Patolop Adverse Reactions

Summary of the safety profile: In clinical studies involving 1680 patients, olopatadine was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg. Approximately 4.5% of patients can be expected to experience adverse reactions associated with the use of olopatadine; however, only 1.6% of patients discontinued the clinical studies due to these adverse reactions. No serious ophthalmic or systemic adverse reactions related to olopatadine were reported in clinical studies. The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0.7%.
Tabulated list of adverse reactions: The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)

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Cases of corneal calcification have been reported very rarely in association with the use of phosphate-containing eye drops in some patients with significantly damaged corneas.