Recommended Topic Related To:

Allegra-D

"Jan. 25, 2011 -- The FDA today approved over-the-counter sale of Allegra, the best-selling antihistamine also sold generically as fexofenadine.

Allegra maker Sanofi-aventis says Allegra will be on retail shelves on March 4, in plenty of"...

Allegra-D

Allegra-D Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Allegra-D (fexofenadine hcl and pseudoephedrine hcl) is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold. Fexofenadine is an antihistamine and pseudoephedrine is a decongestant. This medication is available in generic form. Common side effects include nausea, stomach upset, trouble sleeping, headache, dizziness, nervousness or dry mouth.

The recommended dose of Allegra-D 12 Hour Extended-Release Tablets is one tablet twice daily taken on an empty stomach with water, for adults and children 12 years of age and older. Allegra-D may interact with alcohol, sleeping pills, pain medication, muscle relaxers, medication for seizures, medicines to treat high blood pressure, diuretics (water pills), medications to treat irritable bowel syndrome, bladder or urinary medications aspirin or salicylates, beta-blockers, antidepressants, anti-anxiety medications, and others. Avoid diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Allegra-D should be used only when prescribed during pregnancy. This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Our Allegra-D (fexofenadine hcl and pseudoephedrine hcl) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Allegra-D in Detail - Patient Information: Side Effects

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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • nausea, stomach pain, constipation;
  • mild loss of appetite, stomach upset;
  • sleep problems (insomnia);
  • feeling restless or excited (especially in children);
  • skin rash or itching;
  • dizziness, drowsiness;
  • problems with memory or concentration; or
  • ringing in your ears.

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 Allegra-D (Fexofenadine HCl and Pseudoephedrine HCl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Allegra-D Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, trouble sleeping, nausea, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, shaking (tremor), mental/mood changes (such as anxiety, confusion, nervousness, restlessness), problems urinating.

Get medical help right away if you have any very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Allegra-D (Fexofenadine HCl and Pseudoephedrine HCl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Allegra-D FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR

In one clinical trial (n=651) in which 215 subjects with seasonal allergic rhinitis received the 60 mg fexofenadine hydrochloride/120 mg pseudoephedrine hydrochloride combination tablet twice daily for up to 2 weeks, adverse events were similar to those reported either in subjects receiving fexofenadine hydrochloride 60 mg alone (n=218 subjects) or in subjects receiving pseudoephedrine hydrochloride 120 mg alone (n=218). A placebo group was not included in this study.

The percent of subjects who withdrew prematurely because of adverse events was 3.7% for the fexofenadine hydrochloride/pseudoephedrine hydrochloride combination group, 0.5% for the fexofenadine hydrochloride group, and 4.1% for the pseudoephedrine hydrochloride group. All adverse events that were reported by greater than 1% of subjects who received the recommended daily dose of the fexofenadine hydrochloride/pseudoephedrine hydrochloride combination are listed in the following table.

Adverse Experiences Reported in One Active-Controlled Seasonal Allergic Rhinitis Clinical Trial at Rates of Greater than 1%

Adverse Experience 60 mg Fexofenadine Hydrochloride/120 mg Pseudoephedrine Hydrochloride Combination Tablet Twice Daily
(n=215)
Fexofenadine Hydrochloride 60 mg Twice Daily
(n=218)
Pseudoephedrine Hydrochloride 120 mg Twice Daily
(n=218)
Headache 13.0% 11.5% 17.4%
Insomnia 12.6% 3.2% 13.3%
Nausea 7.4% 0.5% 5.0%
Dry Mouth 2.8% 0.5% 5.5%
Dyspepsia 2.8% 0.5% 0.9%
Throat Irritation 2.3% 1.8% 0.5%
Dizziness 1.9% 0.0% 3.2%
Agitation 1.9% 0.0% 1.4%
Back Pain 1.9% 0.5% 0.5%
Palpitation 1.9% 0.0% 0.9%
Nervousness 1.4% 0.5% 1.8%
Anxiety 1.4% 0.0% 1.4%
Upper Respiratory Infection 1.4% 0.9% 0.9%
Abdominal Pain 1.4% 0.5% 0.5%

Many of the adverse events occurring in the fexofenadine hydrochloride/pseudoephedrine hydrochloride combination group were adverse events also reported predominately in the pseudoephedrine hydrochloride group, such as insomnia, headache, nausea, dry mouth, dizziness, agitation, nervousness, anxiety, and palpitation.

Fexofenadine Hydrochloride

In placebo-controlled clinical trials, which included 2461 subjects receiving fexofenadine hydrochloride at doses of 20 mg to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated subjects. The incidence of adverse events, including drowsiness, was not dose related and was similar across subgroups defined by age, gender, and race. The percent of subjects who withdrew prematurely because of adverse events was 2.2% with fexofenadine hydrochloride vs 3.3% with placebo.

Events that have been reported during controlled clinical trials involving subjects with seasonal allergic rhinitis and chronic idiopathic urticaria at incidences less than 1% and similar to placebo and have been rarely reported during postmarketing surveillance include: insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, cardiac arrhythmias and ischemic colitis have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

Read the entire FDA prescribing information for Allegra-D (Fexofenadine HCl and Pseudoephedrine HCl) »

A A A

Allegra-D - User Reviews

Allegra-D User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Allegra-D sorted by most helpful. Patient Discussions FAQs

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.


Allergies & Asthma

Improve treatments & prevent attacks.