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Danocrine Side Effects

Generic Name: danazol

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

For the Consumer

Applies to danazol: oral capsule

In addition to its needed effects, some unwanted effects may be caused by danazol (the active ingredient contained in Danocrine). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • 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
  • Enlarged clitoris
  • hoarseness or deepening of voice
  • unnatural hair growth
For males onlyRare
  • Changes in semen
  • decrease in the size of the testicles

Minor Side Effects

Some of the side effects that can occur with danazol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

For both females and malesLess common:
  • Flushing or redness of the skin
  • mood or mental changes
  • nervousness
  • 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


Cardiovascular side effects have included edema and congestive heart failure.[Ref]


Endocrine side effects have included the inhibition of estrogen synthesis, resulting in flushing, sweating, vaginal dryness and irritation, and reduction in breast size. During administration of danazol (the active ingredient contained in Danocrine) endogenous testosterone synthesis and release may be inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of danazol may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH). Danazol may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.[Ref]


Gastrointestinal side effects have included nausea and vomiting. Rare cases of pancreatitis have been reported.[Ref]


Genitourinary side effects have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop.

In female patients, the use of danazol (the active ingredient contained in Danocrine) may result in virilization including deepening voice, hirsutism, acne, clitomegaly (rare), and menstrual abnormalities. Discontinuation of medication at signs of mild virilization may prevent irreversible virilization.

Alterations in libido may occur (increased/decreased).[Ref]


Hematologic side effects have included thromboembolic and thrombophlebotic events (including sagittal sinus thrombosis), some resulting in fatal strokes, and increased red cell production.[Ref]


Metabolic side effects have included significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL). Decreased glucose tolerance requiring adjustments in hyperglycemic control has occurred.[Ref]


Other side effects in female patients have included virilization, including deepening voice, hirsutism, acne, clitomegaly (rare), and menstrual abnormalities, due the androgenic activity of danazol (the active ingredient contained in Danocrine) Discontinuation of danazol at signs of mild virilization may prevent irreversible virilization. Reduction in breast size may occur due to decreased estrogen synthesis.[Ref]


Renal side effects have included the retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.[Ref]


Oncologic side effects have included rare cases of hepatic neoplasms following prolonged use.[Ref]


Hepatic side effects have included life-threatening peliosis hepatitis and benign hepatic adenoma following prolonged danazol (the active ingredient contained in Danocrine) administration. Rare cases of hepatic neoplasms following prolonged use have been reported. Danazol can exacerbate acute intermittent porphyria. Serum transaminase levels may be increased.[Ref]


1. Bretza JA, Novey HS, Vaziri ND, Warner AS "Hypertension: a complication of danazol therapy." Arch Intern Med 140 (1980): 1379-80

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

3. Hory B, Blanc D, Boillot A, Panouse-Perrin J "Guillain-Barre syndrome following danazol and corticosteroid therapy for hereditary angioedema." Am J Med 79 (1985): 111-4

4. Wardle PG, Whitehead MI, Mills RP "Non-reversible and wide ranging voice changes after treatment with danazol." Br Med J (Clin Res Ed) 287 (1983): 946

5. Madanes AE, Farber M "Danazol." Ann Intern Med 96 (1982): 625-30

6. Hosea SW, Santaella ML, Brown EJ, Berger M, Katusha K, Frank MM "Long-term therapy of hereditary angioedema with danazol." Ann Intern Med 93 (1980): 809-12

7. Gray RG "Bilateral carpal tunnel syndrome and arthritis associated with Danazol administration." Arthritis Rheum 21 (1978): 493-4

8. Fraser IS "Post danazol amenorrhoea." Clin Reprod Fertil 2 (1983): 229-33

9. Baker HW, Snedecor PA "Clinical trial of danazol for benign breast disease." Am Surg 45 (1979): 727-9

10. Miller EJ, Coleman FH "Pseudohypertestosteronemia during danazol therapy. A case report." J Reprod Med 35 (1990): 661-2

