DuoTrav Adverse Reactions

Tabulated summary of adverse drug reactions from clinical trials: Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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). (See Table 1.)

Click on icon to see table/diagram/image

Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reactions have been derived from post-marketing experience with DuoTrav via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Table 2.)

Click on icon to see table/diagram/image

Additional adverse reactions previously reported with the individual components of DuoTrav: See Product Information for Timolol 2.5 mg/mL and 5 mg/mL Eye Drops, Solution and Travoprost 30 micrograms/mL and 40 micrograms/mL Eye Drops, Solution.