Leader Allergy Relief D-24 Side Effects
Generic Name: loratadine / pseudoephedrine
Note: This document contains side effect information about loratadine / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Leader Allergy Relief D-24.
For the Consumer
Applies to loratadine / pseudoephedrine: oral tablet extended release 12 hour, oral tablet extended release 24 hour
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling nervous and excitable.
- Not able to sleep.
- Feeling sleepy.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Nervous system side effects of loratadine have included headaches in approximately 7% of treated patients. Loratadine has not been shown to cause significant drowsiness, sedation, or impair psychomotor skills.
Nervous system side effects of pseudoephedrine have included nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache, somnolence, and dizziness have also occurred in patients receiving pseudoephedrine.[Ref]
Cardiovascular side effects of loratadine have included at least one report of syncopal episodes, premature ventricular complexes, and a prolonged QT interval.[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.
Adverse effects which have been reported during therapy with loratadine and pseudoephedrine included dizziness, syncopal episodes, palpitations, ventricular arrhythmias including torsades de pointes, cardiac arrest, and cardiac death.[Ref]
Gastrointestinal side effects have included anorexia and gastric irritation in approximately 5% of patients treated with pseudoephedrine. Dry mouth, nose, or throat have occurred in up to 15% of patients. Gastrointestinal effects of loratadine have been rare and included nausea and dry mouth. A few cases of mechanical upper gastrointestinal tract obstruction have been reported with Claritin-D 24 Hour tablets (brand of loratadine-pseudoephedrine), primarily in patients who have difficulty swallowing tablets or in whom there is upper gastrointestinal tract narrowing or abnormal esophageal peristalsis. Ischemic colitis has been reported.[Ref]
Hypersensitivity side effects of pseudoephedrine have included reports of fixed drug eruptions.[Ref]
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2. Monroe EW, Bernstein DI, Fox RW, Grabiec SV, Honsinger RW, Kalivas JT, Katz HI, Cuss F, Danzig MR, Garvin PR, et al "Relative efficacy and safety of loratadine, hydroxyzine, and placebo in chronic idiopathic urticaria." Arzneimittelforschung 42 (1992): 1119-21
3. 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
4. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
5. "Product Information. Claritin-D (loratadine-pseudoephedrine)." Schering-Plough, Liberty Corner, NJ.
6. Loizou LA, Hamilton JG, Tsementzis SA "Intracranial haemorrhage in association with pseudoephedrine overdose." J Neurol Neurosurg Psychiatry 45 (1982): 471-2
7. 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
8. 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
9. Smith SJ "Cardiovascular toxicity of antihistamines." Otolaryngol Head Neck Surg 111 Suppl (1994): 348-54
10. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2
11. 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
12. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1
13. Good AP, Rockwood R, Schad P "Loratadine and ventricular tachycardia." Am J Cardiol 74 (1994): 207
14. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8
15. 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
16. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40
17. Quan MB, Chow WC "Nonpigmenting fixed drug eruption after pseudoephedrine." Int J Dermatol 35 (1996): 367-70
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Leader Allergy Relief D-24 (loratadine / pseudoephedrine)
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