Azelastine

There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using azelastine during pregnancy.

Azelastine is excreted into the milk in low quantities. For that reason azelastine is not recommended during lactation.

Fertility

Effects on human fertility have not been investigated.

The mild, transient irritation which can be experienced after application of azelastine is unlikely to affect vision to any greater extent. However, if there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.

The assessment of undesirable effects is based on the following frequencies:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Immune system disorders

Very rare: Allergic reactions (such as rash and pruritus)

Nervous system disorders

Uncommon: Bitter taste

Eye disorders

Common: Mild, transient irritation in the eye