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What the FDA labels say about taking them together

Ketoconazole and tadalafil

Tadalafil's FDA label of June 3, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name tadalafil. The tadalafil label: “CYP3A4 inhibitors increase CIALIS exposure requiring dose adjustment:”

Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the tadalafil FDA label on DailyMed (effective June 3, 2026, Eli Lilly and Company).

What does the ketoconazole label say about tadalafil?

Ketoconazole's label (effective January 28, 2026) does not name tadalafil in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed

What does the tadalafil label say about ketoconazole?

Tadalafil label, drug interactions

CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase CIALIS exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment:

Tadalafil label, warnings and precautions

The dose of CIALIS for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole [see Drug Interactions ( 7.2 )].

Adcirca label (United Therapeutics Corporation, December 15, 2025), drug interactions

In patients taking potent inhibitors of CYP3A such as ketoconazole, and itraconazole, avoid use of ADCIRCA [see Clinical Pharmacology ( 12.3 )].

Source: FDA drug label (Adcirca, NDA022332), United Therapeutics Corporation, effective December 15, 2025 (SPL set ff61b237-be8e-461b-8114-78c52a8ad0ae), via openFDA

Source: FDA drug label (Tadliq, NDA214522), CMP Pharma, Inc., effective October 15, 2022 (SPL set 7a909b25-3772-403e-a5fe-e4a040293fb7), via openFDA

Source: FDA drug label (Cialis), Eli Lilly and Company, effective June 3, 2026 (SPL set bcd8f8ab-81a2-4891-83db-24a0b0e25895), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

30Ketoconazole generic labelers
49Tadalafil generic labelers
KetoconazoleTadalafil
Labeled forFungal infectionsErectile dysfunction, Enlarged prostate (BPH), Pulmonary arterial hypertension
Boxed warningNoNo
Pharmacy cost (NADAC)$0.249 per gram 2% cream$0.167 per tablet 20 mg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?