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One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness; bone pain; breast enlargement; chest pain; chills; confusion; convulsions (seizures); coughing up blood; deafness; decrease in amount of urine or in frequency of urination; dizziness or lightheadedness, especially when getting up from a lying or sitting position; dry eyes; dry mouth; dryness, redness, scaling, or peeling of the skin; eye pain; fainting or faintness; fast, irregular, or pounding heartbeat; feeling of something in the eye; groups of skin lesions with swelling; headache (severe or continuing); heart failure; hives; increase in size of pupil; increased sweating; increased thirst; itching of skin; low blood pressure; lower back or side pain; migraine headache; nausea (severe or continuing); nervousness; numbness of hands; painful, swollen joints; redness, itching, or tearing of eyes; shortness of breath or troubled breathing; skin paleness; skin rash; skin ulcers; sore throat and fever or Visual disturbances occurred more commonly at higher levels of sildenafil exposure. 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