GLP-1 medicines and sudden vision loss: what regulators and studies say about NAION

GLP-1 medicines and sudden vision loss: what regulators and studies say about NAION

Quick answer. NAION is a sudden, painless loss of vision in one eye that happens when blood flow to the optic nerve drops. In June 2025 the European Medicines Agency's safety committee concluded it is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people, and U.K. and Australian regulators followed. The current U.S. labels for Wegovy, Zepbound and Mounjaro do not name it. Studies disagree about the size of any added risk, and a crowded optic disc a person is born with is the best-established risk factor.

What NAION is

NAION stands for non-arteritic anterior ischemic optic neuropathy. In plain terms, the optic nerve at the back of one eye gets too little blood and is damaged. It usually causes sudden, painless vision loss in one eye. A 2026 review describes it as typically sudden, painless and irreversible. It happens to people who have never taken a GLP-1 medicine.

Background rates help put the studies in context. In the Danish and Norwegian national registries, people with type 2 diabetes who started a different diabetes medicine (an SGLT2 inhibitor) developed NAION at 1.18 cases per 10,000 person-years in Denmark and 0.92 in Norway. A person-year is one person followed for one year.

Who is at higher risk, whatever medicine they take

Reviews name a small cup-to-disc ratio as the most robust anatomical predictor. That means a crowded optic nerve head, sometimes called a disc at risk, which a person is born with. Diabetes, high blood pressure, high cholesterol, sleep apnea and advanced kidney disease are also linked to higher susceptibility. Australia's regulator says people with a disc at risk have the highest risk with semaglutide.

What regulators decided

Regulators in Europe, the U.K. and Australia have acted. The U.S. FDA has not changed the labels the Atlas read.

RegulatorDecisionSize of the risk, as statedWhat patients are told
European Medicines Agency (June 6, 2025)Its safety committee concluded NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy.Very rare means up to about 1 in 10,000 people. In adults with type 2 diabetes, about a twofold higher risk, roughly one extra case per 10,000 person-years of treatment.Contact a doctor without delay if vision is suddenly lost or quickly worsens. If NAION is confirmed, semaglutide should be stopped.
U.K. MHRA (February 5, 2026)A Drug Safety Update said semaglutide (Wegovy, Ozempic, Rybelsus) may be very rarely associated with NAION, and that product information will be updated.Up to 1 in 10,000, with about a twofold relative risk and one extra case per 10,000 treated per year, taken from the EU review. The U.K. Yellow Card scheme had 3 suspected reports from 2018 to August 1, 2025.Seek urgent care at an eye casualty or A&E for sudden or rapidly worsening vision change. Prescribers are told to stop semaglutide if NAION is confirmed.
Australia, Therapeutic Goods Administration (after an October 2025 advisory meeting)A new special warning for semaglutide (Ozempic, Wegovy), and NAION listed as an adverse effect. For dulaglutide (Trulicity), tirzepatide (Mounjaro) and liraglutide (Saxenda), NAION was added as a post-marketing adverse effect.Called rare but serious. The advisory committee found the evidence may support a signal for semaglutide but not for dulaglutide or tirzepatide, and class-wide wording was still applied.Seek urgent medical attention for sudden vision loss, including partial loss.
U.S. FDA (labels read in October 2026)The Wegovy (6/2026), Zepbound (8/2026), Mounjaro (8/2026) and Foundayo (7/2026) labels do not name NAION or optic neuropathy. The Atlas found no FDA statement or label change on NAION.Not stated.The labels carry a different eye warning, about diabetic retinopathy in people with type 2 diabetes (see below).

A regulator listing a side effect means the evidence was judged enough to warn about. It does not mean the cause is proven. Label text changes, so check the current label.

What the studies found

Nearly all the research is on semaglutide and in people with type 2 diabetes. The studies were built differently and point in different directions, which is why the table shows them one by one.

