Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
DANAZOL vs ANDEMBRY
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Danazol is a synthetic androgen derived from ethisterone that suppresses pituitary-ovarian axis by inhibiting gonadotropin release, leading to decreased estrogen and progesterone levels. It also has weak androgenic and progestational activity.
Binds to androgens, progesterone, and estradiol, inhibiting their effects on hormone-responsive tissues; also binds to microtubules and inhibits tubulin polymerization.
FDA: Treatment of endometriosis, fibrocystic breast disease, hereditary angioedema,Off-label: Idiopathic thrombocytopenic purpura, precocious puberty, gynecomastia
Castration-resistant prostate cancer (chemotherapy-naïve or docetaxel-treated),Metastatic castration-resistant prostate cancer
300-600 mg orally twice daily; maximum 800 mg/day
ANDEMBRY (capivasertib) 400 mg orally twice daily, taken with or without food, in combination with fulvestrant. Continue until disease progression or unacceptable toxicity.
Terminal elimination half-life is 4-4.5 hours; clinical context: requires multiple daily dosing to maintain therapeutic levels.
Terminal elimination half-life is 12-15 hours in healthy adults; may be prolonged up to 20-25 hours in patients with moderate to severe hepatic impairment.
Primarily hepatic: undergoes oxidation and conjugation via CYP3A4, with metabolites excreted in urine and feces.
Hepatic via CYP3A4; active metabolites include abiraterone sulfate, abiraterone N-oxide, and abiraterone glucuronide.
Primarily hepatic metabolism; approximately 60% excreted in feces, 30% in urine as metabolites.
Primarily renal excretion of unchanged drug (approximately 70-80%) and as metabolites (10-15%); biliary/fecal elimination accounts for less than 10%.
Highly protein bound: 97-99%, primarily to albumin.
Approximately 95% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein.
Approximately 1.5 L/kg; indicates extensive distribution into tissues, exceeding total body water.
Volume of distribution is 0.6-0.8 L/kg, indicating distribution into total body water and some tissue binding.
Oral bioavailability is approximately 100% due to extensive absorption, but first-pass metabolism reduces systemic availability to about 70-80%.
Oral bioavailability is 85-90%; intravenous administration yields 100% bioavailability.
No adjustment required for GFR ≥10 m L/min; avoid use in GFR <10 m L/min due to fluid retention risk
No dose adjustment required for mild-to-moderate renal impairment (Cr Cl ≥30 m L/min). Not studied in severe renal impairment (Cr Cl <30 m L/min) or end-stage renal disease; avoid use.
Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated
Mild hepatic impairment (Child-Pugh A): no dose adjustment. Moderate hepatic impairment (Child-Pugh B): reduce dose to 320 mg orally twice daily. Severe hepatic impairment (Child-Pugh C): not recommended.
2-5 mg/kg/dose orally twice daily; maximum 400 mg/day
Safety and efficacy not established in pediatric patients (<18 years); no recommended dose.
Start at low end of adult dose, titrate cautiously due to increased risk of fluid retention and thromboembolism
No specific dose adjustment required based on age. Monitor renal function and for increased risk of adverse events (e.g., diarrhea, hyperglycemia) in elderly patients.
Danazol may cause thrombotic events, including pulmonary embolism and thrombophlebitis. It is contraindicated in patients with a history of thrombosis.
None.
Hepatotoxicity (monitor LFTs), pseudotumor cerebri (benign intracranial hypertension), androgenic effects (hirsutism, acne, voice deepening), lipid changes (decreased HDL, increased LDL), thromboembolic events, and premature closure of epiphyses in children.
Hepatotoxicity, mineralocorticoid excess, cardiovascular events, adrenal insufficiency, and bone marrow suppression.
Pregnancy, lactation, porphyria, severe hepatic/renal/cardiac disease, undiagnosed abnormal genital bleeding, history of thromboembolic disorders, androgen-dependent tumors.
Hypersensitivity to abiraterone acetate or any component, severe hepatic impairment (Child-Pugh C), and women who are or may become pregnant.
Take with food or milk to minimize gastrointestinal irritation. Avoid grapefruit juice as it may alter drug metabolism. Limit alcohol consumption due to increased risk of hepatotoxicity.
ANDEMBRY can be taken with or without food. However, grapefruit and grapefruit juice may increase trofinetide levels; avoid concurrent consumption. No other significant food interactions reported.
Danazol is contraindicated in pregnancy. First trimester exposure is associated with virilization of female fetus including clitoromegaly, labioscrotal fusion, and urogenital sinus abnormalities. Risk in second and third trimesters is also significant due to androgenic effects; fetal growth restriction and preterm birth may occur. No safe gestational period exists.
Category X. First trimester: Major congenital malformations (neural tube defects, craniofacial abnormalities). Second/third trimester: Spontaneous abortion, fetal death, growth restriction. Contraindicated in pregnancy.
