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What Parker Waichman LLP Found
A commonly prescribed medication for erectile dysfunction and enlarged prostate symptoms has been linked to a higher risk of glaucoma in a large international study. This raises new concerns for men who have used tadalafil for long periods and later developed serious vision issues.
Tadalafil is the main ingredient in Cialis and many generic drugs. It is part of a group called phosphodiesterase type 5 inhibitors, or PDE5 inhibitors. Millions of men have used these drugs for erectile dysfunction, and tadalafil is also prescribed daily for urinary symptoms linked to an enlarged prostate.
The new research is significant because glaucoma can damage the optic nerve gradually and permanently. Vision loss may begin at the edges of a person’s visual field and progress before the patient realizes anything is wrong. Once glaucoma-related optic nerve damage has occurred, lost vision generally cannot be restored.
Researchers examined nearly 74,000 men and found that tadalafil users experienced higher rates of glaucoma, ocular hypertension, and primary open-angle glaucoma than comparable men who did not use PDE5 inhibitors. After matching the groups for numerous medical and demographic factors, tadalafil users had a 22% higher risk of glaucoma, a 32% higher risk of ocular hypertension, and a 33% higher risk of primary open-angle glaucoma over as long as five years of follow-up. Tadalafil users were also 33% more likely to begin glaucoma treatment.
These findings do not establish that tadalafil causes glaucoma. The study was observational, and additional research will be necessary to determine whether the relationship is causal and whether particular patients face greater risks than others. Nevertheless, the findings create important questions about the long-term ocular effects of tadalafil, what manufacturers knew or reasonably should have known about potential vision risks, and whether patients received adequate information that would have allowed them and their physicians to make fully informed treatment decisions.
For patients who took tadalafil or Cialis and subsequently developed glaucoma or another serious eye disorder, the medical history, duration of use, timing of diagnosis, existing glaucoma risk factors, prescription records, eye examinations, and applicable drug warnings may all become important evidence in evaluating a potential pharmaceutical injury claim.
The research, published in the British Journal of Ophthalmology, was designed specifically to evaluate whether tadalafil use among men with lower urinary tract symptoms was associated with the development of glaucoma.
Researchers used the TriNetX healthcare database and identified men age 40 and older who had lower urinary tract symptoms between 2012 and 2022. Patients who already had glaucoma before entering the study were excluded.
The investigators ultimately compared 36,927 tadalafil users with 36,927 similar patients who had not used a PDE5 inhibitor. The researchers used propensity-score matching to make the two groups more comparable based on factors including age, race, medical conditions, kidney function, and other medications. Patients were followed for as long as five years.
The results showed several statistically significant associations:
Researchers also calculated the five-year cumulative incidence of glaucoma. Approximately 3.93% of tadalafil users developed glaucoma compared with 3.16% of nonusers.
The distinction between relative and absolute risk is important. A 22% relative increase does not mean that 22% of tadalafil users developed glaucoma. The absolute difference reported by the researchers was less than one percentage point over five years. Even so, relatively small changes in risk can become medically important when a medication is used by a large population, particularly when the possible outcome involves irreversible vision damage.
Researchers found no statistically significant association with low-tension glaucoma or primary angle-closure glaucoma.
The study authors concluded that ophthalmic evaluation and continuing follow-up may be worth considering for tadalafil users, particularly patients who already have glaucoma risk factors.
Primary open-angle glaucoma is the most common form of glaucoma. It develops when damage occurs to the optic nerve, the structure responsible for carrying visual information from the eye to the brain.
The condition often progresses slowly. Unlike a traumatic eye injury or sudden retinal event, open-angle glaucoma may initially cause no noticeable symptoms.
A person may continue reading, driving, working, and performing ordinary tasks while the disease is gradually reducing peripheral vision. By the time a patient recognizes a change, irreversible optic nerve damage may already have occurred.
