Fexofenadine

Fexofenadine is both an over-the-counter and a prescription medication used to relieve the allergy symptoms of seasonal allergic rhinitis. It is also used to relieve symptoms of urticaria (hives) such as red, itchy raised areas of the skin, including itching and rash . 

Fexofenadine is in a class of medications called antihistamines. These works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Fexofenadine comes as a tablet, an orally disintegrating tablet, and a suspension (liquid) to take by mouth. It is usually taken with water once or twice a day.

Common side effects of fexofenadine include headache, back pain, cough, diarrhea, and fatigue.

Fexofenadine can also cause dizziness. Do not drive or operate heavy machinery until you know how fexofenadine affects you.

Fexofenadine is a prescription medication used to relieve the following:

• symptoms of seasonal allergic rhinitis in patients 2 years of age and older
• symptoms of urticaria (hives) such as red, itchy raised areas of the skin, including itching and rash, in patients 6 months of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Fexofenadine may be found in some form under the following brand names:

• Allegra

• Allegra-D

• Wal-Fex

• Wal-Fex D

Serious side effects have been reported with fexofenadine. See the “Fexofenadine Precautions” section.

Common side effects of fexofenadine in subjects age 12 years and older include the following:

• headache
• back pain
• dizziness
• stomach discomfort
• pain in extremities

Common side effects of fexofenadine in subjects age 6 to 11 years include the following:

• cough
• upper respiratory tract infections
• fever
• ear infection

Common side effects of fexofenadine in subjects age 6 months to 5 years include the following:

• vomiting
• diarrhea
• fatigue
• runny nose

This is not a complete list of fexofenadine side effects. Ask your doctor or pharmacist for more information.

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

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids containing aluminum hydroxide and/or magnesium hydroxide such as Maalox
• ketoconazole (Nizoral)
• erythromycin (Ery-tab)

This is not a complete list of fexofenadine drug interactions. Ask your doctor or pharmacist for more information.

Fexofenadine Orally Disintegrating Tablet (ODT) contains phenylalanine. Patients with phenylketonuria, a rare genetic condition in which the body is unable to process phenylalanine, should talk to their doctor before using fexofenadine. Fexofenadine products other than ODT formulations do not contain phenylalanine.

Fexofenadine can cause dizziness. Do not drive or operate heavy machinery until you know how fexofenadine affects you.

Do not take fexofenadine if you are allergic to fexofenadine or to any of its ingredients.

Fruit juices such as grapefruit, orange, and apple juice may interact with fexofenadine. Discuss the use of fruit juices with your doctor. Fexofenadine should be taken with water instead.

Before taking fexofenadine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to fexofenadine or to any of its ingredients
• have phenylketonuria (fexofenadine Orally Disintegrating Tablet (ODT) contains phenylalanine)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have decreased kidney function

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fexofenadine falls into category C. There are no well-controlled studies that have been done in pregnant women. Fexofenadine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fexofenadine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fexofenadine.

Take fexofenadine exactly as prescribed.

Fexofenadine comes as a tablet, an orally disintegrating tablet, and a suspension (liquid) to take by mouth.

Fexofenadine tablets are taken once or twice daily with water.

Fexofenadine Oral Disintegrating Tablets (ODT) are taken once or twice daily with or without water on an empty stomach. Let fexofenadine ODT disintegrate on the tongue before swallowing. Do not chew fexofenadine ODT. Do not break or use partial tablets.

• Store fexofenadine ODT in its original blister package. Do not remove fexofenadine ODT from the original blister package until the time of administration.

Fexofenadine oral suspension (liquid) is taken once or twice daily. Shake bottle well, before each use.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fexofenadine at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function
• your age

The recommended dose of Allegra (fexofenadine) tablets for the treatment of seasonal allergic rhinitis or urticaria (hives) is:

• adults and children 12 years and older: 60mg twice daily or 180mg once daily
• children 6 to 11 years old: 30mg twice daily

Orally disintegrating tablets

The recommended dose of Allegra ODT (fexofenadine) for the treatment of seasonal allergic rhinitis or urticaria (hives), in children 6-11 years old, is 30mg twice daily.

Oral suspension

The recommended dose of Allegra oral suspension (fexofenadine) for the treatment of seasonal allergic rhinitis, in children 2 -11 years, is 30 mg (5mL) twice daily.

The recommended dose of Allegra oral suspension (fexofenadine) for the treatment of urticaria (hives) is:

• children 2 to 11 years old: 30 mg (5mL) twice daily.
• children 6 months to 2 years old: 15 mg (2.5mL) twice daily.

If you take too much fexofenadine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store fexofenadine at room temperature 20–25°C (68–77°F).
• Keep this and all medicines out of the reach of children.
• Foil-blister packs containing fexofenadine tablets or fexofenadine orally disintegrating tablets should be protected from excessive moisture.
• Do not remove fexofenadine orally disintegrating tablets from the original blister package until you are ready to use them.
• Shake fexofenadine oral suspension bottle well, before each use.