Leader Allergy Relief D-24 Side Effects

Generic Name: loratadine / pseudoephedrine

Note: This page contains information about the side effects of loratadine / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Leader Allergy Relief D-24.

Not all side effects for Leader Allergy Relief D-24 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 loratadine / pseudoephedrine: 12-hour sustained-release tablets, 24-hour sustained-release tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Coughing; dizziness; drowsiness; dry mouth; excitability; fatigue; headache; loss of appetite; mild stomach upset; nausea; nervousness; sleeplessness; sore throat; thirst.

Seek medical attention right away if any of these SEVERE side effects occur while taking loratadine / pseudoephedrine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fast or irregular heartbeat; mental or mood changes; seizures; severe dizziness; uncontrolled shaking or tremor.

For Healthcare Professionals

Applies to loratadine / pseudoephedrine: oral tablet extended release

Nervous system

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

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

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

Hypersensitivity side effects of pseudoephedrine have included reports of fixed drug eruptions.[Ref]

References

1. Clissold SP, Sorkin EM, Goa KL "Loratadine. A preliminary review of its pharmacodynamic properties and therapeutic efficacy." Drugs 37 (1989): 42-57

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

4. 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

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

10. Smith SJ "Cardiovascular toxicity of antihistamines." Otolaryngol Head Neck Surg 111 Suppl (1994): 348-54

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

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