Elevated intraocular pressure is an important glaucoma risk factor. Pressure can increase when fluid within the eye does not drain normally. Over time, excessive pressure can contribute to optic nerve injury.
The 2026 tadalafil study is therefore notable not only because researchers observed an increased incidence of glaucoma, but also because tadalafil users demonstrated a 32% increased risk of ocular hypertension.
Glaucoma treatment is primarily intended to prevent or slow further deterioration. Depending upon the patient, treatment may involve prescription eye drops, laser procedures, surgery, or combinations of these approaches.
The American Academy of Ophthalmology’s current primary open-angle glaucoma clinical guidance emphasizes ongoing diagnosis, monitoring, and management of the disease.
For patients whose vision has already been damaged, treatment cannot simply restore destroyed optic nerve tissue. This is why delayed diagnosis can have such serious consequences.
One feature that makes glaucoma particularly concerning is its frequently silent progression.
Patients tend to associate serious eye disease with obvious symptoms such as pain, redness, blurred vision, flashing lights, or sudden blindness. Primary open-angle glaucoma does not necessarily behave that way.
Peripheral vision typically deteriorates gradually. The brain can partially compensate for missing visual information, making early damage difficult for a person to recognize without formal testing.
An ophthalmic examination can include intraocular pressure measurement, evaluation of the optic nerve, visual-field testing, examination of the drainage angle, and imaging designed to detect structural changes.
For a patient who has taken tadalafil for years and did not know that long-term treatment might potentially have implications for glaucoma risk, an important legal question may eventually become whether appropriate safety information would have affected treatment or monitoring decisions.
A physician who knew about a material glaucoma association might, for example, consider baseline eye testing or periodic follow-up for a patient with other risk factors. Whether such precautions were medically indicated in any individual case must be evaluated based upon that patient’s history and the medical knowledge available at the relevant time.
The new glaucoma research does not arise in a vacuum. PDE5 inhibitors have previously been scrutinized for potential ocular effects.
FDA-approved tadalafil labeling has included warnings concerning sudden vision loss associated with non-arteritic anterior ischemic optic neuropathy, commonly abbreviated NAION. FDA labeling advises patients to seek immediate medical attention following sudden loss of vision in one or both eyes. Federal labeling has also discussed observational evidence suggesting an association between recent PDE5 inhibitor use and NAION while acknowledging that available evidence does not establish whether the medication directly caused those events.
NAION and glaucoma are different diseases.
NAION generally involves sudden damage to the optic nerve associated with inadequate blood flow. Primary open-angle glaucoma usually develops progressively and is associated with chronic optic nerve damage.
That distinction matters. A warning about sudden vision loss caused by one optic nerve disorder does not necessarily communicate the possibility of gradually developing glaucoma.
The newer glaucoma findings may therefore create a separate safety issue requiring additional scientific evaluation.
A patient’s underlying susceptibility matters when assessing glaucoma. Recognized glaucoma risk factors can include increasing age, family history, elevated intraocular pressure, certain anatomical features of the eye, severe nearsightedness, and particular medical conditions.
The tadalafil study found that the increased association remained consistent among men older than 50 and across several comorbidity categories.
A potentially affected patient should therefore preserve medical records showing eye health both before and after tadalafil use.
Those records can help establish whether the individual had elevated eye pressure or evidence of glaucoma before treatment, when abnormalities first appeared, whether the disease progressed during treatment, and what interventions became necessary.
The absence of an eye examination before medication use does not automatically preclude a potential claim, but baseline medical evidence can become valuable when determining the chronology of an injury.
The publication of an epidemiological study does not automatically establish legal liability, and the current evidence does not prove that tadalafil causes glaucoma.
Nevertheless, a person who used tadalafil and later developed glaucoma may have circumstances warranting investigation.
Potential pharmaceutical product-liability theories can include failure to adequately warn about a known or reasonably knowable risk, negligent drug safety practices, defective labeling, or other claims recognized under the law applicable to that person’s case.
