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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the incidence of diabetic retinopathy in people with type 2 diabetes (T2D) receiving Mounjaro® (tirzepatide)?
Diabetic retinopathy has been reported as an adverse event in 1% or less of adults with T2D in the SURPASS studies. Real-world data on early worsening of diabetic retinopathy in patients with T2D treated with tirzepatide have also been published.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Diabetic Retinopathy Label Precautions
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.1
Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.1
Diabetic Retinopathy in the T2D Studies
The SURPASS clinical study program assessed the efficacy and safety of tirzepatide as a treatment to improve glycemic control in people with T2D.2-7
Tirzepatide has not been studied in patients with the following conditions, as these were excluded from clinical trials
- non-proliferative diabetic retinopathy requiring acute therapy,
- proliferative diabetic retinopathy, or
- diabetic macular edema.1
As assessed by baseline fundoscopic examination, retinopathy was reported in
- 15% of the population in a pool of 7 controlled clinical studies, and
- 13% of the population in a pool of 2 placebo-controlled clinical studies.1
Diabetic retinopathy was reported as a pre-existing condition in 12.5% of SURPASS-6 study participants.8
Treatment-emergent diabetic retinopathy has been reported in 1% or less of SURPASS-1 to 6 study participants (see Cases of Diabetic Retinopathy Reported in SURPASS Studies).2-7
Study, n (%)a |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorb |
SURPASS-1 |
0 |
0 |
0 |
0 |
SURPASS-2 |
0 |
2 (0.4) |
0 |
0 |
SURPASS-3 |
2 (1) |
0 |
1 (<1) |
0 |
SURPASS-4 |
2 (<1) |
1 (<1) |
1 (<1) |
1 (<1) |
SURPASS-5 |
0 |
0 |
0 |
0 |
SURPASS-6 |
2 (0.8) |
0 |
0 |
4 (0.6) |
aData are n (%); Safety analyses included all randomly assigned participants who took at least 1 dose of study drug with data from the start of the treatment to end of safety follow-up period.
bComparator was placebo in SURPASS-1 and SURPASS-5 for 40 weeks. Comparator was semaglutide 1 mg once weekly in SURPASS-2 for 40 weeks. Comparator was titrated insulin degludec in SURPASS-3 for 52 weeks. Comparator was titrated insulin glargine in SURPASS-4 for 52 weeks. Comparator was titrated insulin lispro in SURPASS-6 for 52 weeks.
Adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice, due to the varying conditions clinical trials are conducted under.1
Diabetic Retinopathy From Real-world Data
In a retrospective cohort study using real-world clinical data from the Imperial College London Diabetes Centre in the United Arab Emirates, 3435 individuals with T2D who were treated with tirzepatide for at least 180 days were matched 1:1 with 3434 individuals with T2D who had not received tirzepatide. Matching criteria included sex, duration of diabetes, retinopathy status, glycated hemoglobin (HbA1c) levels, number of retinal screening episodes, and use of glucose-lowering medications.9
In this study, new-onset proliferative diabetic retinopathy (grades R3M0 and R3M1) was reported in 1.1% (n=33) of individuals treated with tirzepatide compared with 0.5% (n=17) of individuals not treated with tirzepatide. The majority of these cases occurred in individuals with
- moderate-to-severe nonproliferative diabetic retinopathy with maculopathy (R2M1; tirzepatide: n=16; unexposed: n=11), or
- mild nonproliferative diabetic retinopathy with maculopathy (R1M1; tirzepatide: n=13; unexposed: n=5).9
Few cases were reported in individuals with
- mild nonproliferative diabetic retinopathy without maculopathy (tirzepatide: n=1; unexposed, n=0)
- moderate nonproliferative diabetic retinopathy without maculopathy (grade R2M0; tirzepatide: n=1; unexposed, n=0), or
- no previously detected diabetic retinopathy (grade R0M0; tirzepatide n=2; unexposed: n=1).9
In multivariate analyses after adjustment for established risk factors, tirzepatide was associated with an increased risk of new-onset proliferative diabetic retinopathy (odd ratio (OR), 2.15; 95% CI, 1.24-3.74; p<.01).9
However, tirzepatide was also associated with
- reduced risk of new onset of retinopathy in individuals without diabetic retinopathy at baseline (grade R0M0; OR, 0.73; 95% CI, 0.62-0.86; p<.001), and
- no significant risk of retinopathy progression in individuals with mild nonproliferative diabetic retinopathy (grades R1M0 and R1M1; OR, 1.29; 95% CI, 0.89-1.88, p=.18).9
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6
3Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519
4Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4
5Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7
6Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. https://doi.org/10.1001/jama.2022.0078
7Rosenstock J, Frías JP, Rodbard HW, et al. Tirzepatide vs insulin lispro added to basal insulin in type 2 diabetes: the SURPASS-6 randomized clinical trial. JAMA. 2023;330(17):1631-1640. https://doi.org/10.1001/jama.2023.20294
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9Buckley AJ, Tan GD, Gruszka-Goh M, et al. Early worsening of diabetic retinopathy in individuals with type 2 diabetes treated with tirzepatide: a real-world cohort study. Diabetologia. Published online July 10, 2025. https://doi.org/10.1007/s00125-025-06466-8
Date of Last Review: November 25, 2025