Avorna Duo Adverse Reactions

The most common undesirable effects during combined administration of Dutasteride and Tamsulosin hydrochloride related to the organ system "Reproductive system and breast". These undesirable effects were observed more frequently with the combination therapy than with the respective monotherapies and in each case were more frequent in the first year of treatment than in the subsequent years of treatment. The undesirable effects, which were observed either during one of the two monotherapies or in the co-administration study, are listed as follows by organ system and frequency.
Neoplasms: Unknown: Breast cancer in men.
Immune system disorders: Uncommon: Rash, pruritus, urticaria.
Rare: Angioedema.
Very rare: Stevens-Johnson syndrome.
Psychiatric disorders: Common: Decreased libido.
Very rare: Depressive mood.
Nervous system disorders: Common: Dizziness.
Rare: Syncope.
Eyes: Unknown: Blurred vision, visual disturbances.
Following market launch there have also been reports of a relationship between the occurrence of what is known as Intraoperative Floppy Iris Syndrome (IFIS) during cataract and glaucoma surgery and treatment tamsulosin.
Cardiovascular disorders: Uncommon: Palpitations, orthostatic hypotension.
Unknown: Tachycardia, arrhythmias (e.g. atrial fibrillation).
Respiratory disorders: Uncommon: Rhinitis.
Unknown: Epistaxis, dyspnoea.
Gastrointestinal disorders: Uncommon: Nausea, constipation, diarrhoea, vomiting, dry mouth.
Skin and subcutaneous tissue disorders: Unknown: Exfoliative dermatitis, erythema multiforme.
Reproductive system and breast disorders: Common: Impotence, ejaculation disorders (such as retrograde ejaculation), gynaecomastia, breast tenderness.
Very rare: Priapism, testicular pain and testicular swelling.
Unknown: Persistent sexual dysfunction (such as impotence, ejaculation disorders and decreased libido) even after discontinuation of therapy.
General disorders: Uncommon: Asthenia.