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FDA approved December 2024 based on SURMOUNT-OSA

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Seek immediate medical attention if you experience: Chest pain , shortness of breath , or irregular heartbeat Prolonged erections lasting over 4 hours (priapism) Sudden loss of vision in one or both eyes (a rare event linked to non-arteritic anterior ischemic optic neuropathy) Sudden hearing loss or ringing in the ears Severe dizziness , fainting , or signs of a drop in blood pressure These side effects are listed in the FDA-approved labeling for sildenafil, tadalafil, and vardenafil and are emphasized in BlueChews safety guidelines