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Dapsone Side Effects

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

For the Consumer

Applies to dapsone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by dapsone. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking dapsone:

More common
  • Back, leg, or stomach pains
  • bluish fingernails, lips, or skin
  • difficult breathing
  • fever
  • loss of appetite
  • pale skin
  • skin rash
  • unusual tiredness or weakness
Rare
  • Itching, dryness, redness, scaling, or peeling of the skin, or loss of hair
  • mood or other mental changes
  • numbness, tingling, pain, burning, or weakness in hands or feet
  • sore throat
  • unusual bleeding or bruising
  • yellow eyes or skin

Some of the side effects that can occur with dapsone 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:

Rare
  • Headache
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • trouble in sleeping

For Healthcare Professionals

Applies to dapsone: oral tablet

Hematologic

Hematologic side effects have been the most pronounced. These have included methemoglobinemia, aplastic anemia, leukopenia, agranulocytosis, eosinophilia, macrocytic anemia, and Heinz bodies. Dapsone may induce a dose-related hemolytic anemia, which is more likely with doses greater than 200 mg/day or in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Leukopenia, megaloblastic pancytopenia, and hemolysis have been reported. At least one case of pure red cell aplasia has also been reported, in addition to a case of exanthema with desquamation of the trunk and extremities.[Ref]

Agranulocytosis usually occurs during the first few months of therapy and has been fatal. In one case report, filgrastim (G-CSF) was used to control the agranulocytosis.

Dapsone may induce methemoglobinemia, which may be important in patients with underlying respiratory insufficiency, anemia, or cardiovascular disease. Patients with methemoglobinemia may show normal oxygen saturation by pulse oximetry and by arterial blood gas (ABG). The diagnosis is based on cyanosis, dyspnea (usually only in patients with underlying respiratory insufficiency), elevated methemoglobin level from ABG sampling, and reversal of brown blood to red after addition of cyanide in vitro. Methemoglobin levels exceeding 10% may lead to peripheral cyanosis. Concentrations greater than 35% often produce symptoms of weakness, headache, or dyspnea, while those greater than 70% may result in fatality.

Recent data indicate vitamin E may be protective against dapsone-induced hemolytic anemia and methemoglobinemia, although more studies are needed.

Aplastic anemia due to dapsone has been reported occasionally. The onset of aplastic anemia has ranged from 2 to 12 weeks following initiation of therapy and has been fatal.

A 75-year-old male with granuloma annulare experienced pure red cell aplasia (PRCA) coincident with dapsone therapy. He was given dapsone 100 mg per day. Four weeks after the start of this therapy, the patient presented with asthenia. A diagnosis of PRCA was made based off of hematological counts. Dapsone was discontinued, and the patient received blood transfusions until his condition improved considerably. Hematological counts gradually returned to normal levels.[Ref]

Nervous system

Peripheral neuropathy often affects the hands, resulting in thenar, hypothenar, and interosseous muscle atrophy. Rare cases of pure sensory loss associated with dapsone-induced peripheral neuropathy have been reported. In the treatment of leprosy, peripheral neuropathy may be difficult to distinguish from that of a leprosy reactional state. There has also been an isolated case of optic atrophy reported in a patient receiving dapsone 600 mg/day for 10 days.[Ref]

Nervous system side effects have included peripheral neuropathy and manifested predominantly as motor deficits, but in up to 40% of cases, also included sensory loss. The peripheral neuropathy is reversible upon discontinuation of dapsone. Dizziness, vertigo, blurred vision, and headache have also been reported. At least one case of paresthesias has also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included mild nausea, vomiting, and abdominal pains.[Ref]

Hepatic

Hepatic side effects have frequently included elevations in liver function tests, which may occur as part of the dapsone syndrome. Rare cases of hepatitis and cholestatic jaundice have been reported. Hyperbilirubinemia has also been reported.[Ref]

Hyperbilirubinemia may occur more often in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.[Ref]

Respiratory

Respiratory side effects including at least two cases of pulmonary eosinophilia have been reported. One patient received pyrimethamine and dapsone, and the other patient received just dapsone. Both patients recovered upon drug withdrawal.[Ref]

Immunologic

Rare cases of dapsone-induced lupus erythematosus and exacerbations of existing lupus erythematosus have been reported.[Ref]

Psychiatric

Psychiatric side effects have rarely included depression, psychosis, and hypomania.[Ref]

