Avodart Adverse Reactions

Clinical Trial Data: Avodart Monotherapy for BPH: Approximately 19% of the 2,167 patients who received dutasteride in the 2-year Phase III placebo-controlled trials developed adverse reactions during the first year of treatment. The majority of events were mild to moderate and occurred in the reproductive system. No change to the adverse event profile was apparent over a further 2 year in open-label extension studies.
Table 1 shows adverse reactions from controlled clinical trials and post-marketing experience. The listed adverse events from clinical trials are investigator-judged drug-related events (with incidence more than or equal to 1%) reported with a higher incidence in patients treated with dutasteride compared with placebo during the first year of treatment. Adverse events from post-marketing experience were identified from spontaneous post-marketing reports, therefore, the true incidence is unknown. (See Table 1.)


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Avodart and Tamsulosin Combination Therapy for BPH: The following investigator-judged drug-related adverse events (with a cumulative incidence of greater than or equal to 1%) have been reported in the CombAT (Combination of Avodart and Tamsulosin) study, a comparison of Avodart 0.5 mg and tamsulosin 0.4 mg once daily for four years in combination or as monotherapy. (See Table 2.)


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Post-Marketing Data: Adverse drug reactions are listed by system organ class and frequency.
Frequencies are defined as: 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) including isolated reports. Frequency categories determined from post-marketing data refer to reporting rate rather than true frequency.
Immune System Disorders: Very Rare: Allergic reactions, including rash, pruritus, urticaria, localised oedema and angioedema.
Psychiatric Disorders: Very Rare: Depressed mood.
Skin and Subcutaneous Tissue Disorders: Rare: Alopecia (primary body hair loss), hypertrichosis.
Reproductive System and Breast Disorders: Very Rare: Testicular pain and testicular swelling.