Important Safety Information: ED medications
This page summarizes the most important safety information in the FDA prescribing information (labels) for sildenafil and tadalafil, medicines used to treat erectile dysfunction (ED). These labels have no boxed warning. This page does not include everything in the labels; read the patient information that comes with your prescription.
Who should not take sildenafil or tadalafil
Do not take these medicines if you use any form of nitrate, such as nitroglycerin for chest pain, because the combination can lower blood pressure to a dangerous level. The labels also rule them out for people who take riociguat or another guanylate cyclase stimulator, and for anyone with a known allergy to the medicine.
Heart health comes first
Sexual activity puts some strain on the heart. The labels say these medicines should not be used by men for whom sexual activity is not advisable because of their heart health. Your provider asks about your heart history, blood pressure and medicines before any decision. If you get chest pain during sex after taking one of these medicines, stop and get emergency care, and tell the emergency team which medicine you took and when.
Serious risks
- Prolonged erection: get emergency treatment if an erection lasts more than 4 hours. If it is not treated right away, the labels warn that penile tissue damage and lasting loss of potency could result.
- Sudden vision loss: stop the medicine and get medical care right away if you lose vision in one or both eyes. This can be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
- Sudden hearing loss: stop the medicine and get prompt care if your hearing suddenly decreases or stops, sometimes with ringing in the ears or dizziness.
- Low blood pressure: taking these medicines with alpha-blockers or other blood pressure medicines, can lower blood pressure and cause dizziness or fainting. The tadalafil label adds a warning about drinking a large amount of alcohol.
- Severe allergic skin reactions (Stevens-Johnson syndrome, exfoliative dermatitis) have been reported with tadalafil.
- Other ED medicines: do not combine with other ED medicines, or with sildenafil or tadalafil prescribed for lung blood pressure.
- Other medicines: some medicines, such as ritonavir, ketoconazole and other strong CYP3A4 inhibitors, raise the level of these drugs in the body, and the dose may need to change.
Common side effects
The labels list headache, flushing, indigestion, stuffy nose, back pain and muscle aches among the most common side effects. Sildenafil can also cause changes in vision, nausea, dizziness and rash, and tadalafil can cause pain in the arms or legs.
Tell your provider
Tell your provider about every medicine and supplement you take, including nitrates, blood pressure medicines, prostate medicines and recreational drugs called poppers (amyl nitrite). Also tell your provider about heart, liver or kidney problems, eye problems, a blood or bleeding disorder, or a past prolonged erection. ED can have causes that need their own care, so the labels call for a medical assessment before treatment.
When to get medical help right away
Call 911 or get emergency care for chest pain, fainting, an erection lasting more than 4 hours, or sudden loss of vision or hearing.
You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Who decides
A licensed provider reviews your history and decides whether one of these medicines is appropriate for you.
Prescription treatment requires an evaluation by a licensed healthcare provider, who decides whether treatment is appropriate for you. Not everyone qualifies. Completing an assessment, booking a visit, or paying a fee does not guarantee a prescription.