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What the FDA labels say about taking them together

Danazol and simvastatin

Danazol's FDA label of April 30, 2020 names simvastatin in its drug interactions section, and simvastatin's label names danazol too. The simvastatin label: “The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR. Gemfibrozil may cause myopathy when given alone.”

Check it at the source: the danazol FDA label on DailyMed (effective April 30, 2020, Lannett Company, Inc.); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).

What does the danazol label say about simvastatin?

Danazol label, drug interactions

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin and lovastatin.

Source: FDA drug label (Danazol), Lannett Company, Inc., effective April 30, 2020 (SPL set f2c9b713-aafc-49ca-866e-334d9b5c2e2d), via openFDA; the full label on DailyMed

What does the simvastatin label say about danazol?

Simvastatin label, contraindications

Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any excipient in ZOCOR

Simvastatin label, drug interactions

Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR. Gemfibrozil may cause myopathy when given alone. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR is contraindicated [see ].

Simvastatin label, warnings and precautions

The concomitant use of ZOCOR with gemfibrozil, cyclosporine, or danazol is also contraindicated [see Contraindications (4) and Drug Interactions (7.1) ].

Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), 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

4Danazol generic labelers
27Simvastatin generic labelers
DanazolSimvastatin
Labeled forn/aHeart attack and coronary artery disease, High cholesterol, High triglycerides
Boxed warningYesNo
Pharmacy cost (NADAC)$2.65 per capsule 200 mg capsule$0.0321 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)

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