NEW
Ilevro

Ilevro Adverse Reactions

nepafenac

Manufacturer:

Novartis Indonesia
Full Prescribing Info
Adverse Reactions
Tabulated list of adverse reactions [Clinical Studies]: The following adverse reactions have been reported during clinical trials with Ilevro and are classified according to the subsequent convention: 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) and very rare (<1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 1.)


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Patients with evidence of corneal epithelial breakdown including corneal perforation should immediately discontinue use of Ilevro and should be monitored closely for corneal health.
Tabulated list of adverse reactions [Post-Marketing Surveillance]: Post marketing experience with topical NSAIDs suggest that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reaction which may become sight threatening.
Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness. (See Table 2.)


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