Cialis ® (tadalafil) tablets

2.5 mg, 5 mg, 10mg, 20 mg tablets

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Vision Side Effects When Taking CIALIS (tadalafil)

Ophthalmologic adverse events, including nonarteritic anterior ischemic optic neuropathy (NAION), have been reported during use of CIALIS.

Reports of vision-related adverse events

Patients should stop taking Cialis® (tadalafil) and consult a physician immediately in the event of sudden loss of vision in one or both eyes.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in clinical studies of tadalafil, and use in these patients is not recommended.

Across all studies with any tadalafil dose, reports of changes in color vision were rare (<0.1% of patients).

In clinical studies of tadalafil, less than 2% of patients reported

  • blurred vision

  • changes in color vision

  • conjunctivitis (including conjunctival hyperemia),

  • eye pain

  • increased lacrimation, or

  • swelling of eyelids.

During post‑approval use of tadalafil, less than 0.1% of patients have reported

  • visual field defect

  • retinal artery occlusion, or

  • retinal vein occlusion.

NAION

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil.

Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors.

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.

Reference

CIALIS [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.

Date of Last Review: April 26, 2017

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