Clofazimine Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 29, 2020.
For the Consumer
Applies to clofazimine: oral capsules
Side effects include:
For Healthcare Professionals
Applies to clofazimine: oral capsule
Gastrointestinal (GI) side effects have included clofazimine enteropathy. Abdominal and epigastric pain, diarrhea, nausea, vomiting, and GI intolerance have been reported in 40% to 50% of patients. Rare reports of GI bleeding, bowel obstruction, anorexia, constipation, weight loss, and eosinophilic enteritis have been reported in less than 1% of patients.[Ref]
Clofazimine enteropathy may manifest as colicky abdominal pain, nausea, vomiting, diarrhea, and weight loss. In some cases these side effects have prompted unnecessary discontinuation or exploratory laparotomy. Exploratory laparotomy findings in some patients with clofazimine-associated severe abdominal pain have often shown diffuse visceral hyperpigmentation, lymphadenopathy, eosinophilic mucosal and submucosal infiltration. Clofazimine crystalline infiltration in the intestinal and gall bladder mucosa, and in the bile, liver, and spleen have been documented.[Ref]
Dermatologic side effects have been commonly reported. These have included pigmentation from pink to brownish-black in 75% to 100% of the patients within a few weeks of treatment. Ichthyosis and dryness have been reported in 8% to 28% of patients. Rash and pruritus have been reported in 1% to 5% of patients. Erythroderma, acneiform eruptions, monilial cheilosis have been reported in less than 1% of patients. Phototoxicity and erythroderma have been reported rarely. Melanosis has also been observed, which resolved at a slower rate after the drug was discontinued.[Ref]
The reddish-brown rash may become generalized, but typically involves only lepromatous lesions in patients with leprosy. The discoloration is reversible upon drug discontinuation, may be seen for up to 5 years, and may also involve the tears, saliva, feces, and sputum.[Ref]
Rare cases of "bull's eye" retinopathy due to annular macular pigmentary abnormalities have been reported, but may have been associated with CMV retinitis in some of the patients since they also had AIDS and, in some cases, evidence of CMV infection.[Ref]
Ocular side effects have included corneal and conjunctival pigmentation and decreased visual acuity. Diminished vision and ocular dryness, burning, itching, and irritation have been reported in greater than 1% of patients. Macular pigmentary abnormalities have also been reported.[Ref]
Rare cases of exfoliative dermatitis have been believed to be due to hypersensitivity since rechallenge with even small doses reproduced the signs and symptoms.[Ref]
Hypersensitivity side effects have rarely included exfoliative dermatitis.[Ref]
Cardiovascular side effects including thromboembolism have been reported.
Genitourinary side effects including cystitis have been reported in less than 1% of patients.
Musculoskeletal side effects including bone pain have been reported in less than 1% of patients.
Psychiatric side effects including depression secondary to skin discoloration have been reported. At least two cases of suicides have also been reported.
Hematologic side effects including elevated erythrocyte sedimentation rate (ESR) have been reported in greater than 1% of patients. Eosinophilia, splenic infarction, anemia, and lymphadenopathy have been reported in less than 1% of patients.[Ref]
Other side effects including elevated albumin, fever, and edema have been reported in less than 1% of patients.
1. Merrett MN, King RW, Farrell KE, Zeimer H, Guli E "Orange/black discolouration of the bowel (at laparotomy) due to clofazimine." Aust N Z J Surg 60 (1990): 638-9
2. Chong PY, Ti TK "Severe abdominal pain in low dosage clofazimine." Pathology 25 (1993): 24-6
3. Belaube P, Devaux J, Pizzi M, Boutboul R, Privat Y "Small bowel deposition of crystals associated with the use of clofazimine (Lamprene) in the treatment of prurigo nodularis." Int J Lepr Other Mycobact Dis 51 (1983): 328-30
4. Venencie PY, Cortez A, Orieux G, Jost JL, Chomette G, Puissant A "Clofazimine enteropathy." J Am Acad Dermatol 15 (1986): 290-1
5. Holdiness MR "Clinical pharmacokinetics of clofazimine: a review." Clin Pharmacokinet 16 (1989): 74-85
6. Ravi S, Holubka J, Veneri R, Youn K, Khatib R "Clofazimine-induced eosinophilic gastroenteritis in AIDS." Am J Gastroenterol 88 (1993): 612-3
7. Pavithran K "Exfoliative dermatitis after clofazimine." Int J Lepr Other Mycobact Dis 53 (1985): 645-6
8. Craythorn JM, Swartz M, Creel DJ "Clofazimine-induced bull's-eye retinopathy." Retina 6 (1986): 50-2
9. Karat AB, Jeevaratnam A, Karat S, Rao PS "Controlled clinical trial of clofazimine in untreated lepromatous leprosy." Br Med J 4 (1971): 514-6
10. Brandt L "Reduced number of peripheral blood granulocytes in chronic myeloid leukaemia during administration of clofazimine (B 663)." Scand J Haematol 9 (1972): 159-66
11. Walinder PE, Gip L, Stempa M "Corneal changes in patients treated with clofazimine." Br J Ophthalmol 60 (1976): 526-8
12. Job CK, Yoder L, Jacobson RR, Hastings RC "Skin pigmentation from clofazimine therapy in leprosy patients: a reappraisal." J Am Acad Dermatol 23 (1990): 236-41
13. "Product Information. Lamprene (clofazimine)." Novartis Pharmaceuticals, East Hanover, NJ.
14. Oommen T "Clofazimine-induced lymphoedema ." Lepr Rev 61 (1990): 289
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