openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 General Antihistamines may cause drowsiness and may have additive CNS effects with alcohol or other CNS depressants such as hypnotics, sedatives, and tranquilizers. 5.2 Special Risk Patients Use with caution in patients with diabetes, hypertension, or cardiovascular disease, hyperthyroidism, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck. Antihistamines may cause excitability, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients and should be prescribed with caution.
6 ADVERSE REACTIONS The most common side effects associated with antihistamines include drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare. Other reactions may include: Dermatologic: urticaria, drug rash, photosensitivity, pruritus Cardiovascular: hypotension, hypertension, cardiac arrhythmias, palpitations Central Nervous System (CNS): disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria Genitourinary: urinary frequency, difficult urination Gastrointestinal: epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation Respiratory: tightness of chest and wheezing, shortness of breath Hematologic: hemolytic anemia, thrombocytopenia, agranulocytosis To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.