XELPROS SIDE EFFECTS
- Generic Name: latanoprost ophthalmic emulsion
- Brand Name: Xelpros
SIDE EFFECTS
The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:
- Iris pigmentation changes
- Eyelid skin darkening
- Eyelash changes (increased length, thickness, pigmentation, and number of lashes)
- Intraocular inflammation (iritis/uveitis)
- Macular edema, including cystoid macular edema
Clinical Trials Experience
Because clinical trials 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 clinical practice.
Across multiple clinical trials conducted with XELPROS (latanoprost ophthalmic emulsion) 0.005%, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia, reported in 55% and 41% of XELPROS treated patients, respectively (Table 1). Less than 1% of patients discontinued therapy because of intolerance to the eye pain/stinging or to the ocular hyperemia.
Table 1. Ocular Adverse Reactions Reported by ≥ 1% of Subjects Receiving XELPROS
| System Organ Class/ Preferred Term |
XELPROS (N = 448) |
| Eye disorders | 325 (73%) |
| Eye pain / stinging | 246 (55%) |
| Ocular hyperemia | 185 (41%) |
| Conjunctival hyperemia | 65 (15%) |
| Eye discharge | 53 (12%) |
| Growth of eyelashes | 47 (11%) |
| Eyelash thickening | 35 (8%) |
| Ocular Itching | 20 (5%) |
| Visual acuity reduced | 16 (4%) |
| Dry eye | 13 (3%) |
| Erythema of eyelid | 14 (3%) |
| Foreign body sensation in eyes | 9 (2%) |
| Punctate keratitis | 6 (1%) |
| Eyelash discoloration | 5 (1%) |
| Eyelid edema | 7 (2%) |
| Conjunctival edema | 5 (1%) |
Postmarketing Experience
The following reactions have been identified during postmarketing use of topical latanoprost products in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to latanoprost ophthalmic emulsion or a combination of these factors, include:
- Nervous System Disorders: Dizziness, headache, toxic epidermal necrolysis
- Eye Disorders: Corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva
- Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea
- Skin and Subcutaneous Tissue Disorders: Pruritus
- Infections and Infestations: Herpes keratitis
- Cardiac Disorders: Angina; palpitations; angina unstable
- General Disorders and Administration Site Conditions: Chest pain
SRC: NLM .