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.

CIALIS® (tadalafil): Vision Side Effects

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

Events reported in <2% of patients in clinical studies of tadalafil for once-daily use or use as needed included

  • blurred vision

  • changes in color vision

  • conjenctivitis (including conjunctival hyperemia)

  • eye pain

  • lacrimation increase, and 

  • swelling of eyelids.1

Adverse reactions that have been reported with “very rare” frequency (<0.01% of patients) during postapproval use of tadalafil include

  • blurred vision

  • visual field defect, and

  • retinal vein occlusion.2

Phosphodiesterase 5 Inhibitors and Nonarteritic Anterior Ischemic Optic Neuropathy

In men taking PDE5 inhibitors, including tadalafil, NAION has been rarely reported. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION.1 Although Lilly 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, 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

CIALIS® (tadalafil) tablets, for oral use, Lilly

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1. Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. Laties 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

Glossary

Lilly = Eli Lilly and Company

NAION = nonarteritic anterior ischemic optic neuropathy

PDE5 = phosphodiesterase type 5

Date of Last Review: November 19, 2019

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