65/100 · Elevated
Manufactured by Viatris Specialty LLC
Moderate Safety Concerns with Latanoprost: Eye Irritation and Increased Intraocular Pressure
81,937 FDA adverse event reports analyzed
Last updated: 2026-05-12
LATANOPROST is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 81,937 FDA adverse event reports, LATANOPROST has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for LATANOPROST include TREATMENT FAILURE, DRUG INEFFECTIVE, FATIGUE, EYE IRRITATION, INTRAOCULAR PRESSURE INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LATANOPROST.
Latanoprost has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 81,937 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Treatment Failure, Drug Ineffective, Fatigue. Of classified reports, 55.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include eye irritation and increased intraocular pressure, indicating potential ocular side effects.
Serious reactions such as death, eye pain, and pneumonia are reported, though less frequently. A significant number of reports involve drug ineffectiveness and treatment failure, suggesting variability in patient response. Gastrointestinal issues like nausea and diarrhea are also commonly reported, affecting patient comfort.
Patients taking Latanoprost should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Latoprost may interact with other drugs, and patients should be warned about potential side effects and the importance of correct usage. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Latanoprost received a safety concern score of 65/100 (elevated concern). This is based on a 55.3% serious event ratio across 48,497 classified reports. The score accounts for 81,937 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 27,896, Male: 17,671, Unknown: 180. The most frequently reported age groups are age 75 (1,034 reports), age 77 (892 reports), age 70 (887 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 48,497 classified reports for LATANOPROST:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Latoprost may interact with other drugs, and patients should be warned about potential side effects and the importance of correct usage.
If you are taking Latanoprost, here are important things to know. The most commonly reported side effects include treatment failure, drug ineffective, fatigue, eye irritation, intraocular pressure increased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any serious adverse reactions immediately to their healthcare provider. Follow the prescribed dosage and usage instructions carefully to minimize side effects. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of latanoprost and may require additional studies or label changes based on ongoing data.
The FDA has received approximately 81,937 adverse event reports associated with Latanoprost. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Latanoprost include Treatment Failure, Drug Ineffective, Fatigue, Eye Irritation, Intraocular Pressure Increased. By volume, the top reported reactions are: Treatment Failure (5,915 reports), Drug Ineffective (3,133 reports), Fatigue (2,228 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Latanoprost.
Out of 48,497 classified reports, 26,799 (55.3%) were classified as serious and 21,698 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Latanoprost break down by patient sex as follows: Female: 27,896, Male: 17,671, Unknown: 180. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Latanoprost adverse events are: age 75: 1,034 reports, age 77: 892 reports, age 70: 887 reports, age 72: 874 reports, age 76: 874 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Latanoprost adverse event reports is Viatris Specialty Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Latanoprost include: Headache, Dyspnoea, Death, Eye Pain, Dizziness. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Latanoprost to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Latanoprost has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common reactions include eye irritation and increased intraocular pressure, indicating potential ocular side effects.
Key safety signals identified in Latanoprost's adverse event data include: Eye irritation and increased intraocular pressure are the most frequent reactions.. Serious reactions like death and pneumonia are reported but less common.. Drug ineffectiveness and treatment failure are significant safety signals.. Gastrointestinal issues are frequently reported, affecting patient compliance.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Latoprost may interact with other drugs, and patients should be warned about potential side effects and the importance of correct usage. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Latanoprost.
Patients should report any serious adverse reactions immediately to their healthcare provider. Follow the prescribed dosage and usage instructions carefully to minimize side effects.
Latanoprost has 81,937 adverse event reports on file with the FDA. Serious reactions such as death, eye pain, and pneumonia are reported, though less frequently. The volume of reports for Latanoprost reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of latanoprost and may require additional studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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