Summary of possible benefits and harms

How well does sildenafil work?

Two small studies looked at how well sildenafil works compared with dummy treatment for people with Raynaud's. These studies were too small (77 people in total) and carried out for too short a time (4 weeks) to show whether there was a difference between sildenafil and a dummy treatment in healing ulcers. However, when the results of these 2 small studies were looked at with the results of a similar study with another PDE5 inhibitor, called tadalafil, they suggested that this type of drug may be helpful in healing and improving ulcers.

One other small study in 19 people compared the number of digital ulcers people had before and after treatment with sildenafil. This study found that in the 16 people who completed the study, sildenafil reduced the number of ulcers at the end of 6 months of treatment by an average of 2 ulcers per person.

None of the studies compared sildenafil with other medicines used to treat digital ulcers.

What are the possible harms or side effects?

In the small studies that looked at how well sildenafil works for treating digital ulcers, the most common side effects were headache, indigestion, flushing of the face, palpitations and joint and muscle pain. These are very common side effects with sildenafil and can affect more than 1 in 10 people taking this medicine.

People with certain health problems should not take sildenafil for digital ulcers and their doctor will be able to provide more information about this. For example, people should not take sildenafil if they have a severe heart or liver problem, very low blood pressure, or if they have recently had a stroke or heart attack. People with certain rare inherited eye diseases (such as retinitis pigmentosa), or loss of vision due to non‑arteritic anterior ischaemic optic neuropathy should not take sildenafil. People should not take sildenafil if they are allergic to it or if they are also taking certain medicines, for example, medicines called nitrates (for chest pain) or nitric oxide donors such as amyl nitrite ("poppers"), medicines to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).

Please note that the results of the research studies only indicate the benefits and harms for the populations in the studies. It is not possible to predict what the benefits and harms will be for an individual patient being treated with sildenafil.