Tapcom Adverse Reactions

Adverse drug reactions (including abnormal change in laboratory test values) were reported in 94 of 379 patients (24.8%) in clinical studies in Japan. The major adverse drug reactions were abnormality in eyelashes in 35 patients (9.2%), conjunctival injection in 32 patients (8.4%), corneal epithelium disorder including punctate keratitis in 21 patients (5.5%), blepharal pigmentation in 9 patients (2.4%), eye irritation in 8 patients (2.1%), etc.
Clinically significant adverse reaction: Iris pigmentation (incidence unknown)*: Iris pigmentation may occur. Patients should be examined periodically, and administration should be discontinued depending on clinical status when iris pigmentation is observed.
Ocular pemphigoid (incidence unknown)*: Ocular pemphigoid may occur. Discontinue administration and treat the patient appropriately when symptoms including conjunctival injection, corneal epithelium disorder, keratoconjunctivitis sicca, conjunctival atrophy, ciliary entropion or symblepharon are observed.
Bronchospasm, dyspnea, respiratory failure (incidence unknown)*: Bronchospasm, dyspnea or respiratory failure may occur. Discontinue administration and treat the patient appropriately if such symptoms are observed.
Heart block, congestive heart failure, cerebral ischemia, cardiac arrest, cerebrovascular disorder (incidence unknown)*: Heart block, congestive heart failure, cerebral ischemia, cardiac arrest or cerebrovascular disorder may occur. Discontinue administration and treat the patient appropriately if such symptoms are observed.
Systemic lupus erythematosus (incidence unknown)*: Systemic lupus erythematosus may occur. Discontinue administration and treat the patient appropriately if such symptom is observed.
*Adverse drug reactions which have been reported in use of tafluprost or timolol maleate.
Other adverse drug reactions: If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken. (See Table 4.)

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