Tadalafil Oral Dissolve Tablet is a compounded, prescription-only medication prepared by a licensed pharmacy pursuant to an individual patient prescription. Tadalafil rapid-dissolve tablets are compounded to dissolve in the mouth before swallowing. The extent of absorption through the oral mucosa, onset of action, and bioavailability may vary. This compounded preparation has not been evaluated by FDA for bioequivalence or therapeutic equivalence to FDA-approved tadalafil tablets. Its active ingredient is tadalafil, a medication in the phosphodiesterase type 5 (PDE5) inhibitor class.
It is one option a provider may consider as part of care for erectile dysfunction (ED). This dosage form may be prescribed when a clinician determines that an FDA-approved manufactured product is not appropriate for an identified patient's medical needs. Bayview compounds it pursuant to that prescription as part of our erectile dysfunction compounding line.
How does it work?
Tadalafil is a selective PDE5 inhibitor. During sexual stimulation, it helps relax the smooth muscle and widen the blood vessels in the penis, which increases blood flow and can support an erection (MedlinePlus monograph). It works only with sexual stimulation, and it does not cure erectile dysfunction or increase sexual desire.
This formulation is compounded as a tablet that dissolves in the mouth before swallowing. The extent of absorption through the oral mucosa, onset of action, and bioavailability may vary and have not been evaluated by FDA.
What is it used for?
Providers may prescribe tadalafil as part of care for erectile dysfunction when they determine it is appropriate for a patient. PDE5 inhibitors are among the oral medications described for ED in the American Urological Association ED guideline. Only a licensed provider can decide whether this formulation is right for an individual; Bayview Pharmacy does not provide consultations or determine appropriateness, and a valid prescription is required.
How does it compare to other ED options?
ED treatments differ mainly in how they are taken and how long they last. The table below describes those differences for education only.
| Option | Form / route | How it's used |
|---|---|---|
| Tadalafil Oral Dissolve Tablet | Dissolves under the tongue (sublingual) | Compounded to dissolve in the mouth; not evaluated by FDA for bioequivalence to approved tablets |
| Tadalafil tablets (swallowed) | Tablet, swallowed by mouth | Manufactured, FDA-approved tablet in a different dosage form |
| Injectable therapy (e.g., Bimix, Trimix) | Intracavernosal injection | Small injection that acts locally on penile blood vessels |
Differences in form, route, and duration are described for education only and are not a statement that any option is better, stronger, faster, or more effective. Your provider determines what is appropriate for you.
How is it used?
Place the tablet under your tongue and allow it to dissolve fully, do not chew it or swallow it whole, and follow the exact timing and dose set by your prescriber. Strength, dose, and frequency are determined by the prescriber for the individual patient. Your prescriber sets your dose and schedule, so never change your dose on your own. A Bayview pharmacist is available if you have questions about your prescription.
Side effects & safety
As with any medication, side effects are possible. Reported effects of PDE5 inhibitors can include headache, flushing, stuffy or runny nose, indigestion, and dizziness. Back pain and muscle aches are also reported with tadalafil and usually ease on their own. Some people notice temporary vision changes such as blurred vision or increased light sensitivity. Report any of these to your provider.
Stop and seek medical care right away if you have a sudden loss of vision or hearing, chest pain, or a reaction that concerns you.
Who should not use it?
Tadalafil is not appropriate for everyone. It should not be used by people taking nitrate medications or riociguat, and extra caution applies to those taking alpha-blockers or other blood-pressure medications (the combination can lower blood pressure too much), and to those with certain heart conditions or for whom sexual activity is inadvisable. Tell your provider about your health conditions and all medications and supplements you take so they can determine whether this formulation is appropriate for you.
How should it be stored?
Orally dissolving tablets are sensitive to moisture. Store exactly as directed on your label, keep the tablets dry, in their original packaging until use, away from heat, light, and humidity, and out of the reach of children. Do not use a tablet that has become damaged or damp.
Why is this compounded?
Compounding lets a licensed pharmacy tailor the strength and dosage form to an individual prescription, for example preparing tadalafil as a tablet that dissolves in the mouth. This dosage form may be prescribed when a clinician determines that an FDA-approved manufactured product is not appropriate for an identified patient's medical needs. As a 503A compounding pharmacy, Bayview Pharmacy prepares each order in small batches under USP <795> standards using quality ingredients. Other compounded options include compounded tadalafil troches, Sildenafil Oral Dissolve Tablets, and Vardenafil Oral Dissolve Tablets. Conventional Tadalafil Tablets are manufactured, FDA-approved products that Bayview dispenses and does not compound. The full list of compounded preparations is in our compounded medications catalog.
Clinical details for prescribers
Mechanism & form. Tadalafil is a selective PDE5 inhibitor that potentiates cGMP-mediated cavernosal smooth-muscle relaxation in response to nitric-oxide release during sexual stimulation. This compounded formulation is an orally dissolving tablet compounded to dissolve in the mouth before swallowing; the extent of transmucosal absorption, onset of action and bioavailability may vary and have not been evaluated by FDA, and the preparation has not been evaluated for bioequivalence or therapeutic equivalence to FDA-approved tadalafil tablets. Conventional tadalafil tablets are manufactured products that Bayview dispenses rather than compounds.
Contraindications & interactions:
- Nitrates, nitric-oxide donors, or riociguat, contraindicated (risk of profound hypotension)
- Additive hypotension with alpha-blockers and antihypertensives
- Consider hepatic/renal function and concomitant CYP3A4 inhibitors
Counseling points:
- Dose timing as directed by the prescriber
- Characteristic back/muscle pain
- Priapism precaution: erection >4 hours is an emergency
References: MedlinePlus monograph; professional monograph. Account setup, licensing, and ordering are covered on our for providers page.
This is a prescription-only compounded medication and is not FDA-approved. Your provider determines whether it is appropriate and sets the formulation and dose.