Danazol is excreted in human milk; M/P ratio not determined. Potential for adverse effects in breastfed infant (e.g., androgenization). Use is contraindicated during breastfeeding due to risk of virilization and other hormonal effects.
Excreted in human milk; M/P ratio unknown. Potential for serious adverse effects in nursing infant. Contraindicated during breastfeeding.
Danazol is contraindicated in pregnancy; no dose adjustment recommendations exist. If inadvertently used during pregnancy, discontinue immediately and monitor for fetal effects. Pharmacokinetic changes in pregnancy are not studied; dose modifications are not applicable due to contraindication.
Do not use in pregnancy. No dose recommendations available; contraindicated.
Monitor liver function tests; androgenic effects (acne, hirsutism, voice deepening) may occur; use with caution in patients with cardiac or renal impairment; may potentiate warfarin; effective for hereditary angioedema prophylaxis; check pregnancy test before initiation due to teratogenicity.
ANDEMBRY (trofinetide) is indicated for the treatment of Rett syndrome. Administer orally twice daily with or without food. Monitor for diarrhea and vomiting, which are common adverse effects; consider dose reduction or temporary discontinuation if severe. Assess liver enzymes and bilirubin before and during treatment due to potential hepatotoxicity. Avoid use in patients with severe hepatic impairment. Do not crush or chew capsules; for patients unable to swallow, sprinkle contents onto soft food and administer immediately.
Do not take if pregnant or planning pregnancy; use effective contraception.,Report symptoms of liver toxicity (jaundice, dark urine, abdominal pain) immediately.,Avoid alcohol as it may increase hepatotoxicity risk.,May cause weight gain, acne, or voice changes; report if bothersome.,Take with food to reduce GI upset.,Use sunscreen due to photosensitivity risk.,Do not discontinue abruptly; taper under medical supervision.
Take ANDEMBRY exactly as prescribed, twice daily with or without food.,If you miss a dose, skip it and take the next dose at the regular time; do not double the dose.,Common side effects include diarrhea and vomiting; inform your doctor if these become severe or persistent.,Avoid alcohol while taking this medication as it may increase the risk of liver injury.,Report any signs of liver problems such as yellowing of skin or eyes, dark urine, or abdominal pain.,Do not crush or chew the capsules; if you have trouble swallowing, open the capsule and mix the contents with a small amount of soft food (e.g., applesauce) and take immediately.,Keep this medication out of reach of children and store at room temperature away from moisture.
"Formestane, an aromatase inhibitor, reduces estrogen synthesis, while danazol, a synthetic androgen, possesses weak androgenic and anabolic activity. Concomitant use may lead to additive fluid retention due to danazol's mineralocorticoid-like effects and formestane's potential to cause fluid retention through estrogen withdrawal. This can result in peripheral edema, hypertension, or exacerbation of heart failure in susceptible patients."
"Danazol, a synthetic androgen with weak androgenic activity, may reduce the therapeutic efficacy of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used for glycemic control in type 2 diabetes. The proposed mechanism involves danazol-induced activation of cytochrome P450 enzymes (particularly CYP3A4) and potential upregulation of glucagon counter-regulatory pathways, leading to increased vildagliptin clearance and diminished inhibition of DPP-4. Clinically, this interaction may result in elevated postprandial glucose levels and reduced HbA1c reduction, compromising glycemic management."
"Danazol, an androgenic steroid, can induce hepatic microsomal enzymes, particularly CYP2C9, which accelerates the metabolism of glipizide, a sulfonylurea antidiabetic agent. This increased clearance reduces glipizide's plasma concentrations, diminishing its insulinotropic effect and potentially leading to hyperglycemia and loss of glycemic control in patients with type 2 diabetes mellitus."
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about DANAZOL vs ANDEMBRY, answered by our medical review team.
DANAZOL is a Androgen/Antigonadotropin that works by Danazol is a synthetic androgen derived from ethisterone that suppresses pituitary-ovarian axis by inhibiting gonadotropin release, leading to decreased estrogen and progesterone levels. It also has weak androgenic and progestational activity.. ANDEMBRY is a Gonadotropin that works by Binds to androgens, progesterone, and estradiol, inhibiting their effects on hormone-responsive tissues; also binds to microtubules and inhibits tubulin polymerization.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between DANAZOL and ANDEMBRY depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of DANAZOL is: 300-600 mg orally twice daily; maximum 800 mg/day. The standard adult dose of ANDEMBRY is: ANDEMBRY (capivasertib) 400 mg orally twice daily, taken with or without food, in combination with fulvestrant. Continue until disease progression or unacceptable toxicity.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between DANAZOL and ANDEMBRY in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. DANAZOL is classified as Category C. Danazol is contraindicated in pregnancy. First trimester exposure is associated with virilization of female fetus including clitoromegaly, labioscrotal fusion, and urogenital sinus. ANDEMBRY is classified as Category C. Category X. First trimester: Major congenital malformations (neural tube defects, craniofacial abnormalities). Second/third trimester: Spontaneous abortion, fetal death, growth res. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.