Lumigan Side Effects

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

Side Effects of Lumigan - for the Consumer

Lumigan 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 Lumigan Drops:

Changes in eyelash growth; cold symptoms; eye burning, dryness, itching, or redness; feeling of having something in your eye; headache; increased tear production.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); darkening of the eyelid, eye color, or whites of the eyes; eye or eyelid discharge, inflammation, irritation, pain, or swelling; severe or persistent eye fatigue; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Lumigan Side Effects - for the Professional

Lumigan

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical studies with bimatoprost ophthalmic solutions (0.01% or 0.03%) the most common adverse event was conjunctival hyperemia (range 25% – 45%). Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common events (>10%) included growth of eyelashes, and ocular pruritus.

Additional ocular adverse events (reported in 1 to 10% of patients) with bimatoprost ophthalmic solutions included 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, eyelash darkening, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, conjunctival edema, conjunctival hemorrhage, and abnormal hair growth. Intraocular inflammation, reported as iritis was reported in less than 1% of patients.

Systemic adverse events reported in approximately 10% of patients with bimatoprost ophthalmic solutions were infections (primarily colds and upper respiratory tract infections). Other systemic adverse events (reported in 1 to 5% of patients) included headaches, abnormal liver function tests, and asthenia.

Side Effects by Body System - for Healthcare Professionals

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 (<1%). Macular edema, including cystoid macular edema, has also been reported.

Dermatologic

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.

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.

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 (<5%).

Hepatic

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

Other

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

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