Danocrine Side Effects

Generic name: danazol

Medically reviewed by Drugs.com. Last updated on Nov 17, 2023.

Note: This document provides detailed information about Danocrine Side Effects associated with danazol. Some dosage forms listed on this page may not apply specifically to the brand name Danocrine.

Applies to danazol: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Use of danazol in pregnancy is contraindicated.

A sensitive test capable of determining early pregnancy is recommended immediately prior to start of therapy.

A nonhormonal method of contraception should be used during therapy.

Androgenic effects on the female fetus exposed in utero have been reported. Thromboembolism, thrombotic and thrombophlebitic events have been reported.

Experience with long-term therapy is limited.

Physician should be alert to the possibility of potentially silent peliosis hepatis and benign hepatic adenoma with long-term use.

Determine the lowest dose that will provide adequate protection.

Attempt to decrease or withdraw therapy if initiated during exacerbation of hereditary angioneurotic edema due to trauma, stress, or other cause.

Several cases of benign intracranial hypertension have been reported.

Screen for papilledema and advise to discontinue immediately if symptoms are present.

Serious side effects of Danocrine

Along with its needed effects, danazol (the active ingredient contained in Danocrine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking danazol:

For both females and males

Less common side effects

• acne
• 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

Rare side effects

• 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
• chills
• complete or partial numbness or weakness on one side of body
• cough
• coughing up blood
• diarrhea
• difficulty with speaking
• difficulty with swallowing
• discharge from the nipple
• eye pain
• fast heartbeat
• fever
• headache
• hives or other skin rash
• joint pain
• light-colored stools
• loss of appetite (continuing)
• loss of muscle coordination
• more frequent nosebleeds
• muscle aches
• nausea
• purple- or red-colored, or other spots on the body or inside the mouth or nose
• restlessness
• shortness of breath
• sore throat
• sweating
• 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
• vomiting
• yellow eyes or skin

For females only

More common side effects

• decrease in the breast size
• irregular menstrual periods
• weight gain

Rare side effects

• enlarged clitoris
• hoarseness or deepening of voice
• unnatural hair growth

For males only

Rare side effects

• changes in semen
• decrease in the size of the testicles

Other side effects of Danocrine

Some side effects of danazol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For both females and males

Less common side effects

• flushing or redness of the skin
• mood or mental changes
• nervousness

Rare side effects

• increased sensitivity of the skin to sunlight

For females only

Less common side effects

• burning, dryness, or itching of the vagina
• vaginal bleeding

For healthcare professionals

Applies to danazol: compounding powder, oral capsule.

General adverse events

The most commonly reported side effects included acne, edema, and flushing.^[Ref]

Dermatologic

• Very common (10% or more): Acne (up to 13%)
• Common (1% to 10%): Facial edema, hair loss, hirsutism/mild hirsutism, maculopapular rash, papular rash, petechial rash, purpuric rash, seborrhea, sun sensitivity/sun sensitive rash, sweating, vesicular rash
• Uncommon (0.1% to 1%): Pruritus, urticaria
• Very rare (less than 0.01%): Erythema multiforme, inflammatory erythematous nodules, skin pigmentation/skin pigmentation change, Stevens-Johnson syndrome
• Frequency not reported: Exfoliative dermatitis, rash^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, backache/back pain, extremity pain, fasciculation, joint lock-up, joint swelling, muscle cramps, muscle spasms, muscle tremors, neck pain, spasms/pains
• Rare (0.01% to 0.1%): Benign intracranial hypertension, dizziness
• Very rare (less than 0.01%): Carpal tunnel syndrome
• Frequency not reported: Altered creatine phosphokinase, creatinine phosphokinase increased, joint pain, limb pain^[Ref]

