How long does it take for Plaquenil to cause eye problems?

October 10, 2025 •

5 min read

Studies show the risk of Plaquenil's (hydroxychloroquine) retinal toxicity is very low in the first five years of treatment, but it increases significantly with prolonged use. Knowing how long does it take for Plaquenil to cause eye problems is crucial for patients and providers to protect vision, as damage is often irreversible.

Quick Summary

Plaquenil-induced retinal toxicity is a rare but serious side effect, typically occurring after five or more years of use. Key risk factors include dose, duration, and kidney function, making regular eye screening vital for early detection before symptoms appear.

Key Points

Risk is Time and Dose-Dependent: The risk of Plaquenil retinal toxicity is low during the first 5 years of therapy but increases significantly with prolonged use and higher daily dosages.
Toxicity is Asymptomatic Initially: Early retinal damage from Plaquenil often has no noticeable symptoms, underscoring the critical need for regular, advanced eye screening.
Screening Guidelines are Key: For low-risk patients, annual eye exams with modern diagnostic tools are recommended after 5 years of treatment, with a baseline exam within the first year.
Damage Can Be Irreversible: Once retinal toxicity is confirmed, the damage is typically irreversible and can continue to progress even after the medication is stopped.
Multiple Risk Factors Increase Vulnerability: High daily dose, longer duration of use, kidney disease, older age, and concurrent use of other retina-toxic medications can accelerate the risk of eye problems.
Regular Monitoring is a Lifelong Commitment: Patients on long-term Plaquenil therapy should maintain consistent eye monitoring as part of their treatment plan to catch any changes early.

Understanding Plaquenil and Retinal Toxicity

Plaquenil, the brand name for hydroxychloroquine, is a cornerstone medication for managing various autoimmune diseases, such as lupus and rheumatoid arthritis. While it effectively controls these conditions, its long-term use carries a risk of retinal toxicity, or hydroxychloroquine retinopathy. This condition involves damage to the retina, particularly the retinal pigment epithelium (RPE) and photoreceptors, which are essential for vision. In advanced stages, this damage can create a distinctive "bull's-eye" pattern on the macula, the central part of the retina responsible for sharp, detailed vision. Early-stage toxicity is often asymptomatic, meaning patients may not notice any changes in their sight until significant damage has occurred. This silent progression makes regular and thorough eye screenings with modern technology an indispensable part of Plaquenil therapy.

The Plaquenil Toxicity Timeline

The timeframe for Plaquenil-induced eye problems is directly related to the duration of treatment and the daily dosage. The risk of developing retinal toxicity is not uniform over time; it is cumulative and increases significantly the longer a patient is on the medication.

For patients taking the recommended daily dose of less than 5.0 mg/kg of real body weight, the risk profile typically looks like this:

First 5 Years: The risk of retinal toxicity is very low, typically below 1%. A baseline eye exam is recommended within the first year of treatment to document the initial health of the retina.
Between 5 and 10 Years: The risk remains relatively low but begins to increase. Annual eye screening becomes highly recommended for all patients at this point. A 2022 study showed the overall cumulative risk of retinopathy was 2.5% at 10 years.
After 10 Years: The risk escalates more markedly with increasing treatment duration. Vigilance is critical, and annual screening is mandatory.
After 20 Years: The risk rises dramatically. Studies suggest the risk can climb to nearly 20% after 20 years of continuous use. A 2023 study found the cumulative incidence could reach 11.5% at 20 years.

It is important to note that these timelines are averages. As a 2024 case study reported, atypical, rapid-onset toxicity can occur, although it is extremely rare.

Key Risk Factors That Influence the Timeline

Several factors can increase a person's risk and accelerate the timeline for developing Plaquenil retinopathy:

High Daily Dosage: A daily dose exceeding 5.0 mg/kg of real body weight significantly increases the risk of retinal damage. The dose should be based on actual, not ideal, body weight.
Cumulative Dose: The total amount of the drug taken over time is a major risk factor. The longer the duration of therapy, the greater the total cumulative dose, and thus the higher the risk.
Kidney or Liver Disease: Since Plaquenil is cleared by the kidneys and metabolized by the liver, impairment in these organs can lead to higher systemic drug levels and increased risk.
Concomitant Tamoxifen Use: Taking tamoxifen alongside Plaquenil can compound the risk of retinal toxicity.
Pre-existing Retinal or Macular Disease: Individuals with existing retinal conditions are more susceptible to damage.
Older Age: Being over 60 years old at the start of treatment increases the risk.
Genetic Factors: Recent research suggests genetic predispositions may play a role in individual susceptibility to toxicity.

