Is Spray Tadalafil Real?
No, spray tadalafil is not an FDA-approved or guideline-recognized formulation for treating erectile dysfunction. Tadalafil is only approved and recommended in oral tablet form, either as on-demand dosing (10-20 mg) or daily dosing (2.5-5 mg) 1, 2.
Approved Formulations of Tadalafil
- Tadalafil is administered orally as tablets and is established as first-line therapy for erectile dysfunction by the American Urological Association and American College of Physicians 1, 2
- The only approved dosing strategies are oral tablets taken on-demand (10 mg or 20 mg) or once-daily (2.5-5 mg), with no spray formulation recognized in clinical guidelines 2, 3
- For benign prostatic hyperplasia with or without erectile dysfunction, tadalafil 5 mg once daily is the FDA-approved oral dose 3
Research on Spray Formulations
- One research study from 2020 investigated spray-dried amorphous solid dispersions of tadalafil using glycyrrhizin as a carrier to enhance dissolution rates in rats, but this was a pharmaceutical development study, not a clinically approved product 4
- This experimental formulation showed improved dissolution rates (4.07-fold increase) and aphrodisiac activity in male rats, but it remains an investigational compound with no human clinical trials or regulatory approval 4
Why Oral Tablets Remain the Standard
- High-quality evidence demonstrates that oral tadalafil tablets achieve 69% successful sexual intercourse attempts versus 33% with placebo, with proven efficacy across all severities and etiologies of erectile dysfunction 1, 2
- The long half-life of 17.5 hours with oral tadalafil provides a therapeutic window of up to 36 hours, eliminating the need for alternative delivery methods 2, 5
- Oral tadalafil has been extensively studied in diverse populations including men with diabetes, cardiovascular disease, post-prostatectomy, and other comorbidities, with established safety profiles 1, 2
Critical Safety Concerns with Unapproved Products
- Any non-FDA-approved formulation of tadalafil, including sprays, carries unknown risks regarding dosing accuracy, absorption rates, and potential for dangerous drug interactions, particularly with nitrates which can cause fatal hypotension 2
- Patients must be explicitly counseled that only oral tablet formulations have undergone rigorous safety testing and regulatory approval 2
If patients encounter spray tadalafil products online or elsewhere, they should be advised these are not legitimate pharmaceutical products and may pose serious health risks.