11. Jick SS, Myers MW "A study of danazol's safety." Pharmacotherapy 15 (1995): 740-1

12. Mercaitis PA, Peaper RE, Schwartz PA "Effect of danazol on vocal pitch: a case study." Obstet Gynecol 65 (1985): 131-5

13. Webb AM, Russell J, Elstein M "Comparison of Yuzpe regimen, danazol, and mifepristone (RU486) in oral postcoital contraception." BMJ 305 (1992): 927-31

14. Miyata T, Tamechika Y, Torisu M "Ischemic colitis in a 33-year-old woman on danazol treatment for endometriosis." Am J Gastroenterol 83 (1988): 1420-3

15. Andriole GL, Brickman C, Lack EE, Sesterhenn IA, Javadpour N, Linehan WM, Frank MM "Danazol-induced cystitis: an undescribed source of hematuria in patients with hereditary angioneurotic edema." J Urol 135 (1986): 44-6

16. Laveder F, Marcolongo R, Zamboni S "Thrombocytopenic purpura following treatment with danazol." Br J Haematol 90 (1995): 970-1

17. Rabinowe SN, Miller KB "Danazol-induced thrombocytopenia." Br J Haematol 65 (1987): 383-4

18. Nakajima T, Mizushima N, Matsuda H, Matsumoto M, Tamakoshi K, Ishii H, Morioka S, Ikeda Y, Terao T, Kanai K "Fulminant hepatic failure associated with aplastic anaemia after treatment with danazol. Case report." Br J Obstet Gynaecol 93 (1986): 1013-5

19. Shepherd J "Danazol and plasma lipoprotein metabolism." Int J Gynaecol Obstet 50 Suppl 1 (1995): s23-6

20. Williams G "Metabolic effects of danazol." Am J Obstet Gynecol 164 (1991): 933-4

21. Martino S "Danazol induced hypercalcemia in breast cancer." Breast Cancer Res Treat 4 (1984): 53

22. Seifer DB, Freedman LN, Cavender JR, Baker RA "Insulin-dependent diabetes mellitus associated with danazol." Am J Obstet Gynecol 162 (1990): 474-5

23. Barbieri RL "Danazol and thyroid function." Ann Intern Med 92 (1980): 133-4

24. Enyeart JJ, Price WA "Bilateral sensorineural hearing loss from danazol therapy. A case report." J Reprod Med 29 (1984): 351-3

25. Seffart G ed. "Drug Dosage in Renal Insufficiency." Dordrecht, South Holland, : Kluwer Academic Publishers (1991):

26. Middleton C, McCaughan GW, Painter DM, Stephen MS, Beale M, Fraser I "Danazol and hepatic neoplasia: a case report." Aust N Z J Med 19 (1989): 733-5

27. Kahn H, Manzarbeitia C, Theise N, et al "Danazol-induced hepatocellular adenomas: A case report and review of the literature." Arch Pathol Lab Med 115 (1991): 1054-7

28. Fermand JP, Levy Y, Bouscary D, D'Agay MF, Clot P, Frija J, Brouet JC "Danazol-induced hepatocellular adenoma." Am J Med 88 (1990): 529-30

29. Xiol X, Martinez-Lacasa J, Pons M, Marti E, Casais L "Jaundice after danazol therapy for endometriosis." Am J Gastroenterol 84 (1989): 834-5

30. Yaginuma T, Okamura T, Takeuchi T, Nishii O, Fujimori R "Preventive effect of traditional herbal medicine, shosaiko-to, on danazol-induced hepatic damage." Int J Gynaecol Obstet 29 (1989): 337-41

31. Johnson KF "Splenomegaly and an abnormal peripheral smear associated with the use of danazol: case report." Am J Obstet Gynecol 149 (1984): 691

32. Makdisi WJ, Cherian R, Vanveldhuizen PJ, Talley RL, Stark SP, Dixon AY "Fatal peliosis of the liver and spleen in a patient with agnogenic myeloid metaplasia treated with danazol." Am J Gastroenterol 90 (1995): 317-8

33. Pearson K, Zimmerman HJ "Danazol and liver damage." Lancet 1 (1980): 645-6

Not all side effects for Danocrine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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. 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.