Azatadine / pseudoephedrine Side Effects
For the Consumer
Applies to azatadine / pseudoephedrine: oral tablet extended release
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 any of these serious side effects:
fast, pounding, or uneven heartbeat;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
urinating less than usual or not at all.
Keep using the medication and talk with your doctor if you have any of these less serious side effects:
mild loss of appetite;
nausea, stomach pain, constipation;
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
skin rash or itching;
problems with memory or concentration;
ringing in your ears; or
restless or excitability (especially in children).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
For Healthcare Professionals
Applies to azatadine / pseudoephedrine: oral tablet extended release
Nearly all patients treated with azatadine experience drowsiness. This drowsiness may subside in some patients with extended use. Patients should be warned against driving, as well as concomitant ingestion of alcohol and other sedative-hypnotic drugs, while taking azatadine.
At higher than normal doses of azatadine, dystonic reactions have occurred.[Ref]
Nervous system side effects have commonly occurred with azatadine administration, resulting in drowsiness in most patients. Azatadine has also caused dizziness and disrupted coordination.
Pseudoephedrine has produced nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also occurred in patients receiving pseudoephedrine.[Ref]
Gastrointestinal side effects from azatadine have included dry mouth and constipation due to its anticholinergic effects. Patients have also experienced epigastric distress and nausea. Increased appetite has been reported with azatadine use.
Pseudoephedrine has caused anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients.[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.[Ref]
Cardiovascular side effects of pseudoephedrine have included significant increases in heart rate. Hypertension and arrhythmias have occurred in susceptible patients. Azatadine has rarely caused hypotension, tachycardia, and palpitations.[Ref]
Ocular side effects of azatadine have included blurred vision, diplopia, and dry eyes due to its anticholinergic effect.[Ref]
Genitourinary tract side effects have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention. These effects may be due to azatadine's anticholinergic effect.[Ref]
Hematologic side effects have rarely been reported with azatadine use and include bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]
Respiratory side effects have included thickening of bronchial secretions.[Ref]
Hypersensitivity reactions to azatadine or pseudoephedrine have occurred. Fixed drug eruptions secondary to pseudoephedrine have been reported.[Ref]
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2. Loizou LA, Hamilton JG, Tsementzis SA "Intracranial haemorrhage in association with pseudoephedrine overdose." J Neurol Neurosurg Psychiatry 45 (1982): 471-2
3. Luscombe DK, Nicholls PJ, Parish PA "Comparison of the effects of azatadine maleate and terfenadine on human performance." Pharmatherapeutica 3 (1983): 370-5
4. 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
5. Joske DJ "Dystonic reaction to azatadine." Med J Aust 141 (1984): 449
6. Small P, Barrett D, Biskin N "Effects of azatadine, terfenadine, and astemizole on allergen-induced nasal provocation." Ann Allergy 64 (1990): 129-31
7. "Product Information. Trinalin (pseudoephedrine-azatadine)." Schering Laboratories, Kenilworth, NJ.
8. Wilson JD, Hillas JL, Somerfield SD "Azatadine maleate (Zadine): evaluation in the management of allergic rhinitis." N Z Med J 94 (1981): 79-81
9. "Azatadine (optimine)--a new antihistamine." Med Lett Drugs Ther 19 (1977): 77-9
10. Kaminszczik I, Barbon L "Relieving symptoms of upper respiratory allergies and the common cold: azatadine maleate/pseudoephedrine sulfate syrup versus placebo." J Int Med Res 11 (1983): 101-7
11. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):
12. 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
13. Luscombe DK, Nicholls PJ, Spencer PS "Effect of azatadine on human performance." Br J Clin Pract 34 (1980): 75-9
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. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2
16. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1
17. 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
18. 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
19. Quan MB, Chow WC "Nonpigmenting fixed drug eruption after pseudoephedrine." Int J Dermatol 35 (1996): 367-70
20. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40
21. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8
Not all side effects for azatadine / pseudoephedrine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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