Clofazimine Side Effects
For the Consumer
Applies to clofazimine: oral capsule
In addition to its needed effects, some unwanted effects may be caused by clofazimine. 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 clofazimine:Rare
- Bloody or black, tarry stools
- colicky or burning abdominal or stomach pain
- mental depression
- yellow eyes or skin—may be an orange color if already have a pink to brownish-black skin or eye discoloration
Minor Side Effects
Some of the side effects that can occur with clofazimine 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:More common:
- dry, rough, or scaly skin
- loss of appetite
- nausea or vomiting
- pink or red to brownish-black discoloration of skin and eyes
- skin rash and itching
- Changes in taste
- dryness, burning, itching, or irritation of the eyes
- increased sensitivity of skin to sunlight
Clofazimine commonly causes discoloration of the feces, lining of the eyelids, sputum, sweat, tears, and urine. Usually this side effect does not require medical attention, but the discoloration may not go away. However, clofazimine may also cause bloody or black, tarry stools. This side effect may be a symptom of serious bleeding problems that do require medical attention.
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]
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]
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]
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 "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]
Metabolic side effects have been unusually reported. These have included significant increases in the fasting serum glucose and hypokalemia.[Ref]
Hypersensitivity side effects have rarely included exfoliative dermatitis.[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]
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.
Nervous system side effects including dizziness, drowsiness, fatigue, headache, giddiness, neuralgia, taste disorder, and vascular pain have been reported in less than 1% of patients.[Ref]
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]
Hepatic side effects including hepatitis, jaundice, enlarged liver, elevated AST (SGOT), and elevated total bilirubin 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.
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2. 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
3. Ravi S, Holubka J, Veneri R, Youn K, Khatib R "Clofazimine-induced eosinophilic gastroenteritis in AIDS." Am J Gastroenterol 88 (1993): 612-3
4. 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
5. Chong PY, Ti TK "Severe abdominal pain in low dosage clofazimine." Pathology 25 (1993): 24-6
6. Venencie PY, Cortez A, Orieux G, Jost JL, Chomette G, Puissant A "Clofazimine enteropathy." J Am Acad Dermatol 15 (1986): 290-1
7. Pavithran K "Exfoliative dermatitis after clofazimine." Int J Lepr Other Mycobact Dis 53 (1985): 645-6
8. 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
9. Craythorn JM, Swartz M, Creel DJ "Clofazimine-induced bull's-eye retinopathy." Retina 6 (1986): 50-2
10. Walinder PE, Gip L, Stempa M "Corneal changes in patients treated with clofazimine." Br J Ophthalmol 60 (1976): 526-8
11. Karat AB, Jeevaratnam A, Karat S, Rao PS "Controlled clinical trial of clofazimine in untreated lepromatous leprosy." Br Med J 4 (1971): 514-6
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
Not all side effects for clofazimine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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