Danocrine Side Effects
Generic name: danazol
Medically reviewed by Drugs.com. Last updated on Nov 18, 2024.
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine does not cause unwanted effects. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use an effective form of birth control (e.g., a condom, a diaphragm, spermicide) to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may cause irregular monthly periods or absence of menstrual period. If your regular monthly period does not begin within 60 to 90 days after you Stop taking danazol (the active ingredient contained in Danocrine) check with your doctor right away.
Check with your doctor right away if you are a female and have a larger clitoris (sexual organ), deepening of your voice, or unusual hair growth after taking danazol. Your doctor may advise you to stop taking the medicine so these side effects do not get worse.
Stop using this medicine and check with your doctor if you have the following symptoms while taking this medicine: blurred vision; change in the ability to see colors, especially blue or yellow; headache; nausea; or vomiting.
For patients with diabetes:
- This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, check with your doctor.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Danazol may rarely cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness, or other discoloration of the skin, or a severe sunburn. Check with your doctor if this occurs.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or supplements.
Serious side effects of Danocrine
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 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]
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References
1. (2001) "Product Information. Danocrine (danazol)." Sanofi Winthrop Pharmaceuticals
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
More about Danocrine (danazol)
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- Drug class: antigonadotropic agents
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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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.