Avodart Adverse Reactions

Clinical Trial Data: Avodart Monotherapy: Approximately 19% of the 2167 patients who received dutasteride in the 2-year Phase III placebo-controlled trials developed adverse reactions during the 1st 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 years 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 ≥1%) reported with a higher incidence in patients treated with dutasteride compared with placebo during the 1st year of treatment. Adverse events from post-marketing experience were identified from spontaneous post-marketing reports, therefore, the true incidence is unknown.


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Avodart and Tamsulosin Combination Therapy for BPH: The following investigator-judged drug-related adverse events (with a cumulative incidence of ≤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 4 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 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) 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.
Skin and Subcutaneous Tissue Disorders: Rare: Alopecia (primary body hair loss), hypertrichosis.