Avodart Adverse Reactions

Clinical Trial Data: Dutasteride (Avodart) Monotherapy for BPH: The following investigator-judged drug-related adverse events (with incidence ≥1%) have been reported more commonly in the 3 phase III placebo-controlled studies on Avodart treatment compared to placebo (See Table 1).

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No change to the adverse event profile was apparent over a further 2 years in open-label extension studies.
Dutasteride (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 Dutasteride (Avodart) and tamsulosin) Study, a comparison of Dutasteride (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 as follows by system organ class and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <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 reaction including rash, pruritus, urticaria, localized edema and angioedema.
Psychiatric disorders: Very rare: Depressed mood.
Skin and subcutaneous tissue disorders: Rare: Alopecia (primarily body hair loss), hypertrichosis.
Reproductive system and breast disorders: Very rare: Testicular pain and swelling.