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Azelastine Hydrochloride Ophthalmic Solution 0.05%

Verified·Apr 23, 2026
NDC
62332-506
ICD-10 indication
H10.449

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About Azelastine Hydrochloride Ophthalmic Solution 0.05%

What is this medication? Azelastine hydrochloride ophthalmic solution 0.05 percent is an antihistamine medication designed to relieve the symptoms of allergic conjunctivitis. It is specifically used to treat itchy eyes caused by seasonal allergens such as pollen and grass, as well as year-round triggers like pet dander and dust mites. The solution works by blocking histamine receptors in the eye, which prevents the inflammatory response that leads to itching and discomfort.

The medication is typically administered as a single drop into each affected eye twice daily. It provides relatively fast relief and helps manage the eye irritation associated with environmental allergies. Patients who wear contact lenses should remove them before applying the medication and wait at least ten minutes before reinserting them to ensure the drops are fully absorbed and do not interfere with the lenses.

Copay & patient assistance

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Prescribing information

From the FDA-approved label for Azelastine Hydrochloride Ophthalmic Solution 0.05%. Official source: DailyMed (NLM) · Label effective Jan 2, 2025

Indications and usage
INDICATIONS & USAGE Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Dosage and administration
DOSAGE & ADMINISTRATION The recommended dose is one drop instilled into each affected eye twice a day.
Contraindications
CONTRAINDICATIONS Azelastine hydrochloride ophthalmic solution 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Warnings
WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular use only and not for injection or oral use.
Adverse reactions
ADVERSE REACTIONS In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1–10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied.
Use in pregnancy
PREGNANCY Teratogenic Effects: Pregnancy Category C. Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68.6 mg/kg/day (57,000 times the recommended ocular human use level). At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus) and the incidence of 14th rib were increased in rats. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels is unknown. There are no adequate and well-controlled studies in pregnant women. Azelastine hydrochloride ophthalmic solution 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.