OMIDRIA SIDE EFFECTS
- Generic Name: phenylephrine and ketorolac injection
- Brand Name: Omidria
Last updated on MDtodate: 10/9/2022
SIDE EFFECTS
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 the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of adult patients as seen in the combined clinical trial results from three randomized, placebo-controlled studies.
Table 1: Ocular Adverse Reactions Reported by ≥ 2% of Adult Patients
| MedDRA Preferred Term | Placebo (N=462) |
Omidria (N=459) |
| n (%) | n (%) | |
| Ocular Events | ||
| Anterior Chamber Inflammation | 102 (22%) | 111 (24%) |
| Intraocular Pressure Increased | 15 (3%) | 20 (4%) |
| Posterior Capsule Opacification | 16 (4%) | 18 (4%) |
| Eye Irritation | 6 (1%) | 9 (2%) |
| Foreign Body Sensation in Eyes | 11 (2%) | 8 (2%) |
In a safety study that enrolled 72 pediatric patients up to 3 years old, no overall difference in safety was observed between pediatric and adult patients.
SRC: NLM .