"Treatment approaches for endometriosis often rely on a combination of evidence-based and experience-based (“unsubstantiated” by systematic data and research) approaches. As a result, women with endometriosis may find only temporary or no relief f"...
Danocrine Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Danocrine (danazol) is a steroid used to treat endometriosis and fibrocystic breast disease. Danocrine is also used to prevent attacks of angioedema in people with an inherited form of this disorder. The brand name Danocrine is discontinued, but generic versions may be available. Common side effects of Danocrine (danazol) include
- acne or other skin problems
- increased hair growth or hair loss
- weight gain
- breast changes
- deepened voice
- sore throat
- increased sweating
- flushing (warmth, redness, or tingly feeling under your skin
- decreased amount of semen released during sex
- changes in your menstrual periods
- unusual vaginal bleeding or spotting,
- or vaginal dryness/discomfort/itching
In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg Danocrine given in two divided doses is recommended. The total daily dosage of Danocrine for fibrocystic breast disease ranges from 100 mg to 400 mg given in two divided doses depending upon patient response. Danocrine may interact with blood thinners, or carbamazepine. Tell your doctor all medications and supplements you use. Danocrine can cause birth defects. Do not use Danocrine if you are pregnant. Tell your doctor if you become pregnant during treatment. Before you start taking Danocrine, you may need to have a pregnancy test to make sure you are not pregnant. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective to prevent pregnancy during treatment. Breastfeeding is not recommended while using this drug.
Our Danocrine (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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Danocrine in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, danazol can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness (especially on one side of the body), confusion, problems with speech or balance;
- severe headache, ringing in your ears, dizziness, nausea, vomiting, vision problems, pain behind your eyes;
- chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- swelling or rapid weight gain, especially in your face and midsection;
- bloody, black, or tarry stools;
- cough up blood or vomit that looks like coffee grounds; or
- upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- acne or other skin problems, increased sweating;
- increased hair growth or hair loss;
- breast changes;
- decreased amount of semen released during sex;
- hoarse or deepened voice, sore throat;
- flushing (warmth, redness, or tingly feeling);
- changes in your menstrual periods;
- unusual vaginal bleeding or spotting;
- vaginal dryness, discomfort, or itching.
Read the entire detailed patient monograph for Danocrine (Danazol)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Danocrine Overview - Patient Information: Side Effects
Weight gain, acne, flushing, sweating, voice changes (hoarseness, change in pitch), abnormal growth of body hair (in women), vaginal dryness/irritation, or decreased breast size may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling hands/ankles/feet, menstrual changes (such as spotting, missed periods), mental/mood changes (such as nervousness, mood swings).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Danocrine (Danazol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Danocrine FDA Prescribing Information: Side Effects
The following events have been reported in association with the use of DANOCRINE:
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 DANOCRINE, 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 DANOCRINE of 400 mg or more. It is recommended that patients receiving DANOCRINE be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported. (See WARNINGS and PRECAUTIONS.)
Abnormalities in laboratory tests may occur during therapy with DANOCRINE 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 DANOCRINE 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 Danocrine (Danazol)
Additional Danocrine Information
Danazol - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.