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Danocrine Side Effects

Generic Name: danazol

Note: This document contains side effect information about danazol. Some of the dosage forms listed on this page may not apply to the brand name Danocrine.

For the Consumer

Applies to danazol: oral capsule

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

  • 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

  • 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

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

Rare

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

For males only

Rare

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

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

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

Rare

  • Increased sensitivity of the skin to sunlight

For females only

Less Common

For Healthcare Professionals

Applies to danazol: compounding powder, oral capsule

General

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]

References

1. "Product Information. Danocrine (danazol)." Sanofi Winthrop Pharmaceuticals, New York, NY.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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.

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