Xalacom Adverse Reactions

For latanoprost, the majority of adverse reactions relate to the ocular system. In data from the extension phase of the Xalacom pivotal trials, 16% - 20% of patients developed increased iris pigmentation, which may be permanent. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see Precautions). Other ocular adverse reactions are generally transient and occur on dose administration. For timolol, the most serious adverse reactions are systemic in nature, including bradycardia, arrhythmia, congestive heart failure, bronchospasm and allergic reactions.
Like other topically applied ophthalmic drugs, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.
Treatment related adverse reactions seen in clinical trials with Xalacom are listed as follows.
Adverse reactions are categorized by frequency as follows: 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) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data). (See Table 1.)

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Additional adverse reactions have been reported specific to the use of the individual components of Xalacom in either clinical studies, spontaneous reports or in the available literature.
For latanoprost, these are: (See Table 2).

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For timolol, these are: (See Table 3).

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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.