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Important safety information

Compounded Sildenafil

Important Safety Information for Compounded Sildenafil (Lemonaid Bliss)

Who Should Avoid Using Sildenafil

Do not use sildenafil if you regularly take nitrates (medication for chest pain, nitroglycerin, isosorbide mononitrate or dinitrate, or poppers) or riociguat.

Use of Sildenafil

Compounded sildenafil is legally permitted under federal law but has not been FDA-approved and does not undergo review for safety, effectiveness, or manufacturing standards.

Sildenafil is prescribed for treatment of erectile dysfunction.

Before using Sildenafil, tell your healthcare provider about

All of your medical conditions. Provide your complete medical history, particularly if you have cardiovascular disease including low or high blood pressure, chest pain, recent stroke, arrhythmia or heart attack; pulmonary veno-occlusive disease (PVOD) or pulmonary arterial hypertension; bleeding problems; stomach ulcer; hearing problems; anatomical penis deformation; blood cell problems including sickle cell anemia; eye problems including but not limited to retinitis pigmentosa or if you have experienced sudden vision loss.

All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take.

Sildenafil may cause serious side effects, including:

  • Vision changes. Stop sildenafil use and seek medical attention for sudden loss of vision in one or both eyes. Vision color changes, photophobia (light sensitivity in the eyes), and blurred vision have been reported.
  • Hearing loss. Stop sildenafil use and seek medical attention for sudden decrease or loss of hearing, with or without dizziness and ringing in the ears.
  • Prolonged erection. Seek immediate medical attention if an erection lasts longer than 4 hours.
  • Decreased blood pressure. Sildenafil may cause low blood pressure.
  • Serious allergic reactions. Stop sildenafil use immediately and seek medical assistance if you experience symptoms like swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching.

Common side effects of Sildenafil may include headache, flushing, upset stomach, diarrhea, back or limb pain, nosebleeds, or nasal congestion.

If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Compounded products have not been approved by the FDA. The FDA does not verify the safety or effectiveness of compounded drugs.