Genitourinary

• Common (1% to 10%): Amenorrhea/persistent amenorrhea/prolonged posttherapy amenorrhea, alteration in cycle timing, menstrual disturbances, pelvic pain, spotting, vaginal dryness/irritation
• Uncommon (0.1% to 1%): Breast size changes
• Rare (0.01% to 0.1%): Hypertrophy of the clitoris
• Very rare (less than 0.01%): Abnormalities in semen volume/viscosity/sperm count/motility, hematuria, testicular atrophy
• Frequency not reported: Bartholin's cyst, nipple discharge^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, depression/depressed mood, emotional lability, irritability, libido changes, nervousness
• Frequency not reported: Sleep disorders^[Ref]

Gastrointestinal

• Common (1% to 10%): Constipation, gastroenteritis, indigestion, nausea, vomiting
• Rare (0.01% to 0.1%): Pancreatitis
• Very rare (less than 0.01%): Epigastric pain
• Frequency not reported: Bleeding gums^[Ref]

Respiratory

• Common (1% to 10%): Hoarseness, pitch deepening/instability, sore throat, voice change
• Uncommon (0.1% to 1%): Nasal congestion
• Very rare (less than 0.01%): Interstitial pneumonitis, pleuritic pain^[Ref]

Metabolic

• Common (1% to 10%): Appetite changes, increased insulin requirements (in patients with diabetes), weight gain
• Rare (0.01% to 0.1%): Fluid retention
• Frequency not reported: Abnormal glucagon, abnormal glucose tolerance, altered glucose tolerance, altered glucagon, decreased apolipoproteins AI and AII, decreased high density lipoprotein cholesterol, increased total cholesterol/low density lipoprotein cholesterol, induction of amino levulinic acid synthetase^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, flushing
• Rare (0.01% to 0.1%): Arterial thrombosis, blood pressure elevation, hypertension/hypertension exacerbation, palpitation/palpitation exacerbation, tachycardia/tachycardia exacerbation, thrombotic events
• Frequency not reported: Myocardial infarction^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Rare (0.01% to 0.1%): Faintness, vertigo, tremor
• Very rare (less than 0.01%): Epilepsy aggravation, migraine/migraine provocation
• Frequency not reported: Benign intracranial hypertension, cerebrovascular thrombosis, convulsions, dizziness, Guillain-Barre syndrome, paresthesia, sagittal sinus thrombosis^[Ref]

Other

• Common (1% to 10%): Fever
• Rare (0.01% to 0.1%): Fatigue, weakness
• Frequency not reported: Altered plasma proteins, chills, fasciculation^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hepatic dysfunction
• Rare (0.01% to 0.1%): Cholestatic jaundice, hepatic adenoma
• Very rare (less than 0.01%): Malignant hepatic tumor, peliosis hepatitis
• Frequency not reported: Benign hepatic adenomata, hepatic failure, hepatocellular focal nodular hyperplasia, hepatocellular injury, hepatocellular jaundice, increased AST, jaundice, serum transaminase level increases, reversible elevated serum enzymes^[Ref]

Hematologic

• Rare (0.01% to 0.1%): Increased platelet count, increased red cell count, leukopenia, polycythemia/reversible polycythemia, thrombocytopenia
• Very rare (less than 0.01%): Eosinophilia/reversible eosinophilia, reversible erythrocytosis, splenic peliosis
• Frequency not reported: Leukocytosis^[Ref]

Ocular

• Rare (0.01% to 0.1%): Blurred vision, difficulty wearing contact lenses, focusing difficulty, refraction disorders requiring correction
• Frequency not reported: Cataracts^[Ref]

Endocrine

• Frequency not reported: Altered sex hormone binding globulin, blunted cyclical surges of luteinizing hormone (LH), decreased protein bound iodine, decreased thyroid binding globulin and T4, increased T3 uptake, no disturbance of thyroid stimulating hormone/free thyroxine index^[Ref]

Oncologic

• Frequency not reported: Malignant liver tumors^[Ref]

Hypersensitivity

• Frequency not reported: Hereditary angioedema^[Ref]

Further information

Danocrine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer