Allegra-D 12 Hour Side Effects

Generic Name: fexofenadine / pseudoephedrine

Note: This page contains information about the side effects of fexofenadine / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Allegra-D 12 Hour.

Not all side effects for Allegra-D 12 Hour may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fexofenadine / pseudoephedrine: oral tablet extended release, oral tablet extended release 24 hr

In addition to its needed effects, some unwanted effects may be caused by fexofenadine / pseudoephedrine. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking fexofenadine / pseudoephedrine, check with your doctor or nurse as soon as possible:

More common
  • Trouble in sleeping
Less common
  • Cough
  • dizziness
  • irregular heartbeat
  • nervousness
  • sore throat
Incidence not known
  • Difficult or labored breathing
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • feeling of warmth
  • fever
  • hives or welts
  • itching skin
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • reddening of the skin, especially around ears
  • redness of the face, neck, arms and occasionally, upper chest
  • shortness of breath
  • skin rash
  • tightness in chest
  • swelling of eyes, face, or inside of nose
  • unusual tiredness or weakness
  • wheezing

Some of the side effects that can occur with fexofenadine / pseudoephedrine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Headache
  • nausea
Less common
  • Abdominal or stomach pain
  • agitation
  • anxiety
  • back pain
  • dry mouth
  • heartburn
Incidence not known
  • Terrifying dreams causing sleep disturbances

For Healthcare Professionals

Applies to fexofenadine / pseudoephedrine: oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included nausea (7.4%), dry mouth (2.8%), dyspepsia (2.8%), throat irritation (2.3%), and abdominal pain (1.4%).[Ref]

Cardiovascular

Cardiovascular side effects have included palpitations (1.9%).[Ref]

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Nervous system

Nervous system side effects have included headache (13%), insomnia (12.6%), dizziness (1.9%), agitation (1.9%), nervousness (1.4%), and anxiety (1.4%).[Ref]

Hypersensitivity

In rare cases, rash urticaria, pruritus, angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.[Ref]

Hypersensitivity reactions have included fixed drug eruptions.[Ref]

Respiratory

Respiratory side effects have included upper respiratory infections (1.4%).[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain (1.9%).[Ref]

References

1. Sussman GL, Mason J, Compton D, Stewart J, Ricard N "The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis." J Allergy Clin Immunol 104 (1999): 100-6

2. Stroh JE, Jr Ayars GH, Bernstein IL, Kemp JP, Podleski WK, Prenner BM, Schoenwetter WF, Salzmann JK "A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis." J Int Med Res 16 (1988): 420-7

3. Dowd J, Bailey D, Moussa K, Nair S, Doyle R, CulpepperMorgan JA "Ischemic colitis associated with pseudoephedrine: Four cases." Am J Gastroenterol 94 (1999): 2430-4

4. "Product Information. Allegra-D (fexofenadine-pseudoephedrine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

5. Taylor DM, O'Toole KS, Auble TE, Ryan CM, Sherman DR "The psychometric and cardiac effects of pseudoephedrine in the hyperbaric environment." Pharmacotherapy 20 (2000): 1045-50

6. Mores N, Campia U, Navarra P, Cardillo C, Preziosi P "No cardiovascular effects of single-dose pseudoephedrine in patients with essential hypertension treated with beta-blockers." Eur J Clin Pharmacol 55 (1999): 251-4

7. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13

8. Dickerson J, Perrier D, Mayersohn M, Bressler R "Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man." Eur J Clin Pharmacol 14 (1978): 253-9

9. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1

10. Lyon CC, Turney JH "Pseudoephedrine toxicity in renal failure." Br J Clin Pract 50 (1996): 396-7

11. Wiener I, Tilkian AG, Palazzolo M "Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion." Cathet Cardiovasc Diagn 20 (1990): 51-3

12. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2

13. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):

14. Gordon RD, Ballantine DM, Bachmann AW "Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma." Clin Exp Pharmacol Physiol 19 (1992): 287-90

15. Loizou LA, Hamilton JG, Tsementzis SA "Intracranial haemorrhage in association with pseudoephedrine overdose." J Neurol Neurosurg Psychiatry 45 (1982): 471-2

16. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40

17. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8

18. Vidal C, Prieto A, PerezCarral C, Armisen M "Nonpigmenting fixed drug eruption due to pseudoephedrine." Ann Allergy Asthma Immunol 80 (1998): 309-10

19. Quan MB, Chow WC "Nonpigmenting fixed drug eruption after pseudoephedrine." Int J Dermatol 35 (1996): 367-70

20. Shelley WB, Shelley ED "Nonpigmenting fixed drug eruption as a distinctive reaction pattern: examples caused by sensitivity to pseudoephedrine hydrochloride and tetrahydrozoline." J Am Acad Dermatol 17 (1987): 403-7

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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