Lumigan Side Effects

Generic name: bimatoprost ophthalmic

Note: This document contains side effect information about bimatoprost ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Lumigan.

Some side effects of Lumigan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bimatoprost ophthalmic: ophthalmic solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking bimatoprost ophthalmic (the active ingredient contained in Lumigan) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using bimatoprost ophthalmic and call your doctor at once if you have a serious side effect such as:

• redness, swelling, itching, or pain in or around your eye;

• oozing or discharge from your eye;

• increased sensitivity to light;

• vision changes.

Less serious side effects of bimatoprost ophthalmic may include:

• mild eye discomfort;

• dizziness;

• feeling like something is in your eye;

• dry or watery eyes; or

• stinging or burning of the eyes after using the drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bimatoprost ophthalmic: ophthalmic solution

Ocular

Bimatoprost 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.

The manufacturer reports approximately 3% of patients discontinue therapy due to conjunctival hyperemia.

One study (n=133) reported trace or mild conjunctival hyperemia in up to 55.4% of patients with a mean grade of 0.55 on a scale of 0 to 3. Also reported were eyelash growth (10.5%), ocular pruritus (9.8%), and ocular burning (5.3%).

Ocular side effects have been reported the most frequently. Ocular side effects reported in 15% to 45% of patients have included conjunctival hyperemia, growth of eyelashes, and ocular pruritus. Ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, pigmentation of the periocular skin, blepharitis, cataract, superficial punctate keratitis, eyelid erythema, ocular irritation, and eyelash darkening have been reported in 3% to 10% of patients. Eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increased iris pigmentation, and conjunctival edema have been reported in 1% to 3% of patients. Intraocular inflammation or iritis has been reported rarely (less than 1%). Macular edema, including cystoid macular edema, has also been reported. Postmarketing reports have included eyelid edema and periorbital and lid changes associated with a deepening of the eyelid sulcus.

Dermatologic

A 59-year-old Hispanic woman developed hypertrichosis of vellus hairs on the left malar region within 4 weeks of initiating unilateral therapy (left eye). Therapy was discontinued and the condition did not recur following epilation.

Two cases of poliosis were reported in as early as six weeks of treatment. Affected lashes were interspersed with normally pigmented lashes. Hypertrichosis was also reported in these patients.

Dermatologic side effects have included increases in length, thickness, pigmentation, and/or number of eyelashes. These changes may be permanent. Bimatoprost may also cause increased brown pigmentation of the eyelashes, periorbital and/or eyelid tissue of the treated eye. Hirsutism has been reported in less than 5% of patients. There is a single case report of hypertrichosis of vellus hairs in the malar region.

Respiratory

Respiratory side effects have included colds and upper respiratory tract infections in approximately 10% of patients.

Nervous system

Nervous system side effects have included headache (less than 5%). Postmarketing reports have included dizziness.

Hepatic

Hepatic system side effects have included abnormal liver function tests (<5%).

Other

Other side effects have included asthenia (<5%).

Cardiovascular

Cardiovascular side effects have included hypertension.

Gastrointestinal

Gastrointestinal side effects have included nausea.

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