If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Cialis ® (tadalafil) tablets
2.5 mg, 5 mg, 10mg, 20 mg tablets
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 are the side effects of CIALIS® (tadalafil) on vision?
Ophthalmologic adverse events, including nonarteritic anterior ischemic optic neuropathy (NAION), have been reported during use of tadalafil.
Reports of Vision-Related Adverse Events
Patients should stop taking tadalafil and consult a physician immediately in the event of sudden loss of vision in one or both eyes.1
Across all studies with any tadalafil dose, changes in color vision were rare (<0.1% of patients).1
Vision-related events reported in <2% of patients in controlled clinical studies of tadalafil for once-daily use or use as needed included
- blurred vision
- changes in color vision
- conjunctivitis (including conjunctival hyperemia)
- eye pain
- lacrimation increase, and
- swelling of eyelids.1
Vision-related adverse reactions that have been identified during postapproval use of tadalafil include
- visual field defect
- retinal vein occlusion, and
- retinal artery occlusion.1
Phosphodiesterase 5 Inhibitors and Nonarteritic Anterior Ischemic Optic Neuropathy
In men taking phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil, nonarteritic anterior ischemic optic neuropathy (NAION) has been rarely reported. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup-to-disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.1 Although Eli Lilly and Company continues to monitor this closely, a causal relationship has not been established. Currently, it is not possible to determine whether NAION is related directly to the use of PDE5 inhibitors or other factors.1-3
Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye and in patients among the general population with a "crowded" optic disc, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.1
Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.1
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.
2Laties AM. Vision disorders and phosphodiesterase type 5 inhibitors: a review of the evidence to date. Drug Saf. 2009;32(1):1-18. http://dx.doi.org/10.2165/00002018-200932010-00001
3Penedones A, Alves C, Batel Marques F. Risk of nonarteritic ischaemic optic neuropathy with phosphodiesterase type 5 inhibitors: a systematic review and meta-analysis. Acta Ophthalmol. 2020;98(1):22-31. https://dx.doi.org/10.1111/aos.14253
Date of Last Review: December 01, 2022