Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
DANAZOL vs A.P.L.
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.
A. P. L. (Chorionic Gonadotropin) acts as a luteinizing hormone (LH) agonist, binding to LH receptors in the gonads to stimulate testosterone production in males and ovulation in females.
FDA: Treatment of endometriosis, fibrocystic breast disease, hereditary angioedema,Off-label: Idiopathic thrombocytopenic purpura, precocious puberty, gynecomastia
Induction of ovulation in anovulatory infertile women,Treatment of hypogonadism and cryptorchidism in males,Off-label: Assisted reproductive technology (ART) protocols
300-600 mg orally twice daily; maximum 800 mg/day
500-1000 mg every 4-6 hours, not to exceed 3000 mg/day in adults.
Terminal elimination half-life is 4-4.5 hours; clinical context: requires multiple daily dosing to maintain therapeutic levels.
Terminal elimination half-life: 2.5–3.5 hours (elimination phase); clinical context: requires repeated dosing for sustained effect.
Primarily hepatic: undergoes oxidation and conjugation via CYP3A4, with metabolites excreted in urine and feces.
Primarily via glucuronidation (60%) and sulfation (35%) in the liver, with a minor portion (5%) via CYP2E1 oxidation to the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI), which is normally detoxified by glutathione.
Primarily hepatic metabolism; approximately 60% excreted in feces, 30% in urine as metabolites.
Renal: 10% unchanged; hepatic metabolism to inactive metabolites excreted in urine and feces (90% combined).
Highly protein bound: 97-99%, primarily to albumin.
80–90% bound to sex hormone-binding globulin (SHBG) and albumin.
Approximately 1.5 L/kg; indicates extensive distribution into tissues, exceeding total body water.
0.5–0.9 L/kg, indicating moderate tissue distribution (primarily gonads and liver).
Oral bioavailability is approximately 100% due to extensive absorption, but first-pass metabolism reduces systemic availability to about 70-80%.
IM: 100%; Subcutaneous: ~80% (relative to IM); Oral: <5% (not clinically used).
No adjustment required for GFR ≥10 m L/min; avoid use in GFR <10 m L/min due to fluid retention risk
No specific adjustment required for mild to moderate renal impairment. In severe renal impairment (Cr Cl < 10 m L/min), extend dosing interval to every 8 hours.
Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated
Caution in severe hepatic impairment; consider dose reduction or extended interval. Avoid use in active liver disease.
2-5 mg/kg/dose orally twice daily; maximum 400 mg/day
Weight-based: 10-15 mg/kg every 4-6 hours, not to exceed 5 doses per day or 75 mg/kg/day.
Start at low end of adult dose, titrate cautiously due to increased risk of fluid retention and thromboembolism
No specific dose adjustment, but consider renal and hepatic function and avoid exceeding 3000 mg/day.
Danazol may cause thrombotic events, including pulmonary embolism and thrombophlebitis. It is contraindicated in patients with a history of thrombosis.
No black box warning.
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.
May cause fluid retention, ovarian hyperstimulation syndrome (OHSS) in females,Increased risk of thromboembolic events,Precocious puberty in males,Not for use in prepubertal children unless for cryptorchidism
Pregnancy, lactation, porphyria, severe hepatic/renal/cardiac disease, undiagnosed abnormal genital bleeding, history of thromboembolic disorders, androgen-dependent tumors.
Hypersensitivity to chorionic gonadotropin or any component,Precocious puberty (in males),Prostatic carcinoma or other androgen-dependent neoplasms,Ovarian cyst or enlargement not due to polycystic ovary syndrome
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.
No known food interactions. Avoid alcohol during treatment.
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.
A. P. L. (chorionic gonadotropin) is not expected to increase the risk of congenital anomalies when used in early pregnancy. However, use in the first trimester is generally avoided unless indicated for specific conditions. Data are limited; no increased fetal risk reported in inadvertent exposures. Second and third trimester use is not associated with teratogenicity but may increase risk of multiple gestation (if used for ovulation induction).
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.
Chorionic gonadotropin is not detected in breast milk following maternal administration. M/P ratio not established. Considered compatible with breastfeeding; no adverse effects on infant reported. Use with caution if high doses are administered.
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 pharmacokinetic studies in pregnancy. Dose adjustments are not typically required during pregnancy for standard indications. For ovulation induction, dosing is based on follicular development. In first trimester for luteal support, standard doses are used. No evidence of altered clearance or need for dose changes due to pregnancy.
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.
A. P. L. (chorionic gonadotropin) is used to trigger ovulation in assisted reproductive technology. Administer when follicles are mature (≥18 mm). Risk of ovarian hyperstimulation syndrome (OHSS) increases with higher doses. Monitor for abdominal pain, distension, and weight gain. Use caution in patients with prior thromboembolism.
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.
This medication is given as an injection exactly as prescribed to trigger ovulation.,A single dose is usually sufficient; follow your doctor's timing instructions closely.,Common side effects include headache, fatigue, and injection site reactions.,Seek immediate medical help if you experience severe pelvic pain, nausea, vomiting, or sudden weight gain (signs of OHSS).,Report symptoms of blood clots: leg pain, chest pain, or shortness of breath.
"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 A.P.L., 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.. A.P.L. is a Gonadotropin that works by A. P. L. (Chorionic Gonadotropin) acts as a luteinizing hormone (LH) agonist, binding to LH receptors in the gonads to stimulate testosterone production in males and ovulation in females.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between DANAZOL and A.P.L. 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 A.P.L. is: 500-1000 mg every 4-6 hours, not to exceed 3000 mg/day in adults.. 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 A.P.L. 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. A.P.L. is classified as Category C. A.P.L. (chorionic gonadotropin) is not expected to increase the risk of congenital anomalies when used in early pregnancy. However, use in the first trimester is generally avoided . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.