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Allegra-D

  • Generic Name: fexofenadine hcl and pseudoephedrine hcl
  • Brand Name: Allegra-D

Allegra-D(Fexofenadine HCl and Pseudoephedrine HCl) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Allegra-D Side Effects Center

What Is Allegra-D?

Allegra-D (fexofenadine hcl and pseudoephedrine hcl) is a combination of an antihistamine and a decongestant 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. Allegra-D is available in generic form and over-the-counter.

What Are Side Effects of Allegra-D?

Common side effects of Allegra-D include:

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

Tell your doctor if you have serious side effects of Allegra-D including:

  • fast/irregular/pounding heartbeat,
  • shaking (tremors),
  • mental/mood changes (such as anxiety, confusion, nervousness, restlessness), or
  • problems urinating.

Dosage for Allegra-D

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.

What Drugs, Substances, or Supplements Interact with Allegra-D?

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 During Pregnancy and Breastfeeding

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 breastfeeding.

Additional Information

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.

 

Allegra-D Consumer Information

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

Stop using fexofenadine and pseudoephedrine and call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest; or
  • severe dizziness, anxiety, restless feeling, tremors, or nervousness.

Common side effects may include:

  • mild dizziness;
  • dry mouth, nose, or throat;
  • nausea; or
  • sleep problems (insomnia).

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)

 

Allegra-D Professional Information

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)

&Copy; Allegra-D Patient Information is supplied by Cerner Multum, Inc. and Allegra-D Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.