Latanoprost is a medicine sold in the U.S. under 3 brand and generic names, for open-angle glaucoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Xelpros (application NDA206185). Other latanoprost products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of XELPROS should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including XELPROS is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular pressure (IOP) lowering effect or cause paradoxical elevations in IOP. Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. XELPROS may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of XELPROS, and may be reinserted 15 minutes after administration. One drop in the affected eye(s) once daily in the evening. ( 2 )
Most common ocular adverse reactions (incidence ≥5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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%)…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 62/100 | Prescription | Solution | Generic | $2 | View → | |
| 2 | Not yet rated | Prescription | Drops | Generic | $2 |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
CGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Xelpros (latanoprost ophthalmic emulsion) 0.005%
Failed Release Testing: Out of specification for particulate matter test.
SUN PHARMACEUTICAL INDUSTRIES INC · Apr 22, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Known hypersensitivity to latanoprost, or any other ingredients in this product. Known hypersensitivity to latanoprost or any other ingredients in this product. ( 4 )
In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart. The combined use of two or more prostaglandins, or prostaglandin analogs including XELPROS is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Thimerosal: Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart. ( 7 )
| 3 | Not yet rated | Prescription | Drops | Generic | $2 | View → |