What the label lists and what reports show
Clofazimine side effects
Clofazimine's FDA label: “Most common adverse reactions reported in 40% to 50% of patients are skin and body fluid discoloration, abdominal and epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance.” FAERS holds 6,351 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is electrocardiogram qt prolonged (762 reports).
- No generic listed
Check it at the source: the clofazimine FDA label on DailyMed (effective August 17, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions reported in 40% to 50% of patients are skin and body fluid discoloration, abdominal and epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the labeling: Abdominal Obstruction and Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1)] QT Prolongation [see Warnings and Precautions (5.2)] Skin and Body Fluid Discoloration and Other Skin Reactions [see Warnings and Precautions (5.3)] Psychological Effects of Skin Discoloration [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of LAMPRENE were identified. Because these adverse reactions are reported from different studies, these adverse reactions cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions Occurring In More Than 1% of Patients Skin: Pigmentation from pink to brownish-black in 75% to 100% of the patients within a few weeks of treatment; ichthyosis and dryness (8% to 28%); rash and pruritus (1% to 5%). Gastrointestinal: Abdominal and epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance (40% to 50%). Ocular: Diminished vision, conjunctival and corneal pigmentation due to clofazimine crystal deposits; dryness; burning; itching; irritation. Other: Discoloration of urine, feces, sputum, sweat; elevated blood sugar; elevated erythrocyte sedimentation rate (ESR). …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 17, 2026 (SPL set 2e07448f-f888-4747-80ab-570c1b621250), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,351 reports list clofazimine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,259 are coded as a death and 2,078 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Clofazimine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions