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| Criteria | Definition |
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| Malar rash | Fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds |
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| Discoid rash | Erythematous raised patches with adherent keratotic scaling and follicular plugging; atrophic scarring occurs in older lesions |
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| Photosensitivity | Skin rash as a result of unusual reaction to sunlight, by patient history or physician observation |
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| Oral ulcers | Oral or nasopharyngeal ulceration, usually painless, observed by a physician |
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| Arthritis | Nonerosive arthritis involving two or more peripheral joints, characterized by tenderness, swelling, or effusion |
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| Serositis | (a) Pleuritis—convincing history of pleuritic pain or rub heard by a physician or evidence of pleural effusion
(b) Pericarditis—documented by ECG or rub or evidence of pericardial effusion |
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| Renal disorder | (a) Persistent proteinuria > 0.5 g/day > 3+ if quantitation is not performed
(b) Cellular casts—may be red blood cell, hemoglobin, granular tubular, mixed |
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| Neurologic disorder | (a) Seizures—in the absence of offending drugs or known metabolic derangements (e.g., uremia, acidosis, or electrolyte imbalance)
(b) Psychosis—in the absence of offending drugs or known metabolic derangements (e.g., uremia, acidosis, or electrolyte imbalance) |
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| Hematologic disorder | (a) Hemolytic anemia with reticulocytosis
(b) Leukopenia—<4000/mm
(c) Lymphopenia—<1500/mm
(d) Thrombocytopenia—<100,000/mm in the absence of offending drugs |
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| Immunologic disorder | (a) Anti-DNA—antibody to native DNA in abnormal titer
(b) Anti-Sm—presence of antibody to Sm nuclear antigen
(c) Positive finding of antiphospholipid antibodies based on (1) abnormal serum concentration of IgG or IgM anticardiolipin antibodies, (2) positive test result for lupus anticoagulant using a standard method, or (3) false-positive serologic test for syphilis known to be positive for at least 6 mo and confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody absorption test |
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| ANA | Abnormal titer of ANA by immunofluorescence or equivalent assay at any point in time and in the absence of drugs known to be associated with drug-induced lupus syndrome |
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