Cialis (Tadalafil) Side Effects: Which Ones Can Become Permanent?

Which side effects can become permanent?

The Cialis label uses permanent-harm language for NAION and priapism. For NAION, it describes a rare condition and a cause of decreased vision, including permanent loss of vision, reported rarely after marketing with all PDE5 inhibitors. [1] For priapism, it says priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. [1]

Sudden decrease or loss of hearing, possibly with tinnitus and dizziness, has also been reported; the label says to stop Cialis and seek prompt medical attention. [1]

Severe hypersensitivity is another serious label issue. The Cialis label contraindicates the drug in people with a known serious hypersensitivity to tadalafil, including reported Stevens-Johnson syndrome and exfoliative dermatitis. [1]

What does the label say about NAION?

NAION is rare. Based on published literature, the label gives an annual incidence of 2.5 to 11.8 cases per 100,000 in males aged 50 and older. [1] The label warns that sudden loss of vision in one or both eyes may be NAION and says patients should stop Cialis and seek medical attention. [1]

One observational study compared PDE5 inhibitor use within 5 half-lives before NAION with use in an earlier period. A similar study reported a consistent result. The two risk estimates, which suggest an approximate 2-fold increase in NAION risk, were 2.15 (95% CI 1.06 to 4.34) and 2.27 (95% CI 0.99 to 5.20). [1] Neither established that PDE5 inhibitors caused NAION: the label says neither the rare postmarketing reports nor these studies substantiate a causal relationship. [1]

The label advises caution in patients with a history of NAION and notes that a 'crowded' optic disc may increase risk. [1] Use is not recommended in hereditary retinal disorders such as retinitis pigmentosa. [1]

Can priapism from Cialis cause permanent erectile dysfunction?

The label reports rare cases of prolonged erections greater than 4 hours and priapism, which it describes as painful erections greater than 6 hours in duration, with this class of compounds. [1] It says priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. [1] The label says an erection lasting more than 4 hours, whether painful or not, needs emergency medical attention. [1]

The label advises caution in people with conditions that may predispose them to priapism: sickle cell anemia, multiple myeloma, leukemia, or anatomical deformation of the penis such as angulation, cavernosal fibrosis, or Peyronie's disease. [1]

How long do common side effects last?

In eight 12-week placebo-controlled trials of as-needed Cialis for ED, the most common reactions were headache, dyspepsia, back pain, myalgia, nasal congestion and flushing; at 20 mg, headache was reported by 15% vs 5% on placebo. [1] Back pain or myalgia generally began 12 to 24 hours after dosing and typically resolved within 48 hours. [1] About 0.5% of on-demand users discontinued for back pain or myalgia. [1]

The label's back pain/myalgia note says the pain was usually mild or moderate and resolved without medical treatment, though severe back pain was reported with a low frequency, less than 5% of all reports. [1]