Safety Information

Phosphodiesterase type 5 (PDE5) inhibitors are prescription medications used to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. These medications do not cause an erection without sexual stimulation and are only available through prescription by a licensed healthcare provider.

Stop and seek emergency care

Whichever treatment you have been prescribed, stop taking it and get emergency medical help if you experience any of the following:

• an erection lasting more than 4 hours (priapism);
• sudden vision loss in one or both eyes;
• a sudden decrease or loss of hearing; or
• chest pain, severe dizziness, or fainting.

Never combine any of these medications with nitrates. Nitrate medications — including nitroglycerin, isosorbide, and recreational “poppers” — and guanylate cyclase stimulators such as riociguat can cause a dangerous drop in blood pressure when taken with a PDE5 inhibitor.

Tadalafil

Tadalafil is a PDE5 inhibitor FDA-approved for the treatment of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). It works by increasing blood flow to help achieve and maintain an erection when sexually stimulated.

Absolute contraindications — do NOT use tadalafil if you:

• are allergic to tadalafil or any of its ingredients;
• are taking any form of nitrate medication for chest pain or heart conditions; or
• are taking guanylate cyclase stimulators such as riociguat.

Drug interactions — do NOT use tadalafil if you take:

• nitrate medications including nitroglycerin, isosorbide, or recreational “poppers”;
• guanylate cyclase stimulators such as riociguat; or
• certain HIV protease inhibitors or antifungal medications without provider guidance.

Serious side effects — stop treatment and seek emergency care if you experience:

• an erection lasting more than 4 hours (priapism);
• sudden vision loss in one or both eyes;
• a sudden decrease or loss of hearing; or
• chest pain, severe dizziness, or fainting.

Common side effects — talk to your provider if you experience:

• headache;
• flushing;
• indigestion or upset stomach;
• back pain or muscle aches; or
• nasal congestion.

Tadalafil may cause a temporary drop in blood pressure, especially when taken with blood pressure medications or alpha-blockers.

Sildenafil

Sildenafil is a PDE5 inhibitor FDA-approved for the treatment of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). It works by increasing blood flow to help achieve and maintain an erection when sexually stimulated.

Absolute contraindications — do NOT use sildenafil if you:

• are allergic to sildenafil or any of its ingredients;
• are taking any form of nitrate medication for chest pain or heart conditions; or
• are taking guanylate cyclase stimulators such as riociguat.

Drug interactions — do NOT use sildenafil if you take:

• nitrate medications including nitroglycerin, isosorbide, or recreational “poppers”;
• guanylate cyclase stimulators such as riociguat; or
• certain HIV protease inhibitors or antifungal medications without provider guidance.

Serious side effects — stop treatment and seek emergency care if you experience:

• an erection lasting more than 4 hours (priapism);
• sudden vision loss in one or both eyes;
• a sudden decrease or loss of hearing; or
• chest pain, severe dizziness, or fainting.

Common side effects — talk to your provider if you experience:

• headache;
• flushing;
• indigestion or upset stomach;
• nasal congestion; or
• visual disturbances such as increased light sensitivity or color changes.

Sildenafil may cause a temporary drop in blood pressure, especially when taken with blood pressure medications or alpha-blockers.

Vardenafil

Vardenafil is a PDE5 inhibitor FDA-approved for the treatment of erectile dysfunction (ED). It works by increasing blood flow to help achieve and maintain an erection when sexually stimulated.

Absolute contraindications — do NOT use vardenafil if you:

• are allergic to vardenafil or any of its ingredients;
• are taking any form of nitrate medication for chest pain or heart conditions;
• are taking guanylate cyclase stimulators such as riociguat; or
• have phenylketonuria (PKU) or fructose intolerance when prescribed rapidly disintegrating tablets.

Drug interactions — do NOT use vardenafil if you take:

• nitrate medications including nitroglycerin, isosorbide, or recreational “poppers”; or
• guanylate cyclase stimulators such as riociguat.

Serious side effects — stop treatment and seek emergency care if you experience:

• an erection lasting more than 4 hours (priapism);
• sudden vision loss in one or both eyes;
• a sudden decrease or loss of hearing; or
• chest pain, severe dizziness, or fainting.

Common side effects — talk to your provider if you experience:

• headache;
• flushing;
• indigestion or upset stomach;
• back pain; or
• nasal congestion.

Vardenafil may cause a temporary drop in blood pressure, especially when taken with blood pressure medications or alpha-blockers.

Apomorphine

Apomorphine is a prescription medication that acts as a non-ergoline dopamine agonist. It is FDA-approved for the acute, intermittent treatment of “off” episodes associated with advanced Parkinson’s disease and may be prescribed for other uses when clinically appropriate. Apomorphine is only available through prescription by a licensed healthcare provider.

Absolute contraindications — do NOT use apomorphine if you:

• are allergic to apomorphine or any of its ingredients, including sodium metabisulfite; or
• are taking 5-HT3 antagonist anti-emetic medications such as ondansetron, granisetron, dolasetron, palonosetron, or alosetron.

Drug interactions — do NOT use apomorphine if you take:

• any 5-HT3 antagonist anti-emetic medications, due to the risk of severe hypotension and loss of consciousness.

Serious side effects — stop treatment and seek emergency care if you experience:

• severe or persistent nausea and vomiting;
• confusion, hallucinations, or sudden changes in mental status;
• significant drops in blood pressure, dizziness, or fainting; or
• trouble breathing, chest pain, or allergic reactions.

Common side effects — talk to your provider if you experience:

• drowsiness or sudden sleep episodes;
• yawning;
• nausea;
• runny nose; or
• involuntary movements.

Apomorphine may cause low blood pressure, sedation, or sudden sleep onset. Use caution when standing, driving, or operating machinery, especially when first starting treatment or adjusting dosage.

Important apomorphine disclaimer

This information does not include all possible side effects, interactions, or warnings. Apomorphine is not appropriate for everyone. Always follow your prescribing provider’s instructions and inform them of all medications, supplements, and medical conditions.

Non-prescription ingredients

Some BraveRX formulations also contain Icariin or L-Citrulline alongside their prescription ingredients. Neither is a prescription medication or FDA-approved for erectile dysfunction, but both can affect blood pressure and interact with other medicines. The cautions below apply in addition to those for the prescription ingredients in your formulation.

Icariin

Icariin is a plant compound (a flavonoid) from Epimedium, also known as horny goat weed. In laboratory studies it relaxes blood vessels and has mild PDE5-inhibiting activity, which means it can add to the effects of the prescription PDE5 inhibitor in your formulation.

Do NOT use icariin if you:

• are allergic to icariin, Epimedium (horny goat weed), or any of its ingredients.

Talk to your provider first if you:

• have low blood pressure or a heart condition;
• have a bleeding disorder or have surgery scheduled; or
• have a hormone-sensitive condition, including a hormone-sensitive cancer.

Drug interactions — talk to your provider before using icariin if you take:

• blood thinners or antiplatelet medications such as warfarin, clopidogrel, or daily aspirin;
• blood pressure medications, including alpha-blockers; or
• other ED medications or supplements, including any that contain horny goat weed.

Serious side effects — stop treatment and seek medical care if you experience:

• a fast or irregular heartbeat;
• fainting or severe dizziness;
• unusual bleeding or bruising, or a nosebleed that will not stop; or
• trouble breathing.

Common side effects — talk to your provider if you experience:

• dizziness;
• dry mouth or thirst;
• nausea or stomach discomfort; or
• nosebleeds.

L-Citrulline

L-Citrulline is an amino acid that the body makes on its own and that is also found in foods such as watermelon. The body converts it into L-arginine, which it uses to make nitric oxide, a molecule that relaxes blood vessels. Because of this, L-Citrulline can lower blood pressure, and that effect adds to the blood-pressure-lowering effect of the PDE5 inhibitor in your formulation.

Do NOT use L-Citrulline if you:

• are allergic to L-Citrulline or any of its ingredients.

Talk to your provider first if you:

• have low blood pressure; or
• often feel dizzy or lightheaded when you stand up.

Drug interactions — talk to your provider before using L-Citrulline if you take:

• nitrate medications, which must never be combined with any BraveRX treatment (see the warning at the top of this page);
• blood pressure medications, including alpha-blockers;
• separate L-Citrulline or L-Arginine supplements; or
• other ED medications outside your BraveRX prescription.

Serious side effects — stop treatment and seek medical care if you experience:

• severe dizziness, lightheadedness, or fainting.

Common side effects — talk to your provider if you experience:

• upset stomach; or
• mild dizziness or lightheadedness, especially when standing up.

Important note on non-prescription ingredients

This information does not include all possible side effects, interactions, or warnings. Always follow your prescribing physician’s instructions and tell them about all medications, supplements, and medical conditions, including any supplements you take on your own.

Reporting side effects

Report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

To reach your care team about a side effect you are experiencing, log in to your Patient Portal or contact us and we will route your question to a provider. BraveRX support staff cannot give medical advice.