XALATAN SIDE EFFECTS
- Generic Name: latanoprost ophthalmic
- Brand Name: Xalatan
- Drug Class: Antiglaucoma, Prostaglandin Agonists
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, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.
Table 1: Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5-15% of Patients Receiving Latanoprost
| Symptom/Finding | Adverse Reactions (incidence (%)) | |
| Latanoprost (n=460) |
Timolol (n=369) |
|
| Foreign body sensation | 13 | 8 |
| Punctate keratitis | 10 | 9 |
| Stinging | 9 | 12 |
| Conjunctival hyperemia | 8 | 3 |
| Blurred vision | 8 | 8 |
| Itching | 8 | 8 |
| Burning | 7 | 8 |
| Increased pigmentation of the Iris | 7 | 0 |
Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.
Table 2: Adverse Reactions That Were Reported in 1-5% of Patients Receiving Latanoprost
| Adverse Reactions (incidence (%)) | ||
| Latanoprost (n=460) |
Timolol (n=369) |
|
| Ocular Events/Signs and Symptoms | ||
| Excessive tearing | 4 | 6 |
| Eyelid discomfort/pain | 4 | 2 |
| Dry eye | 3 | 3 |
| Eye pain | 3 | 3 |
| Eyelid margin crusting | 3 | 3 |
| Erythema of the eyelid | 3 | 2 |
| Photophobia | 2 | 1 |
| Eyelid edema | 1 | 3 |
| Systemic Events | ||
| Upper respiratory tract infection/nasopharyngitis/influenza | 3 | 3 |
| Myalgia/arthralgia/back pain | 1 | 0.5 |
| Rash/allergic skin reaction | 1 | 0.3 |
The ocular event/signs and symptoms of blepharitis have been identified as “commonly observed” through analysis of clinical trial data.
Postmarketing Experience
The following reactions have been identified during postmarketing use of XALATAN 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 XALATAN, or a combination of these factors, include:
Nervous System disorders: Dizziness; headache; toxic epidermal necrolysis
Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; 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; localised 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 .