In general, Lamprene (clofazimine) is well tolerated when administered in dosages no greater than 100 mg daily. The most consistent adverse reactions are usually dose related and are usually reversible when Lamprene (clofazimine) is discontinued.
Adverse Reactions Occurring In More Than 1% of Patients
Skin: Pigmentation from pink to brownish-black in 75%-100% of
the patients within a few weeks of treatment; ichthyosis and dryness (8%-28%);
rash and pruritus (1%-5%).
Gastrointestinal: Abdominal and epigastric pain, diarrhea, nausea,
vomiting, gastrointestinal intolerance (40%-50%).
Ocular: Conjunctival and corneal pigmentation due to clofazimine
crystal deposits; dryness; burning; itching; irritation.
Other: Discoloration of urine, feces, sputum, sweat; elevated
blood sugar; elevated ESR.
Adverse Reactions Occurring In Less Than 1% of Patients
Skin:Phototoxicity, erythroderma, acneiform eruptions, monilial
Gastrointestinal:Bowel obstruction (see WARNINGS), gastrointestinal
bleeding (see WARNINGS), anorexia, constipation, weight loss, hepatitis,
jaundice, eosinophilic enteritis, enlarged liver.
Ocular: Diminished vision.
Nervous: Dizziness, drowsiness, fatigue, headache, giddiness,
neuralgia, taste disorder.
Psychiatric:Depression secondary to skin discoloration; two
suicides have been reported.
Laboratory: Elevated levels of albumin, serum bilirubin, and
AST (SGOT); eosinophilia; hypokalemia.
Other:Splenic infarction (see WARNINGS), thromboembolism,
anemia, cystitis, bone pain, edema, fever, lymphadenopathy, vascular pain.
Preliminary data which suggest that dapsone may inhibit the anti-inflammatory activity of Lamprene (clofazimine) have not been confirmed. If leprosy-associated inflammatory reactions develop in patients being treated with dapsone and clofazimine, it is still advisable to continue treatment with both drugs.