A potential claim would require considerably more than showing that the patient took tadalafil and later received a glaucoma diagnosis.
Important questions could include:
These are fact-intensive cases. The answers can vary substantially between patients.
Glaucoma can impose consequences extending far beyond the cost of an eye examination.
A person with significant visual-field loss may experience difficulty driving, reading, working, using stairs, recognizing hazards, participating in recreational activities, and living independently.
Potential damages in a successful pharmaceutical injury case vary under state law but may include past and future medical expenses, lost income, diminished earning ability, pain and suffering, loss of enjoyment of life, disability-related losses, and other legally recoverable damages.
Long-term medical expenses may include ophthalmology visits, repeated visual-field examinations, optic nerve imaging, prescription medications, laser therapy, surgery, and continued disease monitoring.
Severe visual impairment can also require assistance with transportation or activities of daily living.
Permanent vision damage can substantially affect quality of life, which makes accurate documentation of the progression and functional consequences of glaucoma particularly important.
Every state imposes deadlines for bringing personal injury claims, and those deadlines vary significantly.
Pharmaceutical injury cases can create difficult timing questions because diseases such as glaucoma may develop gradually. A patient may take a medication for years before receiving a diagnosis, and it may take additional time before the patient has reason to suspect that a medication could be associated with the condition.
Different states use different rules to determine when a claim accrues and whether a discovery rule applies.
Waiting for additional scientific studies or widespread litigation before requesting a case review can therefore create unnecessary risk. Someone who believes tadalafil may be connected to a glaucoma diagnosis should have the applicable filing deadline evaluated based on the state law governing that person’s claim.
Possibly. A glaucoma diagnosis following tadalafil use does not, by itself, establish that the medication caused the disease or that a manufacturer is legally responsible. An attorney would need to evaluate your medical history, duration and dosage of tadalafil treatment, eye examinations before and after treatment, other glaucoma risk factors, prescription records, and the scientific evidence concerning tadalafil and eye disease. A potential pharmaceutical case may also examine whether manufacturers possessed safety information that should have resulted in stronger warnings and whether a different warning would have affected the prescribing physician’s treatment or monitoring decisions. Because applicable laws and filing deadlines differ by state, individual claims must be evaluated separately.
No. The study establishes an epidemiological association rather than causation. Researchers reported higher rates of glaucoma among tadalafil users after matching them with similar men who did not use PDE5 inhibitors, but the research was retrospective and observational. The investigators acknowledged limitations, and additional research will be needed. Another 2026 study involving chronic PDE5 inhibitor use reported a lower hazard of open-angle glaucoma, further demonstrating that the scientific literature is not settled.
The new research specifically identified increased rates of glaucoma, ocular hypertension, and primary open-angle glaucoma among tadalafil users. Potential cases may become particularly significant when patients have documented optic nerve damage, visual-field loss, treatment for glaucoma, or permanent impairment. Tadalafil labeling has also contained warnings concerning sudden vision loss associated with NAION, which is a separate optic nerve disorder. A complete review should distinguish between glaucoma, NAION, retinal disease, and other causes of impaired vision because different conditions involve different medical and legal evidence.
A glaucoma diagnosis can permanently change a person’s ability to drive, work, read, and live independently. When serious vision loss follows years of prescription medication use, patients deserve to know whether the drug may have contributed to their condition and whether they were adequately warned about potential risks.
Parker Waichman LLP is a national personal injury law firm representing people harmed by dangerous drugs and other defective or inadequately warned-about products. Our attorneys can review prescription records, ophthalmology reports, treatment history, scientific evidence, applicable warnings, and the circumstances surrounding a patient’s tadalafil exposure to determine whether there may be grounds for a claim.
If you or a family member used Cialis or generic tadalafil and subsequently developed glaucoma, ocular hypertension, optic nerve damage, or serious vision loss, Parker Waichman LLP offers a free consultation. Call 1-800-YOUR-LAWYER (1-800-968-7529) to discuss your potential claim. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.
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