Danocrine Side Effects
Generic Name: danazol
Note: This page contains information about the side effects of danazol. Some of the dosage forms included on this document may not apply to the brand name Danocrine.
Not all side effects for Danocrine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to danazol: oral capsule
In addition to its needed effects, some unwanted effects may be caused by danazol (the active ingredient contained in Danocrine). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking danazol:For both females and malesLess common
- dark-colored urine
- increased oiliness of the hair or skin
- muscle cramps or spasms
- rapid weight gain
- swelling of the feet or lower legs
- unusual tiredness or weakness
- Bleeding gums
- bloating, pain, or tenderness of the abdomen or stomach
- blood in the urine
- burning, numbness, pain, or tingling in all fingers except the smallest finger
- changes in vision
- chest pain
- complete or partial numbness or weakness on one side of body
- coughing up blood
- difficulty with speaking
- difficulty with swallowing
- discharge from the nipple
- eye pain
- fast heartbeat
- hives or other skin rash
- joint pain
- light-colored stools
- loss of appetite (continuing)
- loss of muscle coordination
- more frequent nosebleeds
- muscle aches
- purple- or red-colored, or other spots on the body or inside the mouth or nose
- shortness of breath
- sore throat
- tingling, numbness, or weakness in the legs, which may move upward to the arms, trunk, or face
- unusual bruising or bleeding
- unusual tiredness, weakness, or general feeling of illness
- yellow eyes or skin
- Decrease in the breast size
- irregular menstrual periods
- weight gain
- Enlarged clitoris
- hoarseness or deepening of voice
- unnatural hair growth
- Changes in semen
- decrease in the size of the testicles
Some of the side effects that can occur with danazol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:For both females and malesLess common
- Flushing or redness of the skin
- mood or mental changes
- Increased sensitivity of the skin to sunlight
- Burning, dryness, or itching of the vagina
- vaginal bleeding
For Healthcare Professionals
Applies to danazol: compounding powder, oral capsule
Cardiovascular side effects have included edema and congestive heart failure.
Endocrine side effects have included the inhibition of estrogen synthesis, resulting in flushing, sweating, vaginal dryness and irritation, and reduction in breast size. During administration of danazol (the active ingredient contained in Danocrine) endogenous testosterone synthesis and release may be inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of danazol may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH). Danazol may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.
Gastrointestinal side effects have included nausea and vomiting. Rare cases of pancreatitis have been reported.
Genitourinary side effects have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop.
In female patients, the use of danazol (the active ingredient contained in Danocrine) may result in virilization including deepening voice, hirsutism, acne, clitomegaly (rare), and menstrual abnormalities. Discontinuation of medication at signs of mild virilization may prevent irreversible virilization.
Alterations in libido may occur (increased/decreased).
Hematologic side effects have included thromboembolic and thrombophlebotic events (including sagittal sinus thrombosis), some resulting in fatal strokes, and increased red cell production.
Metabolic side effects have included significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL). Decreased glucose tolerance requiring adjustments in hyperglycemic control has occurred.
Other side effects in female patients have included virilization, including deepening voice, hirsutism, acne, clitomegaly (rare), and menstrual abnormalities, due the androgenic activity of danazol (the active ingredient contained in Danocrine) Discontinuation of danazol at signs of mild virilization may prevent irreversible virilization. Reduction in breast size may occur due to decreased estrogen synthesis.
Renal side effects have included the retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.
Oncologic side effects have included rare cases of hepatic neoplasms following prolonged use.
Hepatic side effects have included life-threatening peliosis hepatitis and benign hepatic adenoma following prolonged danazol (the active ingredient contained in Danocrine) administration. Rare cases of hepatic neoplasms following prolonged use have been reported. Danazol can exacerbate acute intermittent porphyria. Serum transaminase levels may be increased.
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