ADVERSE REACTIONS:
The following events have been reported in association with the use of danazol:
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 include menstrual disturbances in the form of 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 danazol, 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 danazol of 400 mg or more. It is recommended that patients receiving danazol 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 danazol 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 danazol 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; 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; other: increased insulin requirements in diabetic patients, change in libido, elevation in blood pressure, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.
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REPORTS OF SUSPECTED DANAZOL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Danazol. The information is not vetted and should not be considered as verified clinical evidence.
Possible Danazol side effects / adverse reactions in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2011-11-04
Patient: 72 year old female
Reactions: Blood Creatine Phosphokinase Increased, Hypoglycaemia, Bundle Branch Block Left, Hyperhidrosis, Medication Error, Chest Pain, Presyncope, Troponin I Increased, Asthenia, Myocardial Infarction, Drug Dispensing Error
Adverse event resulted in: hospitalization
Suspect drug(s):
Danazol
Indication: Idiopathic Thrombocytopenic Purpura
Glyburide
Other drugs received by patient: Perindopril Erbumine; Levothyroxine Sodium
Possible Danazol side effects / adverse reactions in 47 year old female
Reported by a physician from Switzerland on 2011-11-29
Patient: 47 year old female
Reactions: Hepatocellular Injury
Suspect drug(s):
Danazol
Other drugs received by patient: Tramadol Hydrochloride; ALL Other Therapeutic Products; Calcimagon; Fosamax; Livial
Possible Danazol side effects / adverse reactions in 91 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-03
Patient: 91 year old male weighing 73.0 kg (160.6 pounds)
Reactions: Renal Impairment, Rhabdomyolysis, Drug Interaction, White Blood Cell Count Increased
Suspect drug(s):
Danazol
Dosage: 400 mg;qd;unk
Indication: Idiopathic Thrombocytopenic Purpura
Lovastatin
Dosage: 40 mg;qd;unk
Other drugs received by patient: Isosorbide Dinitrate; Clopidogrel; Metoprolol Succinate; Glipizide; Levothyroxine Sodium; Lisinopril; Aspirin
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