Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reaction (30% to 50%) is conjunctival hyperemia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or the FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reaction observed in controlled clinical trials with travoprost ophthalmic solution 0.004% was ocular hyperemia, which was reported in 30% to 50% of patients.
Up to 3% of patients discontinued therapy due to conjunctival hyperemia.
Ocular adverse reactions, reported at an incidence of 5% to 10% in these clinical trials, included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus.
Ocular adverse reactions, reported at an incidence of 1% to 4% in clinical trials with travoprost ophthalmic solution 0.004%, included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, and tearing.
Non-ocular adverse reactions, reported at an incidence of 1% to 5% in these clinical studies, were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence, and urinary tract infections.
6.2 Postmarketing Experience Additional adverse reactions have been identified during post approval use of travoprost ophthalmic solution 0.004% in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to travoprost ophthalmic solution, or a combination of these factors, include: arrhythmia, vomiting, epistaxis, tachycardia, and insomnia.
5 WARNINGS AND PRECAUTIONS Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes can occur.
Iris pigmentation likely to be permanent (5.1) Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes.
Usually reversible (5.2) 5.1 Pigmentation Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues.
The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes.
Pigmentation is expected to increase as long as travoprost is administered.
Like all medications, Travoprost can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: