IMPORTANT SAFETY INFORMATION — VigorAir^℞

(Inhaled sildenafil 25mg)

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What it is

VigorAir is a compounded prescription of inhaled sildenafil for on-demand treatment of erectile dysfunction (ED). It is delivered as a single 25mg capsule for inhalation only using a breath-activated dry-powder inhaler.

Compounded under §503A for individual patients. Not FDA-approved; the FDA has not evaluated this formulation for safety or efficacy.

Sexual stimulation is required for effect. Not for daily continuous use.

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Who should not use VigorAir^℞

Do not use if you:

• take nitrates or nitric-oxide donors (e.g., nitroglycerin, isosorbide dinitrate/mononitrate, or recreational “poppers”);
• take guanylate cyclase stimulators (e.g., riociguat);
• are allergic to sildenafil or any ingredient in this product (includes lactose; people with severe milk-protein allergy should not use lactose-containing DPIs);
• have been told by a clinician to avoid sexual activity because of heart disease.
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Before using, tell your clinician if you:

• have heart problems, recent heart attack or stroke, abnormal heart rhythm, low blood pressure, or uncontrolled high blood pressure;
• have retinal disorders (including NAION or “crowded” optic disc) or hearing problems;
• have lactose intolerance or any milk allergy. (Note: lactose intolerance affects digestion; milk-protein allergy is different and can cause allergic reactions with lactose-containing inhaled powders.)
• have conditions that raise risk of priapism (e.g., sickle cell disease, leukemia, multiple myeloma) or an anatomical penile abnormality;
• have liver or kidney disease;
• use alpha-blockers, other blood-pressure medicines, or strong CYP3A inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin) — these can raise sildenafil levels and increase the risk of low blood pressure;
• have asthma, COPD, or reactive airway disease (inhaled powders can rarely trigger cough or bronchospasm);
• regularly drink alcohol (can worsen dizziness and impair erectile function);
• take any other ED medicines or PDE5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil).
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How to use

• One capsule (25 mg) by inhalation shortly before sexual activity, as instructed.
• Do not exceed one dose in 24 hours.
• For inhalation only — do not swallow the capsule. Use only with the supplied inhaler.
• If you develop chest pain after dosing, do not take nitrates; seek emergency care and tell responders you used sildenafil.
• Keep capsules dry; store at room temperature. Keep out of reach of children.
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Possible side effects

Common: headache, flushing, nasal congestion, indigestion/heartburn, dizziness, nausea, back or muscle pain, temporary visual changes (e.g., color tinge or light sensitivity), throat irritation or cough.

Serious (seek care immediately):

• Priapism — erection lasting >4 hours;
• Sudden vision loss in one or both eyes (possible NAION);
• Sudden hearing decrease or loss, sometimes with ringing;
• Severe dizziness, fainting, or chest pain;
• Breathing problems such as wheeze, bronchospasm, or severe/persistent cough;
• Allergic reaction (e.g., rash, itching, swelling of face/lips/tongue, wheeze, trouble breathing) — stop use and seek care immediately, especially if you have a milk-protein allergy.
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Drug and substance interactions

• Absolutely do not combine with nitrates/NO donors or riociguat.
• Use caution with alpha-blockers or other antihypertensives; risk of symptomatic hypotension.
• Strong CYP3A inhibitors (e.g., ritonavir, ketoconazole) can markedly increase sildenafil levels — your clinician may advise not to use VigorAir while on these medicines.
• Do not use within 24 hours of any other PDE5 inhibitor or ED treatment.
• Limit alcohol; it can increase dizziness and reduce erectile response.
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Additional information

• Not indicated for pulmonary arterial hypertension (PAH) — dosing and safety for PAH are different.
• Not for use in women or children.
• VigorAir does not protect against sexually transmitted infections.
• Report side effects to your clinician or to FDA MedWatch (1-800-FDA-1088 or www.fda.gov/medwatch).
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Trademark: Viagra® is a registered trademark of Pfizer Inc. ForHumanity is not affiliated with, sponsored, or endorsed by Pfizer.

Rev. 2025-09

This information is not comprehensive. For broader safety information about FDA-approved oral sildenafil tablets (Viagra®/Revatio®), see the FDA labeling on DailyMed. That labeling is reference information only and does not describe this compounded inhaled formulation or its dosing.

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View FDA-approved oral sildenafil labeling (reference)