Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
DANOCRINE 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. It suppresses the pituitary-ovarian axis by inhibiting gonadotropin (LH and FSH) release, leading to anovulation and amenorrhea. It also binds to androgen, progesterone, and glucocorticoid receptors, exerting weak androgenic, antiestrogenic, and antigonadotropic effects. Additionally, it may directly inhibit ovarian steroidogenesis and increase clearance of endogenous sex hormones.
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.
Treatment of endometriosis amenable to hormonal management,Management of fibrocystic breast disease,Hereditary angioedema (prophylaxis of attacks)
Induction of ovulation in anovulatory infertile women,Treatment of hypogonadism and cryptorchidism in males,Off-label: Assisted reproductive technology (ART) protocols
100-200 mg orally twice daily for endometriosis; 200-400 mg twice daily for fibrocystic breast disease; 200 mg twice daily for hereditary angioedema. Maximum dose: 800 mg/day.
500-1000 mg every 4-6 hours, not to exceed 3000 mg/day in adults.
Terminal elimination half-life: 10–30 hours (mean 15 hours); clinically, steady-state reached after 2–4 days.
Terminal elimination half-life: 2.5–3.5 hours (elimination phase); clinical context: requires repeated dosing for sustained effect.
Danazol is extensively metabolized in the liver via hydroxylation and conjugation. It is a substrate of CYP3A4 and may inhibit CYP3A4, CYP2C9, and CYP2C19. The major metabolites include 2-hydroxymethylethisterone and ethisterone, which exhibit some androgenic activity.
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.
Renal (metabolites, ~50%), biliary/fecal (~30%), unchanged drug minimal.
Renal: 10% unchanged; hepatic metabolism to inactive metabolites excreted in urine and feces (90% combined).
~80–90%, primarily to albumin and sex hormone-binding globulin (SHBG).
80–90% bound to sex hormone-binding globulin (SHBG) and albumin.
Vd ~0.5–1.0 L/kg; moderate tissue distribution.
0.5–0.9 L/kg, indicating moderate tissue distribution (primarily gonads and liver).
Oral: ~80–100% (well absorbed).
IM: 100%; Subcutaneous: ~80% (relative to IM); Oral: <5% (not clinically used).
No specific guidelines; use with caution in renal impairment. Monitor fluid balance and renal function.
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.
Contraindicated in severe hepatic impairment (Child-Pugh class C). For mild to moderate impairment, use reduced dose and monitor liver function; avoid in active liver disease.
Caution in severe hepatic impairment; consider dose reduction or extended interval. Avoid use in active liver disease.
Not recommended for use in pediatric patients due to potential for premature epiphyseal closure and other adverse effects.
Weight-based: 10-15 mg/kg every 4-6 hours, not to exceed 5 doses per day or 75 mg/kg/day.
No specific dosing adjustments; use lowest effective dose due to potential for increased sensitivity to androgenic effects and hepatic metabolism changes.
No specific dose adjustment, but consider renal and hepatic function and avoid exceeding 3000 mg/day.
None
No black box warning.
Risk of thromboembolic events (DVT, pulmonary embolism),Hepatotoxicity (elevated liver enzymes, jaundice, peliosis hepatis, benign hepatic adenoma),Intracranial hypertension (pseudotumor cerebri),Androgenic effects (acne, hirsutism, voice deepening, weight gain, clitoral hypertrophy),Carcinogenicity (increased risk of hepatocellular carcinoma),Use in pregnancy causes pseudothermalphroditism in female fetuses,May suppress the immune system; increased risk of infections,Can cause pancreatitis, hyperglycemia, and insulin resistance,May increase LDL and decrease HDL cholesterol,Monitor liver function, lipid profile, and signs of thrombosis
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
Undiagnosed abnormal genital bleeding,Severely impaired hepatic, renal, or cardiac function,Pregnancy or breastfeeding,Porphyria,Androgen-dependent tumors (e.g., prostate carcinoma),Breast cancer in males,History of thromboembolic disease,Hypersensitivity to danazol or components
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
No significant food interactions. Grapefruit juice may affect metabolism; advise caution.
No known food interactions. Avoid alcohol during treatment.
Danocrine (danazol) is contraindicated in pregnancy. It is an androgen derivative and can cause virilization of the female fetus, including clitoromegaly, labial fusion, and urogenital sinus abnormalities. Risk is highest during the first trimester when genital differentiation occurs; exposure at any gestational age may result in androgenic effects.
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 into breast milk. The M/P ratio is unknown. Due to potential androgenic effects in the nursing infant (e.g., virilization), breastfeeding is not recommended during danocrine therapy.
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.
Danocrine is contraindicated in pregnancy. No dose adjustment is applicable; therapy must be discontinued immediately if pregnancy is suspected or confirmed. Pharmacokinetic changes in pregnancy are not relevant 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.
Danocrine suppresses pituitary-ovarian axis by inhibiting gonadotropin release; monitor liver function, lipid profile, and for signs of virilization. Avoid in pregnancy and porphyria.
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.
Take with food to reduce GI upset.,Report symptoms of thromboembolism (chest pain, leg swelling) immediately.,Use non-hormonal contraception due to teratogenicity and pregnancy disruption.,May cause weight gain, edema, acne, or voice deepening; notify doctor if severe.,Avoid alcohol due to potential hepatotoxicity.
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.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about DANOCRINE vs A.P.L., answered by our medical review team.
DANOCRINE is a Androgen/Antigonadotropin that works by Danazol is a synthetic androgen derived from ethisterone. It suppresses the pituitary-ovarian axis by inhibiting gonadotropin (LH and FSH) release, leading to anovulation and amenorrhea. It also binds to androgen, progesterone, and glucocorticoid receptors, exerting weak androgenic, antiestrogenic, and antigonadotropic effects. Additionally, it may directly inhibit ovarian steroidogenesis and increase clearance of endogenous sex hormones.. 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 DANOCRINE 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 DANOCRINE is: 100-200 mg orally twice daily for endometriosis; 200-400 mg twice daily for fibrocystic breast disease; 200 mg twice daily for hereditary angioedema. Maximum dose: 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 DANOCRINE 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. DANOCRINE is classified as Category C. Danocrine (danazol) is contraindicated in pregnancy. It is an androgen derivative and can cause virilization of the female fetus, including clitoromegaly, labial fusion, and urogen. 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.