Hypersensitivity

A 39-year-old female with paucibacillary leprosy experienced renal hypersensitivity vasculitis coincident with dapsone therapy. She was prescribed dapsone 100 mg per day and rifampicin 600 mg per month. After 23 days of treatment, she stopped treatment because of low fever, headache, dizziness, and weakness. On presentation, in addition to the symptoms described, the patient was toxic with fever, respiratory discomfort, dry cough, jaundice, hepatomegaly, and arterial hypotension. She developed edema and pruritus of the face, with a vesicopustular skin rash. The skin rash worsened to exfoliative erythroderma, associated with purpura of the lower extremities. Severe acute failure and oliguria were observed within 4 days after admission. On day 7, kidney histopathologic and immunohistochemical studies illustrated interstitial perivascular lymphocytic infiltrate affecting the media of arched and interlobular arteries, composed of T cells. The patient's renal function and dermatological condition normalized 2 months after admission.[Ref]

Hypersensitivity side effects have been commonly reported, especially in HIV-infected patients. Rash has been reported the most frequently. Stevens-Johnson syndrome, toxic erythema, erythema multiforme, toxic epidermal necrolysis, and morbilliform and scariatiniform reactions have been reported in a few patients treated with dapsone or other sulfone agents. Rare cases of dapsone-induced lupus erythematosus and exacerbations of existing lupus erythematosus have been reported. Sulfone syndrome has been reported. At least one case of renal hypersensitivity vasculitis has also been reported.[Ref]

Renal

Renal side effects have rarely included nephritic syndrome and renal papillary necrosis.[Ref]

Other

Other side effects including the "dapsone syndrome" have been reported. The "dapsone syndrome" is manifested by viral illness-like symptoms (fever, chills, myalgias, arthralgias, exanthema, lymphadenopathy, edema, lymphocytosis), hepatomegaly, elevated liver function tests, methemoglobinemia, and anemia. Some or all of these signs and symptoms may be present in less than 0.5% of patients. Dapsone syndrome usually occurs within the first 6 weeks of therapy and may be fatal. The dapsone syndrome is neither dose-related nor predictable. It is often confused with infectious mononucleosis.[Ref]

"Leprosy reactional states" can commonly occur as a result of effective treatment for leprosy. They are generally classified into two types: reversal reactions (type 1) and erythema nodosum leprosum (ENL or type 2). Reversal reactions primarily occur in borderline or tuberculoid leprosy patients soon after the initiation of chemotherapy and consist of fever and swelling of existing skin and nerve lesions. Acute neuritis may develop. ENL occurs mostly in lepromatous patients (approximately 50% of treated patients within the first year) and a small number of borderline patients. Manifestations include fever and tender erythematous skin nodules sometimes associated with malaise, neuritis, orchitis, albuminuria, joint swelling, iritis, epistaxis or depression. In addition, skin lesions may become pustular and/or ulcerate. Histologically, there is vasculitis with an intense polymorphonuclear infiltrate. In general, antileprosy treatment is continued. Patients with severe reactions require hospitalization. Therapeutic management for reversal reactions may include administration of analgesics and/or corticosteroids and surgical decompression of swollen nerve trunks. Analgesics, corticosteroids, and other agents may be used for ENL reactions. For guidance concerning the management of reactional states, the Gillis W. Long Hansen's Disease Center in Carville, Louisiana (tel: 800-642-2477) should be contacted.[Ref]

References

1. Raizman MB, Fay AM, Weiss JS "Dapsone induced neutropenia in patients treated for ocular cicatricial pemphigoid." Ophthalmology 101 (1994): 1805-7

2. Werth VP, Fivenson D, Pandya AG, et al. "Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris." Arch Dermatol 144 (2008): 25-32

3. Prussick R, Ali M, Rosenthal D, Guyatt G "The protective effect of vitamin E on the hemolysis associated with dapsone treatment in patients with dermatitis herpetiformis." Arch Dermatol 128 (1992): 210-3

4. Kraus A, Jakez J, Palacios A "Dapsone induced sulfone syndrome and systemic lupus exacerbation." J Rheumatol 19 (1992): 178-9

5. Sin DD, Shafran SD "Dapsone- and primaquine-induced methemoglobinemia in HIV-infected individuals." J Acquir Immune Defic Syndr Hum Retrovirol 12 (1996): 477-81

6. Todd P, Samaratunga IR, Pembroke A "Screening for glucose-6-phosphate dehydrogenase deficiency prior to dapsone therapy." Clin Exp Dermatol 19 (1994): 217-8

7. Antinori A, Murri R, Ammassari A, Deluca A, Lanzalone A, Cingolani A, Damiano F, Maiuro G, Vecchiet J, Scoppettuolo G, Tamburrini "Aerosolized pentamidine, cotrimoxazole and dapsone pyrimethamine for primary prophylaxis of pneumocystis carinii pneumonia and toxoplasmic encephalitis." AIDS 9 (1995): 1343-50

8. Mills J, Leoung G, Ileana M, Hopewell PC, Hughes WT, Wofsy C "Dapsone treatment of pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome." Antimicrob Agents Chemother 32 (1988): 1057-60

9. Hughes WT "Use of dapsone in the prevention and treatment of Pneumocystis carinii pneumonia: A review." Clin Infect Dis 27 (1998): 191-204

10. Miyagawa S, Shiomi Y, Fukumoto T, Ishii Y, Shirai T "Recombinant granulocyte colony-stimulating factor for dapsone-induced agranulocytosis in leukocytoclastic vasculitis." J Am Acad Dermatol 28 (1993): 659-61

11. Woodbury GR, Jr Fried W, Ertle JO, Malkinson FD "Dapsone-associated agranulocytosis and severe anemia in a patient with leukocytoclastic vasculitis." J Am Acad Dermatol 28 (1993): 781-3

12. Duhra P, Charles-Holmes R "Linear IgA disease with haemorrhagic pompholyx and dapsone-induced neutropenia." Br J Dermatol 125 (1991): 172-4

13. Moore RD, Fortgang I, Keruly J, Chaisson RE "Adverse events from drug therapy for human immunodeficiency virus disease." Am J Med 101 (1996): 34-40

14. Cook I, Kish M "Haematological safety of long-term malarial prophylaxis with dapsone-pyrimethamine." Med J Aust 143 (1985): 139-41

15. McConkey B "Adverse reactions to dapsone." Lancet 2 (1981): 525

16. Beumont MG, Graziani A, Ubel PA, Macgregor RR "Safety of dapsone as pneumocystis carinii pneumonia prophylaxis in human immunodeficiency virus-infected patients with allergy to trimethoprim/sulfamethoxazole." Am J Med 100 (1996): 611-6

17. Cockburn EM, Wood SM, Waller PC, Bleehen SS "Dapsone-induced agranulocytosis: spontaneous reporting data." Br J Dermatol 128 (1993): 702-3

18. Laing A "Unusual reaction to intramuscular sulfone in two leprosy patients in malaysia." Int J Lepr 48 (1980): 70

19. Sanders S, Zone J, Foltz R, et al "Hemolytic anemia induced by dapsone transmitted through breast milk." Ann Intern Med 96 (1982): 465-66

20. Hsia CC, Chin-Yee IH "Dapsone hemolysis." Blood 119 (2012): 5349

21. Figueiredo M, Pinto B, Zago M "Dapsone-induced haemolytic anaemia and agranulocytosis in a patient normal glucose-6-phosphate-dehydrogenase activity." Acta Haematol 82 (1989): 144-5

22. Potter M, Yates P, Slade R, Kennedy C "Agranulocytosis caused by dapsone therapy for granuloma annulare." J Am Acad Dermatol 20 (1989): 87-8

23. Borras-Blasco J, Conesa-Garcia V, Navarro-Ruiz A, Devesa P, Matarredona J, Marin-Jimenez F "Pure red cell aplasia associated with dapsone therapy (June)." Ann Pharmacother 39 (2005): 1137-8

24. Gallant J, Howhn-Saric E, Smith M "Respiratory insufficiency from dapsone-induced methemoglobinemia." AIDS 5 (1991): 1392-3

25. Meyerson MA, Cohen PR "Dapsone-induced aplastic anemia in a woman with bullous systemic lupus erythematosus." Mayo Clin Proc 69 (1994): 1159-62

26. Hornsten P, Keisu M, Wiholm B "The incidence of agranulocytosis during treatment of dermatitis herpetiformis with dapsone as reported in Sweden, 1972 through 1988." Arch Dermatol 126 (1990): 919-22

27. Trillo R, Aukburg S "Dapsone-induced methemoglobinemia and pulse oximetry." Anesthesiology 77 (1992): 594-6

28. Choy A, Lang C "Gall-bladder performation after long-term dapsone therapy." J Intern Med 228 (1990): 409-10

29. Leonard J, Tucker W, Fry L, Marsh RJ, Ford S "Dapsone and the retina." Lancet 1 (1982): 453

30. Homeida M, Babikr A, Daneshmend T "Dapsone-induced optic atrophy and motor neuropathy." Br Med J 281 (1980): 1180

31. Daneshmend T "The neurotoxicity of dapsone." Adverse Drug React Acute Poisoning Rev 3 (1984): 43-58

32. Waldinger T, Siegle R, Weber W, Voorhees J "Dapsone-induced peripheral neuropathy." Arch Dermatol 120 (1984): 356-59

33. Ahrens E, Meckler R, Callen J "Dapsone-induced peripheral neuropathy." Int J Dermatol 25 (1986): 314-6

34. Rhodes LE, Coleman MD, Lewisjones MS "Dapsone-induced motor peripheral neuropathy in pemphigus foliaceus." Clin Exp Dermatol 20 (1995): 155-6

35. Jayalakshmi P, Ting H "Dapsone-induced liver necrosis." Histopathology 17 (1990): 89-91

36. Mills J, Leoung G, Medina I, et al "Dapsone treatment of pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome." Antimicrob Agents Chemother 32 (1988): 1057-60

37. Lawrence W, Olsen H, Nickles D "Dapsone hepatitis." Arch Intern Med 147 (1987): 175

38. Begbie S, Burgess KR "Maloprim-induced pulmonary eosinophilia." Chest 103 (1993): 305-6

39. Janier M, Guillevin L, Badillet G "Pulmonary eosinophilla associated with dapsone." Lancet 343 (1994): 860-1

40. Gan T, Van Der Weyde M "Dapsone-induced infectious mononucleosis-like syndrome." Med J Aust 1 (1982): 350-1

41. "Product Information. Dapsone USP (dapsone)." Jacobus Pharmaceutical Company, Princeton, NJ.

42. Carmichael A, Paul C "Idiosyncratic dapsone induced manic depression." Br Med J 298 (1989): 1524

43. Gawkrodger D "Manic depression induced by dapsone in a patient with dermatitis herpetiformis." BMJ 299 (1989): 860-1

44. Pertel P, Hirschtick R "Adverse reactions to dapsone in persons infected with human immunodeficiency virus." Clin Infect Dis 18 (1994): 630-2

45. Alves-Rodrigues EN, Ribeiro LC, Silva MD, et al. "Renal Hypersensitivity Vasculitis Associated With Dapsone." Am J Kidney Dis 46 (2005): e51-e53

46. Zhu YI, Stiller MJ "Dapsone and sulfones in dermatology: overview and update." J Am Acad Dermatol 45 (2001): 420-34

47. Chalasani P, Baffoebonnie H, Jurado RL "Dapsone therapy causing sulfone syndrome and lethal hepatic failure in an HIV-infected patient." South Med J 87 (1994): 1145-6

48. Mohle-Boetani J, Akula SK, Holodniy M, et al "The sulfone syndrome in a patient receiving dapsone prophylaxis for pneumocystis carinii pneumonia." West J Med 156 (1992): 303-6

49. Mok CC, Lau CS "Dapsone syndrome in cutaneous lupus erythematosus." J Rheumatol 23 (1996): 766-8

50. Wille C, Morrow J "Case report: capsone hypersensitivity syndrome associated with treatment of the bite of a brown recluse spider." Am J Med Sci 296 (1988): 270-1

51. Grayson L, Yung A, Doherty R "Severe dapsone syndrome due to weekly maloprim." Lancet 1 (1988): 531

52. Saito S, Ikezawa Z, Miyamoto H, Kim S "A case of the dapsone syndrome." Clin Exp Dermatol 19 (1994): 152-6

53. Kromann N, Vilhelmsen R, Stahl D "The dapsone syndrome." Arch Dermatol 118 (1982): 531-2

54. Lau G "A fatal case of drug-induced multi-organ damage in a patient with hansen's disease: dapsone syndrome or rifampicin toxicity?" Forensic Sci Int 73 (1995): 109-15

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