Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
DANAZOL vs ELAGOLIX
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.
Gonadotropin-releasing hormone (Gn RH) receptor antagonist that competitively binds to Gn RH receptors in the anterior pituitary, reducing luteinizing hormone (LH) and follicle-stimulating hormone (FSH) release, thereby suppressing ovarian estradiol production.
FDA: Treatment of endometriosis, fibrocystic breast disease, hereditary angioedema,Off-label: Idiopathic thrombocytopenic purpura, precocious puberty, gynecomastia
Management of moderate to severe pain associated with endometriosis
300-600 mg orally twice daily; maximum 800 mg/day
200 mg orally twice daily
Terminal elimination half-life is 4-4.5 hours; clinical context: requires multiple daily dosing to maintain therapeutic levels.
Terminal elimination half-life is approximately 4–6 hours. Clinical context: Steady state achieved within 5 days; tid dosing maintains therapeutic concentrations.
Primarily hepatic: undergoes oxidation and conjugation via CYP3A4, with metabolites excreted in urine and feces.
Primarily metabolized by CYP3A4; minor contribution from CYP2D6 and CYP2C8.
Primarily hepatic metabolism; approximately 60% excreted in feces, 30% in urine as metabolites.
Renal (approximately 70% as unchanged drug and metabolites), fecal (approximately 30%)
Highly protein bound: 97-99%, primarily to albumin.
Approximately 99% bound to albumin and alpha-1-acid glycoprotein
Approximately 1.5 L/kg; indicates extensive distribution into tissues, exceeding total body water.
Vd/F is approximately 40–60 L (0.5–0.8 L/kg). Clinical meaning: Extensive tissue distribution, consistent with a large volume of distribution.
Oral bioavailability is approximately 100% due to extensive absorption, but first-pass metabolism reduces systemic availability to about 70-80%.
Oral: Approximately 30% (low due to first-pass metabolism); food increases exposure by approximately 30%.
No adjustment required for GFR ≥10 m L/min; avoid use in GFR <10 m L/min due to fluid retention risk
e GFR 30-89 m L/min: no adjustment. e GFR 15-29 m L/min: 100 mg twice daily. e GFR <15 m L/min: not recommended.
Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated
Child-Pugh A: no adjustment. Child-Pugh B: 100 mg twice daily. Child-Pugh C: not recommended.
2-5 mg/kg/dose orally twice daily; maximum 400 mg/day
Not established; safety and efficacy in pediatric patients have not been studied.
Start at low end of adult dose, titrate cautiously due to increased risk of fluid retention and thromboembolism
No specific dose adjustment required; clinical studies included limited patients ≥65 years, but no differences in safety or efficacy observed.
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.
Hepatic transaminase elevations: monitor liver function before and during treatment; discontinue if elevation >3x ULN or if signs of liver injury occur.,Bone density loss: monitor bone mineral density with long-term use; consider additional calcium/vitamin D.,Mood changes: increased risk of depression, suicidal ideation; monitor for new or worsening symptoms.,Altered menstrual bleeding; exclude pregnancy before starting.,Risk of osteoporosis with prolonged use.
Pregnancy, lactation, porphyria, severe hepatic/renal/cardiac disease, undiagnosed abnormal genital bleeding, history of thromboembolic disorders, androgen-dependent tumors.
Known hypersensitivity to elagolix or any excipients,Concomitant use with strong organic anion-transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine, gemfibrozil),Pregnancy, or women of reproductive potential not using effective contraception,Existing osteoporosis or severe bone loss,History of suicidal ideation or behavior
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.
Avoid grapefruit and grapefruit juice as they inhibit CYP3A4 and may increase elagolix levels. No other food restrictions.
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.
First trimester: High risk of pregnancy loss and major birth defects based on animal data and mechanism of action. Second and third trimesters: Contraindicated due to potential for harm. Elagolix is 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.
Elagolix is excreted in animal milk; no human data. M/P ratio unknown. Not recommended 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.
No dose adjustments studied; contraindicated in pregnancy. No data on PK changes requiring dose modification.
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.
Elagolix is an oral Gn RH antagonist for endometriosis-associated pain. Monitor bone mineral density (BMD) with dual-energy X-ray absorptiometry (DXA) if using >12 months or in patients with osteoporosis risk. Avoid use with strong CYP3A inducers (e.g., rifampin) or inhibitors (e.g., ketoconazole). May reduce efficacy of hormonal contraceptives. Assess pregnancy status before starting due to teratogenicity.
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 elagolix at the same time daily with or without food.,Avoid grapefruit or grapefruit juice during treatment.,Use non-hormonal contraception (e.g., condoms) because elagolix may reduce hormonal contraceptive effectiveness.,Report severe headaches, vision changes, or heavy bleeding promptly.,Do not take elagolix if pregnant or planning to become pregnant; use effective birth control.
"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 ELAGOLIX, 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.. ELAGOLIX is a Gonadotropin-Releasing Hormone Antagonist that works by Gonadotropin-releasing hormone (Gn RH) receptor antagonist that competitively binds to Gn RH receptors in the anterior pituitary, reducing luteinizing hormone (LH) and follicle-stimulating hormone (FSH) release, thereby suppressing ovarian estradiol production.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between DANAZOL and ELAGOLIX 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 ELAGOLIX is: 200 mg orally twice daily. 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 ELAGOLIX 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. ELAGOLIX is classified as Category C. First trimester: High risk of pregnancy loss and major birth defects based on animal data and mechanism of action. Second and third trimesters: Contraindicated due to potential for. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.