Association of Glucagon-Like Peptide-1 Receptor Agonists With Optic Nerve and Retinal Adverse Events: A Population-Based Observational Study Across 180 Countries.

Lakhani M, Kwan ATH, Mihalache A, Popovic MM, Nanji K, Xie JS, Feo A, Rabinovitch D, Shor R, Sadda S, Sarraf D, Hurley B and 4 more

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Margolin EA, Kertes PJ, Chaudhary V, Muni RH

American journal of ophthalmology16 May 2025Cited by 35 (Europe PMC)

PMID40383360DOI10.1016/j.ajo.2025.05.007PepBankPUB-40383360

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanObservational studySafety outcome
In adverse event reports, semaglutide was associated with higher odds of ischemic optic neuropathy than comparator drugs in FAERS and VigiBase.
In plain wordsIn drug safety reports, semaglutide was linked to more optic nerve damage reports than other drugs. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreaseIschemic optic neuropathy reports
Study
n: not reported in source
Comparator
All other drugs (FAERS); metformin etc. (VigiBase)
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
11.12 ratio
FAERS
ROR
68.58 ratio
VigiBase
Source sentences
Summary
Semaglutide showed significantly higher odds of ischemic optic neuropathy (ION) (FAERS: ROR = 11.12, 95% CI = 8.15-15.16; VigiBase: ROR = 68.58, 95% CI = 16.75-280.67)
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336001
02HumanObservational studySafety outcome
In adverse event reports, semaglutide was associated with higher odds of diabetic retinopathy than comparator drugs in FAERS and VigiBase.
In plain wordsIn drug safety reports, semaglutide was linked to more reports of diabetic retinopathy than other drugs. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreaseDiabetic retinopathy reports
Study
n: not reported in source
Comparator
All other drugs (FAERS); metformin etc. (VigiBase)
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
17.28 ratio
FAERS
ROR
7.81 ratio
VigiBase
Source sentences
Summary
diabetic retinopathy (DR) (FAERS: ROR = 17.28, 95% CI = 13.62-21.91; VigiBase: ROR = 7.81, 95% CI = 5.60-10.90)
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336002
03HumanObservational studySafety outcome
In adverse event reports, semaglutide was associated with higher odds of retinal or vitreous detachment, retinal or vitreous hemorrhage and retinal tear in FAERS and VigiBase.
In plain wordsIn drug safety reports, semaglutide was linked to more reports of retinal detachment, bleeding and tears than other drugs. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreaseRetinal/vitreous detachment, hemorrhage and retinal tear reports
Study
n: not reported in source
Comparator
All other drugs (FAERS); metformin (VigiBase)
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
2.44 to 5.89 ratio
FAERS
ROR
5.49 to 20.91 ratio
VigiBase
Source sentences
Summary
as well as retinal/vitreous detachment, retinal/vitreous hemorrhage, and retinal tear (FAERS: ROR = 2.44-5.89, 95% CI = 1.70-8.97, all P < .001, IC₀₂₅ = 0.49, compared to all other drugs.
3 context sentences(design, population, supporting numbers)
Summary · context
VigiBase: ROR = 5.49-20.91, 95% CI = 2.71-90.11, all P ≤ .0001, IC₀₂₅ ≥ 0.53, compared to metformin).
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336003
04HumanObservational studySafety outcome
In VigiBase reports, semaglutide was associated with higher odds of macular edema than metformin.
In plain wordsIn drug safety reports, semaglutide was linked to more reports of macular swelling than metformin. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreaseMacular edema reports (VigiBase)
Study
n: not reported in source
Comparator
Metformin
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
3.87 ratio
VigiBase
Source sentences
Summary
macular edema (ROR = 3.87, 95% CI = 1.89-7.92)
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336004
05HumanObservational studySafety outcome
In VigiBase reports, semaglutide was associated with higher odds of macular hole than metformin.
In plain wordsIn drug safety reports, semaglutide was linked to more reports of macular hole than metformin. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreaseMacular hole reports (VigiBase)
Study
n: not reported in source
Comparator
Metformin
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
20.9 ratio
VigiBase
Source sentences
Summary
macular hole (ROR = 20.90, 95% CI = 2.65-165.01)
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336005
06HumanObservational studySafety outcome
In VigiBase reports, semaglutide was associated with higher odds of papilledema than metformin.
In plain wordsIn drug safety reports, semaglutide was linked to more reports of optic disc swelling than metformin. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreasePapilledema reports (VigiBase)
Study
n: not reported in source
Comparator
Metformin
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
6.97 ratio
VigiBase
Source sentences
Summary
papilledema (ROR = 6.97, 95% CI = 2.53-19.17)
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336006
07HumanObservational studySafety outcome
