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 reaction 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 reactions ( > 10%) included growth of eyelashes and ocular pruritus.

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

Postmarketing Experience

The following reactions have been identified during postmarketing use of LUMIGAN® 0.01% and 0.03% 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 LUMIGAN®, or a combination of these factors, include: dizziness, eyelid edema, hypertension, nausea, and periorbital and lid changes associated with a deepening of the eyelid sulcus.

Last reviewed on RxList: 3/22/2012
This monograph has been modified to include the generic and brand name in many instances.