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Click on icon to see table/diagram/imageNo change to the adverse event profile was apparent over a further 2 years in open label extension studies.
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.)
Click on icon to see table/diagram/imagePost-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 reactions, including rash, pruritus, urticaria, localised oedema, 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 testicular swelling.
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