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Danazol Side Effects

For the Consumer

Applies to danazol: oral capsule

Along with its needed effects, danazol 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 malesLess 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 onlyMore common
  • Decrease in the breast size
  • irregular menstrual periods
  • weight gain
Rare
  • Enlarged clitoris
  • hoarseness or deepening of voice
  • unnatural hair growth
For males onlyRare
  • 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 malesLess common
  • Flushing or redness of the skin
  • mood or mental changes
  • nervousness
Rare
  • Increased sensitivity of the skin to sunlight
For females onlyLess common
  • Burning, dryness, or itching of the vagina
  • vaginal bleeding

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. "Australian Product Information." O 0

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

Some side effects of danazol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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