No adverse drug reactions (ADRs) specific for GANFORT have been observed in clinical studies. The ADRs have been limited to those earlier reported for bimatoprost and timolol.
The majority of ADRs were ocular, mild in severity and none were serious. Based on 12-month clinical data, the most commonly reported ADR was conjunctival hyperaemia (mostly trace to mild and thought to be a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients.
The following ADRs were reported during clinical trials with GANFORT (within each frequency grouping, undesirable effects are presented in order of decreasing seriousness): Nervous system disorders:
Uncommon (>1/1000, <1/100): headache.
Very common: (>1/10): conjunctival hyperaemia, growth of eyelashes.
Common: (>1/100, <1/10): superficial punctuate keratitis, corneal erosion, burning sensation, eye pruritus, stinging sensation in the eye, foreign body sensation, eye dryness, eyelid erythema, eye pain, photophobia, eye discharge, visual disturbance, eyelid pruritus.
Uncommon (>1/1000, <1/100): iritis, eye irritation, conjunctival oedema, blepharitis, epiphora, eyelid oedema, eyelid pain, visual acuity worsened, asthenopia, trichiasis.
Respiratory, thoracic and mediastinal disorders:
Uncommon (>1/1000, <1/100): rhinitis.
Skin and subcutaneous tissue disorders:
Common: (>1/100, <1/10): blepharal pigmentation.
Uncommon (>1/1000, <1/100): hirsutism.
Additional adverse events that have been seen with one of the components and may potentially occur also with GANFORT.
Infections and infestations: infection (primarily colds and upper respiratory symptoms).
Nervous system disorders: dizziness.
Eye disorders: allergic conjuctivitis, cataract, eyelash darkening, increased iris pigmentation, blepharospasm, cystoid macular oedema, eyelid retraction, retinal haemorrhage, uveitis.
Vascular disorders: hypertension.
General disorders and administration site condition: asthenia, peripheral oedema.
Investigations: liver function tests (LFT) abnormal.
Psychiatric disorders: insomnia, nightmares, decreased libido.
Nervous system: dizziness, memory loss, increase in signs and symptoms of myasthenia gravis, paresthaesia, cerebral ischaemia.
Eye disorders: decreased corneal sensitivity, diplopia, ptosis, choroidal detachment (following filtration surgery), refractive changes (due to withdrawal of miotic therapy in some cases), keratitis.
Ear and labyrinth disorders: tinnitus.
Cardiac disorders: heart block, cardiac arrest, arrhythmia, syncope, bradycardia, cardiac failure, congestive heart failure.
Vascular disorders: hypotension, cerebrovascular accident, claudication, Raynaud's phenomenon, cold hands and feet, palpitation.
Respiratory, thoracic and mediastinal disorders: bronchospasm (predominantly in patients with pre-existing bronchospastic disease) dyspnoea, cough.
Gastrointestinal disorders: nausea, diarrhoea, dyspepsia, dry mouth.
Skin and subcutaneous tissue disorders: alopecia, psoriasis rash or exacerbation of psoriasis.
Musculoskeletal and connective tissue disorders: systemic lupus erythematosus.
Renal and urinary disorders: Peyronie's disease.
General disorders and administration site conditions: oedema, chest pain, fatigue.
Ganfort PF: Clinical Study-Ganfort PF (Single Dose)-Study 192024-050:
Study 192024-050 was a multicenter, double-masked, randomized, parallel study comparing the efficacy and safety of Ganfort PF (single dose) to Ganfort Eye Drops Solution (multidose) in patients with glaucoma or ocular hypertension and treated once daily for 3 months. A total of 278 and 283 patients were randomized to the Ganfort PF (single dose) and Ganfort Eye Drop Solution (multidose) treatment groups, respectively.
Table 1 presents the undesirable effects considered related to treatment that were reported in ≥1% of patients during treatment with Ganfort PF (single dose). Most were ocular, mild and none was serious.
Click on icon to see table/diagram/image
Table 2 presents the adverse reactions with incidence rates <1%.
Click on icon to see table/diagram/image
Additional Adverse Reactions:
Bimatoprost 0.03% single dose (for ophthalmic use): Eye Disorders: Conjunctival edema, hair growth abnormal, iris hyperpigmentation, vision blurred.
Timolol (ophthalmic use): Eye Disorders: Blepharitis, choroidal detachment following filtration surgery (see Precautions), Cystoid macular edema, decreased corneal sensitivity, diplopia, Eye discharge, pseudopemphigoid, ptosis, refractive changes; signs and symptoms of ocular irritation including conjunctivitis and keratitis.
Cardiac Disorders: Arrhythmia, atrioventricular block, bradycardia (see Contraindications), cardiac arrest, cardiac failure, chest pain, congestive heart failure, edema, heart block, palpitations, pulmonary edema, worsening of angina pectoris.
Ear and Labyrinth Disorders: Tinnitus.
Gastrointestinal Disorders: Abdominal pain, anorexia, diarrhea, dry mouth, dysgeusia, dyspepsia, nausea, vomiting.
General Disorders and Administration Site Conditions: Asthenia/Fatigue.
Immune System Disorders: Systemic allergic reactions including anaphylaxis, angioedema, generalized and localized rash, pruritis, urticaria; Systemic lupus erythematosus.
Metabolism and Nutrition Disorders: Hypoglycemia (in diabetic patients-see Precautions).
Musculoskeletal and Connective Tissue Disorders: Myalgia.
Nervous System Disorders: Cerebral ischemia, cerebrovascular accident, increase in signs and symptoms of myasthenia gravis; paresthesia, syncope
Psychiatric Disorders: Behavioral changes and psychic disturbances including anxiety, confusion, depression, disorientation, hallucinations, insomnia, nervousness, memory loss, somnolence; Nightmares.
Reproductive System and Breast Disorders: Decreased Libido, Peyronie's disease, retroperitoneal fibrosis, sexual dysfunction.
Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease) (see Precautions), cough, dyspnea, nasal congestion, respiratory failure, upper respiratory infection.
Skin and Subcutaneous Tissue Disorders: Alopecia, exacerbation of psoriasis, psoriasiform rash, skin rash.
Vascular Disorders: Claudication, cold hands and feet, hypotension, Raynaud's phenomenon.