Lumigan 0.01% Adverse Reactions

Clinical Studies Experience: In a 12-month, Phase 3 clinical study, in patients with glaucoma or ocular hypertension (Study Report 192024-031), approximately 38% (71/185) of patients treated with bimatoprost 0.01% eye drops solution experienced undesirable effects considered related to treatment. The most frequently reported treatment-related adverse event was conjunctival hyperemia (mostly mild and thought to be of a non-inflammatory nature) occurring in 29% of patients. Approximately 4% (8/185) of patients in the bimatoprost 0.01% arm of the study discontinued due to any adverse event in the 12-month study, with 1.6% (3/185) discontinuing due to conjunctival hyperemia.
The following undesirable effects considered related to treatment were reported during treatment with bimatoprost 0.01% eye drops (Study Report 192024-031, 12-months). Most were ocular, mild and none was serious.
The frequency is defined as follows: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000).
Eye disorders: Very Common: Ocular/Conjunctival hyperemia.
Common: Eye irritation, erythema of eyelid, eye pruritus, eyelids pruritus, growth of eyelashes, punctate keratitis.
Skin and subcutaneous tissue disorders: Common: Hypertrichosis, skin hyperpigmentation.
General disorders and administration site conditions: Common: Instillation site irritation.
Postmarketing Experience: The following adverse reactions have been identified during postmarketing use of LUMIGAN 0.01% in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not possible to reliably estimate the frequency of these reactions: Eye disorders: Blepharal pigmentation, dry eye, eye discharge, eye edema, eyelid edema, eye pain, foreign body sensation in eye, iris hyperpigmentation, lacrimation increased, macular edema, ocular discomfort, periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus, eyelid ptosis, enophthalmos and eyelid retraction, photophobia, vision blurred.
Immune system disorders: Hypersensitivity reaction including sign and symptoms of eye allergy and allergic dermatitis.
Nervous system disorders: Dizziness, headache.
Respiratory, thoracic and mediastinal disorders: Asthma, exacerbation of asthma, dyspnea.
Vascular disorders: Hypertension.
Inform the doctor of undesirable effects occurred during drug use.