StudyWhoWhat it foundWhat to know
Hathaway and colleagues, JAMA Ophthalmology, 202416,827 patients seen by neuro-ophthalmologists at one academic centerIn 710 people with type 2 diabetes, 17 NAION events on semaglutide against 6 on other diabetes medicines (hazard ratio 4.28, 95% CI 1.62 to 11.29). In 979 people with overweight or obesity, 20 against 3 (hazard ratio 7.64, 2.21 to 26.36).Everyone was already under eye-nerve specialists, so the rates do not apply to the general population. The authors said causation needs further study.
Simonsen and colleagues, Diabetes, Obesity and Metabolism, 202561,377 adults with type 2 diabetes in Danish and Norwegian national registries who started semaglutide, compared with people starting SGLT2 inhibitors. 32 NAION events were counted.Per 10,000 person-years: 2.19 on semaglutide against 1.18 on SGLT2 inhibitors in Denmark, and 2.90 against 0.92 in Norway. Pooled hazard ratio 2.81 (1.67 to 4.75), an extra 1.41 cases per 10,000 person-years (0.53 to 2.29).Type 2 diabetes only. Results differed by country (hazard ratio 2.17 in Denmark, 7.25 in Norway). A second analysis comparing each person's own time on and off semaglutide was less clear: ratios of 1.14 and 2.67, both with intervals that include 1.
Lampsas and colleagues, Graefe's Archive, 2026A meta-analysis of 8 retrospective cohorts and 14,255,247 people with type 2 diabetesPooled hazard ratio 3.36 (1.44 to 7.84) at 1 year and 2.37 (1.46 to 3.85) at 2 years.The studies disagreed widely at 1 year. Built from observational studies.
Lieberman and colleagues, Military Medicine, 20261,212,775 Military Health System beneficiaries (973,529 with type 2 diabetes, 239,246 with overweight or obesity) and 2,447 NAION diagnosesIn type 2 diabetes, semaglutide went with lower odds of NAION than other medicines (odds ratio 0.36, 0.25 to 0.51). In overweight or obesity there was no significant difference (odds ratio 0.10, with a very wide interval of 0.01 to 1.35).The opposite direction from the studies above. Observational, and people prescribed a medicine can differ from people who are not. The authors concluded NAION risk should not preclude use.
Robertson and colleagues, Ophthalmology, 2026 (Disc-at-Risk Study Group)Unaffected eyes of people with NAION at 16 neuro-ophthalmology centers (1,812 eyes from 2,169 people), compared with control eyesOptic disc shape was the same whether or not people had taken GLP-1 medicines. A measured cup-to-disc ratio of 0.20 or less carried 46 times the odds of NAION of a ratio above 0.40 (odds ratio 46.3, 22.9 to 93.4). A ratio above 0.20 up to 0.40 carried 6.8 times (3.5 to 13.2).The authors say the study cannot show whether GLP-1 medicines are an independent risk factor.
Kakkar and colleagues, Diabetes, Obesity and Metabolism, 2026Reports to the FDA Adverse Event Reporting System from each medicine's approval through the third quarter of 2025Reporting odds ratios for optic ischemic neuropathy: 94.45 for semaglutide (355 reports), 4.58 for liraglutide (13 reports) and 2.94 for tirzepatide (49 reports), with no signal for dulaglutide, exenatide or lixisenatide. Among semaglutide reports, disability was documented in 18% and hospitalization in 11%.Spontaneous reports depend on who chooses to report, so they cannot give a rate of risk. The authors say the pattern argues against a single class-wide effect.
Two 2026 reviews (Ruan and colleagues, Journal of the Endocrine Society; Malluhi and colleagues, Biomolecules and Biomedicine)Narrative reviews of the published researchThe first put relative risk estimates between 1.2 and 4.3 and called the link a safety signal, not a contraindication. The second found the most consistent signal with high-exposure injected semaglutide, and absent, inconsistent or weaker findings for oral semaglutide, liraglutide, dulaglutide, exenatide and tirzepatide. It said current evidence does not support class-wide prescribing restrictions.Reviews, not new data. The second review's exposure threshold is described by its authors as preliminary and hypothesis-generating.

What the numbers mean in plain terms

Three ideas help read these studies. First, NAION is rare in anyone, so even a doubling of risk means a small number of extra cases. The Danish and Norwegian study estimated about 1.4 extra cases per 10,000 people per year, close to the regulators' figure of one extra case per 10,000 person-years.

Second, the studies look at different people, mostly with type 2 diabetes, and compare against different medicines, which is one reason their results point in different ways.

Third, none of them can show cause. Observational studies cannot fully separate the effect of the medicine from the effect of the diabetes, blood vessel disease or sleep apnea that led to the prescription.

Tirzepatide, higher doses and the pills

For tirzepatide the Atlas found reports in the FDA database with a smaller signal than semaglutide's, a published case report of NAION in a woman four weeks after starting, and Australian advisers who did not find the evidence supported a signal. A 2026 review said that semaglutide 7.2 mg (the Wegovy HD strength) and the pill orforglipron (Foundayo) warrant monitoring for eye effects, while noting that direct evidence of NAION risk with either is not available.

Sudden vision changes: what regulators say

The EMA, the U.K.'s MHRA and Australia's TGA give the same safety message: sudden loss of vision, including partial loss, or vision that worsens quickly, needs urgent medical attention. The EMA and MHRA add that semaglutide should be stopped if NAION is confirmed. That decision belongs to the clinician who confirms it.

One 2026 review suggests that checking for crowded optic disc anatomy and asking about any past NAION may be worth considering before treatment starts. That is the review authors' suggestion. No U.S. label the Atlas read mentions an eye exam for NAION.

A different condition: diabetic retinopathy

Diabetic retinopathy is damage to the retina from high blood sugar over time. The Wegovy, Zepbound and Mounjaro labels each warn that rapid improvement in blood sugar control has been associated with a temporary worsening of diabetic retinopathy, and that people with a history of it should be monitored. A 2026 review found worsening more closely tied to the size of the drop in HbA1c than to a class-specific effect on the retina.

Quick answers

Can Ozempic or Wegovy cause blindness?
Regulators in Europe, the U.K. and Australia list NAION, a sudden loss of vision in one eye, as a very rare or rare side effect of semaglutide, and the loss can be permanent. Whether the medicine causes it is still debated: the studies point in different directions, and the Danish and Norwegian study estimated about 1.4 extra cases per 10,000 people per year.
Do U.S. labels warn about NAION?
Not in the versions the Atlas read. The Wegovy (6/2026), Zepbound (8/2026) and Mounjaro (8/2026) labels do not name NAION or optic neuropathy. They do warn about diabetic retinopathy complications in people with type 2 diabetes.
How common is NAION?
In the Danish and Norwegian registries, 0.92 to 1.18 cases per 10,000 person-years among people with type 2 diabetes who started an SGLT2 inhibitor, and 2.19 to 2.90 among those who started semaglutide.
Is tirzepatide linked to NAION?
The evidence is thinner. Reports to the FDA database show a smaller signal than for semaglutide, and a 2026 review called findings for tirzepatide absent, inconsistent or weaker. Australia added NAION to the tirzepatide product information as a post-marketing adverse effect, using class wording.
Who is most at risk of NAION?
Reviews point to a crowded optic disc (a small cup-to-disc ratio) as the best-established risk factor, with diabetes, high blood pressure, high cholesterol, sleep apnea and advanced kidney disease also linked to higher susceptibility.
What are the warning signs?
Regulators describe sudden vision loss, including partial loss, or vision that worsens quickly in one or both eyes. Their advice is to seek urgent medical attention.
Do I need an eye exam before starting?
No U.S. label the Atlas read requires one for NAION. One 2026 review suggests checking for crowded optic disc anatomy may be worth considering. Ask your prescriber and an eye doctor.
Does stopping the medicine help?
The EMA and MHRA say semaglutide should be stopped if NAION is confirmed. The Atlas found no study showing that stopping restores vision.

Questions to ask

  • Do I have a crowded optic disc or other eye risk factors, and should an eye doctor take a look?
  • Have I ever had NAION in either eye?
  • Do my diabetes, blood pressure, cholesterol or sleep apnea change the picture?
  • What vision changes should make me call right away, and who do I call after hours?
  • If my vision changes suddenly, who should I see first, and how fast?

What is still unknown

  • Whether GLP-1 medicines cause NAION. Every study the Atlas found is observational, reviews call the link a safety signal, and the studies disagree on direction.
  • The size of any added risk in people without diabetes. Most large studies are in type 2 diabetes.
  • Whether tirzepatide, the pills and higher doses carry the same risk as semaglutide. Reviews describe the evidence as absent, inconsistent, weaker or not yet available.
  • Why the military health-records study found lower odds in type 2 diabetes while others found higher odds.
  • Whether the FDA will add NAION to U.S. labels. The Atlas found no FDA statement on it.
  • Label text and regulator pages change. The versions here were read in October 2026.

