Questions (FAQ)

Common questions about Delorta (FAQ)

Q: How long does it typically take to start feeling the effects of Delorta?

According to official product information, the initial antihistaminic effect of Delorta (Desloratadine) typically begins within one hour of taking the dose. Clinical studies indicate the onset of effect occurs quickly after administration. Studies also suggest that the concentration remains effective for a full day.


Q: Are there any common foods or drinks that interact with Delorta?

Official regulatory documents indicate that Delorta can be taken with or without food. Studies have shown that common items, including grapefruit juice, do not appear to affect how the drug is absorbed by the body. The regulatory information confirms that food restrictions are not typically necessary for Delorta.


Q: What happens if I miss taking a dose of Delorta?

If a dose of Delorta is missed, official patient information describes taking the missed dose as soon as possible when remembered. However, if it is almost time for your next scheduled dose, the regulatory guidance is to skip the missed dose entirely and resume your normal routine. Patient guidance states that two doses should not be taken at the same time to compensate for a forgotten dose.


Q: How long does Delorta stay in your system after the last dose?

Pharmacokinetic data from regulatory documents describes the drug’s elimination from the body. The average elimination half-life for Desloratadine is approximately 27 hours. This means that 27 hours is the typical time it takes for half of the drug to be processed and removed from the body.


Q: Is Delorta a scheduled or controlled substance?

Delorta, which contains the active ingredient Desloratadine, is not classified as a controlled substance. It is not listed on the schedules maintained by the US Drug Enforcement Administration (DEA). The absence of a DEA schedule classification indicates the drug is not subject to controlled substance regulation.


Q: Is Delorta considered addictive or prone to misuse?

Based on regulatory documents, there is no known information to suggest that Delorta (Desloratadine) carries a potential for abuse, misuse, or physical dependence. Regulatory documents indicate there is no known information suggesting a potential for physical dependence or abuse.


Q: What are the restrictions on activities like driving while taking Delorta?

Although Delorta is generally described as non-sedating, regulatory patient information includes a general warning regarding activities. Official guidance describes avoiding driving or operating machinery until an individual is certain how the medication affects them, due to the potential for effects on the central nervous system.


Q: Does Delorta carry a black box warning?

Official prescribing information confirms that Delorta (Desloratadine) does not carry a Boxed Warning. A Boxed Warning is a required safety measure that alerts prescribers and patients to potentially serious risks.


Q: Can Delorta be used by older adults (e.g., over 65)?

Regulatory documents indicate that clinical studies in adults aged 65 and older did not show different side effect profiles compared to younger patients. However, older adults are more likely to have reduced kidney or liver function. Official information advises that dose adjustments may be necessary for elderly patients who have pre-existing severe renal or hepatic impairment.


Q: Can Delorta be taken by people with a history of heart problems?

Regulatory safety reviews and clinical studies have assessed the effect of Delorta on the heart's electrical rhythm (the QTc interval). These studies have not established a link between the medicine and clinically relevant abnormal heart rhythms. The decision to use Delorta should always be made by a medical professional who is aware of an individual’s history of heart conditions.


Q: Are there known interactions with common supplements or herbal remedies?

Official product information includes general caution to inform a healthcare provider about all products you are currently taking. This includes all prescribed medicines, over-the-counter drugs, and any dietary or herbal supplements. The reason for this caution relates to the possibility that other products could affect how Delorta is processed by the body.


Q: Is there a generic version of Delorta available?

Yes, official records show that the FDA has approved the medication under an Abbreviated New Drug Application (ANDA). The approval under ANDA means that a generic version of the drug has been given regulatory permission for market entry.


Q: Are there certain groups who may respond differently to Delorta based on genetics?

Studies have investigated how the body processes the drug and identified that a small subset of the population (around 6%) are considered 'slow metabolizers.' This genetic difference in how the drug is processed can lead to higher concentrations of Delorta in the plasma, which has been documented in pharmacokinetic studies.

How should Delorta be stored and disposed of?

Official Storage and Disposal Requirements

Storage of Delorta (Desloratadine) must strictly adhere to regulatory guidelines to maintain its chemical stability and safety. The medication is required to be stored at room temperature, ensuring the temperature does not exceed 30 C (86 F). A mandatory constraint is to keep the product from freezing.

To preserve integrity, Delorta must be protected from environmental factors. It must be stored away from moisture and direct light in its original package, with the container tightly closed.

For safety, the medicine must be stored out of the sight and reach of children. Disposal of any expired or unused Delorta should be handled by asking a pharmacist or healthcare provider for the proper method, such as a medicine take-back program. Disposal must follow local regulations and should avoid release to the environment.

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

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