Tadalafil Drug Schedule Classification
Tadalafil is not a controlled substance and has no DEA schedule classification—it is a prescription-only medication available by prescription without controlled substance restrictions. 1
Regulatory Status
- Tadalafil is FDA-approved for multiple indications including erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension, but carries no controlled substance scheduling 2, 3
- The medication requires a prescription due to significant safety considerations, particularly the absolute contraindication with nitrate medications which can cause life-threatening hypotension 1, 4
Key Prescribing Restrictions
While tadalafil is not scheduled, prescribing requires critical safety verification:
- Absolute contraindication: Patients taking nitrates in any form must not receive tadalafil due to risk of potentially fatal hypotension—a minimum 48-hour interval is required after the last tadalafil dose before nitrate administration 5, 1, 4
- Cardiovascular screening required: Assess the patient's ability to perform moderate physical activity (walk 1 mile in 20 minutes or climb 2 flights of stairs) before prescribing, with cardiology referral for those unable to do so 1
- Alpha-blocker caution: Combination with alpha-blocking agents like doxazosin requires hemodynamic stability and close blood pressure monitoring 4
Clinical Context
The lack of controlled substance status reflects tadalafil's mechanism as a phosphodiesterase type 5 inhibitor with no abuse potential, addiction risk, or psychoactive properties 6, 7. Its prescription-only status is based entirely on cardiovascular safety concerns rather than abuse liability 4.