Back to getting started

Sources

  1. PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy European Medicines Agency, Pharmacovigilance Risk Assessment Committee (PRAC). Published June 6, 2025 and revised June 13, 2025. Regulator
  2. Semaglutide (Wegovy, Ozempic and Rybelsus): risk of non-arteritic anterior ischemic optic neuropathy (NAION) Medicines and Healthcare products Regulatory Agency (UK), Drug Safety Update, February 5, 2026 (volume 19, issue 7). Regulator
  3. GLP-1 RAs and rare vision disorder Therapeutic Goods Administration (Australia), safety update. The page gives no date and refers to an October 2025 meeting of the Advisory Committee on Medicines. Regulator
  4. Wegovy (semaglutide) injection and tablets: prescribing information Novo Nordisk, on DailyMed (U.S. National Library of Medicine). Label version 6/2026. One label covers both the injection and the tablets. Official FDA label on DailyMed
  5. Zepbound (tirzepatide) injection: prescribing information Eli Lilly and Company, on DailyMed (U.S. National Library of Medicine). Label version 8/2026. Official FDA label on DailyMed
  6. Mounjaro (tirzepatide) injection: prescribing information Eli Lilly and Company, on DailyMed (U.S. National Library of Medicine). Label version 8/2026. Official FDA label on DailyMed
  7. Foundayo (orforglipron) tablets: prescribing information Eli Lilly and Company, on DailyMed (U.S. National Library of Medicine). Label version 7/2026. Official FDA label on DailyMed
  8. Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide Hathaway JT, et al. JAMA Ophthalmol. 2024;142(8):732-739. PMID 38958939. Funding: Not stated in the abstract. Journal article
  9. Use of semaglutide and risk of non-arteritic anterior ischaemic optic neuropathy: a Danish-Norwegian cohort study Simonsen E, et al. Diabetes Obes Metab. 2025;27(6):3094-3103. PMID 40098249. Funding: Not stated in the abstract. Journal article
  10. Semaglutide and risk of non-arteritic anterior ischemic optic neuropathy (NAION) in type 2 diabetes mellitus: a systematic review and meta-analysis Lampsas S, et al. Graefes Arch Clin Exp Ophthalmol. 2026;264(9):2611-2621. PMID 42201355. Funding: Not stated in the abstract. Journal article
  11. Semaglutide decreases risk of non-arteritic anterior ischemic optic neuropathy in type 2 diabetic patients Lieberman RA, et al. Mil Med. 2026;191(5-6):e1020-e1025. PMID 41217382. Funding: U.S. government (Military Health System study). Journal article
  12. Cup-to-disc ratio in glucagon-like peptide 1 receptor agonist-associated nonarteritic anterior ischemic optic neuropathy (Disc-at-Risk Study Group) Robertson CM, et al. Ophthalmology. 2026;133(11):1296-1305. PMID 42556433. Funding: See the disclosures in the article. Journal article
  13. Optic ischaemic neuropathy in incretin-based therapy: a comparative analysis of real-world safety data Kakkar AK, et al. Diabetes Obes Metab. 2026;28(8):7527-7535. PMID 42259643. Funding: Not stated in the abstract. Journal article
  14. Current review of glucagon-like peptide 1 receptor agonists and risk of nonarteritic anterior ischemic optic neuropathy Ruan F, et al. J Endocr Soc. 2026;10(11):bvag224. PMID 42857401. Funding: Not stated in the abstract. Journal article
  15. GLP-1 receptor agonists and ocular safety: pharmacokinetic insights into ischemic optic neuropathy and diabetic retinopathy risk, a review Malluhi M, et al. Biomol Biomed. 2026. PMID 42770962. Funding: Not stated in the abstract. Journal article
  16. Acute unilateral NAION following tirzepatide therapy (case report) Valaskova J, et al. Case Rep Ophthalmol. 2026;17(1):806-813. PMID 42569780. Funding: Not stated in the abstract. Journal article