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Clarinex

Last reviewed on RxList: 4/25/2017
Clarinex Side Effects Center

Last reviewed on RxList 10/28/2016

Clarinex (desloratadine) is an antihistamine used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. Clarinex is also used to treat skin hives and itching in people with chronic skin reactions. Clarinex is available over-the-counter and in generic form. Common side effects of Clarinex include:

  • sore throat,
  • muscle pain,
  • nausea,
  • indigestion,
  • loss of appetite,
  • diarrhea,
  • drowsiness,
  • tired feeling,
  • dizziness,
  • fatigue,
  • headache,
  • trouble sleeping,
  • nosebleeds,
  • cough,
  • stomach upset,
  • fever, or
  • dry mouth.

A very serious allergic reaction to Clarinex is rare. Get medical help right away if you notice symptoms of a serious allergic reaction, including:

  • rash,
  • itching/swelling (especially of the face/tongue/throat),
  • severe dizziness, or
  • trouble breathing.

The recommended dose of Clarinex for adults and children 12 years or older is 5 mg daily. Syrup can be used for children two years and older with the dose dependent on the age of the child. There may be other drugs that can affect Clarinex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Clarinex should be used only when prescribed during pregnancy. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Clarinex (desloratadine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Clarinex Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • fever, flu symptoms;
  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dry mouth, sore throat, cough;
  • muscle pain;
  • drowsiness, tired feeling;
  • nausea, diarrhea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Clarinex (Desloratadine)

Clarinex Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Hypersensitivity reactions. [See WARNINGS AND PRECAUTIONS]

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

Allergic Rhinitis: 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
(n=1655)
Placebo
(n=1652)
Infections and Infestations
  Pharyngitis 4.1% 2.0%
Nervous System Disorders
  Somnolence 2.1% 1.8%
Gastrointestinal Disorders
  Dry Mouth 3.0% 1.9%
Musculoskeletal and Connective Tissue Disorders 
  Myalgia 2.1% 1.8%
Reproductive System and Breast Disorders
  Dysmenorrhea 2.1% 1.6%
General Disorders and Administration Site Conditions
  Fatigue 2.1% 1.2%

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in CLARINEX and placebotreated 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): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).

Pediatrics

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 fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).

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.

Post-Marketing Experience

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: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.

Read the entire FDA prescribing information for Clarinex (Desloratadine)

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