Modern Screening for Early Detection

Early detection is the most effective way to prevent irreversible vision loss from Plaquenil toxicity. Modern screening follows the guidelines set by organizations like the American Academy of Ophthalmology (AAO) and relies on advanced diagnostic tools. Unlike older methods, these tools can detect subtle changes long before a patient experiences any symptoms or visual changes are visible during a standard dilated fundus exam.

Recommended Screening Tests:

Baseline Examination: A comprehensive eye exam performed within the first year of starting Plaquenil to document the retina's initial health.
Automated Visual Field (VFs): A functional test that measures peripheral vision, as Plaquenil damage often starts with paracentral vision loss. The 10-2 test is standard for non-Asian patients, while wider tests like 24-2 or 30-2 may be needed for Asian patients.
Spectral-Domain Optical Coherence Tomography (SD-OCT): An imaging test that provides high-resolution, cross-sectional views of the retina. SD-OCT can detect retinal thinning or disruption of photoreceptor layers, which are early signs of toxicity.
Fundus Autofluorescence (FAF): An imaging technique that can identify metabolic changes in the retinal pigment epithelium before structural damage is obvious.
Multifocal Electroretinography (mfERG): An objective test that measures the electrical responses of the retina, useful for confirming visual field defects.

The Importance of Monitoring and Management

If early retinal damage is detected, the ophthalmologist will consult with the prescribing physician to determine the best course of action. For confirmed toxicity, discontinuing Plaquenil is typically recommended to halt further damage. However, patients must be aware that damage may still progress for some time even after stopping the medication. Continued monitoring is essential.

Screening Comparison: Low-Risk vs. High-Risk Patients


Screening Aspect	Low-Risk Patients	High-Risk Patients
Daily Dose	≤ 5.0 mg/kg real body weight	> 5.0 mg/kg real body weight
Major Risk Factors	None (no renal issues, tamoxifen, etc.)	One or more present
Baseline Exam	Within the first year of treatment	Within the first year of treatment
Annual Screening	Begin after 5 years of treatment	Begin from the first year of treatment
Screening Tests	Automated VFs (10-2), SD-OCT, and optional FAF	All recommended tests (VFs, SD-OCT, FAF, mfERG)
Frequency	Annually after the 5-year mark	Annually, or more frequently if signs appear

Conclusion

While Plaquenil is an effective medication for many conditions, the risk of retinal toxicity is a serious concern that requires careful monitoring. Understanding the timeline and key risk factors is vital for protecting vision. The risk of eye problems is minimal in the first five years for those on appropriate doses but increases significantly over time, making a robust screening protocol essential. With modern screening techniques like SD-OCT and regular ophthalmology visits, early signs of toxicity can be detected before irreversible vision loss occurs. Patients must have open conversations with their prescribing physician and ophthalmologist to ensure proper dosing and a consistent screening schedule tailored to their individual risk factors. Continuous vigilance and proactive management are the best strategies for mitigating this long-term risk and preserving visual health.

This article is for informational purposes only and does not constitute medical advice. For specific concerns about your treatment, consult with your healthcare provider.

For more detailed information on hydroxychloroquine retinopathy and screening guidelines, refer to resources from organizations like the American Academy of Ophthalmology.

Frequently Asked Questions

No, eye damage is not guaranteed. While the risk increases with prolonged use, many patients take Plaquenil for decades without developing retinal toxicity. However, long-term use requires consistent monitoring to detect any potential issues early.

The earliest signs are not typically noticeable to the patient. They are subtle changes in the retina that can only be detected with specialized equipment during a comprehensive eye exam, such as SD-OCT and visual field testing.

No, retinal damage from Plaquenil is generally irreversible. The goal of early screening is to detect the damage before it has a significant impact on vision, allowing for the medication to be stopped to prevent further loss.

The American Academy of Ophthalmology recommends a baseline exam within the first year of starting Plaquenil. For low-risk patients, annual screening should begin after 5 years of use. Patients with major risk factors, however, should start annual screening earlier.

If retinal toxicity is confirmed, the prescribing physician will typically recommend stopping the medication. This decision is made in consultation with your ophthalmologist and is based on a careful assessment of the risks versus the benefits of continued treatment.

Basing the dosage on actual body weight (rather than ideal body weight) is crucial for minimizing the risk of toxicity, especially in obese or short individuals. Studies show that a daily dose exceeding 5.0 mg/kg of real body weight significantly increases risk.

You can perform regular Amsler grid tests at home to check for central visual distortion, but this is not a substitute for professional screening. Since toxicity is often asymptomatic in the early stages, it's vital to rely on the advanced screening tests performed by an eye specialist.