Aclexa Adverse Reactions





Uni Drug
Full Prescribing Info
Adverse Reactions
The following tables summarises adverse drug reactions of celecoxib divided into groups according to MedDRA terminology together with their frequency: 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).
Clinical Trials Experience: The following adverse drug reactions (ADRs) in Table 11 were identified with incidence rates greater than 0.01% in celecoxib group and greater than those reported in placebo group, during 12 placebo- and/or active-controlled clinical trials of treatment duration up to 12 weeks at daily doses from 100 mg up to 800 mg in adults.
The frequencies on the ADRs in Table 11 are updated based on a more recent pooling of 89 randomized, controlled clinical trials data representing clinical exposure in 38,102 patients taking celecoxib. (See Table 11.)

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The following additional adverse drug reactions* in Table 12 were identified with incidence rates greater than placebo in long-term polyp prevention studies of duration up to 3 years at daily doses from 400 mg up to 800 mg (see Pharmacology: Pharmacodynamics under Actions). (See Table 12.)

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Post-marketing Experience: Adverse reactions identified from post-marketing experience are provided as follows. Even though these were identified as reactions from post-marketing reports, trial data was consulted to estimate frequency. As previously, frequencies are based on a pooling of trials representing exposure in 38,102 patients. (See Table 13.)

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