DANAZOL

Danazol is a synthetic hormonal agent developed in the 1960s that suppresses pituitary gonadotropins. It produces controlled reduction in ovarian and testicular steroid production, making it useful for diseases driven by hormone fluctuations. Clinical use was approved in the United States in 1971. Regulatory approvals in additional regions followed through the 1970s and 1980s, with clinical adoption focused on endometriosis, fibrocystic breast disease, and hereditary angioedema management.

Danazol is used for: Endometriosis – to reduce pain and prevent the growth of endometrial tissue outside the uterus Fibrocystic breast disease – to relieve breast pain and decrease cyst formation Hereditary angioedema – to prevent episodes of swelling in the face, extremities, and airway Other hormone-related disorders as prescribed by a healthcare professional

Form: Oral capsules or tablets only. Route: Taken by mouth with or without food. Frequency: Commonly 1 to 3 times daily based on condition and physician direction. Therapy duration and dose depend on the treated disorder and clinical response. Not suitable for intravenous or intramuscular administration.

Common side effects may include: Weight gain Acne Headache Nausea and vomiting Menstrual irregularities Less common or rare side effects: Liver dysfunction Mood changes, irritability Hair growth or hair thinning Changes in cholesterol levels Seek medical attention if you experience severe abdominal pain, jaundice, or signs of blood clots.

It can cause liver toxicity, including elevated liver enzymes and rare serious hepatic complications. May lead to blood clot-related events such as stroke, myocardial infarction or venous thrombosis in high-risk individuals. Possible androgen like effects, including voice changes, hair growth pattern shifts and acne, which may become permanent in some cases. Risk of intracranial hypertension, presenting with headache, vision changes or nausea. Can harm an unborn baby; avoid in pregnancy. May cause cholesterol profile disturbances, raising LDL and lowering HDL. Discontinue and seek medical care if yellowing of skin/eyes, severe stomach pain, chest pain, weakness on one side or breathing difficulty occur.

Check baseline liver function tests and repeat periodically. Use caution in patients with cardiac disease, kidney disease or migraine disorders. Avoid use in those with active thrombosis or past severe thrombotic events. Monitor for persistent or intense headaches or visual changes. Assess metabolic risk in individuals with diabetes or lipid disorders. Do not combine with estrogen-containing therapies unless medically directed. Use only during breastfeeding if advised by a clinician. Prefer lowest effective dose for the shortest necessary period. Consider alternative options if signs of virilisation or unacceptable hormonal side effects appear.

https://go.drugbank.com/drugs/DB01406 https://www.ncbi.nlm.nih.gov/books/NBK564344/ https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf