Prostera Adverse Reactions

Adverse reactions are listed by system organ class and the following frequencies: 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); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Infections and infestations: Common: Sinusitis. Not known: Bronchitis, flu symptoms, nasopharyngitis, pharyngitis, rhinitis, urinary tract infections.
Blood and lymphatic system disorders: Not known: Thrombocytopenia.
Immune system disorders: Not known: Anaphylactic reactions.
Metabolism and nutrition disorders: Not known: Gout.
Psychiatric disorders: Common: Nervousness. Uncommon: Decreased libido, depression. Not known: Insomnia.
Nervous system disorders: Very common: Headache, dizziness. Common: Paraesthesia, somnolence. Uncommon: Syncope.
Eye disorders: Common: Blurred vision. Not known: Conjunctivitis.
Ear and labyrinth disorders: Very common: Vertigo. Not known: Tinnitus.
Cardiac disorders: Common: Palpitations, tachycardia. Not known: Arrhythmia, atrial fibrillation.
Vascular disorders: Common: Orthostatic hypotension. Not known: Vasodilatation.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea, nasal congestion. Not known: Cough, epistaxis.
Gastrointestinal disorders: Common: Nausea. Not known: Abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, flatulence, vomiting.
Skin and subcutaneous tissue disorders: Not known: Hyperhidrosis, pruritus, rash.
Musculoskeletal, connective tissue and bone disorders: Common: Pain in extremities, back pain. Not known: Arthralgia, arthritis, arthropathy, myalgia, neck pain, shoulder pain.
Renal and urinary tract disorders: Not known: Urinary frequency increased, urinary incontinence.
Reproductive system and breast disorders: Common: Erectile dysfunction. Not known: Priapism.
General disorders and administration site conditions: Very common: Asthenia. Common: Peripheral edema, fatigue, edema in the mucosa. Uncommon: Edema. Not known: Chest pain, facial edema, pyrexia.
Investigations: Rare: Weight gain. Not known: Decreased albumin, decreased hematocrit, decreased hemoglobin, decreased total protein, reduction of leukocytes.
There was no significant effect on the prostate specific antigen (PSA) levels for up to 24 months reported after treatment with terazosin.