Clofazimine Side Effects

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.

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.

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

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
  • Diarrhea
  • 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
Less common or rare
  • 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

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.

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.

Dermatologic

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.

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.

Ocular

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.

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.

Metabolic

Metabolic side effects have been unusually reported. These have included significant increases in the fasting serum glucose and hypokalemia.

Hypersensitivity

Hypersensitivity side effects have rarely included exfoliative dermatitis.

Rare cases of exfoliative dermatitis have been believed to be due to hypersensitivity since rechallenge with even small doses reproduced the signs and symptoms.

Cardiovascular

Cardiovascular side effects including thromboembolism have been reported.

Genitourinary

Genitourinary side effects including cystitis have been reported in less than 1% of patients.

Musculoskeletal

Musculoskeletal side effects including bone pain have been reported in less than 1% of patients.

Nervous system

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.

Psychiatric

Psychiatric side effects including depression secondary to skin discoloration have been reported. At least two cases of suicides have also been reported.

Hematologic

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.

Hepatic

Hepatic side effects including hepatitis, jaundice, enlarged liver, elevated AST (SGOT), and elevated total bilirubin have been reported in less than 1% of patients.

Other

Other side effects including elevated albumin, fever, and edema have been reported in less than 1% of patients.

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