Restasis Adverse Reactions

Clinical Studies: On combining the data from the pivotal phase III clinical studies, approximately 29% of treated patients experienced treatment related adverse events (adverse reactions) in the first year. The majority were ocular, mild or moderate in severity and none were serious. The most commonly reported adverse reaction was eye burning reported in approximately 17% of patients in the first year with the incidence of new reports decreasing to 5% at 2 years.
The frequency of adverse reactions observed during clinical trials involving 436 patients treated with RESTASIS is presented as follows.
The frequency is defined as follows: Very Common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very Rare (<1/10,000).
Nervous system disorders: Common: Headache.
Uncommon: Dizziness.
Eye disorders: Very common: Eye burning.
Common: Eye irritation, foreign body sensation in eye, ocular/conjunctival hyperaemia, eye pain, eye stinging, eye discharge, photophobia, eye pruritus, visual disturbance (blurred vision), dry eye.
Uncommon: Ulcerative keratitis, eyelid oedema, erythema of eyelid, lacrimation increased.
Gastrointestinal disorders: Uncommon: Nausea.
Skin and subcutaneous tissue disorders: Uncommon: Rash.
Postmarketing Experience: The following additional adverse reactions have been identified during postmarketing use of RESTASIS in clinical practice. Because postmarketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.
Eye Disorders: Eye swelling.
Immune System Disorders: Hypersensitivity.
Rare cases including severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea.
Injury, Poisoning and Procedural Complications: Superficial injury of the eye (from the vial tip touching the eye during administration).
Nervous System Disorders: Burning sensation.
Skin and Subcutaneous Tissue Disorders: Pruritus, urticaria.