IMPORTANT SAFETY INFORMATION — VigorAir
(Inhaled sildenafil 25mg)
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 25 mg 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.
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.
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).
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.
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.
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.
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).
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.
View FDA-approved oral sildenafil labeling (reference)
