Like other topically applied ophthalmic drugs, betaxolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
Listed adverse reactions include reactions seen within the class of ophthalmic beta- blockers. 0% of patients. The following undesirable effects have been observed and reported with the following frequencies: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people Not known: frequency unknown/cannot be estimated from the available data Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Classification MedDRA Preferred Term Immune system disorders Frequency unknown: hypersensitivity Psychiatric disorders Rare: anxiety, insomnia, depression Nervous system disorders Common: headache Rare: syncope Frequency unknown: dizziness Eye disorders Very common: ocular discomfort Common: vision blurred, lacrimation increased Uncommon: punctate keratitis, keratitis, conjunctivitis, blepharitis, visual impairment, photophobia, eye pain, dry eye, asthenopia, blepharospasm, eye pruritus, eye discharge, eyelid margin crusting, eye inflammation, eye irritation, conjunctival disorder, conjunctival oedema, ocular hyperaemia Rare: Cataract, decreased corneal sensitivity, erythema of eyelid Cardiac disorders Uncommon: bradycardia, tachycardia Frequency unknown: arrhythmia Vascular disorders Rare: hypotension Respiratory, thoracic and mediastinal Disorders Uncommon: asthma, dyspnoea, rhinitis Rare: cough, rhinorrhea Gastrointestinal disorders Uncommon: nausea Rare: dysgeusia Skin and subcutaneous tissue disorders Rare: dermatitis, rash, alopecia Reproductive system and breast disorders Rare: libido decreased General disorders and administration site conditions Frequency unknown: asthenia Description of selected adverse reactions Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with Betaxolol eye drops solution: System Organ Classification MedDRA Preferred Term Immune system disorders: Frequency unknown: Systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction.
Metabolism and nutrition disorders:
Frequency unknown: Hypoglycaemia.
Psychiatric disorders:
Frequency unknown: nightmares, memory loss, hallucinations, psychoses, confusion. 4 Special warnings and special precautions for use), corneal erosion, ptosis, diplopia.
Cardiac disorders:
Frequency unknown: Chest pain, palpitations, oedema, congestive heart failure, atrioventricular block, cardiac arrest, cardiac failure.
A slowed AV- conduction or increase of an existing AV-block Vascular disorders:
Frequency unknown: Raynaud's phenomenon, cold and cyanotic hands and feet, Increase of an existing intermittent claudication.
Respiratory, thoracic, and mediastinal disorders:
Frequency unknown: Bronchospasm (predominantly in patients with pre- existing bronchspastic disease) Gastrointestinal disorders: Frequency unknown: dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting.
Skin and subcutaneous tissue disorders:
Frequency unknown: Psoriasiform rash or exacerbation of psoriasis Musculoskeletal and connective tissue disorders: Frequency unknown: Myalgia.
Reproductive system and breast disorders:
Frequency unknown: Sexual dysfunction, impotence.
General disorders and administration site conditions:
Frequency unknown: fatigue. An increase in Anti Nuclear Antibodies (ANA) has been seen; its clinical relevance is unclear. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.