Azatadine / pseudoephedrine Side Effects

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.

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;

  • dry mouth;

  • nausea, stomach pain, constipation;

  • warmth, tingling, or redness under your skin;

  • sleep problems (insomnia);

  • skin rash or itching;

  • blurred vision;

  • dizziness, drowsiness;

  • 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

Nervous system

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.

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.

Gastrointestinal

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.

Cardiovascular

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.

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.

Ocular

Ocular side effects of azatadine have included blurred vision, diplopia, and dry eyes due to its anticholinergic effect.

Genitourinary

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.

Hematologic

Hematologic side effects have rarely been reported with azatadine use and include bone marrow suppression, thrombocytopenia, and aplastic anemia.

Respiratory

Respiratory side effects have included thickening of bronchial secretions.

Hypersensitivity

Hypersensitivity reactions to azatadine or pseudoephedrine have occurred. Fixed drug eruptions secondary to pseudoephedrine have been reported.

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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