Updated safety information for oral ED medications, including CIALIS

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been reported in rare instances in men taking prescription ED tablets, including CIALIS. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS and contact a doctor right away.

Important Safety Information for CIALIS^® (tadalafil)

CIALIS is indicated for the treatment of erectile dysfunction.

CIALIS IS NOT FOR EVERYONE. Tell your doctor about your medical conditions and all medications, and ask if you're healthy enough for sexual activity.

Don't take CIALIS if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.

Don't drink alcohol in excess (to a level of intoxication) with CIALIS, as this may increase your chances of getting dizzy or lowering your blood pressure. CIALIS does not protect against sexually transmitted diseases, including HIV. The most common side effects with CIALIS were headache and upset stomach. Backache and muscle ache were also reported, sometimes with delayed onset.

As with any ED tablet, in the rare event of priapism (an erection lasting more than 4 hours), seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets (including CIALIS) reported a sudden decrease or loss of vision. It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision, stop taking any ED tablet and call your doctor right away.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been reported in rare instances in men taking prescription ED tablets, including CIALIS. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS and contact a doctor right away.

Individual results may vary. In clinical trials, CIALIS was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt. CIALIS has not been studied for multiple sexual attempts per dose.

CIALIS is available by prescription only. For additional safety information, talk to your doctor about this medicine and see the full Patient Information.