Xalatan Side Effects

Please note - some side effects for Xalatan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Xalatan - for the Consumer

Xalatan Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xalatan Drops:

Blurred vision; changes in eyelash growth; cold symptoms; eye burning, dryness, itching, or stinging; feeling of having something in your eye; increased tear production.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; darkening of the eyelid or eye color; eye or eyelid discharge, inflammation, irritation, pain, redness, or swelling; red, swollen, blistered, or peeling skin; vision changes.

Xalatan Side Effects - for the Professional

Xalatan

Adverse events referred to in other sections of this insert

Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema.

Controlled Clinical Trials

The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of the patients on Xalatan Sterile Ophthalmic Solution in the three 6-month, multi-center, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy.

Local conjunctival hyperemia was observed; however, less than 1% of the patients treated with Xalatan required discontinuation of therapy because of intolerance to conjunctival hyperemia.

In addition to the above listed ocular events/signs and symptoms, the following were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain, lid crusting, lid discomfort/pain, lid edema, lid erythema, and photophobia.

The following events were reported in less than 1% of the patients: conjunctivitis, diplopia and discharge from the eye.

During clinical studies, there were extremely rare reports of the following: retinal artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy.

The most common systemic adverse events seen with Xalatan were upper respiratory tract infection/cold/flu, which occurred at a rate of approximately 4%. Chest pain/angina pectoris, muscle/joint/back pain, and rash/allergic skin reaction each occurred at a rate of 1 to 2%.

Clinical Practice

The following events have been identified during postmarketing use of Xalatan in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Xalatan, or a combination of these factors, include: asthma and exacerbation of asthma; corneal edema and erosions; dyspnea; eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); eyelid skin darkening; herpes keratitis; intraocular inflammation (iritis/uveitis); keratitis; macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; dizziness, headache, and toxic epidermal necrolysis.

Side Effects by Body System

Ocular

Ocular side effects have been reported the most frequently. These have included blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy in 5% to 15% of patients. Dry eye, excessive tearing, eye pain, lid crusting, lid discomfort/pain, lid edema, lid erythema and photophobia have been observed in 1% to 4% of patients. Conjunctivitis, diplopia and discharge from the eye have been reported in less than 1% of patients. Retinal artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy have been reported rarely. Choroidal detachment, hypotony, macular edema (including cystoid macular edema), pigmented iris cysts, corneal edema, corneal erosions, keratitis, and herpes keratitis have also been reported. Paradoxical increases in intraocular pressure (IOP) and recurrence of uveal inflammation have been reported in patients with uveitic glaucoma.

Latanoprost can increase the amount of brown pigment in the eye by stimulating melanin production in melanocytes. The change in eye color occurs gradually over months to years and may be permanent. The entire or parts of the iris may be affected. Changes may be more prominent in patients with green- brown, blue/gray- brown or yellow- brown irides.

Conjunctival hyperemia is generally most pronounced during the start of therapy and may subside following prolonged use. In clinical trials, the hyperemia tended to be mild or moderate and rarely resulted in withdrawal from therapy.

A 6- month multicenter, randomized, investigator- masked study (n=136) of patients receiving daily latanoprost therapy reported conjunctival hyperemia in up to 42.5% of patients and a single case of anterior uveitis requiring treatment with topical corticosteroids. The mean grade of hyperemia was 0.28 on a scale of 1 to 3.

An open-label, multinational, multicenter, uncontrolled study of latanoprost administered daily for up to 5 years reported an increase in iris pigmentation in one-third of patients. This effect was generally reported within the first 36 months of therapy in patients with nonhomogenous eye color. There appeared to be no effect on the efficacy or overall safety of latanoprost.

Respiratory

Respiratory side effects have included upper respiratory infections in 4% of patients. Asthma, exacerbation of asthma, and dyspnea have also been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgias and myalgias (usually back pain) in 1% to 2% of patients.

Cardiovascular

Cardiovascular side effects have rarely included chest pain and angina pectoris (1% to 2%).

Hypersensitivity

Hypersensitivity reactions have included rash or skin problems in 1% to 2% of patients.

Dermatologic

The manufacturer reports eyelash changes are usually reversible following discontinuation of therapy.

Four cases of poliosis have been reported in as early as 6 weeks of treatment. The affected lashes were interspersed with normally pigmented lashes. Hypertrichosis was also reported in 2 of the 4 patients.

A 6- month, multicenter, randomized, investigator- masked study (n=136) reported a single case of eyelash growth with daily latanoprost therapy.

A 61- year- old man reported his upper eyelashes had been obscuring his vision for approximately 2 months after instilling latanoprost daily to both eyes for approximately a 2- year duration. Further examination revealed bilateral trichomegaly with potentially irreversible lash ptosis.

Dermatologic side effects have rarely included reversible hyperpigmentation of the eyelids, eyelashes, periocular area, temporal area, neck, and back. Increase in length, thickness, and number of eyelashes and/or vellus hairs, changes in the direction of the growth of eyelashes, poliosis, contact dermatitis, and toxic epidermal necrolysis have also been reported. One case of lash ptosis has been reported.

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