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- Does Clarinex (desloratadine) cause side effects?
- What are the important side effects of Clarinex (desloratadine)?
- Clarinex (desloratadine) side effects list for healthcare professionals
- What drugs interact with Clarinex (desloratadine)?
- Does Clarinex (desloratadine) cause addiction or withdrawal symptoms?
Does Clarinex (desloratadine) cause side effects?
Clarinex (desloratadine) is a long-acting antihistamine chemically similar to loratadine (Claritin) used to treat allergies and hives (chronic urticaria) in adults and children 12 years of age and older.
Histamine is a chemical responsible for many of the signs and symptoms of allergic reactions, for example, swelling of the lining of the nose, sneezing, and itchy eyes. Histamine is released from histamine-storing cells (mast cells) and then attaches to other cells that have receptors for histamine.
The attachment of the histamine to the receptors causes the cells to be "activated," releasing other chemicals which produce the effects that we associate with allergy. Clarinex blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of H1 receptor-containing cells by histamine. Clarinex does not readily enter the brain from the blood and, therefore, causes less drowsiness.
Common side effects of Clarinex include
- sore throat,
- dry mouth,
- muscle pain,
- painful menstruation, and
Drug interactions of Clarinex include ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine, which increase blood levels of Clarinex by reducing the elimination of Clarinex by liver enzymes.
Clarinex (desloratadine) side effects list for healthcare professionals
The following adverse reactions are discussed in greater detail in other sections of the label:
- Hypersensitivity reactions.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adults And Adolescents
- In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received Clarinex Tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg.
- In patients receiving 5 mg daily, the rate of adverse events was similar between Clarinex and placebo-treated patients.
- The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Clarinex group and 2.6% in the placebo group.
- There were no serious adverse events in these trials in patients receiving desloratadine.
- All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Clarinex Tablets (5 mg once daily), and that were more common with Clarinex Tablets than placebo, are listed in Table 1.
Table 1: Incidence of Adverse Events Reported by ≥2% of Adult and Adolescent Allergic Rhinitis Patients Receiving Clarinex Tablets
|Adverse Event||Clarinex Tablets 5 mg|
|Infections and Infestations|
|Nervous System Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Reproductive System and Breast Disorders|
|General Disorders and Administration Site Conditions|
- The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Clarinex and placebo-treated patients.
- There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.
Chronic Idiopathic Urticaria
- In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Clarinex Tablets and 205 received placebo.
- Adverse events that were reported by greater than or equal to 2% of patients who received Clarinex Tablets and that were more common with Clarinex than placebo were (rates for Clarinex and placebo, respectively):
- Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Clarinex Oral Solution for 15 days in three placebo-controlled clinical trials.
- Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.
- In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.
- In subjects 2 to 5 years of age, adverse events reported for Clarinex and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).
- In subjects 12 months to 23 months of age, adverse events reported for the Clarinex product and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were
- In subjects 6 months to 11 months of age, adverse events reported for Clarinex and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were
- upper respiratory tract infections (21.2%, 12.9%),
- diarrhea (19.7%, 8.1%),
- fever (12.1%, 1.6%),
- irritability (12.1%, 11.3%),
- coughing (10.6%, 9.7%),
- somnolence (9.1%, 8.1%),
- bronchitis (6.1%, 0%),
- otitis media (6.1%, 1.6%),
- vomiting (6.1%, 3.2%),
- anorexia (4.5%, 1.6%),
- pharyngitis (4.5%, 1.6%),
- insomnia (4.5%, 0%),
- rhinorrhea (4.5%, 3.2%),
- erythema (3.0%, 1.6%), and
- nausea (3.0%, 0%).
- There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval.
- Only one of the 246 pediatric subjects receiving Clarinex Oral Solution in the clinical trials discontinued treatment because of an adverse event.
Because adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following spontaneous adverse events have been reported during the marketing of desloratadine:
- Cardiac disorders: tachycardia, palpitations
- Respiratory, thoracic and mediastinal disorders: dyspnea
- Skin and subcutaneous tissue disorders: rash, pruritus
- Nervous system disorders: psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures (reported in patients with and without a known seizure disorder)
- Immune system disorders: hypersensitivity reactions (such as urticaria, edema and anaphylaxis)
- Investigations: elevated liver enzymes including bilirubin
- Hepatobiliary disorders: hepatitis
- Metabolism and nutrition disorders: increased appetite
What drugs interact with Clarinex (desloratadine)?
Inhibitors Of Cytochrome P450 3A4
- In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.
- In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.
- In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.
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Related Disease Conditions
Hives, also called urticaria, is a raised, itchy area of skin that is usually a sign of an allergic reaction. The allergy may be to food or medications, but usually the cause of the allergy (the allergen) is unknown.
What Are the Four Types of Allergic Reactions?
Allergists recognize four types of allergic reactions: Type I or anaphylactic reactions, type II or cytotoxic reactions, type III or immunocomplex reactions and type IV or cell-mediated reactions.
An allergy refers to a misguided reaction by our immune system in response to bodily contact with certain foreign substances. When these allergens come in contact with the body, it causes the immune system to develop an allergic reaction in people who are allergic to it. It is estimated that 50 million North Americans are affected by allergic conditions. The parts of the body that are prone to react to allergies include the eyes, nose, lungs, skin, and stomach. Common allergic disorders include hay fever, asthma, allergic eyes, allergic eczema, hives, and allergic shock.
How Long Does an Allergic Reaction Last?
Allergic reactions may last for varying lengths of time. They may take a few hours to a few days to disappear. If the exposure to the allergen continues, such as during a spring pollen season, allergic reactions may last for longer periods such as a few weeks to months.
Indoor allergens are substances that can cause an allergic reaction in some people. Common sources of indoor allergens include dust mites, cockroaches, molds, pets, and plants. Avoiding indoor allergens is one way to reduce allergy and asthma symptoms.
Hay Fever (Allergic Rhinitis)
Hay fever (allergic rhinitis) is an irritation of the nose caused by pollen and is associated with the following allergic symptoms: nasal congestion, runny nose, sneezing, eye and nose itching, and tearing eyes. Avoidance of known allergens is the recommended treatment, but if this is not possible, antihistamines, decongestants, and nasal sprays may help alleviate symptoms.
How to Get Rid of Hives: 20 Ways
Hives or urticarias are red, itchy skin rashes triggered by food, medicine, or other irritants. They can vary from a few millimeters to several centimeters in diameters.
Cold, Flu, Allergy Treatments
Before treating a cold, the flu, or allergies with over-the-counter (OTC) medications, it's important to know what's causing the symptoms, which symptoms one wishes to relieve, and the active ingredients in the OTC product. Taking products that only contain the medications needed for relieving your symptoms prevents ingestion of unnecessary medications and reduces the chances of side effects.
Are Hives (Urticaria) Contagious?
Hives are not contagious are triggered by an allergic response to a substance. Symptoms and signs of hives include a raised, itchy red rash on the skin. An individual should seek medical care for hives if he or she develops dysphagia, wheezing, shortness of breath, or throat tightening.
Sinus Infection vs. Allergies
Both sinus infections and allergies (allergic rhinitis) cause symptoms such as runny or stuffy nose and fatigue. Sinus infection (known as sinusitis) is inflammation of the sinuses, caused by infection from bacteria, viruses, and/or fungi (molds). Allergic rhinitis occurs when certain allergies cause nasal symptoms. When a person with allergies breathes in an allergen, such as pollen, dust, or animal dander, symptoms such as runny or stuffy nose, itching, sneezing, and fatigue occur.
The allergic cascade refers to allergic reactions that happen in the body in response to allergens. A variety of immune cells and chemical messengers participate in the allergic cascade. Symptoms of the allergic cascade range from mild swelling and itching to full-blown anaphylactic shock. Allergen avoidance and medications are used to prevent or treat allergies.
Allergy Treatment Begins at Home
Avoiding allergy triggers at home is one of the best ways to prevent allergy symptoms. Controlling temperature, humidity, and ventilation are a few ways to allergy-proof the home. Cleaning, vacuuming, and using HEPA air filters also helps control allergies.
COVID-19 vs. Allergies
Though there is some overlap in allergy and COVID-19 signs and symptoms there are also significant differences. Symptoms that they have in common include headache, fatigue, tiredness, shortness of breath, wheezing, and sore throat. Fever does not occur with allergies but is one of the defining symptoms of COVID-19 infections.
What Is Causing My Hives?
Hives, medically known as urticaria, are common rashes that anyone can get at any point in their lives. They can happen only once in your life, keep happening often, or stay longer (chronic) for more than 6 weeks.
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Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.