Medication-info.com Search Menu

Clarinex Tablet 5 mg NDA021165: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
5 mg
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Clarinex Tablet 5 mg NDA021165

What is CLARINEX?

CLARINEX is a prescription medicine that contains the medicine desloratadine (an antihistamine).

CLARINEX is used to help control the symptoms of:

  • seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 2 years of age and older.
  • perennial allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 6 months of age and older.
  • chronic idiopathic urticaria (long-term itching) and to reduce the number and size of hives in people 6 months of age and older.

CLARINEX is not for children younger than 6 months of age.

Who should not take CLARINEX?

Do not take CLARINEX if you:

  • are allergic to desloratadine or any of the ingredients in CLARINEX Tablets, CLARINEX RediTabs® or CLARINEX Oral Solution. See the end of this leaflet for a complete list of ingredients for the CLARINEX Tablets.
  • are allergic to loratadine (Alavert, Claritin).

Talk to your doctor before taking this medicine if you have any questions about whether or not to take this medicine.

What should I tell my doctor before taking CLARINEX?

Before you take CLARINEX, tell your doctor if you:

  • have liver or kidney problems.
  • have any other medical conditions.

  • are pregnant or plan to become pregnant. It is not known if CLARINEX will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

  • are breast-feeding or plan to breast-feed. CLARINEX can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take CLARINEX.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. CLARINEX may affect the way other medicines work, and other medicines may affect how CLARINEX works. Especially tell your doctor if you take:

  • ketoconazole (Nizoral)
  • erythromycin (Ery-tab, Eryc, PCE)
  • azithromycin (Zithromax, Zmax)
  • antihistamines
  • fluoxetine (Prozac)
  • cimetidine (Tagamet)

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take CLARINEX?

  • Take CLARINEX exactly as your doctor tells you to take it.
  • Do not change your dose of CLARINEX or take more often than prescribed.

  • CLARINEX can be taken with or without food.

  • Place CLARINEX RediTabs Tablet on your tongue and allow it to dissolve before swallowing. CLARINEX RediTabs can be taken with or without water. Take your CLARINEX RediTabs Tablet right away after opening the blister.
  • Take CLARINEX Oral Solution with a measuring dropper or oral syringe that can measure 2 mL or 2.5 mL. Ask your pharmacist for a dropper or syringe if you do not have one.
  • If you take too much CLARINEX, call your doctor or get medical attention right away.

What are the possible side effects of CLARINEX Tablets?

CLARINEX may cause serious side effects, including:

  • Allergic reactions. Stop taking CLARINEX and call your doctor right away or get emergency help if you have any of these symptoms:

    • rash
    • itching
    • hives
    • swelling of your lips, tongue, face, and throat
    • shortness of breath or trouble breathing

The most common side effects of CLARINEX in adults and children 12 years of age and older with allergic rhinitis include:

  • sore throat
  • dry mouth
  • muscle pain
  • tiredness
  • sleepiness
  • menstrual pain

Increased sleepiness or tiredness can happen if you take more CLARINEX than your doctor prescribed to you.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of CLARINEX. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CLARINEX?

  • Store CLARINEX Tablets between 59°F to 86°F (15°C to 30°C).
  • CLARINEX Tablets are sensitive to heat. Do not store above 86°F (30°C).
  • Protect CLARINEX Tablets from moisture.

Keep CLARINEX Tablets, RediTabs Tablets, and Oral Solution and all medicines out of the reach of children.

General information about CLARINEX

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CLARINEX for a condition for which it was not prescribed. Do not give CLARINEX to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about CLARINEX. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLARINEX that is written for health professionals.

What are the ingredients in CLARINEX?

Active ingredient: desloratadine

Patients with Phenylketonuria: CLARINEX RediTabs Tablets contain phenylalanine.

Inactive ingredients in CLARINEX Tablets: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch NF, talc USP, carnauba wax NF, white wax NF, coating material consisting of lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol, and FD&C Blue #2 Aluminum Lake.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021165 · View the label on DailyMed

Revision date stated in the text: June 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Clarinex Tablet 5 mg NDA021165

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Histamine-1 Receptor Antagonist
Active ingredient Desloratadine 5 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) ORGANON
FDA approval NDA 021165New Drug Application (NDA) Approved December 21, 2001
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Desloratadine with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg – 100 in 1 bottle NDC 78206-119-01
5 mg – 100 in 1 bottle NDC 78206-188-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.