In sensitivity analyses with empagliflozin and dulaglutide as comparators, semaglutide remained significantly associated with ischemic optic neuropathy.
In plain wordsWhen compared with empagliflozin and dulaglutide, semaglutide was still linked to more reports of optic nerve damage from poor blood flow.
Peptide
Semaglutide
Outcome
IncreaseIschemic optic neuropathy in sensitivity analyses (empagliflozin, dulaglutide)
Study
n: not reported in source
Comparator
Empagliflozin and dulaglutide
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Source sentences
Summary
Sensitivity analyses using empagliflozin and dulaglutide revealed significant associations with ION and DR, while vitreous detachment and hemorrhage were significant when compared to dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336007
08HumanObservational studySafety outcome
In sensitivity analyses with empagliflozin and dulaglutide as comparators, semaglutide remained significantly associated with diabetic retinopathy.
In plain wordsWhen compared with empagliflozin and dulaglutide, semaglutide was still linked to more reports of diabetic retinopathy.
Peptide
Semaglutide
Outcome
IncreaseDiabetic retinopathy in sensitivity analyses (empagliflozin, dulaglutide)
Study
n: not reported in source
Comparator
Empagliflozin and dulaglutide
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Source sentences
Summary
Sensitivity analyses using empagliflozin and dulaglutide revealed significant associations with ION and DR, while vitreous detachment and hemorrhage were significant when compared to dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336008
09HumanObservational studySafety outcome
In a sensitivity analysis with dulaglutide as comparator, semaglutide was significantly associated with vitreous detachment and hemorrhage.
In plain wordsWhen compared with dulaglutide, semaglutide was linked to more reports of vitreous detachment and bleeding.
Peptide
Semaglutide
Outcome
IncreaseVitreous detachment and hemorrhage versus dulaglutide
Study
n: not reported in source
Comparator
Dulaglutide
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Source sentences
Summary
Sensitivity analyses using empagliflozin and dulaglutide revealed significant associations with ION and DR, while vitreous detachment and hemorrhage were significant when compared to dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336009
10HumanObservational studySafety outcome
With insulin as comparator, semaglutide showed a higher reporting odds ratio for ischemic optic neuropathy.
In plain wordsCompared with insulin, semaglutide was linked to more reports of optic nerve damage from poor blood flow. This does not prove cause.
Peptide
Semaglutide
Outcome
IncreaseIschemic optic neuropathy versus insulin
Study
n: not reported in source
Comparator
Insulin
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Measurements
ROR
9.84 ratio
vs insulin
Source sentences
Summary
Additionally, when insulin was used as a comparator, semaglutide showed a higher ROR for ION (ROR = 9.84, 95% CI = 4.25-22.81, P < .0001, IC₀₂₅ = 0.42).
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336010
11HumanObservational studySafety outcome
In FAERS reports, tirzepatide was significantly associated with diabetic retinopathy.
In plain wordsIn drug safety reports, tirzepatide was linked to more reports of diabetic retinopathy. This does not prove cause.
Peptide
Tirzepatide
Outcome
IncreaseDiabetic retinopathy reports (FAERS)
Study
n: not reported in source
Comparator
All other drugs
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Source sentences
Summary
However, tirzepatide was only significantly associated with DR in FAERS.
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336011
12HumanObservational studySafety outcome
In FAERS reports, tirzepatide was not significantly associated with optic nerve and retinal adverse events other than diabetic retinopathy.
In plain wordsIn drug safety reports, tirzepatide showed no clear link to other optic nerve or retina problems besides diabetic retinopathy.
Peptide
Tirzepatide
Outcome
No significant changeOther optic nerve and retinal adverse events
Study
n: not reported in source
Comparator
All other drugs
Outcome group
Adverse events · Eye
Studied dose
Dose not stated
Source sentences
Summary
However, tirzepatide was only significantly associated with DR in FAERS.
2 context sentences(design, population, supporting numbers)
Summary · context
We searched the US FAERS database (via OpenVigil 2.1) and WHO's VigiBase (via VigiAccess) for optic nerve and retinal AEs associated with semaglutide and tirzepatide, covering the period from their respective approval dates-December 2017 for semaglutide and May 2022 for tirzepatide-through September 2024.
Summary · context
In FAERS, all other drugs were compared, while in VigiBase, metformin, empagliflozin, dulaglutide, and insulin served as controls.
Report a problemFND-4038336012

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 2
9 Oct 2026, 03:07 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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