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Erectile dysfunction Clinical Knowledge Summary

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Certain health conditions, medicines, and lifestyle factors can increase the risk of side effects

Seek emergency care immediately for signs of allergic reaction, severe abdominal pain with fever, or inability to keep fluids down for more than 6 hours

Limited Scope of FDA Approval The most significant limitation is the narrow approved indication: FDA approval restricted exclusively to acquired, generalized hypoactive sexual desire disorder in premenopausal women No approved indication for men despite Phase 2 evidence of erectile dysfunction improvement No approval for postmenopausal women No approval for other forms of sexual dysfunction beyond HSDD All use outside this single indication represents off-label prescribing based on limited clinical trial data and physician clinical experience