Timolol Adverse Reactions

Summary of safety profile: In clinical trials, the most common adverse drug reactions were ocular hyperaemia and eye irritation, occurring approximately in 5% and 2% of patients respectively.
The most frequently reported undesirable effects with timolol eye drops are local ocular reactions. Like other topically applied ophthalmic drugs, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic undesirable effects after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.
The following adverse reactions are classified according to the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience. (See table.)

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The following additional undesirable effects have been reported in clinical trials with orally administered timolol maleate and can be considered as potential side effects of ophthalmically administered timolol maleate: Blood and lymphatic system disorders: Non-thrombocytopenic purpura.
Endocrine disorders: Hyperglycaemia.
Psychiatric disorders: Decreased libido, increased dreaming frequency.
Nervous system disorders: Disturbance in attention (diminished concentration).
Ear and labyrinth disorders: Tinnitus.
Vascular disorders: Peripheral vascular disorder (arterial insufficiency), intermittent claudication, vasodilatation, sino-auricular block, deterioration of arterial insufficiency.
Respiratory, thoracic and mediastinal disorders: Rhonchi, bronchial obstruction.
Hepatobiliary disorders: Hepatomegaly.
Skin and subcutaneous tissue disorders: Pruritus, skin irritation, increased skin pigmentation, exfoliative dermatitis.
Musculoskeletal and connective tissue disorders: Arthralgia, pain in the limbs.
Renal and urinary disorders: Difficulty in micturation.
General disorders and administration site conditions: Weakness (local).
Investigations: Decreased exercise tolerance, decreased weight.
Laboratory parameters: In only a few cases, the oral administration of timolol maleate has been associated with significant clinical alterations of the laboratory parameters. Slight increase of urea, potassium, urinary acid and triglycerides in the blood has been observed, as well as slight decreases of haemoglobin, hematocrit and HDL cholesterol. However, these alterations were not evolutive and were not associated with clinical abnormalities.
Possible undesirable effects: In addition, a number of undesirable effects have been reported with other beta-adrenergic blocking agents and these may also be considered as potential undesirable effects of ophthalmically administered timolol maleate: Blood and lymphatic system disorders: Agranulocytosis, idiopathic thrombocytopenic purpura.
Immune system disorders: Pyrexia (with aching and sore throat).
Psychiatric disorders: Reversible mental depression leading to catatonia, an acute reversible syndrome characterised by disorientation in time and place, loss of short term memory, emotional instability, slightly clouded sensorium, decreased performance on neuropsychometrics.
Respiratory, thoracic and mediastinal disorders: Laryngospasms.
Gastrointestinal disorders: Mesenteric arterial insufficiency (arterial thrombosis), ischemic colitis.
Renal and urinary disorders: Peyronie's disease.
There have been reports of a syndrome comprising psoriasiform skin rash, conjunctivitis sicca, otitis and sclerosing serositis attributed to the beta-blocking agent, practolol. This syndrome has not been reported with timolol maleate.
Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with TIMOLOL MALEATE: Immune system disorders: Systemic allergic reactions including pruritus, anaphylactic reaction.
Eye disorders: Decreased corneal sensitivity.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Cardiac disorders: Chest pain.
Musculoskeletal and connective tissue disorders: Myalgia.
Reproductive system and breast disorders: Decreased libido.
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.