Tadalafil for Women: Not Recommended Based on Current Evidence
Tadalafil is not recommended for the treatment of female sexual dysfunction due to lack of efficacy data and absence of FDA approval for this indication. The NCCN explicitly states that oral phosphodiesterase type 5 inhibitors (PDE5i), including tadalafil, are not recommended for female sexual dysfunction because of insufficient evidence regarding their effectiveness in women 1.
Evidence Against Use in Women
Guideline Recommendations
The NCCN Survivorship Panel does not recommend PDE5i use in women despite the theoretical mechanism of increasing pelvic blood flow to the clitoris and vagina 1
Randomized clinical trials in various non-cancer populations of women being treated for sexual arousal disorder have shown contradictory results, with no consistent benefit demonstrated 1
The guidelines explicitly state that "more research is needed before a recommendation can be made regarding the use of sildenafil for the treatment of female sexual dysfunction," and this applies equally to tadalafil 1
FDA Approval Status
Tadalafil is FDA-approved only for erectile dysfunction and benign prostatic hyperplasia in men—there is no approved indication for women 2
All FDA dosing recommendations are specific to male patients for erectile dysfunction (5-20 mg) or BPH (5 mg daily) 2
Limited and Conflicting Research Data
Studies Showing Potential Benefit
While some small studies suggest possible benefit, they have significant limitations:
One uncontrolled study of 32 premenopausal women with type 1 diabetes showed improvement in genital arousal with tadalafil 5 mg daily, but lacked a placebo control group, making results unreliable 3
A case series of only 3 women reported benefit from tadalafil 20 mg for antidepressant-induced sexual dysfunction, but this is anecdotal evidence insufficient for clinical recommendations 4
Studies Showing No Benefit
A systematic review of treatment for sexual dysfunction in women with systemic autoimmune rheumatic disorders found that tadalafil did not result in significant improvement based on the Female Sexual Function Index 5
A Cochrane review on antidepressant-induced sexual dysfunction found that for women, it remains uncertain whether sildenafil (and by extension, other PDE5i) is more effective than placebo 6
Recommended Alternative Treatments
The NCCN guidelines provide evidence-based alternatives that should be used instead 1:
First-Line Non-Pharmacological Approaches
Vaginal moisturizers and lubricants (water-, oil-, or silicone-based) for vaginal dryness and sexual pain 1
Pelvic floor muscle training to improve sexual pain, arousal, lubrication, orgasm, and satisfaction 1
Psychotherapy and cognitive behavioral therapy, particularly for survivors of breast, endometrial, and cervical cancer 1
Pharmacological Options with Evidence
Vaginal estrogen (pills, rings, or creams) for postmenopausal women with vaginal dryness, itching, and dyspareunia 1
Ospemifene (FDA-approved for vulvovaginal atrophy in postmenopausal women, though contraindicated in estrogen-dependent cancers) 1
Flibanserin (FDA-approved for premenopausal women with hypoactive sexual desire disorder, though not contraindicated in breast cancer patients) 1
Bupropion 150 mg twice daily showed benefit for antidepressant-induced sexual dysfunction in both men and women 6
Safety Considerations
If tadalafil were to be used off-label in women despite lack of evidence, the same cardiovascular precautions would apply:
Contraindicated with nitrate use due to severe hypotension risk 2
Potential for orthostatic hypotension, particularly with alcohol consumption 2
Risk of sudden vision or hearing loss, though rare 2
Common side effects include dizziness, headache, and flushing 2
Clinical Pitfalls to Avoid
Do not prescribe tadalafil for female sexual dysfunction based on its efficacy in men—the pathophysiology and response differ significantly between sexes 1
Avoid extrapolating male erectile dysfunction data to women—the evidence base explicitly shows contradictory results in female populations 1
Screen for underlying causes of sexual dysfunction including depression, anxiety, relationship issues, medications (especially SSRIs, narcotics, hormone therapy), cardiovascular disease, diabetes, and menopausal symptoms before considering any pharmacological intervention 1
Recognize that the evidence base for female sexual dysfunction interventions is weak overall, requiring a comprehensive approach rather than relying on a single pharmacological agent 1