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Danazol

Last reviewed on RxList: 11/4/2020
Danazol Side Effects Center

What Is Danazol?

Danazol is a synthetic steroid used to treat pelvic pain and infertility due to endometriosis, and also to treat breast pain/tenderness/nodules due to fibrocystic breast disease. Danazol is available in generic form.

What Are Side Effects of Danazol?

Common side effects of Danazol include:

  • weight gain,
  • acne,
  • oily skin or hair,
  • flushing,
  • sweating,
  • hair loss,
  • voice changes (hoarseness, changes in pitch),
  • sore throat,
  • abnormal growth of body hair (in women),
  • vaginal dryness/irritation/burning/itching,
  • decreased breast size,
  • water retention or bloating,
  • depression,
  • irritability,
  • changes in menstrual cycle (spotting, irregular bleeding, missed periods),
  • nervousness, and
  • mood changes.

Dosage for Danazol

To treat endometriosis, a starting dose of 800 mg danazol given in two divided doses is recommended. The total daily dosage of danazol for fibrocystic breast disease ranges from 100 mg to 400 mg, given in two divided doses depending upon patient response.

What Drugs, Substances, or Supplements Interact with Danazol?

Danazol may interact with warfarin, or carbamazepine. Tell your doctor all medications and supplements you use.

Danazol During Pregnancy and Breastfeeding

Danazol should not be used during pregnancy. It may harm a fetus. This drug is not recommended for use while breastfeeding.

Additional Information

Our danazol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Endometriosis occurs deep inside the uterus. See Answer
Danazol Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • loss of appetite, stomach pain (upper right side);
  • cough with bloody mucus or vomit that looks like coffee grounds;
  • jaundice (yellowing of the skin or eyes);
  • bloody or tarry stools, dark urine;
  • swelling or weight gain;
  • a hoarse or deepened voice, sore throat;
  • hair loss, or increased hair growth;
  • acne or other skin problems;
  • unexplained muscle pain, tenderness, or weakness;
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

  • flushing (sudden warmth, redness, or tingly feeling);
  • changes in your menstrual periods;
  • unusual vaginal bleeding or spotting;
  • breast changes;
  • sexual problems;
  • decreased amount of semen released during sex;
  • mood changes, nervousness; or
  • vaginal dryness or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Danazol (Danazol)

SLIDESHOW

What Is Endometriosis? Symptoms, Causes, Treatment See Slideshow
Danazol Professional Information

SIDE EFFECTS

The following events have been reported in association with the use of danazol capsules:

Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.

Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with danazol capsules, persistent amenorrhea has occasionally been reported.

Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.

Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of danazol capsules of 400 mg or more. It is recommended that patients receiving danazol capsules be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, hepatic adenoma, hepatocellular injury, hepatocellular jaundice and hepatic failure have been reported (see WARNINGS and PRECAUTIONS).

Abnormalities in laboratory tests may occur during therapy with danazol capsules including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.

The following reactions have been reported, a causal relationship to the administration of danazol capsules has neither been confirmed nor refuted;

Allergic: urticaria, pruritus and rarely, nasal congestion;

CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain- Barre syndrome;

Gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis;

Musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention;

Genitourinary: hematuria, prolonged posttherapy amenorrhea;

Hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted.

Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme;

Other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure,interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

Read the entire FDA prescribing information for Danazol (Danazol)

Related Resources for Danazol

© Danazol Patient Information is supplied by Cerner Multum, Inc. and Danazol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Endometriosis occurs deep inside the uterus. See Answer

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